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ALPROLIX® prophylaxis offers bleed and joint bleed protection* for pediatric patients and adults/adolescents

*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.

PEDIATRIC PATIENTS Aged 1-11 years

Median overall ABR with ALPROLIX prophylaxis1

Patients aged 1 to 5 years:
1.09 (0-2.9)

Patients aged 6-11 years:
2.13 (0-4.17)

Median joint ABR with
 ALPROLIX prophylaxis1

Patients aged 1 to 5 years:
0 (0-0)

Patients aged 6-11 years:
1.06 (0-2.09)

Median AsBR of ZERO1

Patients aged 1 to 5 years:
0 (0-1.09)

Patients aged 6-11 years:
0 (0-2.09)

Median joint AsBR of ZERO2

Patients aged 1 to 5 years:
0 (0-0)

Patients aged 6-11 years:
0 (0-1)

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. All 30 patients were treated with ALPROLIX on an individualized prophylactic regimen. Fifteen patients were 1 to 5 years of age; 15 patients were 6 to 11 years of age.1

ABR=annualized bleed rate; AsBR=annualized spontaneous bleed rate.

ADULTS AND ADOLESCENTS Aged ≥12 years

ALPROLIX prophylaxis offers effective bleed protection* with tomorrow in mind

Median overall ABR with ALPROLIX prophylaxis1

Interval-adjusted prophylaxis:
1.38 (0-3.43)

Weekly prophylaxis:
2.95 (1.01-4.35)

Median AsBR of ≤1 with ALPROLIX prophylaxis1

Interval-adjusted prophylaxis:
0.88 (0-2.3)

Weekly prophylaxis:
1.04 (0-2.19)

Joint bleed protection* today for what tomorrow may bring

Median joint ABR with ALPROLIX prophylaxis1

Interval-adjusted prophylaxis:
0.36 (0-3.24)

Weekly prophylaxis:
1.11 (1-4.01)

Median joint AsBR of ≤13

Interval-adjusted prophylaxis:
0 (0-1.7)

Weekly prophylaxis:
1 (0-2.1)

*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.

Target joint resolution with ALPROLIX

100%

of adult and adolescent
 patients in B-YOND achieved target joint resolution

  • Target joints were resolved in 37/37 patients who had target joints at baseline in B-LONG
  • In our study, a target joint was defined as a major joint with ≥3 bleeding episodes in a consecutive 3-month period
  • Prior to enrollment in B-LONG, patients were on either an on-demand or prophylactic standard half-life (SHL) treatment regimen
  • In our study, target joint resolution was defined based on the ISTH subcommittee, which defines target joint resolution as ≤2 spontaneous bleeds in the target joint over 12 months
  • Patients had ≥12 months of consecutive follow-up and did not undergo joint surgery within 12 months of the start of follow-up

Clinical trial information
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

B-YOND was an extension trial that studied the long-term safety and efficacy of ALPROLIX in 120 adult, adolescent, and pediatric patients previously treated in Kids B-LONG or B-LONG. The study included a fixed-interval arm (n=74), a fixed-dose arm (n=36), a modified prophylaxis arm (n=17), and an episodic (on-demand) arm (n=15).6

ABR=annualized bleed rate; AsBR=annualized 
spontaneous bleed rate.

PREVIOUSLY UNTREATED
 PATIENTS (PUPs) Aged <18 years

ALPROLIX prophylaxis offers protection* for PUPs today and tomorrow7

Median overall ABR:
1.24 (0-2.49)

Median traumatic ABR:
0.91 (0-1.8)

Spontaneous bleed rates of zero

Median AsBR:
0 (0-0)

Median joint AsBR:
0 (0-0)

*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.

Clinical trial information
PUPs B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 33 previously untreated patients with moderate or severe hemophilia B (≤2% endogenous factor IX activity). Twenty-eight patients completed the study in the prophylaxis arm and 5 patients completed the study in the on-demand arm. At enrollment, the median age was 0.6 years (range: 0.1-2 years).7

ABR=annualized bleed rate; AsBR=annualized spontaneous bleed rate; EHL=extended 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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References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Fischer K, Kulkarni R, Nolan B, et al. Recombinant factor IX Fc fusion protein in children with haemophilia B (Kids B-LONG): results from a multicentre, non-randomised phase 3 study. Lancet Haematol. 2017;4(2):e75-e82. 3. Powell JS, Pasi KJ, Ragni MV, et al. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323. 4. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 5. Blanchette VS, Key NS, Ljung LR, et al. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014;12(11):1935-1939. 6. Pasi KJ, Fischer K, Ragni M, et al. Long-term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: results from the B-YOND extension study. Haemophilia. 2020;26(6):e262-e271. 7. 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.