Data from FDA - Curated by Toby Galbraith - Last updated 19 May 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

• XYNTHA is arecombinantantihemophilic factor indicated in adults and children with hemophilia A for control and prevention of bleeding episodes and for perioperative management.(1)
• XYNTHA is not indicated in patients with von Willebrand’s disease.(1)

Full Prescribing information

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Advisory information

contraindications
Do not use in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins.(4)
Special warnings and precautions

• Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster protein, which is present in trace amounts in XYNTHA. Should such reactions occur, discontinue treatment with the product and administer appropriate treatment. (5.1)
• Development of activity-neutralizing antibodies has been detected in patients receiving factor VIII-containing products, including XYNTHA. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration. (5.2,5.3, 6.2)

Adverse reactions
• The most common adverse reactions (≥ 10%) with XYNTHA in adult and pediatric PTPs were headache, arthralgia, pyrexia, and cough. (6)
• Across all studies, 3 subjects developed factor VIII inhibitors (2.1%). (6.2)

Usage information

Dosing and administration
For intravenous use after reconstitution only (2)

• The required doseis determined using the following formula:

Required units = body weight (kg) x desired factor VIII rise (IU/dL
OR
% of normal) x 0.5 (IU/kg per IU/dL), where IU = International Unit.

• Frequency of XYNTHA administrationis determined by the type of bleeding episode and the recommendation of the treating physician. (2.1, 2.2)
Use in special populations
• Pregnancy: No human or animal data. Use only if clearly needed.(8.1)
• Pediatrics: Half-lives are shorter, volumes of distribution are larger, and recovery is lower after XYNTHA administration in children. Higher or more frequent dosing may be needed. (8.4)

More information

Category Value
Authorisation number BLA125264
Orphan designation No
Product NDC 58394-012; 58394-013; 58394-014; 58394-015; 58394-016; 58394-022; 58394-023; 58394-024; 58394-025
Date First Approved 01-08-2008
Marketing authorisation holder Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc.

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