• Bleeding disorders

Xyntha Generic Name & Formulations

General Description

Antihemophilic Factor (recombinant): nominally 250 IU, 500 IU, 1000 IU, or 2000 IU; per vial; lyophilized pwd for IV inj after reconstitution; plasma/albumin-free; preservative-free; contains polysorbate 80.

Pharmacological Class

Clotting factor.

See Also

How Supplied

Kit—1 (w. diluent, supplies)


Generic Availability


Xyntha Indications


In Hemophilia A: for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.

Xyntha Dosage and Administration

Adults and Children

Individualize and titrate. Give by IV infusion over several minutes. One IU of factor VIII per kg raises the plasma factor VIII activity by about 2 IU/dL. Dose (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Bleeding (Minor): obtain 20–40% FVIII increase every 12–24hrs for ≥1 day depending on severity; (Moderate): obtain 30–60% FVIII increase every 12–24hrs for 3–4 days or until hemostasis achieved; (Major): obtain 60–100% FVIII increase every 8–24hrs until resolved. Peri-op (Minor): obtain 30–60% FVIII increase every 12–24hrs for 3–4 days or until hemostasis achieved (for tooth extraction: a single dose plus oral antifibrinolytic therapy within 1hr may be sufficient); (Major): obtain 60–100% FVIII increase every 8–24hrs until resolved or adequate healing achieved. Routine prophylaxis (<12yrs): initially 25 IU/kg every other day (more frequent or higher doses may be required); (≥12yrs): initially 30 IU/kg 3 times weekly. Adjust dose based on response.

Xyntha Contraindications


Hypersensitivity to hamster proteins.

Xyntha Boxed Warnings

Not Applicable

Xyntha Warnings/Precautions


Discontinue if hypersensitivity reactions occur. Monitor for development of Factor VIII inhibitors; may need dose adjustment. Pregnancy. Labor & delivery. Nursing mothers.

Xyntha Pharmacokinetics

See Literature

Xyntha Interactions

Not Applicable

Xyntha Adverse Reactions

Adverse Reactions

Headache, arthralgia, pyrexia, cough, diarrhea, vomiting, asthenia; anaphylaxis.

Xyntha Clinical Trials

See Literature

Xyntha Note

Not Applicable

Xyntha Patient Counseling

See Literature