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ALPROLIX® has an established safety profile1

Contraindications

ALPROLIX is contraindicated in patients who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients

Hypersensitivity reactions

Hypersensitivity reactions, including anaphylaxis, have been reported with ALPROLIX

Formation of inhibitors

Formation of inhibitors to factor IX has been reported following an administration of ALPROLIX

Thromboembolic complications

The use of factor IX products has been associated with the development of thromboembolic complications, especially in individuals receiving continuous infusion through a central venous catheter

Nephrotic syndrome

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


Common side effects in previously treated patients (PTPs)1:

The most commonly reported adverse reactions (incidence ≥1%) among adults, adolescents, and children

1.3%

headache

1.3%

oral paresthesia

1.3%

obstructive uropathy


Common side effects in previously untreated patients (PUPs)1:

The most commonly reported adverse reactions (incidence ≥1%) among PUPs

3%

injection site erythema

3%

hypersensitivity

3%

factor IX inhibition


ALPROLIX has the longest duration of patient exposure of any EHL factor IX product on the market1-3

  • ALPROLIX has been studied in 153 PTPs (112 adults, 11 adolescents, and 30 children) for more than 26,000 exposure days. ALPROLIX was also studied in 33 PUPs

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. Idelvion® [package insert]. Marburg, Germany: CSL Behring GmbH; 2020. 3. Rebinyn® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2020.