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Baxter Submits Application For FDA Approval Of FEIBA NF For Prophylactic Use In Hemophilia A And B Patients With Inhibitors

About FEIBA NF

FEIBA NF is not indicated for prophylaxis use in the United States. Canada, The Netherlands, Israel, Australia/New Zealand, Japan and South Korea also do not have a prophylaxis indication.

Indications for FEIBA NF

In the U.S., FEIBA NF [Anti-Inhibitor Coagulant Complex] is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.

Clinical experience suggests that patients with a Factor VIII inhibitor titer of less than five Bethesda Units (B.U.) may be successfully treated with Antihemophilic Factor. Patients with titers ranging between five and ten B.U. may either be treated with Antihemophilic Factor or FEIBA NF. Cases with Factor VIII inhibitor titers greater than 10 B.U. have generally been refractory to treatment with Antihemophilic Factor.

Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function that were present before treatment with FEIBA NF, nanofiltered and vapor-heated.

Detailed Important Risk Information for FEIBA NF

Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors.

The use of FEIBA NF is contraindicated:
  • In patients who have known anaphylactic or severe hypersensitivity reactions to the product
  • In patients who are known to have a normal coagulation mechanism
  • For the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX
  • In patients with significant signs of disseminated intravascular coagulation (DIC)
  • In patients with acute thrombosis or embolism (including myocardial infarction)

At first sign or symptoms of an infusion/hypersensitivity reaction or a thrombotic/ thromboembolic event, FEIBA NF administration should be stopped immediately and diagnostic and therapeutic measures initiated as appropriate.

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