Watch Video Now Icon WATCH NOW: Clinical experience with ALPROLIX

ALPROLIX® was the first EHL factor IX product approved for use in hemophilia B1

Since its approval in 20142*:

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More than 1300 patients
have been prescribed ALPROLIX

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More than 800 million units
of ALPROLIX have been shipped across the country

Hear from real patients taking ALPROLIX

Patient stories reflect the real-life experiences of persons diagnosed with hemophilia who have been prescribed ALPROLIX. However, individual experiences may vary. Patient stories are not necessarily representative of what another person using ALPROLIX may experience.

*The FDA approval date for ALPROLIX was March 28, 2014.

Based on specialty pharmacy dispensing records, specialty pharmacy distributor shipment records, third-party logistics’ shipment records, and internal retention estimates from May 2014 through June 2020.2

Units include those that have been shipped to patients from May 2014 through January 2020 and do not include inventory at specialty pharmacy providers or specialty distributors.2

EHL=extended half-life.

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. Data on file. Waltham, MA; Bioverativ Therapeutics Inc.