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KOVALTRY
Bleeding disorders
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Drug Name:

KOVALTRY Rx

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.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

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.

Contraindications:

Mouse or hamster protein sensitivity.

Warnings/Precautions:

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.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Headache, pyrexia, pruritus, inj site reactions, rash; antibody formation, catheter-related infections.

Generic Availability:

NO

How Supplied:

Kit—1 (vial w. diluent and adapter)

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