WATCH NOW: Clinical experience with ALPROLIX

Many patients with hemophilia B may adjust their management approach over time to fit their needs1,2

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Life change

Ongoing prophylaxis may feel burdensome during early adulthood or other transitional life stages, leading to changes in treatment approach1


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Changes in activity

Patients who treat on demand may recognize the need to transition to prophylaxis2

  • Although prophylaxis is ideal for preventing bleeds, including those in the joints, transitioning to a fixed infusion schedule can be challenging for some patients1,2
  • Patients may feel that they don’t bleed often enough to justify a switch to long-term prophylaxis1

41% of adult patients with severe hemophilia B switch their treatment approach to accommodate changes in their lifestyle3

With both on-demand and prophylaxis dosing options, ALPROLIX® can meet your patients’ needs regardless of how they may shift over time4

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. Thornburg CD, Duncan NA. Treatment adherence in hemophilia. Patient Prefer Adherence. 2017;11:1677-1686.2. Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1-e47. 3. 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 experiences, results and opportunities into solutions (B-Hero-S) study. Eur J Haematol. 2017;98:25-34. 4. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.