NovoSeven

Generic Name: Factor VIIa (Recombinant)
Class: Hemostatics
VA Class: BL500

• 
  

  Risk of serious arterial and venous thromboembolic adverse events, particularly when factor VIIa (recombinant) is used outside FDA-labeled indications.^{1 29 36 37 39} (See Thromboembolic Events under Cautions.)

  
  


• 
  

  Both fatal and nonfatal thromboembolic events have been reported in clinical studies and during postmarketing experience.^{1 19 35 36 38}

  
  


• 
  

  Discuss risk of thromboembolism with patient.¹ Monitor for signs and symptoms of coagulation system activation and thrombosis during therapy.¹

  
  

Introduction

Biosynthetic preparation (recombinant DNA origin) of blood coagulation factor VIIa.¹

Uses for NovoSeven

Hemophilia A or B with Inhibitors

Treatment and prevention of hemorrhagic episodes in patients with hemophilia A (antihemophilic factor [factor VIII] deficiency; classic hemophilia) or hemophilia B (factor IX deficiency; Christmas disease) who have developed inhibitors (alloantibodies) to factor VIII or factor IX, respectively;^{1 11 21 22 25 26} designated an orphan drug by FDA for this use.²

Prevention of bleeding in patients with hemophilia A or B with inhibitors to factor VIII or factor IX, respectively, undergoing surgery or invasive procedures;^{1 21 22 25 26} designated an orphan drug by FDA for this use.²

Management of hemophilia in patients with inhibitors may be difficult and consultation with a hemophilia treatment center is strongly recommended.^{11 21}

The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation and other experts state that factor VIIa (recombinant) is one of several therapeutic options for the management of hemophilic patients with inhibitors.^{6 11 21} Treatment of choice depends on several factors (e.g., severity and location of bleeding, type [low- or high-responding] and titer of inhibitor, history of anamnestic response, previous response to these preparations).^{5 6 11 21}

Patients with low titers (e.g., <5–10 Bethesda units/mL) of inhibitors may be effectively treated with high dosages of coagulation factor concentrates (factor VIII or factor IX).^{21 23 33 34 48 49} Bypassing agents (e.g., factor VIIa [recombinant]) generally are used when a response to specific factor replacement therapy has not been obtained or is unlikely.^{21 23} MASAC recommends use of a bypassing agent in hemophilia A or hemophilia B patients with inhibitors in settings where clotting factor preparations would otherwise be used, including before and after surgery and physical therapy.²²

Acquired Hemophilia

Treatment and prevention of bleeding in patients with acquired hemophilia (i.e., those with acquired inhibitor antibodies [autoantibodies] to factor VIII);^{1 20 26} designated an orphan drug by FDA for this use.²

Prevention of bleeding in patients with acquired hemophilia undergoing surgery or invasive procedures;^{1 20 21 25 26} designated an orphan drug by FDA for this use.²

One of several options used to control bleeding in patients with acquired hemophilia.²⁰

Factor VII Deficiency

Management of hemorrhagic episodes in patients with congenital factor VII deficiency; ^{1 11 12 16 24 26} designated an orphan drug by FDA for this use.²

Prevention of bleeding in patients with congenital factor VII deficiency undergoing surgery or invasive procedures;¹ designated an orphan drug by FDA for this use.²

MASAC recommends use of factor VIIa (recombinant) for management of bleeding in patients with congenital factor VII deficiency.¹¹

Nonhemophilic Hemorrhage

Has been used in nonhemophilic patients† in a variety of clinical settings (e.g., intracranial hemorrhage [ICH], advanced liver disease, liver surgery, trauma, cardiac surgery, spinal surgery, GI bleeding, reversal of warfarin anticoagulation) to control or prevent excessive or life-threatening hemorrhage.^{1 19 25 26 35 36 38 39 41 42 43 44 45} However, efficacy and safety of the drug in these settings not established.^{1 36 42 43 45} Additional randomized controlled studies are needed to establish the role of factor VIIa (recombinant) as a general hemostatic agent in patients without hemophilia.^{26 27 36 40 41 42}

NovoSeven Dosage and Administration

General

• 
  

  Administer only under direct supervision of a clinician experienced in the management of bleeding disorders.¹

  
  


• 
  

  Adjust dose and dosing interval based on severity of bleeding and hemostatic response.¹

  
  


• 
  

  Coagulation parameters (e.g., PT/INR, aPTT, plasma factor VII clotting activity [FVII:C]) have not been shown to directly correlate with hemostatic response.^{1 20 25 26 27 31 42} (See Adequate Patient Evaluation and Monitoring under Cautions.)

  
  

Administration

IV Administration

Administer by slow (over 2–5 minutes) IV injection.¹

Has been given as a continuous IV infusion†;^{7 8 9 10 25 26 28 42} however, manufacturer states that the drug should not be admixed with any IV infusion solutions.^{1 13} If flushing of the line is necessary prior to and following drug administration, use 0.9% sodium chloride injection.¹

Reconstitution

Select appropriate vial size and diluent based on indicated dosage.¹ Prior to reconstitution, allow lyophilized powder and diluent supplied by manufacturer (histidine diluent) to warm to room temperature (≤37°C).¹

Reconstitute vials containing 1, 2, or 5 mg of lyophilized factor VIIa (recombinant) with 1.1, 2.1, or 5.2 mL of histidine diluent, respectively, to provide a solution containing approximately 1 mg/mL (1000 mcg/mL).¹ Reconstitute only with the histidine diluent provided by manufacturer; do not use sterile water for injection or any other diluent.¹

Direct diluent toward side of vial; do not inject directly onto powder.¹

Gently swirl solution until all the powder is dissolved.¹

May store reconstituted solutions under refrigeration or at room temperature, but administer within 3 hours after reconstitution; discard any unused solution after 3 hours.¹

Dosage

Pediatric Patients

Hemophilia A or B with Inhibitors

Hemorrhagic Episodes

IV

90 mcg/kg every 2 hours until hemostasis achieved or response to drug is inadequate; doses of 35–120 mcg/kg have been used successfully in clinical studies.^{1 4 5}

For severe bleeding episodes, continue treatment every 3–6 hours after hemostasis is achieved to prevent recurrence of bleeding.¹ Optimum duration of therapy not established; minimize duration of posthemostatic dosing.¹ (See Posthemostatic Dosing under Cautions.)

Surgical Prophylaxis

IV

Minor surgery: 90 mcg/kg immediately prior to procedure; repeat every 2 hours during procedure.¹ Continue every 2 hours postoperatively for 48 hours, then every 2–6 hours until healing achieved.¹

Major surgery: 90 mcg/kg immediately prior to procedure; repeat every 2 hours during procedure.¹ Continue every 2 hours postoperatively for 5 days, then every 4 hours until healing achieved.¹ Administer additional doses, if required.¹

Acquired Hemophilia

IV

70–90 mcg/kg every 2–3 hours until hemostasis achieved.¹

Factor VII Deficiency

Hemorrhagic Episodes and Surgical Prophylaxis

IV

15–30 mcg/kg every 4–6 hours until hemostasis achieved.¹ Although minimum effective dose not established, manufacturer states that doses as low as 10 mcg/kg have been effective.¹

Individualize dose and dosing frequency.¹ Monitor PT and plasma factor VII clotting activity (FVII:C) prior to and following administration.¹ Consider possibility that antibodies to factor VII may have developed if therapeutic response or expected factor VII levels are not achieved with calculated dosages.¹ (See Development of Antibodies to Factor VII under Cautions.)

