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New restrictions enforced on MS drug daclizumab

Back in July 2017, the Medical and Healthcare products Regulatory Agency (MHRA) highlighted restrictions on the use of daclizumab (Zinbryta) for relapsing remitting multiple sclerosis (RRMS) during an urgent EU review into the risk of severe liver injury.

The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with daclizumab and for up to six months after discontinuation. Serious liver reactions, including autoimmune hepatitis, hepatitis, and jaundice, were observed in 1.7% of patients taking daclizumab in clinical trials.

Following the review’s conclusions, daclizumab will now only be offered to adult patients with relapsing forms of multiple sclerosis who have had an inadequate response to at least two other disease-modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or unsuitable.

Daclizumab is a 150mg solution for injection, which was authorised in the EU in July 2016 for the treatment of adults with relapsing forms of multiple sclerosis. Daclizumab has mainly been used in clinical trials in the UK and use outside of trials has been small to date.

The MHRA has now imposed the following restrictions on this drug:

  • Do not use in patients with pre-existing hepatic disease or hepatic impairment
  • Patients currently receiving daclizumab should be reviewed to check that treatment remains appropriate
  • Patients should be screened for hepatitis B and C viral infections before starting daclizumab and those with evidence of infection to a liver should be referred to a specialist for advice
  • Initiation is not recommended in patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels equal to or greater than 2-times the upper limit of normal or in those with autoimmune conditions other than multiple sclerosis
  • Neurologists are advised to exercise caution when prescribing daclizumab in patients receiving other medication that may be hepatotoxic, including over-the-counter products and herbal medicines

Liver monitoring requirements now advice clinicians to monitor ALT, AST, and bilirubin levels closely before each dose (or more frequently if clinically indicated) and continue monitoring for up to six months after the last dose.

They should also discuss the risk of hepatic injury and monitoring requirements with patients and ensure they read the patient card. Both patient and physician are required to sign an acknowledgement form to confirm that the discussion has taken place and the patient understands the information that has been given to them.

In addition, patients should seek urgent medical attention if they develop any symptoms or signs of potential hepatic injury, such as abdominal pain or swelling, blood in the urine, blood in the stool, vomiting blood, feeling faint, brown urine, jaundice (yellowing of the skin or eyes) and a rapid heart rate (over 100 beats per minute).

Source: MS-UK

Date: 12/01/18

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