Octocog alfa


Concise Prescribing Info
Indications/Uses
Haemorrhagic episodes in patients w/ haemophilia A.
Dosage/Direction for Use
Adult : IV Treatment: Dosage is individualised based on the severity of deficiency, location and extent of bleeding, and clinical condition. Generally, admin of factor VIII 1 IU/kg will increase circulating factor VIII levels by approx 2 IU/dL. Prophylaxis: 20-40 IU/kg 3-4 times/wk.
Dosage Details
Intravenous
Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A
Adult: Treatment: Dosage is individualised based on the severity of deficiency, location and extent of bleeding, and patient's clinical condition. Generally, admin of factor VIII 1 IU/kg will increase circulating factor VIII levels by approx 2 IU/dL. Recommendation: Minor bleeding: 10-20 IU/kg 12-24 hrly for approx 1-3 days. Moderate bleeding: 15-30 IU/kg 12-24 hrly for approx ≥3 days. Major bleeding: 30-50 IU/kg 8-24 hrly until bleeding resolves. Minor surgery: 30-50 IU/kg as a single dose w/in 1 hr of the procedure; repeat after 12-24 hr as needed. Major surgery: 40-60 IU/kg pre-op, repeated 8-24 hrly depending on state of wound healing. Prophylaxis: 20-40 IU/kg 3-4 times wkly. Doses are given via infusion over ≤5 min at max rate of 10 mL/min.
Child: Treatment: Same as adult dose. Patients <6 yr may require more frequent admin: 8-24 hrly (minor/moderate bleeding); 6-12 hrly (major bleeding); 6-24 hrly (major surgery). Prophylaxis: <6 yr 20-50 IU/kg 3-4 times wkly; ≥6 yr Same as adult dose.
Contraindications
Hypersensitivity to mouse or hamster protein.
Special Precautions
Childn. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylaxis), inhibitory antibodies formation, catheter-related complications (e.g. bacteraemia, local infections, catheter-site thrombosis).
Nervous: Dizziness, headache, lightheadedness, asthenia, fatigue, malaise, depersonalisation, somnolence, restlessness, falling.
CV: Chest discomfort or tightness, increased/decreased BP.
GI: Diarrhoea, constipation, vomiting, dry mouth, unpleasant taste.
Resp: Nasopharyngitis, cough, rhinitis, dyspnoea, cough, nasal congestion, wheezing, epistaxis.
Musculoskeletal: Arthralgia, limb pain or injury, joint swelling.
Otic: Earache, ear infection.
Dermatologic: Facial flushing or swelling, rash, pruritus, urticaria.
Immunologic: Flu-like symptoms.
Others: Fever, chills, generalised discomfort, cold feet, inj site reactions (e.g. burning, erythema).
MonitoringParameters
Monitor BP and heart rate before and during admin, plasma factor VIII activity before and during treatment; inhibitor occurrence, Hb, haematocrit, signs of bleeding, and hypersensitivity reactions.
Action
Description: Octocog alfa (coagulation factor VIII, recombinant) is a glycoprotein that is biologically equivalent to the factor VIII glycoprotein found in human plasma. It binds to endogenous von Willebrand Factor in the patient's circulation. Activated factor VIII activates factor X, as co-factor for activated factor IX. Activated factor X converts prothrombin to thrombin, which then converts fibrinogen to fibrin, forming a stable clot.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Approx 10-15 min, up to 1-2 hr.
Distribution: Circulates in plasma bound to von Willebrand factor; w/ minimal extravascular distribution (approx 14%).
Excretion: Terminal elimination half-life: 12 hr.
Storage
Store between 2-8°C. Do not freeze.
Any unused portions should be disposed of in accordance w/ local requirements.
MIMS Class
References
Advate (Baxalta US Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/05/2017 .

Anon. Antihemophilic Factor (Recombinant). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/05/2017 .

Buckingham R (ed). Factor VIII. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/05/2017 .

McEvoy GK, Snow EK, Miller J et al (eds). Antihemophilic Factor (Recombinant). AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 08/05/2017 .

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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