The product information for Mavenclad, which is used in adults with highly active relapsing multiple sclerosis (MS), lists liver damage with the frequency “uncommon”. Recommendations are also included to check the liver and to stop treatment if necessary.
The MEB advises patients to pay attention to complaints that indicate liver damage, such as not having any appetite for food, nausea or vomiting, abdominal pain, fatigue, yellow skin or eyes, and dark urine.
Liver Function Tests
Healthcare providers should obtain a comprehensive patient history of underlying liver dysfunction or events of liver damage with other medicinal products prior to initiating treatment. Healthcare providers are also advised to review liver function tests such as serum levels for aminotransferases, alkaline phosphatase, and total bilirubin before starting the first and second courses of treatment.
Furthermore, liver function tests must be performed during treatment, the MEB states, which must also be repeated on the basis of clinical signs and symptoms. If a patient develops liver damage, treatment with Mavenclad should be interrupted or discontinued immediately.
DHPC
In consultation with the MEB and the Healthcare and Youth Inspectorate (IGJ), manufacturer Merck has sent a letter on this subject – a Direct Healthcare Professional Communication (DHPC) – to neurologists, neurology nurse specialists, MS nurses, (hospital) pharmacists. and doctors and pharmacists in training.
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