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Drug interactions of Osimertinib

7.1 Effect of Other Drugs on Osimertinib

Strong CYP3A Inducers

Co-administering Osimertinib with a strong CYP3A4 inducer decreased the exposure of osimertinib compared to administering Osimertinib alone. Decreased osimertinib exposure may lead to reduced efficacy.

Avoid co-administering Osimertinib with strong CYP3A inducers. Increase the Osimertinib dosage when co-administering with a strong CYP3A4 inducer if concurrent use isunavoidable . No dose adjustments are required when Osimertinib is used with moderate and/or weak CYP3A inducers.

2.Effect of Osimertinib on Other Drugs

Co-administering Osimertinib with a breast cancer resistant protein (BCRP) or P-glycoprotein (P-gp) substrate increased the exposure of the substrate compared to administering it alone. Increased BCRP or P-gp substrate exposure may increase the risk of exposurerelated toxicity.

Monitor for adverse reactions of the BCRP or P-gp substrate, unless otherwise instructed in its approved labeling, when co-administered with Osimertinib.

3.Drugs That Prolong the QTc Interval

The effect of co-administering medicinal products known to prolong the QTc interval with Osimertinib is unknown. When feasible, avoid concomitant administration of drugs known to prolong the QTc interval with known risk of Torsades de pointes. If not feasible to avoid concomitant administration of such drugs, conduct periodic ECG monitoring.

from FDA,2022.10

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