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Baxter Completes Enrollment In Phase III Clinical Trial Of BAX 855, Extended Half-life Recombinant FVIII For Hemophilia A
Date:11/13/2013

s, including anaphylaxis, are possible and have been reported with ADVATE. Symptoms have manifested as dizziness, paresthesias, rash, flushing, face swelling, urticaria, dyspnea, and pruritus. Discontinue use if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Carefully monitor patients treated with AHF products for the development of FVIII 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 FVIII inhibitor concentration.

The serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to FVIII.

The most common adverse reactions observed in clinical trials (frequency greater than or equal to 10 percent of subjects) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury.

Please see full prescribing information for ADVATE at: http://www.baxter.com/downloads/healthcare_professionals/products/ADVATE_PI.pdf

About Hemophilia A

Hemophilia is a rare genetic[1] blood clotting disorder and the most severe forms of the disease primarily affect males.[2] People living with hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood.[3] Two of the most common forms of hemophilia are A and B.  In people with hemophilia A, clotting factor VIII is not present in sufficient amounts or is absent.  Without enough FVIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painf
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