Data from FDA - Curated by Toby Galbraith - Last updated 19 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:
• Control and prevention of bleeding episodes,
• Perioperative management,
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

ALPROLIX™ is not indicated for induction of immune tolerance in patients with Hemophilia B. (1)

Full Prescribing information

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Advisory information

contraindications

Do not use in individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients. (4)

Special warnings and precautions

• Hypersensitivity reactions, including anaphylaxis, may occur. Should symptoms occur, discontinue ALPROLIX™ and administer appropriate treatment. (5.1)
• Development of neutralizing antibodies (inhibitors) to ALPROLIX™ may occur. Perform an assay that measures Factor IX inhibitor concentration if plasma Factor IX level fails to increase as expected or if bleeding is not controlled with an appropriate dose. (5.2, 5.4)
• The use of Factor IX products has been associated with the development of thromboembolic complications. (5.3)

Adverse reactions
Common adverse reactions (incidence ≥1%) from clinical trials were headache and oral paresthesia. (6)

Usage information

Dosing and administration

For intravenous use after reconstitution only.
Control and prevention of bleeding episodes and perioperative management:
• Each vial of ALPROLIX™ contains the labeled amount of coagulation Factor IX potency in international units (IU). (2.1)
• One unit per kilogram body weight of ALPROLIX increased the circulating Factor IX level by 1% [IU/dL]. (2.1)

Initial
Dose:Type
of Bleeding
Circulating FIX (IU/dL) Dosing Interval
(hours)
Minor and
Moderate
30-60 Repeat every 48 hours as needed
Major 80-100

Consider repeat dose after 6-10 hours, then every 24 hours for 3 days, then every 48 hours until healing achieved

• The maintenance dose or frequency of ALPROLIX™ administration is determined by the type of bleeding episode and the recommendation of the treating healthcare provider. (2.1)
Routine prophylaxis:
50 IU/kg once weekly or 100 IU/kg once every 10 days. Adjust dosing regimen based on individual response. (2.1)

Use in special populations

• Pregnancy: No human or animal data. Use only if clearly needed. (8.1)
• Pediatric: In pediatric patients under 12 years of age, recovery may be lower and body weight adjusted clearance may be higher. Dose adjustment may be needed. (8.4)

More information

Category Value
Authorisation number BLA125444
Orphan designation No
Product NDC 64406-911; 64406-922; 64406-933; 64406-944; 64406-966; 64406-977
Date First Approved 05-05-2014
Marketing authorisation holder Biogen Inc.