From the Research
Ribociclib should be withheld when a patient's creatinine clearance falls below 30 mL/min. For patients with moderate renal impairment (creatinine clearance 30-59 mL/min), no dose adjustment is necessary, as supported by the population pharmacokinetics study 1. However, for severe renal impairment (creatinine clearance less than 30 mL/min), ribociclib has not been adequately studied, and its use should be approached with caution or avoided. Some key points to consider:
- Ribociclib is primarily metabolized by the liver, with renal excretion playing a minor role in its elimination 1.
- Severe kidney dysfunction can affect drug clearance and potentially increase the risk of adverse effects such as neutropenia, QT prolongation, and hepatotoxicity.
- Regular monitoring of renal function is recommended for all patients on ribociclib, especially those with pre-existing kidney disease 2.
- If treatment is necessary in patients with severe renal impairment, consider starting at a reduced dose and monitoring more frequently for toxicities, as suggested by the case report of ribociclib-induced acute kidney injury 3. It's also worth noting that the association between ribociclib and changes in creatinine in patients with hormone receptor positive metastatic breast cancer has been studied, and the results suggest that creatinine rise appears to be due to a reversible inhibition of renal efflux transporters rather than an acute kidney injury in the majority of cases 2.