Hemophilia B coagulation Factor IX concentrate for adults and children

*Terms and conditions apply.

Switch to ALPROLIX^®, the first EHL with 10 years of experience across ages and settings^1-3

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, and 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.
See Important Safety Information below.

^†ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.¹

Trusted protection^†

Bleed protection^†across age groups^1,2

See efficacy data

Extended dosing

Help reduce patient treatment burden^1,2‡

See ALPROLIX dosing

Real-world experience

Observed results in switches from SHLs⁴

See the results

Demonstrated safety

Across ages and settings¹

See the safety data

^‡ALPROLIX prophylaxis provides comparable or reduced number of injections vs SHLs, which may help reduce treatment burden for patients.^1,2

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.

Please see full Prescribing Information.

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Indication

Important Safety Information

EHL=extended half-life; PTP=previously treated patient; PUP=previously untreated patient; SHL=standard half-life.

References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Powell JS, Pasi KJ, Ragni MV, et al. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323. 3. Graf L. Extended half-life factor VIII and factor IX preparations. Transfus Med Hemother. 2018;45(2):86-91. 4. Shapiro A, Chaudhury A, Wang M, et al. Real-world data demonstrate improved bleed control and extended dosing intervals for patients with haemophilia B after switching to recombinant factor IX Fc fusion protein (rFIXFc) for up to 5 years. Haemophilia. 2020;26(6):975-983.

For your patients with Hemophilia B, trusted bleed protection every step of the way1,2

Switch to ALPROLIX®, the first EHL with 10 years of experience across ages and settings1-3

Trusted protection†

Extended dosing

Real-world experience

Demonstrated safety

Indication

Important Safety Information

Contraindication

Warnings and Precautions

Adverse reactions

Indication

Important Safety Information

For your patients with Hemophilia B, trusted bleed protection every step of the way^1,2

Switch to ALPROLIX^®, the first EHL with 10 years of experience across ages and settings^1-3

Trusted protection^†