Watch Video Now Icon WATCH NOW: Clinical experience with ALPROLIX

ALPROLIX® has been evaluated in real-world settings for up to 5 years

Study design1

  • Data are from a multicenter, retrospective chart review of patients with hemophilia B (n=64) aged 2 to 78 years who had received ALPROLIX prophylaxis or on-demand treatment for ≥6 months across 6 sites in the United States
  • The median duration on ALPROLIX was 2.7 (0.5-5) years
  • Some of the data were collected while the patients were in the B-LONG, Kids B-LONG, and B-YOND studies; however, most data were collected after study termination

Study limitations1

  • These data are limited by the retrospective nature of the chart review; small sample sizes; the availability, completeness, and accuracy of medical charts; and the variability of the information collected by different observers
  • Data are presented using descriptive statistics; therefore, extrapolation of results to patients outside the study population may be limited

Patients who switched to ALPROLIX prophylaxis saw a reduction in ABRs regardless of prior factor IX therapy or treatment regimen1

  • The median ABR with ALPROLIX prophylaxis was less than half that of patients’ prior SHL prophylaxis (4.8 vs 2; n=13)
  • 81% of patients (n=26/32) who switched to ALPROLIX prophylaxis from SHL prophylaxis were able to lengthen their dosing interval
  • The median duration on ALPROLIX was 2.7 (0.5-5) years
  • Patients who switched to ALPROLIX prophylaxis from prior SHL prophylaxis saw an ~50% reduction in weekly factor consumption (n=32)
    • – Median baseline consumption was 116 IU/kg on prior SHL therapy, with a reduction to 60 IU/kg at first infusion of ALPROLIX

Severe and moderate patients who switched* to ALPROLIX prophylaxis saw a reduction in ABRs by 76% (from 4.5 to 1.1; n=16) and 52% (from 6.9 to 3.3; n=6), respectively1

*Patients could be on prior SHL prophylaxis treatment or SHL on-demand treatment before switching to ALPROLIX prophylaxis.

Data are not from a head-to-head study. No head-to-head studies were conducted to assess the safety or efficacy of ALPROLIX compared with SHL products.

ABR=annualized bleed rate; SHL=standard half-life.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • ALPROLIX is contraindicated in patients who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

WARNINGS AND PRECAUTIONS:

  • Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with factor replacement therapies, and have been reported with ALPROLIX. Discontinue use of ALPROLIX if hypersensitivity symptoms occur, and initiate appropriate treatment.
  • Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX. Patients using ALPROLIX should be monitored for the development of Factor IX inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor IX levels have been achieved and maintained.
  • The use of Factor IX products has been associated with the development of thromboembolic complications.
  • Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with Factor IX inhibitors and a history of allergic reactions to Factor IX. The safety and efficacy of using ALPROLIX for immune tolerance induction have not been established.

ADVERSE REACTIONS:

  • The most common adverse reactions (incidence ≥1%) in previously untreated patients were injection site erythema, hypersensitivity, and Factor IX inhibition. The most common adverse reactions (incidence ≥1%) in previously treated patients were headache, oral paresthesia, and obstructive uropathy.

INDICATION:

ALPROLIX® is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use
ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.

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Reference: 1. Shapiro A, Chaudhury A, Wang M, et al. Haemophilia. 2020;26(6):975-983.