WATCH NOW: Clinical experience with ALPROLIX

On-demand dosing with ALPROLIX®

ALPROLIX reaches its peak activity level as quickly as
BeneFIX® [coagulation factor IX (recombinant)]
—within 10 minutes of infusion1*

Studies have not been conducted to assess the safety or efficacy of ALPROLIX compared with BeneFIX.

*A subset of 22 patients (the sequential pharmacokinetic subgroup) received consecutive single IV doses of 50 IU/kg BeneFIX and ALPROLIX at the beginning of the B-LONG study (baseline) for direct comparison. For both ALPROLIX and BeneFIX, peak activity was reached approximately 10 minutes after the start of the infusion.1

Peak activity level does not mean bleeds are resolved within 10 minutes.

BeneFIX® is a registered trademark of Pfizer Inc.

Pediatric and adult/adolescent dosing targets for on-demand treatment and control of bleeding episodes1
Type of bleedMinor and moderateaMajorb
Target circulating factor IX (IU/dL or % of normal)30-6080-100
Dosing interval (hours)Repeat every 48 hours if there is further evidence of bleedingConsider a repeat dose after 6 to 10 hours and then every 24 hours for the first 3 days Due to the long half-life of ALPROLIX, the dose may be reduced and the frequency of dosing may be extended after Day 3 to every 48 hours or longer until bleeding stops and healing is achieved

Nearly half (47%) of the adults and adolescents who were treated with ALPROLIX on demand during
B-LONG (n=19) switched to ALPROLIX prophylaxis during the B-YOND extension trial3


Clincial 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).2

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).4

With the widest range of vial strengths in hemophilia B, ALPROLIX offers the potential to resolve bleeds with fewer vials2,5-12

Alprolix Dosing Range

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. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 2. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 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. 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;00:1-10. 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 Inc.; 2020. 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.