7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on CIBINQO
Table 4 includes drugs with clinically significant drug interactions affecting CIBINQO.
Strong CYP2C19 Inhibitors | |
Clinical Impact | Coadministration of CIBINQO with strong CYP2C19 inhibitors increases the combined exposure of abrocitinib and its two active metabolites, M1 and M2 which may increase the adverse reactions of CIBINQO [see Clinical Pharmacology (12.3)]. |
Intervention | Dosage reduction of CIBINQO is recommended when coadministered with strong CYP2C19 inhibitors [see Dosage and Administration (2.5)]. |
Moderate to Strong Inhibitors of both CYP2C19 and CYP2C9 | |
Clinical Impact | Coadministration of CIBINQO with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9 increases the exposure of abrocitinib and its two active metabolites, M1 and M2 which may increase the adverse reactions of CIBINQO [Clinical Pharmacology (12.3)]. |
Intervention | Avoid concomitant use of CIBINQO with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9. |
Strong CYP2C19 or CYP2C9 Inducers | |
Clinical Impact | Coadministration of CIBINQO with strong CYP2C19 or CYP2C9 inducers decreases the combined exposure of abrocitinib and its two active metabolites, M1 and M2, which may result in loss of or reduced clinical response [see Clinical Pharmacology (12.3)]. |
Intervention | Avoid concomitant use of CIBINQO with strong CYP2C19 or CYP2C9 inducers. |
7.2 Effects of CIBINQO on Other Drugs
Table 5 includes clinically significant drug interactions affecting other drugs.
P-gp Substrate Where Small Concentration Changes May Lead to Serious or Life-threatening Toxicities | |
Clinical Impact | Coadministration of CIBINQO with P-gp substrate increases plasma concentrations of P-gp substrates and may result in potential adverse reactions of the P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities (e.g., digoxin) [see Clinical Pharmacology (12.3)]. |
Intervention | Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO. |
Antiplatelet Therapy Drugs | |
Clinical Impact | Coadministration of CIBINQO with antiplatelet therapy drugs may increase the risk of bleeding with thrombocytopenia [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.2)]. |
Intervention | Antiplatelet drugs, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment are contraindicated with CIBINQO [see Contraindications (4)]. |