Alprolix Labeling Updated With Long-Term Data, Additional Adverse Reaction
The Food and Drug Administration (FDA) has approved updated labeling Alprolix (coagulation factor IX [recombinant], Fc fusion protein; Bioverativ) indicated for the treatment of children and adults with hemophilia B.
The update includes interim data from the Phase 3 B-YOND open-label, non-randomized extension trial and final data from the Phase 3 Kids B-LONG pediatric study (children aged <12 years); the data reflects 93 patients treated prophylactically for over 104 weeks with Alprolix.
In the studies, weekly prophylaxis with Alprolix led to a median spontaneous annualized bleeding rate (AsBR) of 0 among children and 1.04 among adults and adolescents; the median joint annualized bleeding rate (ABR) was 0 among children and 1.11 among adults and adolescents. Median overall ABRs following weekly prophylaxis was 1.97 for children and 2.95 for adults and adolescents.
In addition, obstructive uropathy was added to the prescribing information as an adverse reaction. The condition was reported in 2 patients and was resolved upon receipt of hydration.
Alprolix, a recombinant clotting factor therapy, utilizes Fc fusion technology to prolong circulation in the body. Alprolix is available as 500 IU, 1000 IU, 2000 IU, 3000 IU strength lyophilized powder per vial for intravenous (IV) injection after reconstitution.
For more information call (855) 692-5776 or visit Alprolix.com.