Other safety alerts
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| Singapore: Liver injury with Ocrevus® (ocrelizumab) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to inform healthcare professionals that following a recent data review, clinically significant liver injury without findings of viral hepatitis has been classified as an identified risk for Ocrevus® (ocrelizumab), with reasonable evidence showing a temporal association with the first administration of ocrelizumab.
Healthcare professionals are advised to counsel patients on the risks and benefits of ocrelizumab, conduct liver function tests prior to initiating treatment with ocrelizumab and monitor patients for signs and symptoms of any hepatic injury during treatment. Liver function tests should be performed promptly in patients who report symptoms that may indicate liver injury and if liver injury is present, ocrelizumab should be discontinued. In the event that an alternative etiology is identified, treatment with ocrelizumab can be resumed only when the liver injury has fully resolved. The local product information will be updated accordingly.
Ocrevus® is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features, to reduce the frequency of clinical relapses and delay the progression of physical disability. It is also indicated for the treatment of adult patients with early primary progressive multiple sclerosis with imaging features characteristic of inflammatory activity to delay progression of physical disability.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/liver-injury-with-ocrevus--(ocrelizumab)
In Hong Kong, Ocrevus Concentrate For Solution For Infusion 300mg/10ml (HK-67765) is a pharmaceutical product registered by Roche Hong Kong Limited (Roche). The product is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction with regard to ocrelizumab. The DH noted Roche has already disseminated a Dear Healthcare Professional Letter to healthcare professionals in Hong Kong regarding the issue. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Monday, Jul 28, 2025
Issued at HKT 16:45
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