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.
DAURISMO™ (glasdegib) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning.
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
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 ADMINISTRATION
Recommended dosage: 100 mg orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 25 mg. (3)
WARNINGS AND PRECAUTIONS
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.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
No Current Announcements.
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