MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised patients to seek urgent medical attention if they develop any clinical features of liver dysfunction.

The agency urged to discontinue or interrupt cladribine if significant hepatic injury is confirmed. It said, “Liver monitoring requirements for cladribine in the treatment of multiple sclerosis have been introduced following uncommon cases of serious liver injury.”

Cladribine (Mavenclad) is a nucleoside analogue that causes lymphocyte depletion. It is authorised in the UK for the treatment of adults with highly active relapsing multiple sclerosis as defined by clinical or imaging features.

The recommended cumulative dose of cladribine for multiple sclerosis is 3.5 mg/kg bodyweight over 2 years, divided into 2 treatment courses of 1.75 mg/kg per year. Each treatment course is given over 2 separate weeks: 1 week at the start of the first month and the next week at the start of the following month. Single daily doses are given on 4 or 5 days of each week.

Advise for healthcare professionals:

  • a small number of cases of clinically significant liver injury have been reported during cladribine treatment for multiple sclerosis
  • most events occurred within 8 weeks of the start of the first treatment course of cladribine
  • before starting cladribine check if there is a history of liver disorders, including hepatic injury related to other medicines
  • monitor liver function tests (including total bilirubin) before each treatment course in years 1 and 2; and, if clinically necessary, during treatment
  • urgently check liver function tests (including bilirubin) in patients with symptoms or signs of liver injury
  • discontinue or interrupt cladribine treatment in patients with hepatic dysfunction or unexplained increases in liver enzymes
  • report any suspected adverse drug reactions associated with cladribine on a Yellow Card

Advise for healthcare professionals to give to patients and carers:

  • cladribine treatment for multiple sclerosis has been associated with a risk of serious liver injury – these serious events are uncommon and have most commonly happened in the 8 weeks after starting the first treatment
  • blood tests to check your liver function are needed before the start of each treatment course; you may also need tests during each treatment if your doctor thinks they are needed
  • talk to your doctor straight away if you develop any signs of liver problems such as pain in the upper right area of your stomach, yellowing of your skin or the white part of your eyes, loss of appetite, feeling or being sick, dark urine, or widespread itching
  • read carefully the Patient Guide from your doctor and the Patient Information Leaflet that accompanies your medicine; keep them handy in case you need to read them again.

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