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Coadministration of strong CYP3A inhibitors increases ribociclib exposure. Increased ribociclib concentrations may increase the incidence and severity of adverse reactions, including QTcF prolongation. Avoid concomitant use of strong CYP3A inhibitors with Ribociclib and consider alternative concomitant medications with less potential for CYP3A inhibition.
In patients with early breast cancer, if coadministration of Ribociclib with a strong CYP3A inhibitor cannot be avoided, reduce the dose of Ribociclib to 200 mg once daily. In patients with advanced or metastatic breast cancer, if coadministration of Ribociclib with a strong CYP3A inhibitor cannot be avoided, reduce the dose of Ribociclib to 400 mg once daily.
Coadministration of strong CYP3A inducers decreases the plasma exposure of ribociclib. Avoid concomitant use of strong CYP3A inducers and consider an alternate concomitant medication with no or minimal potential to induce CYP3A.
Coadministration of sensitive CYP3A4 substrates with multiple doses of Ribociclib increases the substrate exposure. For CYP3A substrates where minimal increases in the concentration may increase CYP3A substrate adverse reactions, monitor for increased adverse reactions of the CYP3A substrate during treatment with Ribociclib. The dose of the sensitive CYP3A substrate may need to be reduced as Ribociclib can increase its exposure.
Avoid coadministration of Ribociclib with products with a known potential to prolong QT interval, such as antiarrhythmic drugs and other drugs that are known to prolong the QT interval. If concomitant use cannot be avoided, monitor ECG when initiating, during concomitant use, and as clinically indicated.
from FDA，2024.09
