HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DAURISMO safely and effectively. See full prescribing information for DAURISMO.
DAURISMOTM (glasdegib) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning.
DAURISMO can cause embryo-fetal death or severe birth defectswhen administered to a pregnant woman. DAURISMO isembryotoxic, fetotoxic, and teratogenic in animals. (5.1, 8.1)
Conduct pregnancy testing in females of reproductive potentialprior to initiation of DAURISMO treatment. Advise females ofreproductive potential to use effective contraception duringtreatment with DAURISMO and for at least 30 days after the lastdose. (5.1, 8.1, 8.3)
Advise males of the potential risk of exposure through semen and touse condoms with a pregnant partner or a female partner ofreproductive potential during treatment with DAURISMO and forat least 30 days after the last dose to avoid potential drug exposure.(5.1, 8.3)
INDICATIONS AND USAGE
DAURISMO is a hedgehog pathway inhibitor indicated, in combination withlow-dose cytarabine, for the treatment of newly-diagnosed acute myeloid
leukemia (AML) in adult patients who are ≥75 years old or who havecomorbidities that preclude use of intensive induction chemotherapy. (1)
Limitation of Use: DAURISMO has not been studied in patients with thecomorbidities of severe renal impairment or moderate-to-severe hepaticimpairment.
DOSAGE AND ADMINISTRATION
Recommended dose: 100 mg orally, once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 25 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Blood Donation: Advise patients not to donate blood or blood productsduring treatment with DAURISMO and for at least 30 days after the lastdose. (5.1)
QTc Interval Prolongation: Monitor electrocardiograms and electrolytes. IfQTc prolongation occurs, interrupt treatment with DAURISMO. (2.2, 5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20%) are anemia, fatigue,hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema,thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis,constipation, and rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: Consider alternative therapies that are notstrong CYP3A inhibitors or monitor for increased risk of adverse reactions,including QTc interval prolongation. (7)
Strong CYP3A4 Inducers: Avoid concomitant use with DAURISMO. (7)
QTc Prolonging Drugs: Avoid co-administration with DAURISMO. Ifco-administration is unavoidable, monitor for increased risk of QTcinterval prolongation. (7)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 11/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: EMBRYO-FETAL TOXICITY
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose and Schedule
2.2 Monitoring and Dose Modifications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS