ADR that result in revision of patient information
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| European Union: Zolgensma: fatal cases of acute liver failure |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) discussed a direct healthcare professional communications (DHPC) containing important information for Zolgensma (onasemnogene abeparvovec).
Fatal cases of acute liver failure were recently reported in patients treated with Zolgensma (onasemnogene abeparvovec), a gene therapy medicine for the treatment of spinal muscular atrophy (SMA), a serious rare condition of the nerves that causes muscle wasting and weakness.
This DHPC informs healthcare professionals of the fatal cases of liver failure and the updated recommendations for monitoring liver function, assessing suspected liver injury after infusion and further advice regarding tapering the corticosteroid treatment.
The PRAC advises that healthcare professionals should promptly assess patients with worsening liver function tests and/or signs or symptoms of acute liver illness. If patients do not respond adequately to treatment with corticosteroids, treating physicians should consult a paediatric gastroenterologist or hepatologist and consider adjustment of the corticosteroid regimen.
The DHPC for Zolgensma will be forwarded to EMA’s committee for advanced therapies (CAT) and to EMA’s human medicines committee (CHMP). Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holders, according to an agreed communication plan, and published on the ‘Direct healthcare professional communications’ page and in national registers in European Union (EU) 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-9-12-january-2023
In Hong Kong, there is one registered pharmaceutical product containing onasemnogene abeparvovec, namely Zolgensma Solution For Infusion 2 X 10^13 Vector Genomes/ml (HK-67654). The product is registered by Novartis Pharmaceuticals (HK) Limited. It is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to onasemnogene abeparvovec. Related news on the risk of acute liver failure associated with the use of onasemnogene abeparvovec was previously issued by Health Canada, and was posted on the Drug Office website on 13 September 2022. The current package insert of the above local onasemnogene abeparvovec-containing product include safety information on the risk of acute liver failure. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, January 14, 2023
Issued at HKT 12:00
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