Drug interactions of Asciminib

1.Effect of Other Drugs on Asciminib

Strong CYP3A4 Inhibitors Asciminib is a CYP3A4 substrate. Concomitant use of Asciminib with a strong CYP3A4 inhibitor increases both the asciminib Cmax and AUC, which may increase the risk of adverse reactions. Closely monitor for adverse reactions in patients treated with Asciminib at 200 mg twice daily with concomitant use of strong CYP3A4 inhibitors.

Itraconazole Oral Solution Containing Hydroxypropyl-β-cyclodextrin. 

Concomitant use of Asciminib with itraconazole oral solution containing hydroxypropyl-β-cyclodextrin decreases asciminib Cmax and AUC, which may reduce Asciminib efficacy. Avoid coadministration of Asciminib at all recommended doses with itraconazole oral solution containing hydroxypropyl-β cyclodextrin.

2.Effect of Asciminib on Other Drugs

Certain CYP3A4 Substrates

Asciminib is a CYP3A4 inhibitor. Concomitant use of Asciminib increases the Cmax and AUC of CYP3A4 substrates, which may increase the risk of adverse reactions of these substrates.

Closely monitor for adverse reactions in patients treated with Asciminib at 80 mg total daily dose with concomitant use of certain CYP3A4 substrates, where minimal concentration changes may lead to serious adverse reactions. Avoid coadministration of Asciminib at 200 mg twice daily with certain CYP3A4 substrates, where minimal concentration changes may lead to serious adverse reactions. 

CYP2C9 Substrates

Asciminib is a CYP2C9 inhibitor. Concomitant use of Asciminib increases the Cmax and AUC of CYP2C9 substrates, which may increase the risk of adverse reactions of these substrates.

Avoid coadministration of Asciminib at 80 mg total daily dose with certain CYP2C9 substrates, where minimal concentration changes may lead to serious adverse reactions. If coadministration is unavoidable, reduce the CYP2C9 substrate dosage as recommended in its prescribing information.

Avoid coadministration of Asciminib at 200 mg twice daily with sensitive CYP2C9 substrates and certain CYP2C9 substrates, where minimal concentration changes may lead to serious adverse reactions. If coadministration is unavoidable, consider alternative therapy with non-CYP2C9 substrate. 

Certain P-gp Substrates

Asciminib is a P-gp inhibitor. Concomitant use of Asciminib increases the plasma concentrations of P-gp substrates, which may increase the risk of adverse reactions of these substrates.

Closely monitor for adverse reactions in patients treated with Asciminib at all recommended doses with concomitant use of P-gp substrates, where minimal concentration changes may lead to serious toxicities.

from FDA,2021.10