Adults

Hemophilia A or B with Inhibitors

Hemorrhagic Episodes

IV

90 mcg/kg every 2 hours until hemostasis achieved or response to drug is inadequate; doses of 35–120 mcg/kg have been used successfully in clinical studies.^{1 4 5}

For severe bleeding episodes, continue treatment every 3–6 hours after hemostasis is achieved to prevent recurrence of bleeding.¹ Optimum duration of therapy not established; minimize duration of posthemostatic dosing.¹ (See Posthemostatic Dosing under Cautions.)

Surgical Prophylaxis

IV

Minor surgery: 90 mcg/kg immediately prior to procedure; repeat every 2 hours during procedure.¹ Continue every 2 hours for 48 hours postoperatively, then every 2–6 hours until healing achieved.¹

Major surgery: 90 mcg/kg immediately prior to procedure; repeat every 2 hours during procedure.¹ Continue every 2 hours postoperatively for 5 days, then every 4 hours until healing achieved.¹ Administer additional doses, if required.¹

Acquired Hemophilia

IV

70–90 mcg/kg every 2–3 hours until hemostasis achieved.¹

Factor VII Deficiency

Hemorrhagic Episodes and Surgical Prophylaxis

IV

15–30 mcg/kg every 4–6 hours until hemostasis achieved. Although minimum effective dose not established, manufacturer states that doses as low as 10 mcg/kg have been effective.¹

Individualize dose and dosing frequency.¹ Consider possibility that antibodies to factor VII may have developed if therapeutic response or expected factor VII levels are not achieved with calculated dosages.¹ (See Development of Antibodies to Factor VII under Cautions.)

Cautions for NovoSeven

Contraindications

• 
  

  Manufacturer states no known contraindications.¹

  
  

Warnings/Precautions

Warnings

Thromboembolic Events

Risk of serious thromboembolic events.^{1 17 19 20 23 25 26 27 29 35 36} Adverse arterial and venous thromboembolic events reported in clinical studies and during postmarketing experience.^{1 17 19 20 23 25 26 27 29 35 36} Risk of thrombosis, particularly arterial thromboembolic events (e.g., myocardial ischemia, MI, cerebral ischemia and/or infarction), may be further increased in nonhemophilic patients who receive factor VIIa (recombinant) for non-FDA-labeled indications.^{19 35 36 37 38}

Potentially greater risk in patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injuries, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates (APCCs or PCCs) due to circulating tissue factor (TF) or predisposing coagulopathy.^{1 17 19}

Weigh risk of thromboembolism against benefits of factor VIIa (recombinant) therapy.³⁵ Use with caution, especially in patients with known risk factors for thromboembolism (e.g., elderly patients, neonates, those with a history of CHD, liver disease, DIC, or who require postoperative immobilization).^{1 19 20 25 27 29}

Closely monitor for thrombosis or other signs of an activated coagulation system.^{1 25 27 39} Reduce dosage or discontinue therapy if thrombosis occurs or laboratory tests confirm presence of intravascular coagulation.¹

Report thrombotic complications and other adverse effects associated with factor VIIa (recombinant) to the Hemophilia and Thrombosis Research Society (HTRS) Registry at 877-362-7355.^{1 13 36}

Posthemostatic Dosing

Safety and efficacy of prolonged elevations of factor VIIa have not been evaluated, and most appropriate duration of posthemostatic therapy with factor VIIa (recombinant) is not known; exercise caution if factor VIIa (recombinant) used for extended periods to maintain hemostasis.¹ Minimize duration of posthemostatic therapy and closely monitor patients (preferably by a clinician experienced in the posthemostatic management of hemophilia).¹

Development of Antibodies to Factor VII

Development of antibodies to factor VII reported rarely in patients with congenital factor VII deficiency receiving factor VIIa (recombinant).^{1 12 25} In some cases, inhibitory effects were demonstrated in vitro;¹ clinical importance not established.¹²

Monitor PT and factor VII coagulant activity prior to and following drug administration in patients with factor VII deficiency.¹ Suspect antibody formation if factor VIIa activity fails to reach the expected level, PT is not corrected, or bleeding is not controlled after treatment with recommended dosages of factor VIIa (recombinant) and perform appropriate screening tests.¹ (See Adequate Patient Evaluation and Monitoring under Cautions.)

Adequate Patient Evaluation and Monitoring

Monitor patients with congenital factor VII deficiency receiving factor VIIa (recombinant) for evidence of antibody development.¹ (See Development of Antibodies to Factor VII under Cautions.)

Evaluate hemostasis to determine effectiveness of factor VIIa (recombinant) and need for dosage adjustments.¹ Laboratory parameters (e.g., PT/INR, aPTT, plasma factor VII clotting activity) have not been shown to correlate directly with hemostasis; furthermore, coagulation assays may produce different results depending on the specific reagent used.^{1 25 26 27 31 42}

Administration of factor VIIa (recombinant) generally shortens PT and aPTT and has been shown to rapidly normalize INR; however, clinical importance not known.^{1 20 25 31 42 43 44}

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., including anaphylactic shock, flushing, urticaria, rash, angioedema) reported.^{1 17} Administer with caution in patients with known hypersensitivity to factor VIIa (recombinant) or any ingredient in the formulation.¹

Factor VIIa (recombinant) contains trace amounts of animal protein which may stimulate antibody production and cause hypersensitivity reactions.^{1 13} Use with caution in patients with known hypersensitivity to murine, hamster, or bovine proteins.¹

If severe hypersensitivity or anaphylaxis occurs, discontinue drug immediately and initiate appropriate therapy.¹³

Specific Populations

Pregnancy

Category C.¹

Thrombotic events have been reported in women without a bleeding disorder receiving factor VIIa (recombinant) for uncontrolled postpartum hemorrhage.¹ (See Thromboembolic Events under Cautions.)

Lactation

Not known whether factor VIIa (recombinant) is distributed into human milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

NovoSeven RT has not been evaluated in patients ≤16 years of age to determine if there are differences in safety and efficacy among various pediatric age groups.^{1 13} The predecessor product (NovoSeven) has been used in pediatric patients 0–16 years of age; no substantial differences in safety and efficacy relative to adults.^{1 7 13}

In clinical trials, dosing in pediatric patients was determined according to body weight and not age.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.¹ Potential risk of adverse thromboembolic events in geriatric patients; use with caution.^{1 17 19 26} (See Thromboembolic Events under Cautions.)

Common Adverse Effects

Fever,¹ hemorrhage,¹ injection site reaction,¹ arthralgia,¹ headache,¹ BP changes (hypotension or hypertension),¹ nausea,¹ vomiting,¹ pain,¹ edema,¹ rash.¹

Interactions for NovoSeven

Specific Drugs

Drug	Interaction	Comments
Antifibrinolytic agents (e.g., aminocaproic acid, tranexamic acid)	No specific interaction reported with concomitant use21	May be used concomitantly to enhance hemostasis21
Anti-inhibitor coagulant complex (Activated Prothrombin Complex Concentrate; APCC)	Potential additive thrombotic effects1	Avoid concomitant use1
Factor IX Complex (Prothrombin Complex Concentrate; PCC)	Potential additive thrombotic effects1	Avoid concomitant use1

NovoSeven Pharmacokinetics

Absorption

Bioavailability

Circulating factor VIIa concentrations increase approximately 1000-fold following administration of factor VIIa (recombinant).^{25 26}

Onset

Mean maximum factor VII activity observed approximately 10 minutes following single IV infusion in one study.³⁰

Duration

Factor VII activity decreases rapidly and returns to baseline within 24 hours following IV infusion.³⁰

