Factor VIII: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Prophylaxis in severe haemophilia A

Adult: For long-term prevention: Usual dose: 20-50 IU/kg at 2-3 day intervals. Shorter dosage intervals or higher doses may be required in some cases. Dosage recommendations may vary among countries or individual products. Refer to specific product guidelines.
Child: Dosage recommendation may vary among countries or individual products. Refer to specific product guidelines.

Intravenous
Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A

Adult: Dosage requirement, dose frequency, and duration of treatment may vary according to individual factor VIII levels, location and extent of bleeding, patient condition, and type of preparation used. Required dose is calculated according to the empirical finding that 1 IU/kg will increase circulating factor VIII levels by approx 2% of normal activity or 2 IU/dL. Recommended increments in Factor VIII levels: Mild to moderate haemorrhage including early haemarthrosis, muscle or oral bleeding: Increase to 20-40% of normal. Dose may be given 12-24 hourly for at least 1 day until bleeding episode is resolved or healing is achieved. More serious haemorrhage or minor surgery: Increase to 30-60% of normal. Dose may be given 12-24 hourly for 3-4 days or more until acute disability and pain are resolved or for at least 1 day until healing is achieved (minor surgery). Severe haemorrhage: Increase to 60-100% of normal. Dose may be given 8-24 hourly until threat is resolved. Major surgery: Increase to 80-100% of normal. Dose may be given 8-24 hourly until adequate wound healing, continue therapy for at least another 7 days to maintain the 30-60% factor VIII activity. Refer to individual product information for further dosing details.
Child: Dosage recommendation may vary among countries or individual products. Refer to specific product guidelines.

Reconstitution

Reconstitute dried concentrate with the provided diluent then gently swirl or rotate vial. Do not shake. Reconstitution and preparation may vary among individual products (refer to specific product guideline).

Special Precautions

Patient with existing CV risk factors; blood groups A, B, and AB. Pregnancy and lactation.

Adverse Reactions

Significant: Formation of neutralising antibodies or inhibitors; haemolytic anaemia, intravascular haemolysis, and decreased haematocrit (large or frequent doses in patients with A, B, or AB blood groups). Rarely, hypersensitivity or allergic reactions (e.g. angioedema, anaphylaxis, burning and stinging at infusion site, flushing, chills, generalised urticaria, headache, hypotension, hives, lethargy, restlessness, tachycardia, nausea, chest tightness, tingling, wheezing, dyspnoea, vomiting).
Gastrointestinal disorders: Dysgeusia, diarrhoea, abdominal pain.
General disorders and administration site conditions: Fever, malaise.
Investigations: Abnormal LFT, increased blood creatinine phosphokinase.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Dizziness.
Respiratory, thoracic and mediastinal disorders: Cough.
Skin and subcutaneous tissue disorders: Erythema, pruritus, rash, hyperhidrosis.

Pregnancy Category (US FDA)

IV/Parenteral: C

Monitoring Parameters

Monitor blood pressure and heart rate prior to and during IV administration; vital signs, cardiac and CNS status during and after infusion; antihaemophilic factor levels before and during treatment; coagulation status; factor VIII inhibitor development. Observe for signs and symptoms of intravascular haemolysis and falling haematocrit; bleeding, and hypersensitivity reactions.

Action

Description:
Mechanism of Action: Factor VIII is a protein required for clot formation and maintenance of haemostasis that may be derived from human plasma or recombinant sources. It acts as a cofactor for activated factor IX, increasing the conversion of factor X to activated factor X (factor Xa). Factor Xa converts prothrombin into thrombin, which converts fibrinogen into fibrin thus forming a clot.
Synonym: antihaemophilic factor.
Pharmacokinetics:
Excretion: Terminal elimination half-life: Approx 12 hours.

Storage

Store between 2-8°C or below 25°C. Do not freeze. Protect from light. Storage recommendations may vary among individual products. 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

Adynovate (Baxalta US Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 14/01/2021.

Anon. Antihemophilic Factor (Human). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/01/2021.

Anon. Antihemophilic Factor (Human). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/01/2021.

Anon. Antihemophilic Factor (Recombinant [Pegylated]). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/01/2021.

Anon. Antihemophilic Factor (Recombinant [Porcine Sequence]). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/01/2021.

Anon. Antihemophilic Factor (Recombinant). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/01/2021.

Buckingham R (ed). Factor VIII. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/01/2021.

Eloctate Lyophilized Powder for Solution for Intravenous Injection (Biogen Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/01/2021.

Haemoctin Powder and Solvent for Solution for Injection (Biotest Pharma GmbH). MHRA. https://products.mhra.gov.uk/. Accessed 07/01/2021.

Koate Lyophilized Powder for Solution for Intravenous Injection (Kedrion Biopharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/01/2021.

Obizur (Baxalta US Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 14/01/2021.

Octanate Powder and Solvent for Solution for Injection (Pharmaniaga Marketing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 07/01/2021.

Xyntha Powder and Solvent for Solution for Intravenous Injection (Pfizer Pte Ltd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 07/01/2021.

Disclaimer: This information is independently developed by MIMS based on Factor VIII 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 © 2024 MIMS. All rights reserved. Powered by MIMS.com