Interactions : אינטראקציות

7       DRUG INTERACTIONS
7.1     Effect of Other Drugs on SCEMBLIX
Strong CYP3A4 Inhibitors
Asciminib is a CYP3A4 substrate. Concomitant use of SCEMBLIX with a strong CYP3A4 inhibitor increases both the asciminib Cmax and AUC, which may increase the risk of adverse reactions [see Clinical Pharmacology (12.3)]. Closely monitor for adverse reactions in patients treated with SCEMBLIX at 200 mg twice daily with concomitant use of strong CYP3A4 inhibitors.
Itraconazole Oral Solution Containing Hydroxypropyl-β-cyclodextrin
Concomitant use of SCEMBLIX with itraconazole oral solution containing hydroxypropyl-β-cyclodextrin decreases asciminib Cmax and AUC, which may reduce SCEMBLIX efficacy [see Clinical Pharmacology (12.3)]. Avoid coadministration of SCEMBLIX at all recommended doses with itraconazole oral solution containing hydroxypropyl-β- cyclodextrin.
7.2     Effect of SCEMBLIX on Other Drugs
Certain CYP3A4 Substrates
Asciminib is a CYP3A4 inhibitor. Concomitant use of SCEMBLIX increases the Cmax and AUC of CYP3A4 substrates, which may increase the risk of adverse reactions of these substrates [see Clinical Pharmacology (12.3)].
Closely monitor for adverse reactions in patients treated with SCEMBLIX 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 SCEMBLIX 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 SCEMBLIX increases the Cmax and AUC of CYP2C9 substrates, which may increase the risk of adverse reactions of these substrates [see Clinical Pharmacology (12.3)].
Avoid coadministration of SCEMBLIX 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 SCEMBLIX 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 a non-CYP2C9 substrate.


Certain P-gp Substrates
Asciminib is a P-gp inhibitor. Concomitant use of SCEMBLIX increases the plasma concentrations of P-gp substrates, which may increase the risk of adverse reactions of these substrates [see Clinical Pharmacology (12.3)].
Closely monitor for adverse reactions in patients treated with SCEMBLIX at all recommended doses with concomitant use of P-gp substrates, where minimal concentration changes may lead to serious toxicities.
Substrates of OATP1B or BCRP
Asciminib is an OATP1B and BCRP inhibitor. The effect of concomitant use of SCEMBLIX with OATP1B and BCRP substrates has not been established in clinical studies. However, based upon a mechanistic understanding of the elimination of asciminib and its in vitro inhibitory potential [see Clinical Pharmacology (12.3)], concomitant use of SCEMBLIX increases the Cmax and AUC of OATP1B and BCRP substrates, which may increase the risk of adverse reactions of these substrates.
Avoid coadministration of SCEMBLIX at all recommended doses with rosuvastatin and atorvastatin. Closely monitor for adverse reactions in patients treated with SCEMBLIX at all recommended doses with concomitant use of other OATP1B or BCRP substrates. Reduce the dosage of the other OATP1B or BCRP substrates as recommended in their Prescribing Information when used concomitantly with SCEMBLIX at all recommended doses.