Bleeding disorders:
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 1 dose preoperative to achieve 100% activity, 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.
ADVATE Contraindications:
Hypersensitivity reactions to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and/or glutathione).
ADVATE 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.
ADVATE Classification:
Clotting factor.
Adverse Reactions:
Pyrexia, headache, cough, nasopharyngitis, arthralgia,
vomiting, upper respiratory tract infection, limb injury, nasal congestion, diarrhea; antibody formation, hypersensitivity reactions.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1 (w. diluent, Baxject II needleless transfer device)
