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.

For adult and adolescent patients,ALPROLIX® gives the flexibility to find the dosing interval that fits their needs

Bottle Icon

For patients who want convenient
 prophylaxis dosing, initiate treatment at

50 IU/kg every 7 days2

Callout Icon

In a hemophilia survey,* 3 out of 4 prophylaxis patients reported being on a 7-day dosing regimen with an EHL factor IX product5

*Data are from an online survey conducted by Sanofi Genzyme in April 2019 with 359 adult patients and caregivers to provide insights into the US hemophilia A and hemophilia B markets. Ninety respondents were adults with hemophilia B, and 60 respondents were caregivers of a patient with hemophilia B.


For patients looking for fewer infusions, ALPROLIX offers a second prophylaxis starting dose2

  • ALPROLIX can be initiated at 100 IU/kg every 10 days
  • For those on ALPROLIX 50 IU/kg every 7 days and looking to extend,double the dose to 100 IU/kg and extend the interval to every 10 days

For patients who want extended dosing, ALPROLIX offers the potential for ≥14-day dosing

  • In the B-LONG trial, 54% of patients in the interval-adjusted arm (n=26) extended their dosing interval to ≥14 days during the last 3 months on study4

Average dosing interval for interval-adjusted arm4

For 54% of patients in the fixed-dose arm, the average dosing interval was 14 days or longer.
For 54% of patients in the fixed-dose arm, the average dosing interval was 14 days or longer.
  • Overall median dosing interval on study was 12.5 days (IQR: 10.4-13.4)2
  • Patients in the fixed-dose arm received 100 IU/kg with the initial 10-day interval adjusted4
See proven protection with extended intervals

~90% of adult and adolescent patients maintained or extended their dosing interval through the B-YOND extension trial3

  • In B-YOND (n=71), 59 patients maintained and 4 patients extended their dosing interval

Dr De Angulo discusses ALPROLIX

CHAPTER 1 0:34

EFFICACY

CHAPTER 2 0:55

EXPERIENCE

CHAPTER 3 1:26

DOSING

CHAPTER 4 2:43

SAFETY

CHAPTER 1 0:34

EFFICACY

CHAPTER 2 0:55

EXPERIENCE

CHAPTER 3 1:26

DOSING

CHAPTER 4 2:43

SAFETY

ALPROLIX has the widest range of vial strengths inhemophilia B, up to 4000 IUs2,13-20

ALPROLIX offers vial strengths of 250, 500, 1000, 2000, 3000, and 4000 IU
Learn more about how
ALPROLIX
DISTRIBUTES

EHL=extended half-life.

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

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.