Esperoct (Turoctocog Alfa Pegol) – Hemophilia A | DengYueMed

Esperoct Application Scope

Esperoct is a long-acting, PEGylated recombinant factor VIII concentrate used for the treatment and prevention of bleeding episodes in patients with hemophilia A.

Characteristics

• Ingredients: Turoctocog Alfa Pegol

• Properties:

  • Glycopegylated with a 40-kDa PEG molecule

  • Extending its half-life (~1.6x in adults, ~1.9x in children vs. standard FVIII)

  • B-domain truncated, activated by thrombin to release functional FVIIIa

• Packaging Specification: Single-dose vials (500 IU) with prefilled saline diluent syringes (4 mL)

• Storage:

  • Store at 2°C–8°C (36°F–46°F) in original packaging

  • Can be kept at ≤30°C (86°F) for up to 12 months

  • After reconstitution, use within 4 hours at room temperature or 24 hours if refrigerated

• Expiry Date:

  • Up to 30 months from manufacture if refrigerated

  • Discard after 12 months if stored at room temperature

• Executive Standard:

  • Complies with FDA (U.S.)

  • EMA (EU) regulations for biological products

• Approval Number:

  • FDA BLA No.: 125671 35.

  • EMA Product No.: EMEA/H/C/004883

• Date of Revision: Latest EMA revision: 2023-11-20

• Manufacturer: Novo Nordisk A/S

Guidelines for the Use of Esperoct

• Dosage and Administration:

  • Prophylaxis:

    • Adults/adolescents (≥12 yrs): 50 IU/kg every 4 days

    • Children (<12 yrs): 65 IU/kg twice weekly

  • Bleeding episodes: Mild/moderate: 40–65 IU/kg; major: 50–65 IU/kg

  • Surgery: Preoperative dose: 50–65 IU/kg; adjust based on hemostatic needs

• Adverse Reactions:

  • Common (≥1%): Rash, itching, redness, injection-site reactions

  • Rare: Inhibitor development, allergic reactions (including anaphylaxis)

• Contraindications: Hypersensitivity to turoctocog alfa pegol or hamster proteins

• Precautions:

  • Monitor for inhibitors if bleeding is uncontrolled

  • Pediatric patients may require higher/more frequent dosing due to faster clearance

Esperoct Interactions

• Drug Interactions:

  No known significant interactions; avoid mixing with other IV medications

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.