WATCH NOW: Clinical experience with ALPROLIX

ALPROLIX® offers acute bleed control for pediatric patients and adults/adolescents1

  • Most bleeding episodes resolved with just 1 infusion1,2:
    Kids B-LONG:
    75% (n=45/60)
    |
    B-LONG:
    90% (n=575/636)
    |
    Previously untreated patients (PUPs) B-LONG: 87% (n=74/85)
    • Kids B-LONG: 75% (n=45/60)
    • B-LONG: 90% (n=575/636)
    • Previously untreated patients (PUPs) B-LONG: 87% (n=74/85)
  • Response to first infusion was rated as excellent or good,* with abrupt or definite pain reliefand/or improvement in signs of bleeding1,3,4:
    Kids B-LONG:
    89% (n=47/53)
    |
    B-LONG:
    84% (n=513/613)
    |
    PUPs B-LONG:
    91% (n=72/79)
    • Kids B-LONG: 89% (n=47/53)
    • B-LONG: 84% (n=513/613)
    • PUPs B-LONG: 91% (n=72/79)
  • In B-LONG, the median overall ABR for adults and adolescents treated on demand was 17.69 (10.77-23.24)

*Seven first injections for bleeding episodes in children were not evaluated for response and are excluded from this analysis.1

*Seven first injections for bleeding episodes in children were not evaluated for response
and are excluded from this analysis.1

Excellent response was defined as abrupt pain relief and/or improvement in signs of bleeding.Good response was defined as definite pain relief and/or improvement in signs of bleeding but possibly requiring another injection in 1-2 days.1,4

Child Gate Pose

Clinical trial information

Kids B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 30 previously treated pediatric patients with severe hemophilia B. Fifteen patients were 1 to 5 years of age; 15 patients were 6 to 11 years of age.1

B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 123 previously treated adult and adolescent patients aged ≥12 years with severe hemophilia B. The study included a fixed-interval (weekly) arm (n=63), a fixed-dose (interval-adjusted) arm (n=29), an episodic (on-demand) arm (n=27), and a surgical arm (n=12).1

PUPs B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 33 PUPs aged <18 years with moderate or severe hemophilia B (≤2% endogenous factor IX activity). At enrollment, the median age was 0.6 years (range: 0.1-2 years).3

ABR=annualized bleed rate.

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.

Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.

References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Data on file. Waltham, MA: Bioverativ Therapeutics Inc. 3. Nolan B, Klukowska A, Shapiro A, et al. Final results of PUPs B-LONG study: evaluating safety and efficacy of rFIXFc in previously untreated patients with hemophilia B. Poster presented at: The 28th Congress of the International Society of Thrombosis and Haemostasis (ISTH); July 12-14, 2020; Virtual. 4. Study to determine the safety and efficacy of rFIXF in previously untreated males with severe hemophilia b (PUPs B-LONG). ClinicalTrials.gov identifier: NCT02234310. https://clinicaltrials.gov/ct2/show/NCT02234310. Updated July 31, 2020. Accessed November 12, 2020.