- cases of serious liver injury with elevated transaminases, bilirubin and signs and symptoms of hepatic dysfunction have been reported during treatment with fezolinetant. These were generally reversible on discontinuation of therapy
- avoid fezolinetant in patients with known liver disease or patients at higher risk for liver disease
- treatment with fezolinetant must not be initiated if serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) levels are ≥2x the upper limit of normal or if total bilirubin levels are ≥2x the upper limit of normal
- treatment with fezolinetant must be discontinued if:
- transaminase elevations are ≥3x the upper limit of normal with:
total bilirubin >2x the upper limit of normal OR if patients develop symptoms of liver injury
- transaminase elevations >5x the upper limit of normal
- perform liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum alkaline phosphatase (ALP) and serum bilirubin (total and direct), prior to treatment initiation, monthly during the first 3 months of treatment and periodically thereafter based on clinical judgment
- liver function tests must also be performed when signs or symptoms suggestive of liver injury occur
- monitoring should be maintained until liver function tests have normalised
- patients should be advised to seek immediate medical attention if they develop any sign or symptoms of liver injury, including fatigue, pruritus, jaundice, dark urine, pale faeces, nausea, vomiting, decreased appetite and/or abdominal pain
- a Direct Healthcare Professional Communication (DHPC) has been disseminated alongside this Drug Safety Update
- report suspected adverse drug reactions associated with fezolinetant via the Yellow Card scheme
- fezolinetant is used for the treatment of moderate to severe vasomotor symptoms, including hot flushes and night sweats, associated with the menopause
- there have been cases of liver problems in people taking fezolinetant, which were generally reversible following discontinuation of treatment
- all patients will now have their liver function tested before and during treatment
- you will have a blood test to check your liver function before you start taking fezolinetant. This will be repeated monthly during the first 3 months of treatment and then afterwards depending on when your doctor deems appropriate
- seek medical attention immediately if you develop symptoms suggesting a problem with your liver. These include tiredness, itching, yellowing of the skin and eyes, dark urine, light-coloured stools, feeling or being sick, loss of appetite or stomach pain
- always read the leaflet that is provided alongside your medicine, which contains information about taking fezolinetant and a full list of known possible side effects
Fezolinetant and liver injury
Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