ALPROLIX®: the first EHL FIX
WITH >10 years OF REAL-WORLD EXPERIENCE1–3

Click to Explore the BODY of ALPROLIX evidence

FOR COMPLETE SAFETY INFORMATION,
PLEASE REFER TO THE ALPROLIX SMPC14

ALPROLIX safety summary14

Hypersensitivity Allergic type hypersensitivity reactions have been reported with ALPROLIX. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. In post-marketing experience, FIX inhibitor development and hypersensitivity (including anaphylaxis) have been observed.
Neutralising antibodies (inhibitors) After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors). There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Thromboembolism Because of the potential risk of thrombotic complications with factor IX products, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or disseminated intravascular coagulation (DIC). The benefit of treatment with ALPROLIX in these situations should be weighed against the risk of these complications.
Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with factor IX may increase the cardiovascular risk.
Catheter-related complications If a central venous access device (CVAD) is required, there is a risk of CVAD-related complications.