其 他 安 全 警 示
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| European Union: Nulojix: Risk of medication errors due to change in maintenance dose (English only) |
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European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) discussed a direct healthcare professional communication (DHPC) containing important safety information for Nulojix (belatacept).
This DHPC aims to inform healthcare professionals of the risk of medication errors due to a change in the maintenance dose to 6 mg/kg.
Nulojix (belatacept) is used in adults to prevent the body from rejecting a transplanted kidney. It is used together with corticosteroids and mycophenolic acid (other medicines used to prevent organ rejection). Nulojix is a powder that is made up into a solution for infusion (drip into a vein). Doses are calculated using the patient’s weight. In the initial phase, which lasts three months, it is given at a dose of 10 mg per kilogram of body weight. After that phase, Nulojix is given at a maintenance dose every four weeks.
The maintenance dose for Nulojix will be changed from 5 mg/kg to 6 mg/kg as a consequence of the implementation of a new manufacturing process. However, for approximately one to two months, Nulojix from both manufacturing processes will coexist on the market, and therefore two different dose recommendations will apply. A mix-up between the products may lead to medication errors resulting in over- or underdosing. Healthcare professionals are advised to carefully check the dose for the specific product to be administered, to make appropriate adjustments for weight-based dosing calculations.
The DHPC for Nulojix will be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP). Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in European Union Member States.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-april-2022
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, Apr 9, 2022
Issued at HKT 12:00
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