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Strong CYP3A Inhibitors
Pirtobrutinib is a CYP3A substrate. Concomitant use of pirtobrutinib with a strong CYP3A inhibitor increased pirtobrutinib systemic exposure [see Clinical Pharmacology (12.3)], which may increase the risk of pirtobrutinib adverse reactions. Avoid concomitant use of strong CYP3A inhibitors during treatment with pirtobrutinib. If concomitant use of strong CYP3A inhibitors is unavoidable, reduce the pirtobrutinib dosage.
Strong or Moderate CYP3A Inducers
Concomitant use of pirtobrutinib with a strong or moderate CYP3A inducer decreased pirtobrutinib systemic exposure [see Clinical Pharmacology (12.3)], which may reduce pirtobrutinib efficacy. Avoid concomitant use of pirtobrutinib with strong or moderate CYP3A inducers. If concomitant use of moderate CYP3A inducers is unavoidable, increase the pirtobrutinib dosage
Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates
pirtobrutinib is a P-gp inhibitor, a moderate CYP2C8 and BCRP inhibitor, and a weak CYP2C19 and CYP3A inhibitor. Concomitant use of pirtobrutinib with sensitive P-gp, CYP2C8, BCRP, CYP2C19, or CYP3A substrates increased their plasma concentrations [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions related to these substrates for drugs which are sensitive to minimal concentration changes. Follow recommendations for sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP substrates provided in their approved product labeling.
from FDA，2024.06
