Factor VIIa, Recombinant
- Atc Codes:B02BD05#B02BD01
Table of contents
- Brand Names
- Drug Combinations
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Toxicological Effects
- Caution and personalized dose adjustment in patients with the following genotypes
- Other genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: NovoSeven; Belgium: NovoSeven; Czech Republic: NovoSeven; Denmark: NovoSeven; Estonia: NovoSeven; Finland: NovoSeven; France: NovoSeven; Germany: NovoSeven; Greece: NovoSeven; Hungary: NovoSeven; Ireland: NovoSeven; Italy: NovoSeven; Latvia: NovoSeven; Lithuania: NovoSeven; Netherlands: NovoSeven; Poland: NovoSeven; Portugal: NovoSeven; Romania: NovoSeven; Slovakia: NovoSeven; Slovenia: NovoSeven; Spain: Novoseven; Sweden: NovoSeven; UK: NovoSeven.
North America
Canada: Niastase; USA: NovoSeven.
Latin America
Argentina: NovoSeven; Mexico: NovoSeven.
Asia
Japan: NovoSeven.
Drug combinations
Factor VIIa, Factor II, Factor IX, and Factor X, and Protein C Concentrate (Human)
Chemistry
Pharmacologic Category
Antihemorrhagic Agents; Hemostatics. Antihemophilic Agent. Blood Product Derivative. (ATC-Code: B02BD05; B02BD01).
Mechanism of action
Factor VIIa (recombinant) is a biosynthetic preparation of blood coagulation factor VIIa prepared using recombinant DNA technology. Promotes hemostasis through activation of the extrinsic blood coagulation pathway.
Therapeutic use
Used to control hemorrhagic episodes in patients with hemophilia A or hemophilia B who have inhibitors to factor VIII or factor IX. Used for treatment and prevention of hemorrhagic episodes in acquired hemophilia. Also used for treatment of bleeding episodes in congenital factor VII deficiency and for prevention of bleeding in patients with congenital factor VII deficiency undergoing surgical interventions or invasive procedures.
Pregnancy and lactiation implications
There are no adequate, well-controlled studies in pregnant women. Use only if potential benefit justifies potential risk to the fetus. Unknown whether factor VIIa (recombinant) is distributed into human milk.
Unlabeled use
Reduction of hematoma growth in acute intracerebral hemorrhage, warfarin-related intracerebral hemorrhage.
Contraindications
Hypersensitivity to factor VII or any component of the formulation. Hypersensitivity to mouse, hamster, or bovine proteins.
Warnings and precautions
Risk for thromboembolic events (use with caution, especially in known risk factors for thromboembolism). Potentially greater risk in disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injuries, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates due to circulating tissue factor or predisposing coagulopathy. Hypersensitivity reactions (e.g. anaphylaxis, hives, hypotension, tightness of the chest, urticaria, wheezing) reported. Factor VIIa (recombinant) contains trace amounts of animal protein, which may stimulate antibody production. Administration of factor VIIa (recombinant) generally decreases PT and APTT. Potential risk of adverse thromboembolic events in nonhemophilic geriatric patients with intracerebral hemorrhage.