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XYNTHA® Lyophilized Powder (antihemophilic factor (Recombinant)) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use XYNTHA® safely and effectively. See full prescribing information for XYNTHA®.

XYNTHA® (antihemophilic factor [recombinant]) lyophilized powder for solution, for intravenous injection
Initial U.S. Approval: 2008

RECENT MAJOR CHANGES

Indications and Usage (1) 10/2014

INDICATIONS AND USAGE

  • XYNTHA is a recombinant antihemophilic 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)

DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution only (2)

  • The required dose is determined using the following formula:
    Required units = body weight (kg) × desired factor VIII rise (IU/dL or % of normal) × 0.5 (IU/kg per IU/dL), where IU = International Unit.
  • Frequency of XYNTHA administration is determined by the type of bleeding episode and the recommendation of the treating physician. (2.1, 2.2)

DOSAGE FORMS AND STRENGTHS

XYNTHA is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, or 2000 IU. (3)

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)

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)

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

USE IN SPECIFIC 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)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2014

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