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Recombinate Generic Name & Formulations
Legal Class
Rx
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)
Manufacturer
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
Not Applicable
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
