Other safety alerts
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| Singapore: ADVAGRAF® prolonged-release tacrolimus and PROGRAF® tacrolimus - Potential risk of medication errors |
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The Health Sciences Authority (HSA) announced that Janssen would like to provide healthcare professionals with an important safety reminder concerning the risk of medication errors with oral tacrolimus products, which could lead to potential serious adverse drug reactions. ADVAGRAF® is a new prolonged-release formulation of tacrolimus. As part of the launch of ADVAGRAF®, Janssen wishes to remind healthcare professionals about the risk of potential medication errors associated with unsupervised switching between oral tacrolimus products, including ADVAGRAF® tacrolimus prolonged-release capsules and PROGRAF® tacrolimus immediate release capsules. PROGRAF® and ADVAGRAF® are not bioequivalent and therefore not interchangeable without careful therapeutic monitoring. Inadvertent, unintentional or unsupervised switching between the different tacrolimus oral formulations can lead to graft rejection or an increased incidence of undesirable effects. Janssen has undertaken measures to reduce the frequency of medication errors.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, there are six registered pharmaceutical products containing oral tacrolimus under the names of Prograf Cap (0.5mg: HK-47471, 1mg: HK-41915, 5mg: HK-41916) and Advagraf Prolonged-Release Hard Cap (0.5mg: HK-56596, 1mg: HK-56594, 5mg: HK-56595). All products are registered by Astellas Pharma Hong Kong Company and are prescription-only medicines. The approved package inserts of the products in Hong Kong have included the latest safety warnings in the HSA announcement. The Drug Office will keep vigilant on any new safety update on oral tacrolimus products.
Ends/ Wednesday, May 29, 2013
Issued at HKT 12:00
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