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. |
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