Important Safety Information
WARNING: THROMBOSIS
- Serious arterial and venous thrombotic events may occur following administration of SEVENFACT.
- Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive SEVENFACT.
- Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.
Contraindications
SEVENFACT is contraindicated in patients with known allergy to rabbits or rabbit protein, or severe hypersensitivity reaction to SEVENFACT or any of its components.
Warnings and Precautions
There is limited information about the safety of SEVENFACT in patients with a history of arterial or venous thromboembolic disease, because such patients were excluded from SEVENFACT trials. Serious arterial and venous thrombotic reactions can occur with SEVENFACT and have been reported in clinical trials and postmarketing surveillance with a similar class of products.
The following patients may have an increased risk of thromboembolic events with use of SEVENFACT:
- History of concomitant treatment with aPCC/PCC (activated or non-activated prothrombin complex) or other hemostatic agents.
- History of atherosclerotic disease, coronary artery disease, cerebrovascular disease, crush injury, septicemia, or thromboembolism.
Hypersensitivity reactions, including anaphylaxis, are possible with SEVENFACT. Should symptoms occur, patients should discontinue SEVENFACT and seek appropriate medical intervention. Patients with known hypersensitivity to casein may be at higher risk of hypersensitivity reaction.
Indications and Usage
SEVENFACT [coagulation factor VIIa (recombinant)-jncw] is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.
SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency.
Adverse Reactions
The most common adverse reactions reported in clinical trials for SEVENFACT were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever.
Drug Interactions
Clinical experience with pharmacologic use of FVIIa-containing products indicates an elevated risk of serious thrombotic events when used simultaneously with activated prothrombin complex concentrates.
*Eligibility Information
For eligible commercially insured patients, card carries a maximum of $12,000 per calendar year ( January 1 ‑ December 31). Patients are not eligible if prescriptions are paid by any state or other federally funded programs, including, but not limited to Medicare or Medicaid, Medigap, VA or DOD or TriCare, or where prohibited by law. Eligibility rules apply.