DAURISMO™ Patient Counseling Information

(glasdegib)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Embryo-Fetal Toxicity

•
Advise female patients of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].

Females and Males of Reproductive Potential

•
Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose.
•
Advise males of the potential risk of exposure through semen and to use effective contraception, including a condom, even after a vasectomy, to avoid drug exposure to a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose [see Use in Specific Populations (8.3)].

Semen Donation

•
Advise males not to donate semen during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO[see Use in Specific Populations (8.3)].

Lactation

•
Advise women not to breastfeed during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO [see Use in Specific Populations (8.2)].

Blood Donation

•
Advise patients not to donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO [see Warnings and Precautions (5.1)].

Infertility

•
Advise males of reproductive potential of the potential for impaired fertility from DAURISMO. Advise male patients to seek advice on effective fertility preservation before treatment [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

QTc Interval Prolongation

•
Inform patients of signs and symptoms that may be indicative of significant QTc interval prolongation. Advise patients to contact their healthcare provider immediately in the event of syncope, pre-syncopal symptoms, and cardiac palpitations [see Warnings and Precautions (5.2)].

Musculoskeletal Adverse Reactions

•
Advise patients starting therapy with DAURISMO of the risk of muscle-related adverse reactions.
•
Advise patients to report promptly any new unexplained muscle pain, tenderness, or weakness occurring during treatment or that persists after discontinuing DAURISMO [see Warnings and Precautions (5.3)].

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Health Professional Information

Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Embryo-Fetal Toxicity

•
Advise female patients of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].

Females and Males of Reproductive Potential

•
Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose.
•
Advise males of the potential risk of exposure through semen and to use effective contraception, including a condom, even after a vasectomy, to avoid drug exposure to a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose [see Use in Specific Populations (8.3)].

Semen Donation

•
Advise males not to donate semen during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO[see Use in Specific Populations (8.3)].

Lactation

•
Advise women not to breastfeed during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO [see Use in Specific Populations (8.2)].

Blood Donation

•
Advise patients not to donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO [see Warnings and Precautions (5.1)].

Infertility

•
Advise males of reproductive potential of the potential for impaired fertility from DAURISMO. Advise male patients to seek advice on effective fertility preservation before treatment [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

QTc Interval Prolongation

•
Inform patients of signs and symptoms that may be indicative of significant QTc interval prolongation. Advise patients to contact their healthcare provider immediately in the event of syncope, pre-syncopal symptoms, and cardiac palpitations [see Warnings and Precautions (5.2)].

Musculoskeletal Adverse Reactions

•
Advise patients starting therapy with DAURISMO of the risk of muscle-related adverse reactions.
•
Advise patients to report promptly any new unexplained muscle pain, tenderness, or weakness occurring during treatment or that persists after discontinuing DAURISMO [see Warnings and Precautions (5.3)].
Medication Guide

Health Professional Information

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