Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Indications for KOVALTRY:
In patients with Hemophilia A: to treat and control bleeding episodes, for perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.
Adults and Children:
Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Infuse over 1–15mins. Bleeding: Minor: obtain 20–40% FVIII increase; may repeat every 12–24hrs for ≥1 day until resolved or healing is achieved; Moderate: obtain 30–60% FVIII increase; may repeat every 12–24hrs for 3–4 days until pain and acute disability resolved; Major: obtain 60–100% FVIII increase; may repeat every 8–24hrs until resolved. Perioperative: Minor (pre- and post-op): obtain 30–60% FVIII increase; may repeat every 24hrs for ≥1 day until healed; Major (pre- and post-op): obtain 80–100% FVIII increase; may repeat every 8–24hrs until adequately healed, then continue for ≥7 days to maintain Factor VIII activity of 30–60%. Routine prophylaxis: >12yrs: 20–40 IU/kg 2–3 times weekly; ≤12yrs: 25–50 IU/kg 2–3 times weekly or every other day according to requirements.
Mouse or hamster protein sensitivity.
Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Cardiovascular disease or risk factors. Discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.
Headache, pyrexia, pruritus, inj site reactions, rash; antibody formation, catheter-related infections.
Kit—1 (vial w. diluent and adapter)
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