Distribution

Extent

Distributes into a volume 2–3 times that of plasma.³¹

Not known whether distributed into human milk.¹

Elimination

Half-life

2.3 hours (range: 1.7–2.7 hours) in patients with hemophilia A or B and 2.8–3.1 hours in patients with congenital factor VII deficiency.¹

Special Populations

Clearance in children is increased compared with adolescents and adults.^{25 28}

Half-life in children is shorter than that observed in adolescents and adults.^{25 28}

Stability

Storage

Parenteral

Powder for Injection

2–25°C; do not freeze.¹ Protect from light.^{1 13} Do not use beyond expiration date.¹

Store reconstituted solutions of the drug at room temperature or under refrigeration; do not freeze or store in syringes.^{1 13} Use solution within 3 hours of reconstitution.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Do not mix with other infusion solutions.¹

ActionsActions

• 
  

  Factor VIIa (recombinant), a hemostatic agent, is structurally nearly identical to human plasma-derived coagulation factor VIIa.^{1 29}

  
  

• 
  

  Promotes hemostasis through activation of the extrinsic blood coagulation pathway.¹

  
  


• 
  

  Following injury to vessel wall, tissue factor (TF) is exposed to circulating blood; TF-FVIIa complexes are formed on TF-bearing cells, where they activate factor X to factor Xa and factor IX to factor IXa.^{1 25 26 29}

  
  


• 
  

  Factor Xa, in complex with factor V, calcium, and phospholipids, converts prothrombin to thrombin and subsequently activates fibrinogen to fibrin to form a hemostatic plug that provides local hemostasis.^{1 29} This process also may occur on the surface of activated platelets.^{1 26 29}

  
  

• 
  

  Produces hemostasis in the absence of factor VIII or factor IX by binding to activated platelets and directly activating factor X to generate thrombin independently of TF.^{1 11 22 25 26 27 29}

  
  

• 
  

  Produces circulating concentrations of factor VIIa that are approximately 1000-fold higher than physiologic levels.^{25 26 32}

  
  

Advice to Patients

• 
  

  Importance of understanding risks and benefits associated with therapy.¹

  
  


• 
  

  Importance of discontinuing therapy and immediately informing clinician if hives, urticaria, chest tightness, hypotension, wheezing, or anaphylaxis occurs.¹

  
  


• 
  

  Importance of warning patients about the possibility of thromboembolism and advising them to monitor for signs of thrombosis, including new-onset swelling and pain in the limbs or abdomen, new-onset chest pain, shortness of breath, loss of sensation or motor skills, or altered consciousness or speech.¹ Advise patients to immediately seek medical attention if any manifestations of thromboembolism occur.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., diabetes, cancer, cardiovascular disease, thromboembolic disease, liver disease).^{1 25}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Factor VIIa (Recombinant)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV use only	1 mg	NovoSeven RT	Novo Nordisk
		2 mg	NovoSeven RT	Novo Nordisk
		5 mg	NovoSeven RT	Novo Nordisk

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Novo Nordisk. NovoSeven RT (coagulation factor VIIa [recombinant] room temperature stable) prescribing information. Princeton, NJ; 2010 15 Jan.

2. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2001 June. From FDA web site ()

3. Arkin S, Blei F, Fetten J et al. Human coagulation factor FVIIa (recombinant) in the management of limb-threatening bleeds unresponsive to alternative therapies: results from the NovoSeven emergency-use programme in patients with severe haemophilia or with acquired inhibitors. Blood Coag Fibrino. 2000; 11:255-9.

4. Shirahata A, Kamiya T, Takamatsu J et al. Clinical trial to investigate the pharmacokinetics, pharmacodynamics, safety, and efficacy of recombinant factor VIIa in Japanese patients with hemophilia with inhibitors. Int J Hematol. 2001; 73:517-25. [PubMed 11503968]

5. Ingerslev J. Efficacy and safety of recombinant factor VIIa in the prophylaxis of bleeding in various surgical procedures in hemophilic patients with factor VIII and factor IX inhibitors. Semin Thromb Hemost. 2000; 26:425-32. [PubMed 11092219]

6. Kulkarni R, Aledort LM, Berntorp E et al. Therapeutic choices for patients with hemophilia and high-titer inhibitors. Am J Hematol. 2001; 67:240-6. [PubMed 11443636]

7. Shapiro AD. Recombinant factor VIIa in the treatment of bleeding in hemophilic children with inhibitors. Semin Thromb Hemost. 2000; 26:413-9. [PubMed 11092217]

8. Schulman S for the rFVIIa-CI Group. Continuous infusion of recombinant factor VIIa in hemophilic patients with inhibitors: safety, monitoring, and cost effectiveness. Semin Thromb Hemost. 2000; 26:421-4. [PubMed 11092218]

9. Chuansumrit A, Isarangkura P, Angchaisuksiri P et al. Controlling acute bleeding episodes with recombinant factor VIIa in haemophiliacs with inhibitor: continuous infusion and bolus injection. Haemophilia. 2000; 6:61-5. [PubMed 10781189]

10. Baudo F, Redaelli R, Caimi TM et al. The continuous infusion of recombinant activated factor VIIa (rFVIIa) in patients with factor VIII inhibitors activates the coagulation and fibrinolytic systems without clinical complications. Thromb Res. 2000; 99:21-4. [PubMed 10904100]

11. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders (revised April 2010). MASAC recommendation #195. From National Hemophilia Foundation website ().Accessed 17 August 2010.

12. Hunault M, Bauer KA. Recombinant factor VIIa for the treatment of congenital factor VII deficiency. Semin Thromb Hemost. 2000; 26:401-5. [PubMed 11092215]

13. Novo Nordisk Pharmaceuticals, Inc., Princeton, NJ: Personal communication.

14. Shapiro AD, Gilchrist GS, Hoots WK et. al. Prospective, randomized trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors of undergoing surgery. Thromb Haemost. 1998; 80:773-8. [PubMed 9843170]

15. Key NS, Aledort LM, Beardsley D, et al. Home treatment of mild to moderate bleeding episodes using recombinant factor VIIa (NovoSeven) in haemophiliacs with inhibitors. Thromb Haemost. 1998;80:912-8.

16. Mariani G, Testa MG, Paolantonio TD, et al. Use of recombinant, activated factor VII in the treatment of congenital factor VII deficiencies. Vox Sang.1999;77:131-6.

17. NovoNordisk. Dear Health Care Professional letter regarding new warnings and adverse reactions added to NovoSeven coagulation factor VIIa (recombinant). Princeton, NJ; 2005 Nov.

19. Mayer SA, Brun NC, Begtrup K et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005; 352:777-85. [PubMed 15728810]

20. Giangrande P. Acquired hemophilia. Treatment of Hemophilia. 2005. From World Federation of Hemophilia website (). Accessed 2006 Nov 16.

21. World Federation of Hemophilia. Guidelines for the management of hemophilia. 2005. From World Federation of Hemophilia website (). Accessed 2007 Oct 30.

22. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations regarding the use of bypassing agents in patients with hemophilia A or B and inhibitors) (June 3, 2006). MASAC recommendation #167. From National Hemophilia Foundation website ().

23. Mathew P. Current opinion on inhibitor treatment options. Semin Hematol. 2006; 43 (Suppl 4):S8-13.

24. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations regarding rare coagulation factor disorders. MASAC recommendation #174. From National Hemophilia Foundation website ().Accessed 25 October 2007.

25. Roberts HR, Monroe DM, White GC. The use of recombinant factor VIIa in the treatment of bleeding disorders. Blood. 2004; 104:3858-64.

26. Franchini M, Zaffanello M, Veneri D. Recombinant factor VIIa: an update on its clinical use. Thromb Haemost. 2005; 93:1027-35.

