Anjiayin Omfiloctocog alfa for Injection

1. Indications and Usage
Hemophilia A (Congenital Factor VIII Deficiency):
Indicated for control and prevention of bleeding episodes in adults and children with Hemophilia A (congenital Factor VIII deficiency).
Surgical Prophylaxis:
Indicated for perioperative management in adults and children with Hemophilia A.
Note: Not indicated for von Willebrand Disease.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Injection ONLY.
Dosing Principles:
Dosage and duration of treatment depend on the severity of Factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.
Formula: 1 International Unit (IU) of Factor VIII per kg body weight typically raises the circulating Factor VIII activity by approximately 2% of normal activity.
Recommended Dosage:
Minor Bleeding: 20–40 IU/kg every 12–24 hours.
Moderate to Severe Bleeding: 40–60 IU/kg every 8–24 hours.
Severe Hemorrhage: 60–100 IU/kg every 8–12 hours.
Surgical Prophylaxis:
Minor surgery: 25–40 IU/kg.
Major surgery: 50–100 IU/kg (aiming for 80–100% activity).
3. Mechanism of Action
Coagulation Replacement:
Octocog alfa is a recombinant form of human coagulation Factor VIII.
Clotting Cascade:
In the presence of Calcium ions (Ca²⁺), activated Factor VIII (Factor VIIIa) acts as a cofactor for activated Factor IX (Factor IXa). This complex accelerates the conversion of Factor X to activated Factor X (Factor Xa), which subsequently leads to the generation of thrombin and the formation of a fibrin clot.
4. Safety and Warnings
Inhibitor Formation:
The most important safety concern is the development of neutralizing antibodies (inhibitors) against Factor VIII. Patients must be monitored for the development of inhibitors.
Hypersensitivity/Allergic Reactions:
Hypersensitivity reactions (including anaphylaxis) may occur. If signs of allergy appear, discontinue administration immediately.
Thrombotic Events:
Although rare with Factor VIII, thrombotic events can occur, particularly in patients with cardiovascular risk factors.
5. Adverse Reactions
Most Common:
Pyrexia (fever), headache, rash, and injection site reactions (burning/stinging).
Immune Response:
Development of Factor VIII inhibitors (neutralizing antibodies).
6. Drug Interactions
No Significant Interactions:
No formal drug-drug interaction studies have been conducted. No drug interactions are expected as it is a protein replacement therapy.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Octocog alfa (Recombinant Coagulation Factor VIII).
Excipients: Histidine, Sucrose, Polysorbate 80, Calcium Chloride.
Storage:
Store at 2°C to 8°C (36°F to 46°F) or at room temperature up to 22°C (72°F) for a limited period. Do not freeze.