Other safety alerts
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| Singapore: Ofev® (nintedanib) - Risk of severe liver injury in patients with idiopathic pulmonary fibrosis |
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The Health Sciences Authority (HSA) announces that Boehringer Ingelheim would like to inform healthcare professionals that post-marketing cases of drug-induced liver injury (DILI) have been reported in patients with idiopathic pulmonary fibrosis (IPF) treated with Ofev®. Majority of the hepatic events occurred within the first three months of Ofev® initiation. Therefore, transaminases and bilirubin levels should be investigated upon initiation of treatment, at regular intervals during the first three months of treatment and periodically thereafter (e.g. at each patient visit) or as clinically indicated. Boehringer Ingelheim is working with HSA to update the package insert for Ofev® to reflect the new information on the cases of DILI and to provide further guidance on the monitoring schedule of the liver function.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../ofev-nintedanib-riskofsevereliverinjuryinpatientswithidiopathicp.html
In Hong Kong, there are 4 registered pharmaceutical products containing nintedanib, namely Vargatef Capsules 100mg (HK-64395), Vargatef Capsules 150mg (HK-64396), Ofev Capsules 100mg (HK-64604) and Ofev Capsules 150mg (HK-64605). All products are registered by Boehringer Ingelheim (HK) Ltd, and are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to nintedanib, but none of them was related to liver injury. Letters to inform local healthcare professionals of the above safety information will be issued and the DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Dec 13, 2017
Issued at HKT 16:00
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