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.

Resources for your practice and your patients

Protection, Experience, and Dosing:
 A discussion with Dr De Angulo

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

Resources for your practice

Comprehensive Dosing Guide Doctor Discussion Guide

This guide contains helpful information about the flexibility of ALPROLIX. Learn more about dosing across treatment settings and how ALPROLIX may help your on-demand patients get one step closer to prophylaxis.

Coding and Reimbursement Guide

Resources for your patients

For current patients:

ALPROLIX Doctor Discussion Guide Current Patient Guide

For prospective patients:

ALPROLIX Doctor Discussion Guide Prospective Patient Guide
ALPROLIX Instructions for Use Free Trial Plus Program*

Patients can receive their first 30-day supply of ALPROLIX immediately with a valid prescription. Patients may also be able to receive free factor IX for up to 1 year, if needed.

Financial Assistance Form*

For eligible patients, the ALPROLIX Copay Program can cover up to $12,000 of out-of-pocket costs, co-payment, or co-insurance associated with their prescription. There are no income requirements or caps.

Patient Insurance Insights

Patients can learn about their insurance options and build a personalized discussion guide to use in conversations with their family, care team, or employer to help them make informed insurance choices.

*Those with federal and state government insurance, such as Medicare, Medicaid, or TRICARE® are not eligible. Other eligibility requirements may apply. Sanofi Genzyme reserves the right to modify or discontinue programs at any time.

Help manage hemophilia outcomes with MicroHealth tracking

Sanofi Genzyme has joined with MicroHealth in supporting patients and healthcare providers better manage hemophilia.
Learn more.

Hemophilia B Advocacy Groups

The following groups and organizations are dedicated to the bleeding disorders community.They provide valuable resources, information, and support for your patients with hemophilia B.

The Coalition for Hemophilia B National Hemophilia Foundation Hemophilia Federation of America World Federation of Hemophilia

This list is intended to serve as a general reference, and Sanofi Genzyme does not endorse any particular organization or its content and programming.

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.