• Bleeding disorders

Kovaltry Generic Name & Formulations

General Description

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.

Pharmacological Class

Clotting factor.

How Supplied

Kit—1 (vial w. diluent and adapter)


Generic Availability


Kovaltry Indications


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

Kovaltry Dosage and Administration

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.

Kovaltry Contraindications


Mouse or hamster protein sensitivity.

Kovaltry Boxed Warnings

Not Applicable

Kovaltry 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.

Kovaltry Pharmacokinetics

See Literature

Kovaltry Interactions

Not Applicable

Kovaltry Adverse Reactions

Adverse Reactions

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

Kovaltry Clinical Trials

See Literature

Kovaltry Note

Not Applicable

Kovaltry Patient Counseling

See Literature