From the Guidelines
Liver function tests (LFTs) should be repeated at least weekly for the first 6–8 weeks after starting ribociclib, and then every 2–4 weeks, depending on the patient population and combination treatments. This monitoring schedule is based on the recent review article published in 2024 in the Alimentary Pharmacology and Therapeutics journal 1, which provides consensus recommendations for the detection, assessment, and management of suspected drug-induced liver injury during clinical trials in oncology patients. The article suggests that routine monitoring of liver tests, including ALT, AST, ALP, and TBIL, should be performed at least weekly for the first 2 cycles of treatment, or for the first 6–8 weeks.
- Key factors to consider when determining the frequency of LFT monitoring include:
- Preclinical findings
- Patient population
- Combination treatments
- Concomitant medications
- Underlying liver disease
- Known or anticipated drug-related hepatotoxicity As ribociclib can cause hepatotoxicity, with potential elevation of transaminases (ALT and AST) being a known side effect, regular monitoring of LFTs is crucial to detect any abnormalities early and manage them appropriately 1. If abnormalities are detected during treatment, more frequent monitoring, dose interruption, reduction, or discontinuation may be necessary depending on the severity of LFT elevations.
From the FDA Drug Label
Perform liver function tests (LFTs) in all patients before initiating KISQALI Monitor LFTs every 2 weeks for first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated LFTs should be repeated every 2 weeks for the first 2 cycles after starting ribociclib, and then at the beginning of each of the subsequent 4 cycles, and as clinically indicated 2.
From the Research
Liver Function Tests (LFTs) Monitoring
- The frequency of LFTs monitoring after starting ribociclib is not explicitly stated in the provided studies.
- However, it is recommended to perform routine liver enzyme testing during therapy 3.
- In cases of liver enzyme elevation, immediate hepatologic work-up and treatment interruption are highly recommended 3.
- The studies do not provide a specific timeframe for repeating LFTs after starting ribociclib, but it is suggested to monitor liver function tests regularly during treatment.
Hepatotoxicity and Liver Injury
- Ribociclib has been associated with hepatotoxicity, including idiosyncratic drug-induced liver injury (DILI) 3, 4, 5.
- The development of severe idiosyncratic hepatocellular pattern DILI grade 3 has been reported in patients treated with ribociclib 3.
- In cases of severe necroinflammation, corticosteroid treatment should be considered 3.
- The studies highlight the importance of monitoring liver function tests and being aware of the potential risk of hepatotoxicity associated with ribociclib treatment.
General Guidelines for LFTs Monitoring
- Existing guidelines do not support retesting LFTs for at least 48-72 hours 6.
- A study found that repeat LFT testing is common in hospitals, often within 24 hours, despite guidelines not supporting too-early repeat testing 6.
- The study suggests that further research is needed to understand whether better adherence to existing guidelines is required or if guidelines need to be updated based on certain patient subpopulations 6.