27. Lam MSH, Sims-McCallum RP. Recombinant factor VIIa in the treatment of non-hemophiliac bleeding. Ann Pharmacother 2005; 39:885-91.

28. Stachnik JM, Gabay MP. Continuous infusion of coagulation factor products. Ann Pharmacother. 2002; 36:882-91.

29. O'Connell KA, Wood JJ, Wise RP et al. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA.. 2006; 295:293-8.

30. Shirahata A, Kamiya T, Takamatsu J et al. Clinical trial to investigate the pharmacokinetics, pharmacodynamics, safety, and efficacy of recombinant factor VIIa in Japanese patients with hemophilia with inhibitors. Int J Hematol. 2001; 73:517-25.

31. Lindley CM, Sawyer WT, Macik BG et al. Pharmacokinetics and pharmacodynamics of recombinant factor VIIa. Clin Pharmacol Ther. 1994; 55:638-48.

32. Björkman S, Berntorp E. Pharmacokinetics of coagulation factors: clinical relevance for patients with haemophilia. Clin Pharmacokinet. 2001; 40: 815-32.

33. Baxter. Feiba VH anti-inhibitor coagulant complex, vapor heated prescribing information. Westlake Village, CA; 2005 Apr.

34. White GC II, Rosendaal F, Aledort LM et al. Definitions in hemophilia: recommendations of the scientific subcommittee on factor VIII and factor IX of the scientific and standardization committee of the international society on thrombosis and haemostasis. Thromb Haemost. 2001; 85:560. [PubMed 11307831]

35. Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008; 248:61-8. [PubMed 18580208]

36. Hardy JF, Bélisle S, Van der Linden P. Efficacy and safety of recombinant activated factor VII to control bleeding in nonhemophiliac patients: a review of 17 randomized controlled trials. Ann Thorac Surg. 2008; 86:1038-48. [PubMed 18721620]

37. Gill R, Herbertson M, Vuylsteke A et al. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation. 2009; 120:21-7. [PubMed 19546387]

38. Mayer SA, Brun NC, Begtrup K et al. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008; 358:2127-37. [PubMed 18480205]

39. Patanwala AE. Factor VIIa (recombinant) for acute traumatic hemorrhage. Am J Health Syst Pharm. 2008; 65:1616-23. [PubMed 18714107]

40. Ranucci M, Isgrò G, Soro G et al. Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials. Arch Surg. 2008; 143:296-304; discussion 304. [PubMed 18347278]

41. Johnson SJ, Ross MB, Moores KG. Dosing factor VIIa (recombinant) in nonhemophiliac patients with bleeding after cardiac surgery. Am J Health Syst Pharm. 2007; 64:1808-12. [PubMed 17724361]

42. Levi M, Peters M, Büller HR. Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: a systematic review. Crit Care Med. 2005; 33:883-90. [PubMed 15818119]

43. Rosovsky RP, Crowther MA. What is the evidence for the off-label use of recombinant factor VIIa (rFVIIa) in the acute reversal of warfarin? ASH evidence-based review 2008. Hematology Am Soc Hematol Educ Program. 2008; :36-8. [PubMed 19074054]

44. Aguilar MI, Hart RG, Kase CS et al. Treatment of warfarin-associated intracerebral hemorrhage: literature review and expert opinion. Mayo Clin Proc. 2007; 82:82-92. [PubMed 17285789]

45. Lin Y, Stanworth S, Birchall K et al. Recombinant factor VIIa for the prevention and treatment of bleeding in patients without hemophilia (review). Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD005011. DOI: 10.1002/14651858.CD005011.pub2.

46. Marti-Carvajal AJ, Salanti G, Mari-Carvajal PI. Human recombinant activated factor VII for upper gastrointestinal bleeding in patients with liver diseases (review). Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD004887. DOI: 10.1002/14651858.CD004887.pub2.

47. Novo Nordisk. NovoSeven (coagulation factor VIIa [recombinant]) prescribing information. Princeton, NJ; 2006 13 Oct.

48. Baxter Healthcare Corporation. Recombinate antihemophilic factor (recombinant) prescribing information. Westlake Village, CA; 2009 Jul.

49. CSL Behring. Helixate FS antihemophilic factor (recombinant) formulated with sucrose prescribing information. Kankakee, IL; 2009 Aug.

More NovoSeven resources

• NovoSeven Side Effects (in more detail)
• NovoSeven Use in Pregnancy & Breastfeeding
• NovoSeven Drug Interactions
• NovoSeven Support Group
• 0 Reviews for NovoSeven - Add your own review/rating

• NovoSeven injection Concise Consumer Information (Cerner Multum)


• NovoSeven RT Prescribing Information (FDA)


• NovoSeven RT MedFacts Consumer Leaflet (Wolters Kluwer)


• Novoseven Advanced Consumer (Micromedex) - Includes Dosage Information


• Novoseven MedFacts Consumer Leaflet (Wolters Kluwer)

Compare NovoSeven with other medications

• Factor VII Deficiency
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Triaminic Cough &amp; Sore Throat Softchews

Generic Name: acetaminophen and dextromethorphan (a SEET a MIN oh fen and DEX troe me THOR fan)

Brand Names: Children's Triacting, Triaminic Cough & Sore Throat, Triaminic Cough & Sore Throat Softchews, Tylenol Cough and Sore Throat Daytime

What is Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

The combination of acetaminophen and dextromethorphan is used to treat cough and pain or fever caused by the common cold or flu.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen and dextromethorphan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

Do not take this medication if you are allergic to acetaminophen or dextromethorphan. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

It is not known whether acetaminophen and dextromethorphan will harm an unborn baby. Do not use cold or cough medicine without medical advice if you are pregnant. It is not known whether acetaminophen and dextromethorphan will harm an unborn baby. Do not use cold or cough medicine without medical advice if you are pregnant.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and dextromethorphan. You may need to stop using the medicine for a short time. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Since cough or cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include dizziness, drowsiness, feeling restless or nervous, diarrhea, loss of appetite, seizure (convulsions), or coma.

What should I avoid while taking Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.

Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  upset stomach.

  
  


• 
  

  mild loss of appetite; or

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

Tell your doctor about all other medicines you use, especially:

• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  darifenacin (Enablex);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid;

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  ranolazine (Ranexa);

  
  


• 
  

  ritonavir (Norvir, Kaletra);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  gout medication such as probenecid (Benemid);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), bupropion (Wellbutrin, Zyban, Aplenzin), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

  
  

This list is not complete and other drugs may interact with acetaminophen and dextromethorphan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Triaminic Cough & Sore Throat Softchews resources

• Triaminic Cough & Sore Throat Softchews Use in Pregnancy & Breastfeeding
• Triaminic Cough & Sore Throat Softchews Drug Interactions
• 0 Reviews for Triaminic Cough & Sore Throat Softchews - Add your own review/rating

Compare Triaminic Cough & Sore Throat Softchews with other medications

• Cold Symptoms
• Cough
• Pain

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and dextromethorphan.

Theraflu Warming Sinus &amp; Cold

Generic Name: acetaminophen, diphenhydramine, and phenylephrine (a SEET a MIN oh fen, DYE fen HYE dra meen, and FEN il EFF rin)

Brand Names: Benadryl Allergy & Cold, Benadryl Allergy & Sinus Headache, Robitussin Nighttime Multi-Symptom Cold, Sudafed PE Severe Cold, Theraflu Severe Cold & Cough Nighttime, Theraflu Warming Flu & Sore Throat, Theraflu Warming Severe Cold Nighttime, Theraflu Warming Sinus & Cold

What is Theraflu Warming Sinus & Cold (acetaminophen, diphenhydramine, and phenylephrine)?

