Eftrenonacog alfa
Also known as: Alprolix, BeneFIX-Fc, INN: eftrenonacog alfa, recombinant factor IX Fc fusion protein, rFIX-Fc, rFIXFc
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Summary
Eftrenonacog alfa is a recombinant factor IX Fc fusion protein (Alprolix) used for prophylaxis and treatment of bleeding episodes in patients with hemophilia B.
Mechanism of Action
Provides functional factor IX activity by replacing deficient endogenous factor IX, restoring the intrinsic pathway of coagulation and enabling thrombin generation.
Routes of Administration
Goals & Uses
- Hemophilia B prophylaxisPreventiveHigh
- 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
- On-demand treatment of bleeding episodesTherapeuticHigh
Contraindications
- Known inhibitors to factor IX with anaphylactic historyImmunologyHigh
- Known hypersensitivity to eftrenonacog alfa or any excipientAllergy / HypersensitivityHigh
- Life-threatening hypersensitivity to hamster proteinsAllergyHigh
- Presence of high-titer factor IX inhibitorsImmunogenicityModerate
- Known hypersensitivity to eftrenonacog alfa or any of its excipientsAllergyHigh
Adverse Effects
- Thrombotic eventsCardiovascularRare
- Hypersensitivity / anaphylaxisImmunologicalUncommon
- Injection site reactionsLocalCommon
- Injection site discomfortLocal / Infusion RelatedCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Development of inhibitory antibodies (inhibitors)ImmunologicRare
- Thromboembolic eventsCardiovascularRare
- ArthralgiaMusculoskeletalUncommonJoint pain
- Dysgeusia (altered taste)SensoryUncommon
Drug Interactions
- Anticoagulants (e.g., warfarin, direct oral anticoagulants)Moderate
- 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
- Pregnant or breastfeeding womenReproductiveRelative
- Pediatric patients <12 yearsAgeRelative
- Patients with known FIX inhibitorsImmunologicRelative
Regulatory Status
- European UnionApprovedApproved: Hemophilia B prophylaxis, On-demand treatment of bleeding episodesEMA approval in 2015.
- United StatesApprovedApproved: Hemophilia B prophylaxis, On-demand treatment of bleeding episodesFDA approval in 2016.
- United KingdomApprovedApproved: Hemophilia B prophylaxis, On-demand treatment of bleeding episodesMHRA approval aligned with EU status.
Approved by FDA (2016) and EMA (2015) for hemophilia B; marketed under the brand name Alprolix.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Eftrenonacog alfa?
Eftrenonacog alfa is a recombinant factor IX Fc fusion protein (Alprolix) used for prophylaxis and treatment of bleeding episodes in patients with hemophilia B.
What is Eftrenonacog alfa used for?
Eftrenonacog alfa is educationally associated with: Hemophilia B prophylaxis, Prophylaxis of bleeding in hemophilia B, Extended dosing interval / reduced injection frequency, Perioperative hemostasis management, Treatment of acute bleeding episodes, On-demand treatment of bleeding episodes. Educational only — not medical advice.
How is Eftrenonacog alfa administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Eftrenonacog alfa?
Reported adverse effects include: Thrombotic events, Hypersensitivity / anaphylaxis, Injection site reactions, Injection site discomfort, Headache, Development of inhibitory antibodies (inhibitors), Thromboembolic events, Arthralgia, Dysgeusia (altered taste). This list is not exhaustive — consult a qualified clinician.
Who should avoid Eftrenonacog alfa?
Recorded contraindications: Known inhibitors to factor IX with anaphylactic history, Known hypersensitivity to eftrenonacog alfa or any excipient, Life-threatening hypersensitivity to hamster proteins, Presence of high-titer factor IX inhibitors, Known hypersensitivity to eftrenonacog alfa or any of its excipients. Consult a qualified clinician before use.