Factor VIIa Recombinant (Eptacog alfa)

Antihaemorrhagic/Antihemophilic · Antihaemophilic

Indications

Treatment of bleeding episodes & prevention of bleeding in connection with surgery or invasive procedures in patients with congenital haemophilia with inhibitors to Coagulation factors VIII or IX >5 BU, acquired haemophilia, congenital FVII deficiency, Glanzmann's thrombasthaenia with antibodies to GP IIb-IIIa and/or HLA and with past or present refractory platelet transfusions.

Dosage

Adults: Haemophilia A or B with inhibitors or acquired haemophilia: IV bolus. 90 mcg/kg body wt, initially 2-3 hrly interval. May increase dosing frequency to 4, 6, 8 or 12 hrly. FVII deficiency: IV bolus. 15-30 mcg/kg body wt 4-6 hrly. Glanzmann's thrombasthaenia: IV bolus. 90 mcg/kg body wt (80-120 mcg/kg body wt) 2 hrly (1.5-2.5 hr) at least 3 doses. Children: Contact manufacturer.

Administration

IV administration only; bolus over 2-5 min. Administer within 3 hours after reconstitution. Reconstitution: Reconstitute each vial to a final concentration of 1 mg/mL. In 1 mg vial, 1.1 mL histidine diluent is reconstituted. In 2 mg vial, 2.1 mL histidine diluent is reconstituted. In 5 mg vial, 5.2 mL histidine diluent is reconstituted. In 8 mg vial, 8.1 mL histidine diluent is reconstituted. Stability: Prior to reconstitution, store under refrigeration or between 2°C-25°C (36°F-77°F). Do not freeze. Protect from light. Prior to reconstitution bring vial to room temperature at recommended diluent along wall of the vial; do not inject directly onto powder. Gently swirl until dissolved. Reconstituted solutions may be stored at room temperature or under refrigeration, but must be infused within 3 hours of reconstitution. Do not freeze reconstituted solutions. Do not store reconstituted…

Adverse Effects

Fever, pain on inj site, nausea, skin rash, increased D-dimer, thrombophlebitis, MI.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Risk cannot be ruled out. Lactation: Caution advised or effect undetermined. Precautions: Patients who have just undergone surgery, crush injury, thrombotic complications, advanced atherosclerotic disease, septicaemia/toxaemia.

Interactions

Simultaneous use of activated/non-activated prothrombin complex concentrates.

Advice to Patient

This medication is administered via intravenous route only. Wear or carry identification card indicating haemophilic condition. Contact prescriber if there is sudden-onset headache, rashes, chest pain, back pain, wheezing or respiratory difficulties, hives, itching, low-grade fever, stomach pain, nausea or vomiting.

Pharmacokinetics

Haemophilia A or B: Half-life, terminal: Children: 2-12 yrs: 2.6 hrs. Adults: 2.9-3.1 hrs. Excretion: Clearance: Children: 2-12 yrs: 58 mL/hr/kg. Adults: 31-39 mL/hr/kg. Factor VII deficiency: Half-life, terminal: 2.8-3.1 hrs. Excretion: Clearance: 71-79 mL/kg/hr.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.