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ADVATE
Bleeding disorders
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Drug Name:

ADVATE Rx

Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU; per vial; pwd for IV inj after reconstitution; albumin- and preservative-free.

Company:
Baxter

Therapeutic Use:

Indications for ADVATE:

In patients with Hemophilia A: to control and prevent hemorrhagic episodes, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of hemorrhagic episodes.

Adults and Children:

Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Infuse over ≤5 minutes (max infusion rate 10mL/min); monitor pulse; 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. Major: obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Perioperative: Minor: obtain 60–100% FVIII increase; give single bolus infusion within 1 hour of surgery, then every 12–24hrs as needed to control bleeding; Major: pre- and post-op: obtain 80–120% FVIII increase; give pre-op and maintenance bolus infusion, then repeat every 8–24hrs based on healing. Routine prophylaxis: give 20–40 IU/kg every other day (3–4 times weekly). Or, alternatively, an every 3rd day dosing regimen may be followed. Adjust based on response.

Contraindications:

Mouse or hamster protein sensitivity.

Warnings/Precautions:

Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Headache, arthralgia, pyrexia, cough, nasopharyngitis, pharyngolaryngeal pain; antibody formation, hypersensitivity reactions.

Generic Availability:

NO

How Supplied:

Single-dose vial—1 (w. diluent, Baxject II needleless transfer device)

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