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Ocrevus patients urged to seek care for signs of liver injury

Blood collection tubes and sampling equipment at a Swedish health centre, photographed on 16 November 2010.
Calle Eklund/V-wolf / CC BY 3.0

People taking the multiple sclerosis medicine Ocrevus should seek medical attention immediately if they develop symptoms suggesting liver injury, according to a new safety notice published by Sweden’s Medical Products Agency.

The notice, issued on 8 October, identifies drug-induced liver injury as a new risk of treatment. Most reported cases were not serious, but some were severe or life-threatening. How often the side effect occurs is not yet known.

Symptoms to watch for include new or worsening tiredness, loss of appetite, nausea, vomiting, discomfort in the upper right abdomen, dark urine or jaundice. The advice applies to patients and carers; doctors should promptly test liver function when a patient reports possible symptoms.

The notice also calls for liver tests before treatment begins and before the second initial 300 mg infusion. Ocrevus, also known as ocrelizumab, is used for certain forms of multiple sclerosis in adults.

If liver injury is confirmed, the notice instructs doctors to stop Ocrevus and not restart it unless a reasonable alternative cause is established. This is a treatment decision for the clinical team, alongside the immediate advice for patients to seek care.

The manufacturer, Roche, issued the safety communication in agreement with the European Medicines Agency and Läkemedelsverket. Reported cases typically began within a month of the first dose; the product information will be updated with the risk and measures to reduce it.

HealthMedicine safetyMultiple sclerosis
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