Eptacog alfa (activated)


Generic Medicine Info
Indications and Dosage
Intravenous
Haemophilia A with inhibitors, Haemophilia B with inhibitors
Adult: As treatment of bleeding episodes: Initially, 90 mcg/kg; additional doses may be given as necessary to achieve and maintain haemostasis, initially at 2-3 hour intervals. In patients with mild to moderate bleeding episodes (including home therapy): 90 mcg/kg for 2-3 doses given at 3-hour intervals; may give 1 additional dose if required; alternatively, 270 mcg/kg as a single dose. Max duration of home therapy: 24 hours. In patients with serious bleeding episodes: Initially, 90 mcg/kg may be given on the way to the hospital, then adjust dosing according to response. Duration of treatment: 2-3 weeks, or more if clinically indicated. In patients undergoing invasive procedure or surgery: Initially, 90 mcg/kg given immediately before the intervention; repeat dose after 2 hours, then continued at 2-3-hour intervals for the 1st 24-48 hours, depending on the intervention performed and patient’s clinical status. In major surgery: Doses are continued at 2-4-hour intervals for 6-7 days, then the interval may be increased to 6-8 hours for another 2 weeks. Treatment duration may be up to 2-3 weeks until healing has occurred. All doses are given via IV bolus inj over 2-5 minutes. Dosing interval and treatment duration may vary according to the severity of bleeding and the surgery or invasive procedures being performed. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Intravenous
Factor VII deficiency
Adult: As treatment of bleeding episodes or prevention of bleeding in patients undergoing surgery or invasive procedures: 15-30 mcg/kg 4-6 hourly via IV bolus inj over 2-5 minutes until haemostasis is achieved. Dosage is individualised and adjusted according to patient's clinical response. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Intravenous
Acquired haemophilia
Adult: As treatment for bleeding episodes or prevention of bleeding in patients undergoing surgery or invasive procedures: Initially, 90 mcg/kg via IV bolus inj over 2-5 minutes given as early as possible at the start of bleeding episode. Additional doses may be given as necessary to achieve and maintain haemostasis, initially at 2-3 hour intervals. Dosing interval and treatment duration may vary according to the severity of bleeding and the surgery or invasive procedures being performed. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Intravenous
Glanzmann's thrombasthenia
Adult: As treatment of bleeding episodes and prevention of bleeding in patients undergoing surgery or invasive procedures who are refractory to platelet transfusions: 90 mcg/kg 2 hourly via IV bolus inj over 2-5 minutes for at least 3 doses. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Intravenous
Postpartum haemorrhage
Adult: As treatment for severe cases when uterotonics are inadequate to obtain haemostasis: 60-90 mcg/kg as a single dose via IV bolus inj over 2-5 minutes. Dose may be repeated after 30 minutes if with inadequate haemostatic response. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
What are the brands available for Eptacog alfa (activated) in Hong Kong?
Reconstitution
Instructions for reconstitution may vary among individual products and between countries. Refer to specific product guidelines for further instructions on reconstitution.
Contraindications
Hypersensitivity.
Special Precautions
Patient with known risk factors for thromboembolic complications such as history of CHD, disseminated intravascular coagulation (DIC), or those requiring postoperative immobilisation. Patient with increased risk of precipitating thrombosis or DIC caused by pathological conditions associated with circulating tissue factor or predisposing coagulopathy (e.g. advanced atherosclerotic disease, septicaemia, crush injury, DIC). Hepatic impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Serious arterial and venous thrombotic events, induction of disseminated intravascular coagulation, antibody formation; hypersensitivity reactions (e.g. anaphylaxis).
Gastrointestinal disorders: Nausea, vomiting.
General disorders and administration site conditions: Decreased therapeutic response, pyrexia, inj site reaction.
Investigations: Rarely, increased fibrin degradation products, ALT/AST, lactate dehydrogenase or prothrombin.
Musculoskeletal and connective tissue disorders: Haemarthrosis, arthralgia.
Nervous system disorders: Headache, dizziness, intracranial hypertension.
Skin and subcutaneous tissue disorders: Rash (including allergic dermatitis, rash erythematous), pruritus, urticaria, angioedema.
Vascular disorders: Hypertension, hypotension, flushing.
IV/Parenteral: C
Monitoring Parameters
Monitor prothrombin time and factor VII coagulant activity before and after administration of therapy to factor VII deficient patients. Obtain Hb and haematocrit levels. Screen evidence of haemostasis. Assess for signs and symptoms of hypersensitivity reactions, activation of coagulation system or thrombosis (e.g. chest pain, shortness of breath, pain, numbness, duskiness, discolouration or tingling to extremity), excess bleeding (e.g. bruising, mouth or nose bleeding, chest or abdominal pain), and inj site pain or local reaction.
Drug Interactions
Potential enhancement of thrombotic effects and increased risk of thromboembolic events with activated or nonactivated prothrombin complex concentrate or other haemostatic agents.
Action
Description:
Mechanism of Action: Eptacog alfa (activated), is a biosynthetic preparation of endogenous blood coagulation factor VIIa, which activates the extrinsic pathway of the coagulation cascade, leading to haemostasis. It is a vitamin K-dependent glycoprotein that, when complexed with tissue factor, can activate coagulation factor X to Xa and factor IX to IXa. Factor Xa, when complexed with other factors, converts prothrombin to thrombin, an essential step in the formation of a fibrin-platelet haemostatic plug.
Synonym(s): Factor VIIa, recombinant.
Pharmacokinetics:
Excretion: Mean terminal elimination half-life: Approx 3 hours.
Storage
Store below 25°C. Do not freeze. Protect from light. Storage recommendations of reconstituted solutions may vary among individual products and between countries (refer to specific product guidelines).
MIMS Class
Haemostatics
References
Anon. Factor VIIa (Recombinant). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 19/06/2024.

Buckingham R (ed). Factor VII. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/05/2024.

Factor VIIa (Recombinant). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/05/2024.

Joint Formulary Committee. Factor VIIa (Recombinant). British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/05/2024.

Novo Nordisk Pharmaceuticals Ltd. Novoseven RT 1 mg, 2 mg, 5 mg, 8 mg Powder and Solvent for Solution for Injection data sheet 6 November 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 07/05/2024.

NovoSeven 1 mg (50 KIU) and 2 mg (100 KIU) Powder and Solvent for Solution for Injection (Novo Nordisk Pharma [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/05/2024.

NovoSeven 1 mg (50 KIU) Powder and Solvent for Solution for Injection (Novo Nordisk A/S). MHRA. https://products.mhra.gov.uk. Accessed 07/05/2024.

Novoseven RT (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/05/2024.

Disclaimer: This information is independently developed by MIMS based on Eptacog alfa (activated) 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
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in