HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DAURISMO safely and effectively. See full prescribing information for DAURISMO. DAURISMO™ (glasdegib) tablets, for oral use Initial U.S. Approval: 2018 WARNING: EMBRYO-FETAL TOXICITY
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Dosage and Administration, Dosage Modification for Concomitant Use with Moderate CYP3A4 Inducers (2.3) | 3/2020 |
INDICATIONS AND USAGEDAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. (1)
DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. (1)
DOSAGE AND ADMINISTRATIONRecommended dosage: 100 mg orally once daily. (2.1)
Recommended dosage: 100 mg orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHSTablets: 100 mg, 25 mg. (3)
Tablets: 100 mg, 25 mg. (3)
CONTRAINDICATIONSNone. (4)
None. (4)
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost 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. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS- Strong CYP3A4 Inhibitors: Consider alternative therapies that are not strong CYP3A4 inhibitors or monitor for increased risk of adverse reactions, including QTc interval prolongation. (7)
- Strong CYP3A4 Inducers: Avoid concomitant use with DAURISMO. (7)
- Moderate CYP3A4 Inducers: Avoid concomitant use with DAURISMO. If, concomitant use cannot be avoided, increase the dose of DAURISMO (2.3, 7).
- QTc Prolonging Drugs: Avoid co-administration with DAURISMO. If co-administration is unavoidable, monitor for increased risk of QTc interval prolongation. (7)
- Strong CYP3A4 Inhibitors: Consider alternative therapies that are not strong CYP3A4 inhibitors or monitor for increased risk of adverse reactions, including QTc interval prolongation. (7)
- Strong CYP3A4 Inducers: Avoid concomitant use with DAURISMO. (7)
- Moderate CYP3A4 Inducers: Avoid concomitant use with DAURISMO. If, concomitant use cannot be avoided, increase the dose of DAURISMO (2.3, 7).
- QTc Prolonging Drugs: Avoid co-administration with DAURISMO. If co-administration is unavoidable, monitor for increased risk of QTc interval prolongation. (7)
USE IN SPECIFIC POPULATIONSLactation: Advise women not to breastfeed. (8.2)
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2020