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Avoid concomitant use of Adagrasib with strong CYP3A inducers.
Adagrasib is a CYP3A4 substrate. Concomitant use of Adagrasib with a strong CYP3A inducer reduces adagrasib exposure, which may reduce the effectiveness of Adagrasib.
Avoid concomitant use of Adagrasib with strong CYP3A inhibitors until adagrasib concentrations have reached steady state (after approximately 8 days).
Adagrasib is a CYP3A4 substrate. If adagrasib concentrations have not reached steady state, concomitant use of a strong CYP3A inhibitor will increase adagrasib concentrations, which may increase the risk of Adagrasib adverse reactions.
Avoid concomitant use of Adagrasib with sensitive CYP3A substrates unless otherwise recommended in the Prescribing Information for these substrates.
Adagrasib is a CYP3A inhibitor. Concomitant use with Adagrasib increases exposure of CYP3A substrates, which may increase the risk of adverse reactions related to these substrates.
Avoid concomitant use of Adagrasib with sensitive CYP2C9 substrates where minimal concentration changes may lead to serious adverse reactions unless otherwise recommended in the Prescribing Information for these substrates.
Adagrasib is a CYP2C9 inhibitor. Concomitant use with Adagrasib increases exposure of CYP2C9 substrates, which may increase the risk of adverse reactions related to these substrates.
Sensitive CYP2D6 Substrates Avoid concomitant use of Adagrasib with sensitive CYP2D6 substrates where minimal concentration changes may lead to serious adverse reactions unless otherwise recommended in the Prescribing Information for these substrates.
Adagrasib is a CYP2D6 inhibitor. Concomitant use with Adagrasib increases exposure of CYP2D6 substrates, which may increase the risk of adverse reactions related to these substrates.
Avoid concomitant use of Adagrasib with P-gp substrates where minimal concentration changes may lead to serious adverse reactions unless otherwise recommended in the Prescribing Information for these substrates.
Adagrasib is a P-gp inhibitor. Concomitant use with Adagrasib increases exposure of P-gp substrates, which may increase the risk of adverse reactions related to these substrates.
Avoid concomitant use of Adagrasib with other product(s) with a known potential to prolong the QTc interval. If concomitant use cannot be avoided, monitor electrocardiogram and electrolytes prior to starting Adagrasib, during concomitant use, and as clinically indicated. Withhold Adagrasib if the QTc interval is > 500 ms or the change from baseline is > 60 ms.
Adagrasib causes QTc interval prolongation. Concomitant use of Adagrasib with other products that prolong the QTc interval may result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsade de pointes, other serious arrythmias, and sudden death.
FDA,2022.12
