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Octocog alfa


Generic Medicine Info
Indications and Dosage
Intravenous
Haemorrhagic episodes in patients with haemophilia A
Adult: As treatment and prophylaxis: Dosage is individualised based on the severity of factor VIII deficiency, extent and location of bleeding, and patient's clinical response. Recommended target factor VIII concentrations: Early haemarthrosis, muscle bleeding or oral bleeding: 20-40%; doses are given 12-24 hourly for at least 1 day until the bleeding episode, as indicated by pain, is resolved, or healing is attained. More extensive haemarthrosis, muscle bleeding or haematoma: 30-60%; doses are given 12-24 hourly for 3-4 days or more until pain and acute disability are resolved. Life-threatening haemorrhages: 60-100%; doses are given 8-24 hourly until threat is resolved. Minor surgery, including tooth extraction: 30-60%; doses are given 24 hourly for at least 1 day until healing is attained. Major surgery (pre-operative and post-operative): 80-100%; doses are given 8-24 hourly until adequate wound healing, then continue therapy for at least another 7 days to maintain factor VIII levels of 30-60%. Dosage is calculated based on a formula. Required units (international units) = body weight (kg) x desired factor VIII rise (%) x 0.5. Doses are given via inj over ≤5 min at a Max rate of 10 mL/min. Dosage and treatment recommendations may vary between countries (refer to specific local guidelines).
Child: As treatment and prophylaxis: Dosage is individualised based on the severity of factor VIII deficiency, extent and location of bleeding, and patient's clinical response. <6 years Recommended target factor VIII concentrations: Early haemarthrosis, muscle bleeding or oral bleeding: 20-40%; doses are given 8-24 hourly for at least 1 day until the bleeding episode, as indicated by pain, is resolved, or healing is attained. More extensive haemarthrosis, muscle bleeding or haematoma: 30-60%; doses are given 8-24 hourly for 3-4 days or more until pain and acute disability are resolved. Life-threatening haemorrhages: 60-100%; doses are given 6-12 hourly until threat is resolved. Minor surgery, including tooth extraction: 30-60%; doses are given 12-24 hourly for at least 1 day until healing is attained. Major surgery (pre-operative and post-operative): 80-100%; doses are given 6-24 hourly until adequate wound healing, then continue therapy for at least another 7 days to maintain factor VIII levels of 30-60%; ≥6 years Same as adult dose. Dosage is calculated based on a formula. Required units (international units) = body weight (kg) x desired factor VIII rise (%) x 0.5. Doses are given via inj over ≤5 min at a Max rate of 10 mL/min.

Intravenous
Prophylaxis in severe haemophilia A
Adult: For long-term prophylaxis of bleeding episodes: 20-40 international units/kg at intervals of 2-3 days. Alternatively, 20-40 international units/kg every other day (3-4 times weekly). Doses are given via inj over ≤5 min at a Max rate of 10 mL/min. Dosage and treatment recommendations may vary between countries (refer to specific local guidelines).
Child: There is limited information regarding the use of this drug in this population, treatment recommendations may vary between countries (refer to specific local guidelines).
What are the brands available for Octocog alfa in Thailand?
Reconstitution
Instructions for reconstitution may vary between countries (refer to specific product guidelines).
Contraindications
Hypersensitivity.
Special Precautions
Children. Pregnancy and lactation.
Adverse Reactions
Significant: Antibody formation, hypersensitivity reactions (e.g. anaphylaxis).
Blood and lymphatic system disorders: Lymphangitis.
Cardiac disorders: Palpitations, chest pain.
Eye disorders: Eye inflammation.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, upper abdominal pain, dysgeusia.
General disorders and administration site conditions: Pyrexia, peripheral oedema, chills, abnormal feeling, inj site haematoma, inj site reaction, fatigue, malaise.
Infections and infestations: Influenza, laryngitis.
Investigations: Increased monocyte count; decreased coagulation factor VIII level and haematocrit; abnormal laboratory test.
Nervous system disorders: Headache, dizziness, memory impairment, syncope, tremor, migraine.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Skin and subcutaneous tissue disorders: Rash, pruritus, hyperhidrosis, urticaria.
Vascular disorders: Haematoma, hot flush, pallor.
Monitoring Parameters
Obtain factor VIII levels at baseline and during administration. Monitor heart rate and blood pressure before and during administration; Hb, haematocrit; factor VIII inhibitor development. Assess for signs and symptoms of hypersensitivity reactions and intravascular haemolysis.
Action
Description:
Mechanism of Action: Octocog alfa, a recombinant coagulation factor VIII, is a glycoprotein that is biologically equivalent to the factor VIII glycoprotein in human plasma. It replaces the deficient clotting factor VIII present in haemophilia A, which is essential for blood clotting and haemostasis.
Pharmacokinetics:
Excretion: Elimination half-life: 12 hours.
Storage
Intact vial: Store between 2-8°C. Do not freeze. Reconstituted solution: Store at 25°C for up to 3 hours. Storage recommendations may vary between countries (refer to specific product guidelines).
MIMS Class
Haemostatics
ATC Classification
B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
References
Advate (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 14/04/2025.

Advate 2,000 IU Powder and Solvent for Solution for Injection (Takeda Manufacturing Austria AG). MHRA. https://products.mhra.gov.uk. Accessed 14/04/2025.

Advate 250 IU Powder and Solvent for Solution for Injection (Takeda Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 14/04/2025.

Antihemophilic Factor (Recombinant). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 14/04/2025.

Brayfield A, Cadart C (eds). Factor VIII. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/04/2025.

Joint Formulary Committee. Factor VIII Fraction, Dried. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/04/2025.

Takeda New Zealand Limited. Advate 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 3,000 IU, 4,000 IU Powder for Injection with Diluent data sheet 31 May 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 14/04/2025.

Disclaimer: This information is independently developed by MIMS based on Octocog alfa from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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