Important Safety Information
*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.
- 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.
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.
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.
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.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact HEMA Biologics at 1-855-718-4362. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.