Factor VIIa, recombinant


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Bleeding episodes in patients w/ haemophilia As activated eptacog alfa: Initial: 90 mcg/kg. May continue therapy for up to 3 wk or more in cases of serious bleeding episodes. Bleeding episodes due to surgery or invasive procedures in patients w/ factor VII deficiency As activated eptacog alfa: 15-30 mcg/kg 4-6 hrly. Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia As activated eptacog alfa: 90 mcg/kg 2 hrly, give at least 3 doses. All doses to be given via IV bolus over 2-5 min.
Dosage Details
Intravenous
Bleeding episodes in patients with haemophilia
Adult: As activated eptacog alfa: Initially, 90 mcg/kg given via IV bolus over 2-5 min. Additional dose may be given as needed to achieve or maintain haemostasis, initially 2-3 hrly. May adjust dose or dosing interval according to response. May continue therapy for up to 3 wk or more in cases of serious bleeding episodes.

Intravenous
Bleeding episodes due to surgery or invasive procedures in patients with factor VII deficiency
Adult: As activated eptacog alfa: 15-30 mcg/kg 4-6 hrly via IV bolus over 2-5 min until haemostasis is achieved.

Intravenous
Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia
Adult: As activated eptacog alfa: 90 mcg/kg 2 hrly via IV bolus over 2-5 min, give at least 3 doses.
Reconstitution
Add the recommended diluent (histidine), swirl gently until dissolved.
Incompatibility
Should not be mixed w/ infusion soln or be given in a drip.
Contraindications
Hypersensitivity to hamster, bovine or mouse proteins.
Special Precautions
Patient w/ conditions associated w/ circulating tissue factor (e.g. advanced atherosclerosis, crush injury or septicaemia) due to risk of precipitating thrombosis or disseminated intravascular coagulation. Pregnancy and lactation.
Adverse Reactions
Nausea, vomiting, skin reactions, fever, headache and changes in BP. Rarely, anaphylaxis.
IV/Parenteral: C
MonitoringParameters
Monitor prothrombin time/INR, aPTT and factor VII clotting activity prior to and after therapy.
Drug Interactions
Increased risk of thromboembolism w/ activated or non-activated prothrombin complex concentrate.
Action
Description: Recombinant factor VIIa is a biosynthetic preparation of activated factor VII produced by recombinant DNA technology. It is a vitamin K-dependent glycoprotein. It promotes haemostasis by activating the extrinsic pathway of the coagulation cascade. It replaces deficient activated coagulation factor VII, which complexes w/ tissue factor and may activate coagulation factor X and factor IX. Factor VIIa is given as the recombinant form, eptacog alfa (activated).
Pharmacokinetics:
Distribution: Volume of distribution: 103 mL/kg.
Excretion: Elimination half-life: 2.3 hr.
Storage
Store between 2-25°C prior to reconstitution. Do not freeze. Protect from light.
MIMS Class
References
Anon. Factor VIIa (Recombinant). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/09/2014.

Buckingham R (ed). Factor VII. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/09/2014.

NovoSeven RT (Coagulation Factor VIIa [recombinant]) Kit (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/09/2014.

Disclaimer: This information is independently developed by MIMS based on Factor VIIa, recombinant 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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