⛔ FDA Black Box Warning
WARNING: THROMBOSIS ● Serious arterial and venous thrombotic events may occur following administration of SEVENFACT ® . [See Warnings and Precautions ( 5.1 )] ● 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. WARNING: THROMBOSIS See full prescribing information for complete boxed warning. ● Serious arterial and venous thrombotic events may occur following administration of SEVENFACT ® ( 5.1 ). ● 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
4 CONTRAINDICATIONS 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 ).
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies using SEVENFACT in pregnant women to determine whether there is a drug-associated risk. Animal studies evaluating the embryo-fetal teratogenic potential of SEVENFACT have not been conducted. It is unknown whether SEVENFACT can cause fetal harm when administered to a pregnant woman or can affect fertility. In the U.S. general population, the estimated background risks of major birth defect and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.