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ALPROLIX® offers effective hemostatic control for both major and minor surgeries1


Perioperative dosing with ALPROLIX

Pediatric and adult/adolescent dosing targets for perioperative management

Type of surgeryTarget circulating factor IX
(IU/dL or % of normal)
Dosing interval
Minor
(including uncomplicated
dental extraction)
50-80A single infusion may be sufficient. Repeat as needed after 24-48 hours until bleeding stops and healing is achieved
Major
(with or without anesthesia, includes any surgery where a major body cavity was penetrated and exposed, or a substantial impairment of physical or physiological functions was produced)
60-100

Consider a repeat dose after 6-10 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 in the postsurgical setting may be extended after Day 3 to every 48 hours or longer until bleeding stops and healing is achieved

  • Thirty-five major surgeries were performed in 22 patients during B-LONG and B-YOND1
  • An additional 62 minor surgeries were performed in 37 patients during B-LONG, Kids B-LONG, and B-YOND1

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.

Important Safety Information

Contraindication

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

Important Safety Information

References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.

©2024 Sanofi. All rights reserved. ALPROLIX and Sanofi are registered trademarks of Sanofi or an affiliate. All other trademarks are the property of their respective owners. MAT-US-2021403-v7.0-09/2024 Last updated: September 2024