DAURISMO™ Drug Interactions

(glasdegib)

7 DRUG INTERACTIONS

Table 5. Drug Interactions with DAURISMO

Strong CYP3A Inhibitors

Clinical Impact

•
Co-administration of DAURISMO with strong CYP3A inhibitors increased glasdegib plasma concentrations [see Clinical Pharmacology (12.3)].
•
Increased glasdegib concentrations may increase the risk of adverse reactions including QTc interval prolongation [see Warnings and Precautions (5.2)].

Prevention or Management

•
Consider alternative therapies that are not strong CYP3A4 inhibitors during treatment with DAURISMO.
•
Monitor patients for increased risk of adverse reactions including QTc interval prolongation [see Warnings and Precautions (5.2)].

Strong and Moderate CYP3A Inducers

Clinical Impact

Co-administration of DAURISMO with strong and moderate CYP3A inducers decreased glasdegib plasma concentrations [see Clinical Pharmacology (12.3)].

•
Decreased glasdegib concentrations may reduce efficacy.

Prevention or Management

•
Avoid co-administration of DAURISMO with strong and moderate CYP3A4 inducers.
•
If co-administration of DAURISMO with moderate CYP3A4 inducers cannot be avoided, increase the dose of DAURISMO [see Dosage and Administration (2.3)].

QTc Prolonging Drugs

Clinical Impact

Co-administration of DAURISMO with QTc prolonging drugs may increase the risk of QTc interval prolongation [see Warnings and Precautions (5.2)].

Prevention or Management

•
Avoid co-administration of QTc prolonging drugs with DAURISMO or replace with alternative therapies.
•
If co-administration of a QTc prolonging drug is unavoidable, monitor patients for increased risk of QTc interval prolongation [see Warnings and Precautions (5.2)].

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Drug Interactions

7 DRUG INTERACTIONS

Table 5. Drug Interactions with DAURISMO

Strong CYP3A Inhibitors

Clinical Impact

•
Co-administration of DAURISMO with strong CYP3A inhibitors increased glasdegib plasma concentrations [see Clinical Pharmacology (12.3)].
•
Increased glasdegib concentrations may increase the risk of adverse reactions including QTc interval prolongation [see Warnings and Precautions (5.2)].

Prevention or Management

•
Consider alternative therapies that are not strong CYP3A4 inhibitors during treatment with DAURISMO.
•
Monitor patients for increased risk of adverse reactions including QTc interval prolongation [see Warnings and Precautions (5.2)].

Strong and Moderate CYP3A Inducers

Clinical Impact

Co-administration of DAURISMO with strong and moderate CYP3A inducers decreased glasdegib plasma concentrations [see Clinical Pharmacology (12.3)].

•
Decreased glasdegib concentrations may reduce efficacy.

Prevention or Management

•
Avoid co-administration of DAURISMO with strong and moderate CYP3A4 inducers.
•
If co-administration of DAURISMO with moderate CYP3A4 inducers cannot be avoided, increase the dose of DAURISMO [see Dosage and Administration (2.3)].

QTc Prolonging Drugs

Clinical Impact

Co-administration of DAURISMO with QTc prolonging drugs may increase the risk of QTc interval prolongation [see Warnings and Precautions (5.2)].

Prevention or Management

•
Avoid co-administration of QTc prolonging drugs with DAURISMO or replace with alternative therapies.
•
If co-administration of a QTc prolonging drug is unavoidable, monitor patients for increased risk of QTc interval prolongation [see Warnings and Precautions (5.2)].
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