Watch Video Now Icon WATCH NOW: Clinical experience with ALPROLIX

ALPROLIX® is a flexible factor IX product for all dosing scenarios1

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ALPROLIX prophylaxis offers proven protection* at dosing intervals to fit your patients' needs

Recommended Starting Doses

7-day interval

For dosing on the same day every week1

  • The recommended starting dose is 50 IU/kg for adults/adolescents (aged ≥12 years) and 60 IU/kg for children (aged ≤11 years)
  • A 7-day interval is the most common EHL prophylaxis regimen in hemophilia B

10-day interval

For less frequent dosing1

  • Another recommended starting dose is 100 IU/kg for adults and adolescents

  • For patients on ALPROLIX looking to extend their dosing interval beyond their initial starting interval, adjust the dose based on individual patient response
  • Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, the individual patient’s PK profile, and/or the patient’s clinical condition

Extended Dosing

14-day interval

Potential for ≥14-day dosing for fewer infusions2,3

  • In the B-LONG and B-YOND trials, some adult and adolescent patients extended their dosing interval to ≥14 days

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

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.

EHL=extended half-life.

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 open-label extension trial that studied the long-term safety and efficacy of ALPROLIX over 5 years 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).4

PEDIATRIC PATIENTS DOSING

With ALPROLIX, children can start on a treatment that can grow with them, as their needs may change over time1

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For children aged <12 years, the recommended prophylaxis starting regimen is

60 IU/kg once weekly,

with adjustments made based on patient response1

  • More frequent or higher doses may be needed in children aged <12 years, and especially in children aged <6 years
  • On average, 1 IU of ALPROLIX per kg of body weight increases the level of circulating factor IX by approximately 1% in children aged ≥6 years and 0.6% in children aged <6 years

~93%

of pediatric patients maintained or extended their dosing interval through the B-YOND extension trial4

  • In B-YOND (n=27), 21 patients maintained and 4 patients extended their dosing interval

ADULTS AND ADOLESCENTS DOSING

ALPROLIX offers flexibility of prophylaxis dosing intervals to fit your patients' needs

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For patients who want a regimen on the same day every week, initiate treatment at

50 IU/kg every 7 days1

For fewer infusions, ALPROLIX offers a second prophylaxis starting dose1

  • ALPROLIX can be initiated at 100 IU/kg every 10 days

  • To extend the dosing interval beyond a patient's initial starting interval, adjust the dose based on individual patient response
  • Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, the individual patient's pharmacokinetic profile, and/or the patient's clinical condition

~85%

of adult and adolescent patients maintained or extended their dosing interval through the B-YOND extension trial4

  • In B-YOND (n=71), 56 patients maintained and 4 patients extended their dosing interval

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≥14-DAY DOSING

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

  • More than half of patients (54%) in the interval-adjusted arm (n=26) extended their dosing interval to ≥14 days during the last 3 months of B-LONG2

Average dosing interval for interval-adjusted arm2

>14 Day Dosing Chart highlighting the percentage of patients vs. the average dosing interval for interval-adjusted arm plotted over the average dosing interval in days
  • Patients initiated treatment at 100 IU/kg every 10 days; the majority were well controlled and experienced zero bleeds before extending their interval3
  • Overall median dosing interval in B-LONG was 12.5 days (10.4-13.4)1
  • Additional patients were able to extend their dosing interval during the B-YOND extension trial3

Post hoc analysis: ALPROLIX prophylaxis efficacy data at ≥14-day interval (n=22)3:

  • 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)
  • 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

In the interval-adjusted arm of B-LONG (n=29)3:

  • Median overall ABR: 1.38 (0-3.43)
  • Median AsBR: 0.88 (0-2.3)
  • Median joint ABR: 0.36 (0-3.24)

The median duration of the exposure to ALPROLIX at a ≥14-day dosing interval was 3.4 years, as reported in the post hoc analysis3

Protection,* Experience, and Dosing:
A Discussion With Dr De Angulo

With the widest range of vial strengths in hemophilia B, ALPROLIX offers the potential to resolve bleeds with fewer vials1,5-12

ALPROLIX vial strengths range

ABR=annualized bleed rate; AsBR=annualized spontaneous 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.

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References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. 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. 3. 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. 4. 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. 5. Idelvion® [package insert]. Marburg, Germany: CSL Behring GmbH; 2020. 6. Rebinyn® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020. 7. AlphaNine® SD [package insert]. Los Angeles, CA: Grifols Biologicals LLC; 2018. 8. BeneFIX® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.; 2020. 9. Ixinity® [package insert]. Seattle, WA: Aptevo BioTherapeutics LLC; 2020. 10. Mononine® [package insert]. Kankakee, IL: CSL Behring LLC; 2018. 11. Profilnine® SD [package insert]. Los Angeles, CA: Grifols Biologicals Inc.; 2018. 12. Rixubis® [package insert]. Lexington, MA: Baxalta US Inc.; 2020.