CIBINQO Drug Interactions

(abrocitinib)

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on CIBINQO

Table 4 includes drugs with clinically significant drug interactions affecting CIBINQO.

Table 4. 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.

Table 5. Clinically Significant 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)].

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Drug Interactions

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on CIBINQO

Table 4 includes drugs with clinically significant drug interactions affecting CIBINQO.

Table 4. 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.

Table 5. Clinically Significant 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)].

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