Factor VIIa, recombinant: Indication, Dosage, Side Effect, Precaution

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

Generic Medicine Info

Indications and Dosage

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.

Pregnancy Category (US FDA)

IV/Parenteral: C

Monitoring Parameters

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:
Mechanism of Action: 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

Haemostatics

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.

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