Simoctocog Alfa Application Scope

Simoctocog alfa is a recombinant human coagulation factor VIII used for the treatment and prevention of bleeding in patients with hemophilia A (congenital factor VIII deficiency).

simoctocog alfa

Simoctocog Alfa Nuwiq Package Insert

Ingredients: Simoctocog alfa is a purified protein consisting of 1,440 amino acids, produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells.
Properties: White to off-white friable powder.
Specification: Available in vials containing 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU, or 4,000 IU of simoctocog alfa.
Packaging Specification: Each package includes one vial of lyophilized powder and one pre-filled syringe with solvent.
Storage: Store at 2°C to 8°C; do not freeze.
Expiry Date: Refer to the expiration date on the packaging.
Executive Standard: Complies with European Pharmacopoeia standards.
Approval Number: EMA/H/C/002813.
Date of Revision: Refer to the revision date on the packaging.
Manufacturer: Octapharma AB.

Guidelines for the Use of Simoctocog Alfa

Nuwiq Dosing and Administration:
- Treatment of bleeding episodes: The dose and duration depend on the severity and location of the bleeding.
- Prophylactic treatment: Typically administered 30-40 IU/kg every other day or three times per week.
- Surgical procedures: Dosage should be adjusted based on the type of surgery and the patient’s clinical condition.
Nuwiq Side Effects:
- Common: Development of factor VIII inhibitors, headache, dizziness, and nausea.
- Uncommon: Hypersensitivity reactions, including rash, pruritus, and urticaria.
Contraindications: Known hypersensitivity to simoctocog alfa or any of its components.
Precautions:
- Monitoring: Regular monitoring of factor VIII activity levels is recommended to ensure adequate treatment response.
- Hypersensitivity reactions: Patients should be informed of early signs of hypersensitivity reactions. If symptoms occur, discontinue use immediately and seek medical attention.
- Inhibitor development: Patients should be monitored for the development of factor VIII inhibitors, especially if the expected factor VIII activity levels are not achieved or if bleeding is not controlled with an appropriate dose.

Simoctocog Alfa Interactions

Drug Interactions: No known drug interactions. However, patients should inform their healthcare provider of all medications they are taking.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong 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.