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 | 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 PTPs1:
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 PUPs1:
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; PTP=previously treated patient; PUP=previously untreated patient.
Indication
References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Idelvion® [package insert]. Marburg, Germany: CSL Behring GmbH; 2021. 3. Rebinyn® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2022.
