Human Coagulation Factor VIII

Introduction: Human Coagulation Factor VIII (Octanate) belongs to a group of medicines called clotting factors and contains human blood coagulation factor VIII. This is a special protein involved in blood clotting. Octanate is used to treat and prevent bleeding in patients with haemophilia A.

How it works: Factor VIII is an essential component of the blood coagulation cascade required for the formation of a fibrin clot. Haemophilia A patients have a deficiency of this factor, so factor VIII replacement therapy helps control bleeding.

Important Information: Dosage is individualized based on factor VIII activity levels. 1 IU/kg body weight raises plasma factor VIII activity by 1.5%-2%. For long-term prevention: 20-40 IU/kg every 2-3 days.

• Treatment and prevention of bleeding in haemophilia A

Anti-fibrinolytic drugs

Clotting Factor

Octanate contains human blood coagulation factor VIII which is a special protein involved in blood clotting. Factor VIII is an essential component of the blood coagulation cascade required for the formation of a fibrin clot. Haemophilia A is a hereditary condition where there is a lack of coagulation factor VIII in the blood, causing bleeding to go on for longer than expected.

Factor VIII acts as a cofactor for factor IXa in the blood coagulation cascade, facilitating the activation of factor X and leading to fibrin clot formation.

Adult Dose (Bleeding Prevention):

• Severe haemophilia A: 20-40 IU/kg every 2-3 days (long-term prevention)
• Dosage should be adjusted according to response

Dosage Calculation:

• 1 IU/kg body weight raises plasma factor VIII activity by 1.5%-2%
• Required dosage is based on plasma factor VIII activity level

* Use as directed by the registered physician

Intravenous (IV) injection/infusion - inject slowly at a rate of 2-3 ml/minute. Monitor pulse rate before and during injection. Reconstitute powder with solvent before injection.

If you miss a dose, consult your doctor.

Common Side Effects (rare, up to 1 in 1,000):

• Hypersensitivity/allergic reactions
• Burning and stinging at infusion site
• Chest tightness
• Chills
• Tachycardia
• Nausea
• Tingling
• Flushing
• Headache
• Hives/Urticaria
• Hypotension
• Rash
• Restlessness
• Angioedema

Very rare (up to 1 in 10,000): Anaphylaxis (life-threatening allergic reaction)

Precautions:

• Caution in patients with known allergic reaction to hamster protein
• Monitor pulse rate during injection - if marked increase occurs, reduce injection speed or interrupt
• For traceability of biological medicines, record product name and batch number

Contraindications:

• Hypersensitivity to active substance or any excipients
• Known allergic reaction to hamster protein

Drug Interactions: No interactions with other medicinal products have been reported.

Food Interactions: No interaction found/established.

Use in Pregnancy: If pregnant or breastfeeding, ask your doctor for advice before taking this medicine.

Use in Lactation: If pregnant or breastfeeding, ask your doctor for advice before taking this medicine.

Pediatric Use: Use as per doctor's advice for children.

Geriatric Use: Use as per doctor's advice for elderly patients.

Renal & Hepatic Impairment: No known restrictions. However, consult your doctor.

Overdose: Limited information available on overdose. Employ usual supportive measures.

Storage: Store at 2°C-8°C. Do not freeze. Keep vials in outer carton to protect from light. Use reconstituted solution immediately.

Human Coagulation Factor VIII (Octanate)