ALPROLIX^®: the first EHL FIX
WITH >10 years OF REAL-WORLD EXPERIENCE^1–3

Click to Explore the BODY of ALPROLIX evidence

Multi-centre qualitative survey

European chart review Whole-country switch

Previous FIX switch

ALPROLIX special warnings and precautions^12,13

FOR COMPLETE SAFETY INFORMATION,
PLEASE REFER TO THE ALPROLIX SMPC

Contraindications	Hypersensitivity to the active substance or to any of the excipients (Powder: sucrose, histidine, mannitol, polysorbate 20, sodium hydroxide [for pH adjustment], hydrochloric acid [for pH adjustment]; solvent: sodium chloride, water for injections).
Traceability	In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
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. Patients should be informed of the early signs of hypersensitivity reactions including, hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. In case of anaphylactic shock, standard medical treatment for shock should be implemented.
Neutralising antibodies (inhibitors)	After repeated treatment with human coagulation FIX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing. There have been reports in the literature showing a correlation between the occurrence of a FIX inhibitor and allergic reactions. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. It should be noted that patients with FIX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with FIX. Because of the risk of allergic reactions with FIX products, the initial administrations of FIX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Thromboembolism	Because of the potential risk of thrombotic complications with FIX 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 FIX 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.
Excipient-related considerations	This medicinal product contains <1 mmol sodium (23 mg) per vial, that is to say essentially “sodium-free”. In case of treatment with multiple vials, the total sodium content should be taken into consideration. In both the UK and Ireland, ALPROLIX contains polysorbate 20. In Ireland, ALPROLIX contains 0.5 mg of polysorbate 20 in each vial. Polysorbates may cause allergic reactions.

The listed warnings and precautions apply both to adults and children.^12,13