ADVATE [Antihemophilic Factor (Recombinant)] Important Information
ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A
(congenital factor VIII deficiency) for:
Control and prevention of bleeding episodes.
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ADVATE is not indicated for the treatment of von Willebrand disease.
DETAILED IMPORTANT RISK INFORMATION
Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster
protein or other constituents of the product.
WARNINGS & PRECAUTIONS
Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms
include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting.
Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in
previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients
for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If
expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an
expected dose, perform an assay that measures factor VIII inhibitor concentration.
Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions observed in clinical trials (>5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.
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Full Prescribing Information.