Novoseven (Coagulation Factor Viia (Recombinant, Human)) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

The risk of a potential interaction between NovoSeven and coagulation factor concentrates has not been adequately evaluated in preclinical or clinical studies. Simultaneous use of activated prothrombin complex concentrates or prothrombin complex concentrates should be avoided.

Although the specific drug interaction was not studied in a clinical trial, there have been more than 50 episodes of concomitant use of antifibrinolytic therapies (i.e., tranexamic acid, aminocaproic acid) and NovoSeven.

NovoSeven should not be mixed with infusion solutions until clinical data are available to direct this use.

OVERDOSAGE

Dose limiting toxicities of NovoSeven® Coagulation Factor VIIa (Recombinant) have not been investigated in clinical trials. Two cases of accidental overdose by bolus administration have occurred in the clinical program. One hemophilia B patient (16 years of age, 68 kg) received a single dose of 352 µg/kg and one hemophilia A patient (2 years of age, 14.6 kg) received doses ranging from 246 µg/kg to 986 µg/kg on five consecutive days. There were no reported complications in either case. The recommended dose schedule should not be intentionally increased, even in the case of lack of effect, due to the absence of information on the additional risk that may be incurred.

CONTRAINDICATIONS

NovoSeven® Coagulation Factor VIIa (Recombinant) should not be administered to patients with known hypersensitivity to NovoSeven or any of the components of NovoSeven. NovoSeven is contraindicated in patients with known hypersensitivity to mouse, hamster, or bovine proteins.

REFERENCES

1. Roberts, H.R.: Thoughts on the mechanism of action of FVIIa, 2^nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen, Denmark, 1991, pgs. 153-156.
2. Lindley, C.M., et al.: Pharmacokinetics and pharmacodynamics of recombinant Factor VIIa, Clinical Pharmacology & Therapeutics, Vol. 55, No. 6, June 1994, pgs. 638-648.
3. Lusher, J., et al.: Clinical experience with recombinant Factor VIIa, Blood Coagulation and Fibrinolysis 1998, 9:119-128.
4. Bech, M. R.: Recombinant Factor VIIa in Joint and Muscle Bleeding Episodes, Haemostasis 1996;26(suppl 1):135-138.
5. Lusher, J.M.: Recombinant Factor VIIa (NovoSeven®) in the Treatment of Internal Bleeding in Patients with Factor VIII and IX Inhibitors, Haemostasis 1996; 26(suppl 1):124-130.
6. Lusher, J.M., et al.: A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with hemophilia A and B, with and without inhibitor, Haemophilia 1988, 4:790-798.
7. Hedner, U.: Dosing and Monitoring NovoSeven® Treatment, Haemostasis 1996;26(suppl 1):102-108.

Date of issue: February/2003

License Number: 1261

Novo Nordisk® and NovoSeven® are registered trademarks of Novo Nordisk A/S

© 2003 Novo Nordisk Pharmaceuticals, Inc.

U.S. Patent Nos. 4,382,083; 4,479,938; 4,784,950, 5,180,583 and 6,310,183

For Information contact:

   Novo Nordisk Pharmaceuticals, Inc.

   100 College Road West

   Princeton, NJ 08540, USA

   1-877-NOVO-777

www.novoseven-us.com

Manufactured by:

Novo Nordisk A/S

2880 Bagsvaerd, Denmark