Acetaminophen is a pain reliever and fever reducer.

Diphenhydramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, diphenhydramine, and phenylephrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen, diphenhydramine, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Theraflu Warming Sinus & Cold (acetaminophen, diphenhydramine, and phenylephrine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen and can increase certain side effects of diphenhydramine. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking Theraflu Warming Sinus & Cold (acetaminophen, diphenhydramine, and phenylephrine)?

You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  a blockage in your digestive tract (stomach or intestines);

  
  


• 
  

  diabetes;

  
  


• 
  

  kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor); or

  
  


• 
  

  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

It is not known whether acetaminophen, diphenhydramine, and phenylephrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

How should I take Theraflu Warming Sinus & Cold (acetaminophen, diphenhydramine, and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Theraflu Warming Sinus & Cold (acetaminophen, diphenhydramine, and phenylephrine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can increase certain side effects of diphenhydramine. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Theraflu Warming Sinus & Cold (acetaminophen, diphenhydramine, and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, rapid pulse, fast or uneven heart rate;

  
  


• 
  

  confusion, hallucinations, severe nervousness;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, mild headache;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  constipation;

  
  


• 
  

  blurred vision;

  
  


• 
  

  feeling nervous; or

  
  


• 
  

  sleep problems (insomnia);

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Theraflu Warming Sinus & Cold (acetaminophen, diphenhydramine, and phenylephrine)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by diphenhydramine.

Tell your doctor about all other medicines you use, especially:

• 
  

  leflunomide (Arava);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  diphenhydramine (Benadryl) applied to the skin;

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  bladder or urinary medications;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  a bronchodilator;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen, diphenhydramine, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Theraflu Warming Sinus & Cold resources

• Theraflu Warming Sinus & Cold Side Effects (in more detail)
• Theraflu Warming Sinus & Cold Use in Pregnancy & Breastfeeding
• Theraflu Warming Sinus & Cold Drug Interactions
• 0 Reviews for Theraflu Warming Sinus & Cold - Add your own review/rating

Compare Theraflu Warming Sinus & Cold with other medications

• Cold Symptoms

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, diphenhydramine, and phenylephrine.

See also: Theraflu Warming Sinus & Cold side effects (in more detail)

Novolin 70/30 PenFill

Generic Name: insulin isophane and insulin regular (IN su lin EYE soe fane and IN su lin REG ue lar)

Brand Names: HumuLIN 50/50, HumuLIN 70/30, HumuLIN 70/30 Pen, NovoLIN 70/30, NovoLIN 70/30 Innolet, NovoLIN 70/30 PenFill, Relion NovoLIN 70/30 Innolet, ReliOn/NovoLIN 70/30

What is Novolin 70/30 PenFill (insulin isophane and insulin regular)?

Insulin isophane and insulin regular is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin isophane and insulin regular is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin isophane and insulin regular is used to treat diabetes.

Insulin isophane and insulin regular may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Novolin 70/30 PenFill (insulin isophane and insulin regular)?

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my healthcare provider before using Novolin 70/30 PenFill (insulin isophane and insulin regular)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin isophane and insulin regular, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin isophane and insulin regular passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Novolin 70/30 PenFill (insulin isophane and insulin regular)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin isophane and insulin regular is given as an injection (shot) under your skin. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

Carefully shake or rotate the insulin vial (bottle) several times to thoroughly mix the insulin isophane and insulin regular before each use. Shake the mixture until it looks cloudy or milky. Do not use the mixture if has clumps or white particles in it after mixing, or if the white substance remains at the bottom of the vial. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin isophane and insulin regular dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator. Do not freeze. Throw away any insulin not used before the expiration date on the medicine label. Storing after your first use: Keep the "in-use" vials or injection pens at cool room temperature, away from heat and light, and use prior to the expiration date. Throw an in-use injection pen 10 days after the first use, even if there is still medicine left in it.

Do not freeze insulin isophane and insulin regular, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since insulin isophane and insulin regular is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane and insulin regular, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane and insulin regular to make up a missed dose.

It is important to keep insulin isophane and insulin regular on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using Novolin 70/30 PenFill (insulin isophane and insulin regular)?

Do not change the brand of insulin isophane and insulin regular or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin isophane and insulin regular.

Novolin 70/30 PenFill (insulin isophane and insulin regular) side effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane and insulin regular. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane and insulin regular.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Novolin 70/30 PenFill (insulin isophane and insulin regular)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

• 
  

  albuterol (Proventil, Ventolin);

  
  


• 
  

  clonidine (Catapres);

  
  


• 
  

  reserpine;

  
  


• 
  

  guanethidine (Ismelin); or

  
  


• 
  

  beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

  
  

There are many other medicines that can increase or decrease the effects of insulin isophane and insulin regular on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Novolin 70/30 PenFill resources

• Novolin 70/30 PenFill Side Effects (in more detail)
• Novolin 70/30 PenFill Use in Pregnancy & Breastfeeding
• Novolin 70/30 PenFill Drug Interactions
• Novolin 70/30 PenFill Support Group
• 0 Reviews for Novolin 70/30 PenFill - Add your own review/rating

• Humulin 50/50 Pens MedFacts Consumer Leaflet (Wolters Kluwer)


• Humulin 50/50 Prescribing Information (FDA)


• Humulin 70/30 Prescribing Information (FDA)


• Novolin 70/30 Prescribing Information (FDA)


• Novolin 70/30 InnoLets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Novolin 70/30 PenFill with other medications

• Diabetes, Type 1
• Diabetes, Type 2
• Gestational Diabetes

Where can I get more information?

• Your pharmacist can provide more information about insulin isophane and insulin regular.

See also: Novolin 70/30 PenFill side effects (in more detail)

Teniposide

Class: Antineoplastic Agents
VA Class: AN900
Molecular Formula: C₃₂H₃₂O₁₃S
CAS Number: 29767-20-2
Brands: Vumon

• 
  

  Administer only under supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹

  
  


• 
  

  Possible severe myelosuppression with resulting infection and bleeding.^{1 6} (See Myelosuppression under Cautions.)

  
  


• 
  

  Possible serious and potentially fatal hypersensitivity reactions.^{1 14 15 16} Epinephrine, with or without corticosteroids and antihistamines, has been used to alleviate signs and symptoms.^{1 14 15 16} (See Sensitivity Reactions under Cautions.)

  
  

Introduction

Antineoplastic agent; a semisynthetic podophyllotoxin-derivative that is structurally and pharmacologically related to etoposide.^{1 2 3 4 5 6}

Uses for Teniposide

Acute Lymphocytic Leukemia

Induction therapy (as a component of multiple-drug antineoplastic regimens) in childhood acute lymphocytic (lymphoblastic) leukemia (ALL) that is refractory to induction with other therapy or has relapsed despite such therapy^{1 6 26} (designated an orphan drug by FDA for this use).²⁵

May prolong remission;^{1 23} however, experience is limited, and only a minority of patients achieve long-term survival.^{1 2 5 21}

Teniposide Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastics.¹ (See IV Administration under Dosage and Administration.)

  
  

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer diluted solution by slow IV infusion.¹ Do not administer by rapid IV injection.¹ (See Cardiovascular Effects under Cautions.)

To prevent leaching of diethylhexyl phthalate (DEHP) plasticizer, use IV administration sets that do not contain DEHP (e.g., lipid sets, low DEHP-containing nitroglycerin sets).¹

Ensure that IV catheter or needle is in proper position and functional prior to infusion to avoid extravasation.¹ (See Local Effects under Cautions.)

