ADR that result in revision of patient information
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| Canada: GILENYA (fingolimod): Risk of liver injury |
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Health Canada announces that post-market cases of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have been reported in multiple sclerosis (MS) patients treated with GILENYA. Some of these cases have resulted in acute liver failure requiring liver transplant.
The most recent periodic review of international safety data identified cases of liver failure, some requiring liver transplant, in patients treated with GILENYA. Other cases of clinically significant liver injury were also reported in patients treated with GILENYA. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have appeared shortly following the initiation of treatment as well as after prolonged use.
During clinical trials, an increase in hepatic enzymes was identified as a very common adverse drug reaction associated with GILENYA. Given the seriousness and severity of recently reported post-market cases, the Canadian Product Monograph (CPM) for GILENYA has been updated to further inform on the risk of liver injury and to include revised guidance for monitoring liver function and criteria for treatment interruption and/or discontinuation. Health Canada will work with the manufacturers of generic versions of fingolimod to update their respective CPMs.
Healthcare professionals are advised to:
- perform liver function tests, including liver transaminases and bilirubin, before starting treatment with GILENYA, at months 1, 3, 6, 9, 12 during the first year of treatment, and at regular intervals thereafter until 2 months after GILENYA discontinuation.
- monitor patients for signs and symptoms of liver injury, such as unexplained vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine, during treatment with GILENYA.
- promptly check liver transaminases and bilirubin in the presence of signs and symptoms suggestive of liver injury.
- perform more frequent liver function monitoring, or interrupt treatment with GILENYA, if liver transaminases and bilirubin rise above specific levels (please refer to the website in Health Canada for details).
- monitor patients with mild or moderate liver disease more closely as they are at an increased risk of developing elevated liver enzymes during GILENYA treatment.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74803a-eng.php
In Hong Kong, there are 3 registered pharmaceutical products containing fingolimod, namely Gilenya Hard Capsules 0.5mg (HK-61192) and Gilenya Hard Capsules 0.25mg (HK-66472) which are registered by Novartis Pharmaceuticals (HK) Limited; and Fingolimod Teva Capsules 0.5mg (HK-66882) which is registered by Teva Pharmaceutical Hong Kong. All products are prescription-only medicines. So far, the Department of Health (DH) has received 14 cases of adverse drug reaction related to fingolimod, but these cases are not related to liver injury.
Related news was previously issued by Taiwan Food and Drug Administration and the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 16 Dec 2020 and 8 Jan 2021. Letters to inform local healthcare professionals were issued by DH on 16 Dec 2020. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Jan 19, 2021
Issued at HKT 16:00
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