Allergic-type hypersensitivity reactions, including anaphylaxis, are possible and have been reported with ADVATE. Symptoms have manifested as dizziness, paresthesia, rash, flushing, face swelling, urticaria, dyspnea, and pruritis. Discontinue use if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Carefully monitor patients treated with AHF products for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Inhibitors have been reported following administration of ADVATE predominantly in previously-untreated patients (PUPs) and previously minimally-treated patients (MTPs).
If expected plasma FVIII levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.
The serious adverse drug reactions (ADRs) seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to Factor VIII. The most common ADRs observed in clinical trials (frequency
10 percent of patients) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury.
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Hemophilia is a rare genetic blood clotting disorder.(1) People living with hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood.(1) Two of the most common forms of hemophilia are A and B and primarily affect males.(2)
In people with hemophilia A, clotting factor VIII is not present in sufficient amounts or is absent.(2) Without enough FVIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal.(2) People with hemophilia B (also called Christmas disease) do not have sufficient amounts of clotting factor IX.(2) In about 30 percent of cases, there is no family history of hemophilia and the condition is the result of a spontaneous gene mutation.(3)
According to the World Federation of Hemophilia, more than 400,000 people in the world have hemophilia.(1) All races and economic groups are affected equally.(1)
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.