Recombinate

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Recombinate Generic Name & Formulations

General Description

Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU; per bottle; lyophilized pwd for IV infusion after reconstitution; contains albumin; preservative-free.

Pharmacological Class

Clotting factor.

How Supplied

Single-dose bottle—1 (w. diluent)

Recombinate Indications

Indications

Prevention and control of hemorrhagic episodes and perioperative management in Hemophilia A.

Recombinate Dosage and Administration

Adults and Children

Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Infuse at rate of up to 10mL/min. Monitor pulse rate; if increased significantly, reduce infusion rate or hold. Hemorrhage: Mild: obtain 20–40% FVIII increase; give every 12–24hrs for 1–3 days until resolved. Moderate: obtain 30–60% FVIII increase; give every 12–24hrs for 3 days or until pain or disability resolved. Life-threatening: obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Surgery: Minor: obtain 60–80% FVIII increase; give single infusion plus oral antifibrinolytic therapy within 1 hour; Major: pre- and post-op: obtain 80–100% FVIII increase; repeat every 8–24hrs based on healing.

Recombinate Contraindications

Contraindications

Mouse, hamster, or bovine protein sensitivity.

Recombinate Boxed Warnings

Not Applicable

Recombinate Warnings/Precautions

Warnings/Precautions

Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Latex allergy. Pregnancy (Cat.C).

Recombinate Pharmacokinetics

See Literature

Recombinate Interactions

Recombinate Adverse Reactions

Adverse Reactions

Allergic reactions, nausea, fever, chills, urticaria, antibody formation.

Recombinate Clinical Trials

See Literature

Recombinate Note

Not Applicable

Recombinate Patient Counseling

See Literature