Eftrenonacog alfa

Summary

Eftrenonacog alfa (Alprolix) is an extended half-life recombinant factor IX Fc fusion protein approved for the prevention and treatment of bleeding episodes in adults and children with hemophilia B. The Fc fusion technology extends the half-life to approximately 82 hours, allowing once-weekly or every-10-day prophylaxis dosing compared to conventional factor IX products.

Mechanism of Action

Recombinant human coagulation factor IX fused to the Fc region of human IgG1, which extends its half-life via FcRn-mediated recycling. Replaces deficient or absent factor IX, restoring the intrinsic coagulation pathway and enabling thrombin generation and clot formation.

Routes of Administration

Goals & Uses

• Prophylaxis of bleeding in hemophilia BHematology / CoagulopathyHigh
• Extended dosing interval / reduced injection frequencyPatient Adherence / Quality Of LifeHigh
• Perioperative hemostasis managementSurgical / PerioperativeHigh
• Treatment of acute bleeding episodesHematology / CoagulopathyHigh

Contraindications

• Known inhibitors to factor IX with anaphylactic historyImmunologyHigh
• Known hypersensitivity to eftrenonacog alfa or any excipientAllergy / HypersensitivityHigh
• Life-threatening hypersensitivity to hamster proteinsAllergyHigh

Adverse Effects

• Hypersensitivity / anaphylaxisImmunologicalUncommon
• Injection site discomfortLocal / Infusion RelatedCommon
• HeadacheNeurologicCommonPain in the head or upper neck
• Development of inhibitory antibodies (inhibitors)ImmunologicRare
• Thromboembolic eventsCardiovascularRare
• Dysgeusia (altered taste)SensoryUncommon

Drug Interactions

• Activated prothrombin complex concentrates (aPCCs)High
• Recombinant FVIIa (eptacog alfa)Moderate

Population Constraints

• PregnancyReproductive SafetyRelative
• Neonates / infants under 6 monthsPediatricRelative
• Patients with pre-existing thrombotic risk factorsCardiovascularRelative
• Patients with known FIX inhibitorsImmunologicRelative

Regulatory Status

• European UnionApprovedApproved: Treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency)EMA approval granted; marketed as Alprolix. Orphan designation.
• United StatesApprovedApproved: Prophylaxis and on-demand treatment and control of bleeding episodes in adults and children with hemophilia B, Perioperative management of bleeding in hemophilia BFDA approved March 2014 (adults) with subsequent pediatric approval. Orphan drug designation.
• United KingdomApprovedApproved: Treatment and prophylaxis of bleeding in hemophilia BApproved via MHRA post-Brexit recognition of EMA approval.

Approved by the FDA in March 2014 for adults and subsequently for pediatric patients with hemophilia B. Also approved by EMA. Manufactured by Biogen/Swedish Orphan Biovitrum (SOBI).

Evidence & Sources

No sources recorded yet.