Kovaltry (Recombinant Factor VIII) – Hemophilia A | DengYue

Kovaltry Application Scope

Kovaltry is a recombinant human Factor VIII concentrate used in the treatment and prevention of bleeding in people with hemophilia A.

Characteristics

• Ingredients: Recombinant full‑length Factor VIII (octocog alfa)

• Properties:

  • Lyophilized powder for IV injection after reconstitution

  • Potency labeled in IU, calibrated by chromogenic assay; incremental recovery ~2 IU/dL per IU/kg

  • Half‑life in adults ~14 hours; slightly shorter in children

• Packaging Specification:

  • Single‑dose glass vial kits with vial adapter

  • Prefilled diluent syringe (2.5 mL for 250–1000 IU; 5 mL for 2000–3000 IU)

• Storage:

  • Store at 2–8 °C (36–46 °F) for up to 30 months from manufacture.

  • Can be kept up to 25 °C (77 °F) for a single period up to 12 months, once at room temperature

  • Do not return to the fridge and use within those 12 months or until the vial expiry

  • Keep in original carton, protect from light.

• Expiry Date:

  • ​Valid up to labelled expiration when stored properly.

  • After a single period at room temperature, expires at 12 months or original expiry, whichever comes first

• Executive Standard:

  • U.S. FDA-approved under Biologics License Application (BLA) BL 125574,

  • Current prescribing information revised 12/2022

• Approval Number: FDA BLA BL 125574; first approved March 16, 2016

• Date of Revision:

  • Prescribing information last revised December 2022 (12/2022)

  • Vial adapter insert updated 10/2021

• Manufacturer: Bayer HealthCare, LLC (Bayer Pharmaceuticals)

Guidelines for the Use of Kovaltry

• Dosage and Administration:

  • Intravenous infusion after reconstitution.

  • On‑demand bleeding: minor bleed 20–40 IU/kg every 12–24 h;

  • Moderate 30–60 IU/kg; major 60–100 IU/kg, dosing interval 8–24 h until resolution

  • Perioperative:

    • Target 30–60 % peri minor surgery, 80–100 % for major

    • Dosing per established frequency and duration.

  • Routine prophylaxis: adults/adolescents (≥12 yrs): 20–40 IU/kg 2–3× weekly;

  • Children ≤12 yrs: 25–50 IU/kg 2–3× weekly or every other day

• Adverse Reactions:

  • Most common (>5 %):

    • development of inhibitors (especially in previously untreated patients), fever, headache, rash

  • Others:

    • lymphadenopathy, insomnia, abdominal discomfort, injection-site reactions

    • pruritus, urticaria, flushing, palpitations, sinus tachycardia

• Contraindications:

  • Known hypersensitivity to Factor VIII, its excipients, or murine/hamster proteins;

  • History of allergic or anaphylactic reactions

• Precautions:

  • Monitor for FVIII inhibitors—perform the Bethesda assay if expected levels are not reached or bleeding persists

  • Hypersensitivity reactions are possible—stop infusion and treat if they occur.

  • Cardiovascular risk: thrombosis risk in certain populations; monitor accordingly.

Kovaltry Interactions

• Drug Interactions:

  • No specific drug–drug interactions reported;

  • However, inform the physician of all medications/supplements

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.