Flush IV access site thoroughly with 5% dextrose or 0.9% sodium chloride injection prior to and following administration.¹ Heparin should not be used due to potential for drug precipitation.¹

Observe carefully for possible occlusion of the IV access site, including central venous catheters, particularly during prolonged (e.g., 24-hour) infusions.¹ (See Compatibility under Stability.)

Observe closely for possible hypotensive or hypersensitivity reactions during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.¹ (See Cardiovascular Effects and also see Sensitivity Reactions under Cautions.)

Handle cautiously.¹ Skin reactions may occur following accidental exposure; use protective equipment (e.g., gloves).¹ If accidental contact occurs, wash skin thoroughly with soap and water or flush mucosa thoroughly with water.¹

Dilution

Must be diluted before IV infusion.¹

Plastic equipment or devices may soften or crack and possibly leak when used with undiluted teniposide injection.¹

To prevent leaching of DEHP plasticizer, prepare diluted solutions in containers that do not contain DEHP (e.g., glass or polyolefin plastic bags or containers).¹ Use of PVC containers not recommended.¹

For IV infusion, dilute concentrate in 5% dextrose or 0.9% sodium chloride injection to a final concentration of 0.1, 0.2, 0.4, or 1 mg/mL.¹

Rate of Administration

Administer over at least 30–60 minutes to minimize risk of hypotension.^{1 6} (See Cardiovascular Effects under Cautions.) If hypotensive reaction occurs, use slower rate of infusion and monitor carefully if restarting after discontinuance and appropriate treatment.¹

Dosage

Pediatric Patients

Acute Lymphocytic Leukemia

Patients Who Failed Induction Therapy with a Cytarabine-containing Regimen

IV

165 mg/m² (in combination with cytarabine 300 mg/m²) twice weekly for 8 or 9 doses.¹

Patients Who Failed Induction Therapy with Vincristine/Prednisone-containing Regimens

IV

250 mg/m² (in combination with vincristine 1.5 mg/m²) weekly for 4–8 weeks with oral prednisone 40 mg/m² daily for 28 days.¹

Special Populations

Hepatic Impairment

Use with caution; dosage adjustments may be necessary.¹

Renal Impairment

Dosage adjustments may be necessary.¹

Patients with Down’s Syndrome

Initially, give half the usual dose; subsequent doses may be increased depending on degree of myelosuppression and mucositis encountered with previous doses.¹

Cautions for Teniposide

Contraindications

• 
  

  Known hypersensitivity to teniposide or polyoxyl 35 castor oil (Cremophor EL, polyoxyethylated castor oil).¹ (See Sensitivity Reactions under Cautions.)

  
  

Warnings/Precautions

Warnings

Adequate Patient Evaluation and Monitoring

Administer only under supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹

Perform CBCs and renal and hepatic function tests prior to, during, and after completion of therapy.¹ (See Myelosuppression under Cautions.)

Myelosuppression

Risk of dose-limiting myelosuppression (e.g., neutropenia, leukopenia, thrombocytopenia, anemia).^{1 2 5 6 8 9} Severe myelosuppression with resulting infection or bleeding may occur.^{1 6}

Monitor for myelosuppression frequently during and after treatment.¹ Perform CBCs (leukocyte count with differential, platelet count, hemoglobin) prior to initiation of therapy and before each subsequent dose.¹ If severe myelosuppression occurs, consider supportive therapy, antibiotics for complicating infections, and blood product transfusions; repeat bone marrow examination before continuing therapy.¹

Cardiovascular Effects

Transient hypotension reported following rapid IV administration, possibly resulting from direct effect of polyoxyl 35 castor oil contained in preparation.¹

Administer over at least 30–60 minutes; observe patient closely during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.¹

If clinically important hypotension occurs, discontinue infusion.¹ BP usually normalizes within hours in response to infusion discontinuance and administration of IV fluids and other supportive therapy as necessary.¹ Use slower rate of infusion and monitor carefully if restarting after discontinuance and appropriate treatment.¹

Sudden death secondary to intractable hypotension and probable arrhythmia reported in at least 1 geriatric patient receiving teniposide in combination therapy for a nonleukemic malignancy.¹ Hypertensive reactions, sometimes severe and accompanied by cardiac failure, reported rarely.^{12 13}

Nervous System Effects

Acute CNS depression (manifested as somnolence and lethargy) and hypotension, accompanied by metabolic acidosis,¹¹ reported in patients pretreated with antiemetics and receiving high-dose† regimens of teniposide.^{1 11} CNS depression possibly resulting from depressant effects of antiemetic agents and high alcohol content of teniposide formulation.¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.^{1 19} Teratogenicity and embryotoxicity demonstrated in animals.¹ Avoid pregnancy during therapy.¹ If used during pregnancy or if pregnancy occurs during therapy, apprise of potential fetal hazard.¹

Sensitivity Reactions

Hypersensitivity Reactions

Risk of hypersensitivity reactions,^{1 14 15 16} including anaphylaxis-like manifestations (e.g., chills, fever, urticaria, tachycardia, flushing, bronchospasm, dyspnea, hypotension or hypertension).¹ Reaction may occur with initial dose or with repeated exposure and may be life-threatening if not treated promptly with antihistamines, corticosteroids, epinephrine, IV fluids, and other supportive measures as necessary.¹ Etiology unknown, but reactions may result from polyoxyl 35 castor oil component or from teniposide itself.^{1 14 15 16} Frequency possibly increased in patients with neuroblastomas or brain tumors.^{1 14 15} Observe patients closely during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.¹ If manifestations of anaphylaxis occur, discontinue infusion immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, antihistamines, pressor agents, IV fluids).¹

Generally contraindicated in patients with known hypersensitivity to teniposide or polyoxyl 35 castor oil; however, may consider cautious administration when the antileukemic benefit already demonstrated clearly outweighs the possible risk.¹ When reinitiating therapy in a patient who previously developed a hypersensitivity reaction, pretreat with a corticosteroid and antihistamine and observe patient carefully during and after infusion.¹

Appropriate equipment and agents (e.g., epinephrine, antihistamines, corticosteroids, IV fluids, oxygen) should be readily available.¹

No evidence of cross-sensitization between teniposide and etoposide.¹

General Precautions

Toxicity

Administer only under constant supervision by clinicians experienced in therapy with cytotoxic agents and only when the potential benefits outweigh the possible risks.¹

Most adverse effects are reversible if detected early.¹

Discontinue or reduce dosage and institute appropriate measures as necessary when severe adverse effects occur.¹

Reinstitute therapy with caution, considering further need for the drug and possible toxicity recurrence.¹

Local Effects

Extravasation may result in local tissue necrosis and/or thrombophlebitis.¹

Dermatologic Effects

Alopecia reported; usually reversible but sometimes may progress to total baldness.¹

Carcinogenicity

Secondary acute myeloid (myelogenous, nonlymphocytic) leukemia (AML, ANLL), with or without a preleukemic phase, reported in patients receiving maintenance therapy with teniposide in combination with other antineoplastic agents.^{1 10} Assess potential benefit versus risks of therapy.^{1 10}

Animal studies to determine the carcinogenic potential of teniposide have not been performed to date; however, the drug should be considered a potential carcinogen.¹

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether teniposide is distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy established only for combination therapy of refractory childhood ALL.^{1 6} In an analysis of data from 7 studies involving 303 patients ranging in age from 0.5 months to 20 years who received teniposide as a single agent for a variety of hematologic malignancies and solid tumors, no age-related difference in tolerance was reported.^{27 f}

Each mL of teniposide concentrate for injection contains 30 mg of benzyl alcohol.¹ Although a causal relationship has not been established, injections preserved with benzyl alcohol have been associated with toxicity in neonates.^{a b c d e}

Hepatic Impairment

Use with caution.¹ (See Elimination: Special Populations, under Pharmacokinetics.)

