WATCH NOW: Clinical experience with ALPROLIX

ALPROLIX is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B. View full indications and usage.

ALPROLIX® prophyalxis offers joint and bleed protection* today with tomorrow in mind

Median overall ABR with ALPROLIX prophylaxis2

  • Interval-adjusted prophylaxis: 1.38 (0.00-3.43)
  • Weekly prophylaxis: 2.95 (1.01-4.35)

Median AsBR of ≤1 with ALPROLIX prophylaxis2

  • Interval-adjusted prophylaxis: 0.88 (0.00-2.30)
  • Weekly prophylaxis: 1.04 (0.00-2.19)

Median joint ABR with ALPROLIX prophylaxis2

  • Interval-adjusted prophylaxis: 0.36 (0.00-3.24)
  • Weekly prophylaxis: 1.11 (0.00-4.01)

100% of patients achieved target joint resolution✝︎ by switching to ALPROLIX5

  • Target joints were resolved for 37/37 patients who had target joints at the baseline of the B-LONG trial

✝︎A target joint is defined as a major joint with ≥3 bleeding episodes in a consecutive 3-month period.

The International Society on Thrombosis and Haemostasis subcommittee 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.5,6

Median joint AsBR of ZERO4

  • Interval-adjusted prophylaxis: zero (0.00-1.70)
  • Weekly prophylaxis: 1.0 (0.00-2.10)

A post hoc analysis showed the long-term efficacy of ALPROLIX ≥14-day dosing (N=18)7

  • Median overall ABR: 1.6 (0.6-2.7)
  • Median AsBR: 0.7 (0.3-1.1)
  • Median joint ABR: 1.0 (0.3-1.6)

The median duration of the exposure to ALPROLIX at a ≥14-day dosing interval was 3.4 years as reported in the post hoc analysis7

  • Data are reported from a post hoc analysis of 22 adult and adolescent patients (aged ≥12 years) who received ALPROLIX prophylaxis with a dosing interval of ≥14 days at any time during B‑LONG or B‑YOND, up until the time of the second interim analysis
  • The analysis was not powered to show statistical significance
  • There was a small sample size, no control group, and potential for interobserver variability
  • Patients in the Kids B-LONG study were not included in this post hoc analysis because the study design did not allow for dosing intervals longer than 1 week
Learn more about ALPROLIX prophylaxis dosing

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


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For your on-demand patients, ALPROLIX offers effective bleed control2

ALPROLIX is the #1 prescribed EHL factor IX product for on-demand treatment5‡

90%

of bleeding episodes (n=575/636) were resolved with just 1 infusion2


In 8 out of 10 bleeds,

adult and adolescent patients reported abrupt or definite pain relief§ and/or improvement in signs of bleeding with just 1 infusion2

§”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.

In B-LONG, the median overall ABR among adults and adolescents treating on demand was 17.69 (10.77-23.24)2


Nearly half of patients treated with ALPROLIX on demand during B-LONG (n=19) switched to ALPROLIX prophylaxis during the B-YOND extension trial3

Learn more about ALPROLIX on-demand dosing

Clinical trial information

B‑LONG studied 123 previously treated adult and adolescent males for a total of 77 weeks. Patients were enrolled in a fixed‑interval (weekly) prophylaxis arm (n=63), a fixed‑dose (interval‑adjusted) arm (n=29), an on‑demand arm (n=27), or a perioperative arm (n=12).2

B‑YOND included 23 pediatric and 93 adult and adolescent patients who previously completed Kids B‑LONG or B‑YOND. The treatment arms included fixed‑interval (weekly) prophylaxis, fixed‑dose (interval‑adjusted) prophylaxis, modified prophylaxis, and on‑demand (episodic) treatment.3

ADULT DOSING  ▸

ABR=annualized bleed rate; AsBR=annualized spontaneous bleed rate; EHL=extended half-life.

Based on data from hemophilia treatment centers as of June 2019.

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, including in previously untreated patients. 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: Common adverse reactions (incidence ≥1%) observed in clinical trials were headache, oral paresthesia, and obstructive uropathy.

INDICATIONS:

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.

References: 1. 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. 2. ALPROLIX [package insert]. Waltham, MA: Bioverativ; 2019. 3. Pasi KJ, Fischer K, Ragni M, et al. Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B. Thromb Haemost. 2017;117(3):508-518. 4. 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. 5. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 6. 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. 7. Shapiro AD, Pasi KJ, Ozelo MC, et al. Extending recombinant factor IX Fc fusion protein dosing interval to 14 or more days in patients with hemophilia B. Res Pract Thromb Haemost. 2018;3(1):109-113. 8. Kaneko Y, Nimmerjahn F, Ravetch JV. Anti-inflammatory activity of immunoglobulin G resulting from Fc sialylation. Science. 2006;313(5787):670-673. 9. Shapiro A. Development of long-acting recombinant FVIII and FIX Fc fusion proteins for the management of hemophilia. Expert Opin Biol Ther. 2013;13(9):1287-1297. 10. Iorio A, Fischer K, Blanchette V, et al. Tailoring treatment of haemophilia B: accounting for the distribution and clearance of standard and extended half-life FIX concentrates. Thromb Haemost. 2017;117(6):1023-1030. 11. Diao L, Li S, Ludden T, Gobburu J, Nestorov I, Jiang H. Population pharmacokinetic modelling of recombinant factor IX Fc fusion protein (rFIXFc) in patients with haemophilia B. Clin Pharmacokinet. 2014;53(5):467-477. 12. Björkman S. Population pharmacokinetics of recombinant factor IX: implications for dose tailoring. Haemophilia. 2013;19(5):753‐757. 13. IDELVION® [package insert]. Marburg, Germany: CSL Behring GmbH; 2019. 14. AlphaNine® SD [package insert]. Los Angeles, CA: Grifols Biologicals LLC; 2018. 15. BeneFIX® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc; 2019. 16. Ixinity® [package insert]. Seattle, WA: Aptevo BioTherapeutics LLC; 2018. 17. Mononine® [package insert]. Kankakee, IL: CSL Behring LLC; 2018. 18. Profilnine® [package insert]. Los Angeles, CA: Grifols Biologicals LLC; 2018. 19. Rixubis® [package insert]. Lexington, MA: Baxalta US Inc; 2018. 20. Rebinyn® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017. 21. Baumann K, Hernandez G, Witkop, M, et al. Impact of mild to severe hemophilia on engagement in recreational activities by US men, women, and children with hemophilia B: The Bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S) study. Eur J Haematol. 2017;98:25-34.