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. 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 ( 7 ).
SEVENFACT is contraindicated in patients with: known allergy to rabbits or rabbit proteins. Exposure to SEVENFACT in these patients can result in severe hypersensitivity reaction. severe hypersensitivity reaction to SEVENFACT or any of its components. Exposure to SEVENFACT in these patients can result in severe hypersensitivity reaction. Known allergy to rabbits or rabbit proteins. Severe hypersensitivity reaction to SEVENFACT or any of its components ( 4 ).
AND PRECAUTIONS Patients with hemophilia A or B with inhibitors who have other risk factors for thrombosis may be at increased risk of serious arterial and venous thrombotic events ( 5.1 ). Hypersensitivity reactions, including anaphylaxis, are possible with SEVENFACT. Should symptoms occur, patients should discontinue SEVENFACT and seek appropriate medical intervention ( 5.2 ).
5.1 Thrombosis Serious arterial and venous thrombosis can occur with coagulation factor VIIa containing products including SEVENFACT. The following patients may have increased risk of thrombosis with use of SEVENFACT: History of congenital or acquired hemophilia receiving 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. Monitor patients who receive SEVENFACT for the development of signs and symptoms of activation of the coagulation system or thrombosis. When there is laboratory confirmation of intravascular coagulation or presence of clinical thrombosis, reduce the dose of SEVENFACT or stop treatment, depending on the patient’s condition.
5.2 Hypersensitivity and Infusion-Related Reactions Hypersensitivity and infusion-related reactions including anaphylaxis can occur with coagulation factor VIIa containing products including SEVENFACT. Sign and symptoms may include hives, itching, rash, difficulty breathing, swelling around the mouth and throat, tightness of the chest, wheezing, dizziness or fainting, and low blood pressure. Patients with known IgE-based hypersensitivity to casein may be at higher risk of hypersensitivity reactions. In the event of hypersensitivity or infusion-related reactions, discontinue SEVENFACT and manage according to clinical practice guideline.
5.3 Neutralizing Antibodies Neutralizing antibodies may occur with the use of SEVENFACT. If treatment with SEVENFACT does not result in adequate hemostasis, then suspect development of neutralizing antibody as the possible cause and perform testing as clinically indicated. Neutralizing antibodies to other Factor VIIa-containing products have been observed in congenital Factor VII-deficient patients. SEVENFACT has not been studied in this patient population. [ See limitation of use statement under Indications and Usage ( 1 )] .
5.4 Laboratory Tests Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) do not correlate with clinical response to SEVENFACT treatment.