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XYNTHA
Bleeding disorders
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Drug Name:

XYNTHA Rx

Generic Name and Formulations:
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.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for XYNTHA:

In Hemophilia A: to control and prevent bleeding episodes, and for perioperative management.

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. Bleeding (Minor): factor VIII level required is 20–40 IU/dL or % of normal, repeat infusion every 12–24 hours as needed for at least 1 day, until resolution; (Moderate): 30–60 IU/dL or % of normal; repeat infusion every 12–24 hours for 3–4 days or until hemostasis; (Major): 60–100 IU/dL or % of normal, repeat infusion every 8–24 hours until resolution. Perioperative (Minor): 30–60 IU/dL or % of normal, repeat infusion every 12–24 hours for 3–4 days or until hemostasis; (Major): 60–100 IU/dL or % of normal; repeat infusion every 8–24 hours until hemostasis and wound healing occurs.

Contraindications:

Hypersensitivity to hamster proteins.

Warnings/Precautions:

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

See Also:

XYNTHA SOLOFUSE

Pharmacological Class:

Clotting factor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Kit—1 (w. diluent, supplies)

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