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Clinical Impact: Concomitant use of neratinib with proton pump inhibitors (PPIs), H2-receptor antagonists, or antacids may decrease the AUC of neratinib, which could reduce neratinib activity.
Prevention or Management: Avoid concomitant use with PPIs. Administer neratinib at least 2 hours before or at least 10 hours after administration of H2-receptor antagonists. Administer neratinib at least 3 hours after administration of antacids.
Clinical Impact: Concomitant use of neratinib with strong CYP3A4 inhibitors increases the Cmax and AUC of neratinib, which may increase the risk of neratinib toxicity.
Prevention or Management: Avoid concomitant use of neratinib with strong CYP3A4 inhibitors.
Clinical Impact: Concomitant use of neratinib with dual P-gp and moderate CYP3A4 inhibitors may increase the Cmax and AUC of neratinib, which may increase the risk of neratinib toxicity.
Prevention or Management: Avoid concomitant use of neratinib with dual P-gp and moderate CYP3A4 inhibitors.
Clinical Impact: Concomitant use of neratinib with strong or moderate CYP3A4 inducers decreases the Cmax and AUC of neratinib, which could reduce neratinib activity.
Prevention or Management: Avoid concomitant use of neratinib with strong or moderate CYP3A4 inducers.
AUC = Area Under the Concentration-Time Curve; Cmax = Maximum Plasma Concentration
Concomitant use of neratinib increases the concentrations of P-gp substrates, which may elevate the risk of adverse reactions associated with these substrates. Monitor for adverse reactions of certain P-gp substrates for which minimal concentration changes may lead to severe adverse reactions.
FDA，2021.06