Patients with Down’s Syndrome

Possible increased sensitivity to myelosuppressive chemotherapy.¹ Dosage adjustments necessary.¹ (See Down's Syndrome under Dosage and Administration.)

Patients with Hypoalbuminemia

Careful monitoring recommended.¹ (See Distribution: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

Neutropenia, leukopenia, anemia, thrombocytopenia, myelosuppression (nonspecified), mucositis, diarrhea, nausea, vomiting, infection, alopecia, bleeding, hypersensitivity reactions, rash, fever, hypotension.¹

Interactions for Teniposide

Specific Drugs

Drug	Interaction	Comments
Antiemetic agents	Possible CNS depression when used concomitantly with higher than recommended dosages of teniposide1
Methotrexate	Possible increased methotrexate clearance1
Sodium salicylate	Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1	Use concomitantly with caution1
Sulfamethizole	Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1	Use concomitantly with caution1
Tolbutamide	Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1	Use concomitantly with caution1

Teniposide Pharmacokinetics

Distribution

Extent

Limited distribution throughout the body because of extensive protein binding.¹ Limited distribution into the brain; however, CSF concentrations are higher in patients with brain tumors.¹

Concentrations in saliva, CSF, and malignant ascites fluid are low relative to those in plasma.¹

Plasma Protein Binding

>99%.¹

Special Populations

Volume of distribution increases with decreasing albumin concentrations.¹ (See Patients with Hypoalbuminemia under Cautions.)

Elimination

Elimination Route

44% of dose is excreted in urine within 120 hours after dosing (with only 4–12% excreted as unchanged drug); 0–10% of dose is excreted in feces within 72 hours.¹

Half-life

5 hours.¹

Special Populations

Possible association between increased concentrations of serum alkaline phosphatase or γ-glutamyltransferase (γ-glutamyltranspeptidase, GT, GGTP) and a decrease in plasma teniposide clearance.¹ (See Hepatic Impairment under Cautions.)

Stability

Storage

Parenteral

Injection

2–8°C; protect from light.¹

Store diluted solutions at room temperature; do not refrigerate.¹ Diluted solutions at concentrations of 0.1, 0.2, or 0.4 mg/mL are stable for up to 24 hours at room temperature.¹ Diluted solutions at concentration of 1 mg/mL should be administered within 4 hours to reduce potential for precipitation.¹ Stability and use times are identical for solutions prepared in glass or plastic containers.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Possible precipitation of diluted solutions.¹ Precipitation reported during 24-hour infusions of teniposide diluted to concentrations of 0.1–0.2 mg/mL, resulting in occlusion of central venous access catheters.^{1 17} (See IV Administration under Dosage and Administration.) To minimize precipitation, avoid agitation, decrease storage time prior to administration, and avoid contact with other drugs or fluids.¹

Solution Compatibility^HID

Compatible
Dextrose 5% in water
Ringer’s injection, lactated
Sodium chloride 0.9%

Drug Compatibility

Y-Site CompatibilityHID

Compatible
Acyclovir sodium
Allopurinol
Amifostine
Amikacin sulfate
Aminophylline
Amphotericin B
Ampicillin sodium
Ampicillin sodium–sulbactam sodium
Aztreonam
Bleomycin sulfate
Bumetanide
Buprenorphine HCl
Butorphanol tartrate
Calcium gluconate
Carboplatin
Carmustine
Cefazolin sodium
Cefotaxime sodium
Cefoxitin sodium
Ceftazidime
Ceftizoxime sodium
Ceftriaxone sodium
Cefuroxime sodium
Chlorpromazine HCl
Cimetidine HCl
Ciprofloxacin
Cisplatin
Cladribine
Clindamycin phosphate
Co-trimoxazole
Cyclophosphamide
Cytarabine
Dacarbazine
Dactinomycin
Daunorubicin HCl
Dexamethasone sodium phosphate
Diphenhydramine HCl
Doxorubicin HCl
Doxycycline hyclate
Droperidol
Enalaprilat
Etoposide
Etoposide phosphate
Famotidine
Floxuridine
Fluconazole
Fludarabine phosphate
Fluorouracil
Furosemide
Gallium nitrate
Ganciclovir sodium
Gemcitabine HCl
Gentamicin sulfate
Granisetron HCl
Haloperidol lactate
Hydrocortisone sodium phosphate
Hydrocortisone sodium succinate
Hydromorphone HCl
Hydroxyzine HCl
Ifosfamide
Imipenem–cilastatin sodium
Leucovorin calcium
Lorazepam
Mannitol
Mechlorethamine HCl
Melphalan HCl
Meperidine HCl
Mesna
Methotrexate sodium
Methylprednisolone sodium succinate
Metoclopramide HCl
Metronidazole
Minocycline HCl
Mitomycin
Mitoxantrone HCl
Morphine sulfate
Nalbuphine HCl
Netilmicin sulfate
Ondansetron HCl
Potassium chloride
Prochlorperazine edisylate
Promethazine HCl
Ranitidine HCl
Sargramostim
Sodium bicarbonate
Streptozocin
Thiotepa
Ticarcillin disodium
Ticarcillin disodium–clavulanate potassium
Tobramycin sulfate
Vancomycin HCl
Vinblastine sulfate
Vincristine sulfate
Vinorelbine tartrate
Zidovudine
Incompatible
Heparin1
Idarubicin HCl

ActionsActions

• 
  

  Exact mechanism(s) of action not known; apparently produces cytotoxic effects by damaging DNA and thereby inhibiting or altering DNA synthesis.^{1 6 7}

  
  


• 
  

  Induces single- and double-stranded DNA breaks and also induces DNA-protein cross-links,^{1 2 5} possibly through inhibition of type II topoisomerase.^{1 6}

  
  


• 
  

  Cell-cycle specific, inducing G₂-phase arrest and preferentially killing cells in the G₂ and late S phases.^{1 2 5}

  
  

Advice to Patients

• 
  

  Importance of advising patients and/or their parents or guardians of adverse effects and associated manifestations.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and to advise pregnant women of risk to the fetus.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Teniposide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection concentrate, for IV infusion only	10 mg/mL	Vumon (with dehydrated alcohol 42.7% and benzyl alcohol 30 mg and polyoxyl 35 castor oil 500 mg per mL)	Bristol-Myers Squibb

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Bristol-Myers Squibb Oncology Division. Vumon (teniposide injection) prescribing information. Princeton, NJ: 1998 Oct.

2. National Cancer Institute Cancer Therapy Evaluation Program. Group C treatment protocol: VM-26 in combination with Ara-C for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. NCI protocol No. 188-16. Bethesda, MD: National Cancer Institute; 1988 Aug 15.

3. Strife J, Jardine I. Analysis of the anticancer drugs VP 16-213 and VM 26 and their metabolites by high-performance liquid chromatography. J Chromatogr. 1980; 182:211-20. [IDIS 178818] [PubMed 7380913]

4. Grem JL, Hoth DF, Leyland-Jones B et al. Teniposide in the treatment of leukemia: a case study of conflicting priorities in the development of drugs for fatal diseases. J Clin Oncol. 1988; 6:351-79. [PubMed 3276827]

5. National Cancer Institute Therapy Evaluation Program. Group C treatment protocol: VM-26 in combination with Ara-C for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. NCI protocol No. 188-0016. Bethesda, MD: National Cancer Institute; 1989 Jan 25.

