Published: 2 September 2021

Publications

Updated safety information: fingolimod and liver injury

Published: 2 September 2021
Prescriber Update 42(3): 34–35
September 2021

Fingolimod is an immunomodulating drug indicated for the treatment of relapsing multiple sclerosis.¹

Clinically significant liver injury and cases of acute liver failure requiring liver transplant have been reported in patients treated with fingolimod. Information about these cases has been added to the fingolimod (Gilenya) data sheet.²

The data sheet has also been updated with the requirement for liver function monitoring during and after treatment and criteria for stopping treatment to prevent serious drug-induced liver injury, as follows.²

• Recent (within the last 6 months) transaminase and bilirubin levels should be available before initiation of treatment. Measure levels periodically while on treatment, until two months after fingolimod discontinuation.
• Promptly measure transaminase and bilirubin levels if the patient reports signs and symptoms of liver injury (such as unexplained nausea, vomiting, abdominal pain, right upper abdominal discomfort, new or worsening fatigue, anorexia, or jaundice and/or dark urine during treatment). In this clinical context, if the patient is found to have an alanine aminotransferase (ALT) greater than three times the reference range and serum total bilirubin greater than two times the reference range, treatment with fingolimod should be interrupted.
• Do not resume treatment unless a plausible alternative aetiology for the signs and symptoms of liver injury can be established.

Refer to the Gilenya data sheet for further information.

Up to 30 June 2021, the Centre for Adverse Reactions Monitoring (CARM) has received four adverse reaction reports of increased hepatic enzymes where fingolimod was the suspect medicine (CARM IDs: 116984, 117025, 118005, 119172).

References

1. New Zealand Formulary (NZF). 2021. NZF v108: Fingolimod 1 June 2021. URL: nzf.org.nz/nzf_4808 (accessed 21 June 2021).
2. Novartis New Zealand Limited. 2021. Gilenya New Zealand Data Sheet 11 February 2021. URL: medsafe/profs/Datasheet/g/gilenyacap.pdf (accessed 21 June 2021).