eptacog beta: clinical use

Prescribing considerations

• Restrict use to licensed inhibitor populations under specialist haemophilia supervision.
• Base management on bleeding site, severity, procedural context, previous response and clinical haemostasis.
• Evidence is limited in elderly people and those with renal or hepatic impairment.
• Use particular caution with previous thrombosis, atherosclerotic, coronary or cerebrovascular disease, crush injury or sepsis.
• Known IgE-mediated casein allergy may increase hypersensitivity risk.
• Maintain traceability by recording product and batch details.

Contraindications and cautions

• Hypersensitivity to eptacog beta or any excipient.
• Hypersensitivity to rabbits or rabbit proteins.

Monitoring

• Assess bleeding clinically; PT, INR, aPTT and factor VII activity do not reliably predict effectiveness.
• Monitor for arterial or venous thrombosis and activation of coagulation.
• Investigate neutralising antibodies if haemostasis is unexpectedly inadequate.
• Closely monitor perioperative haemostasis and postoperative bleeding.

Clinical pharmacology

Eptacog beta is recombinant activated human factor VII produced using recombinant DNA technology in rabbit milk. It promotes factor X activation, thrombin generation and fibrin formation, bypassing deficient or inhibited factor VIII or IX.

Formulation and product differences

• Lyophilised powder supplied with a prefilled syringe of water for injections.
• The reconstituted product is for intravenous use only and must not be mixed with other medicines.
• Manufacture in rabbit milk makes rabbit or rabbit-protein hypersensitivity specifically relevant.

Injection

Route: Parenteral

Strengths: 1 mg, 2 mg, 5 mg