6. Anon. Teniposide for acute lymphoblastic leukemia. Med Lett Drugs Ther. 1992; 34:105-6. [PubMed 1435505]

7. Krishan A, Paika K, Frei E III. Cytofluorometric studies on the action of podophyllotoxin and epipodophyllotoxins (VM-26, VP-16-213) on the cell cycle traverse on human lymphoblasts. J Cell Biol. 1975; 66:521-30. [PubMed 1057547]

8. O’Dwyer PJ, Alonso MT, Leyland-Jones B et al. Teniposide: a review of 12 years of experience. Cancer Treat Rep. 1984; 68:1455-66. [IDIS 195977] [PubMed 6391663]

9. Bristol-Myers Squibb Oncology Division. Vumon (teniposide) concentrate for injection formulary guide. Princeton, NJ; 1992.

10. Pui CH, Ribeiro RC, Hancock ML et al. Acute myeloid leukemia in children treated with epipodophyllotoxins for acute lymphoblastic leukemia. N Engl J Med. 1991; 325:1682-7. [IDIS 288970] [PubMed 1944468]

11. McLeod HL, Baker DK Jr, Pui CH et al. Somnolence, hypotension, and metabolic acidosis following high-dose teniposide treatment in children with leukemia. Cancer Chemother Pharmacol. 1991; 29:150-4. [PubMed 1760858]

12. Razon-Veronesi S. Cardiovascular toxic effects of VM26 in the treatment of acute lymphatic leukemia: presentation of two cases. Tumori. 1982; 68:253-5. [PubMed 6958114]

13. Shimizu H, Frankel LS, Culbert SJ. Severe hypertensive reactions to teniposide (VM-26) in infants with congenital leukemia. Am J Pediatr Hematol/Oncol. 1987; 9:239-41.

14. O’Dwyer PJ, King SA, Fortner CL et al. Hypersensitivity reactions to teniposide (VM-26): an analysis. J Clin Oncol. 1986; 4:1262-9. [PubMed 3525769]

15. Hayes FA, Abromowitch M, Green AA. Allergic reactions to teniposide in patients with neuroblastoma and lymphoid malignancies. Cancer Treat Rep. 1985; 69:439-41. [IDIS 201327] [PubMed 3857970]

16. Kellie SJ, Crist WM, Pui CH et al. Hypersensitivity reactions to epipodophyllotoxins in children with acute lymphoblastic leukemia. Cancer. 1991; 67:1070-5. [IDIS 277532] [PubMed 1991254]

17. Strong DK, Morris LA. Precipitation of teniposide during infusion. Am J Hosp Pharm. 1990; 47:512,518. [PubMed 2316530]

18. DeMarini DM, Brock KH, Doerr CL et al. Mutagenicity and clastogenicity of teniposide (VM-26) in L5178Y/JK±-3.7.2C mouse lymphoma cells. Mutat Res. 1987; 187:141-9. [PubMed 3821767]

19. Food and Drug Administration. Prescription drug advertising; content and format for labeling of human prescription drugs. Fed Regist. 1979; 44:37434-67.

20. Bleyer WA, Sather H, Hammond GD. Prognosis and treatment after relapse of acute lymphoblastic leukemia and non-Hodgkins lymphoma: 1985. Cancer. 1986; 58:590-4. [PubMed 3459571]

21. Rivera GK, Buchanan G, Boyett JM et al. Intensive retreatment of childhood acute lymphoblastic leukemia in first bone marrow relapse: a Pediatric Oncology Group study. N Engl J Med. 1986; 315:273-8. [IDIS 218989] [PubMed 3523250]

22. Childhood acute lymphoblastic leukemia. From: CancerNet/PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2001 Oct.

23. Sadowitz PD, Smith SD, Shuster J et al. Treatment of late bone marrow relapse in children with acute lymphocytic leukemia: a Pediatric Oncology Group study. Blood. 1993; 81: 602-9.

24. Rivera GK, Raimondi SC, Hancock ML et al. Improved outcome in childhood acute lymphoblastic leukemia with reinforced early treatment and rotational combination chemotherapy. Lancet. 1991; 337:61-6. [IDIS 276376] [PubMed 1670723]

25. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 1998 Aug 13. From FDA web site ().

26. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. [PubMed 15529105]

27. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Vumon (teniposide) [October 1, 2002]. From FDA web site .

a. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10-11. [PubMed 7188569]

b. Centers for Disease Control. Neonatal deaths associated with use of benzyl alcohol. MMWR Morb Mortal Wkly Rep. 1982; 31:290-1. [IDIS 150868] [PubMed 6810084]

c. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]

d. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]

e. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]

f. Bristol-Myers Squibb Company. Vumon (teniposide injection) prescribing information. Princeton, NJ: 2004 Aug.

HID. Trissel LA. Handbook on injectable drugs. 12th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1272-1280.

More Teniposide resources

• Teniposide Side Effects (in more detail)
• Teniposide Use in Pregnancy & Breastfeeding
• Teniposide Drug Interactions
• Teniposide Support Group
• 0 Reviews for Teniposide - Add your own review/rating

• Teniposide Professional Patient Advice (Wolters Kluwer)


• Teniposide MedFacts Consumer Leaflet (Wolters Kluwer)


• teniposide Concise Consumer Information (Cerner Multum)


• teniposide Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Vumon Prescribing Information (FDA)

Compare Teniposide with other medications

• Acute Lymphoblastic Leukemia
• Acute Lymphocytic Leukemia
• Non-Hodgkin's Lymphoma

Neutrogena T/Scalp

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Ala-Cort


• Ala-Scalp HP


• Anusol HC


• Aquanil HC


• Beta HC


• Caldecort


• Cetacort


• Corta-Cap


• Cortagel Extra Strength


• Cortaid


• CortAlo With Aloe


• Corticaine


• Corticool Maximum Strength


• Cortizone-10


• Cortizone-5


• Cotacort


• Delacort


• Dermarest


• Dermtex-HC


• Foille Cort


• Gly-Cort


• Hydrozone Plus


• Hytone


• Instacort-10


• Ivy Soothe


• IvyStat


• Keratol HC


• Kericort 10


• Lacticare-HC


• Locoid


• Locoid Lipocream


• Medi-Cortisone Maximum Strength


• Microcort


• Mycin Scalp


• Neutrogena T/Scalp


• NuCort


• Nupercainal HC


• Nutracort


• Pandel


• Pediaderm HC Kit


• Preparation H Hydrocortisone


• Proctocream-HC


• Recort Plus


• Sarnol-HC Maximum Strength


• Scalacort


• Scalpcort


• Summer's Eve Specialcare


• Texacort


• Therasoft Anti-Itch & Dermatitis


• U-Cort


• Westcort

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Solution


• Cream


• Spray


• Lotion


• Ointment


• Pad


• Liquid


• Gel/Jelly


• Kit


• Foam


• Stick


• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Neutrogena T/Scalp

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Neutrogena T/Scalp

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Neutrogena T/Scalp. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, shake it well before using.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin:
  
  • For topical dosage form (cream):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two to four times per day.
    
    
    • Children—Apply to the affected area of the skin two to four times per day.
    
    
  
  
  • For topical dosage form (ointment):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Neutrogena T/Scalp

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Neutrogena T/Scalp Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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More Neutrogena T/Scalp resources

• Neutrogena T/Scalp Use in Pregnancy & Breastfeeding
• Neutrogena T/Scalp Drug Interactions
• Neutrogena T/Scalp Support Group
• 15 Reviews for Neutrogena T/Scalp - Add your own review/rating

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