FACTOR VIIA,RECOMBINANT-JNCW INJ,LYPHL
Clinical Criteria Summary
Indications & Patient Population
- Indicated for the treatment and control of bleeding episodes in adults and adolescents aged > 12 years with hemophilia A or B with inhibitors.
- Evaluated for on-demand treatment of mild/moderate bleeding events (BEs) and perioperative management/hemostasis.
Dosing & Administration
- Supplied as a lyophilized powder in 1 mg or 5 mg single-use vials; reconstituted to a final concentration of 1 mg/mL.
- Dosing regimens include 75 mcg/kg and 225 mcg/kg as initial doses, with additional 75 mcg/kg doses administered until objective and refractory response.
- Perioperative administration includes preoperative dosing followed by up to 75 mcg/kg postoperative doses as directed by the surgeon/investigator.
Safety, Contraindications & Warnings
- Boxed warning for thrombosis; serious arterial and venous thrombotic events have been reported.
- Contraindicated in patients with known allergy to rabbits or rabbit proteins, or severe hypersensitivity reaction to rFVIIa or its components.
- Patients with other risk factors for thrombosis may be at increased risk of serious arterial or venous thrombotic events.
- Hypersensitivity reactions, including anaphylaxis, are possible.
Formulary & Clinical Guidance
- Indicated for treatment/control of bleeding episodes in adults and adolescents > 12 years with hemophilia A or B with inhibitors.
- Derived from genetically engineered rabbits; risk of thrombosis with emicizumab is unknown.
- For patients on emicizumab prophylaxis, eptacog beta is a reasonable option alongside eptacog alfa.
- May be less costly and require fewer doses per bleed event compared to alternatives in congenital hemophilia A or B with inhibitors.
- Recommended for availability on the VA National Formulary (VANF) without restrictions.