ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.
Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with ALPHANATE should be discontinued, and emergency treatment should be sought.
Development of activity-neutralizing antibodies has been detected in patients receiving FVIII-containing products. Development of alloantibodies to VWF in type 3 von Willebrand disease (VWD) patients has been occasionally reported in the literature.
Thromboembolic events may be associated with AHF/VWF complex (human) in VWD patients, especially in the setting of known risk factors.
Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF complex (human).
Rapid administration of a FVIII concentrate may result in vasomotor reactions.
Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.
The most frequent adverse events reported with ALPHANATE in >5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain, and fatigue.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
Please see full Prescribing Information for ALPHANATE.