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ALPROLIX® is the only factor IX to utilize half-life extension with Fc Fusion technology

The natural recycling pathway of IgG1 allows ALPROLIX to stay in the body for an extended period of time between infusions1

ALPROLIX Structure
  • ALPROLIX is composed of rFIX covalently linked to the Fc region of IgG11,2

    — IgG1 is a naturally occurring protein with anti-inflammatory properties1,2

  • ALPROLIX binds to the neonatal Fc receptor, which diverts ALPROLIX, delaying degradation and extending half-life1
ALPROLIX molecule icon

The half-life of ALPROLIX in adults is 86 hours for a 50 IU/kg dose1

ALPROLIX reaches its peak activity level as quickly as
BeneFIX® [coagulation factor IX (recombinant)]—within 10 minutes of infusion3* 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.3

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

BeneFIX® is a registered trademark of Pfizer Inc.

rFIX=recombinant factor IX.

Experience Fc Fusion technology in action

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. Kaneko Y, Nimmerjahn F, Ravetch JV. Antiinflammatory activity of immunoglobulin G resulting from Fc sialylation. Science. 2006;313(5787):670-673. 3. Data on file. Waltham, MA; Bioverativ Therapeutics Inc.