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DAURISMO™ (glasdegib)
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DAURISMO™ Quick Finder
Highlights
Boxed Warning
WARNING: EMBRYO-FETAL TOXICITY
DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals...
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Indications and Usage
1 INDICATIONS AND USAGE
DAURISMO is 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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage and Schedule
The recommended dosage of DAURISMO is 100 mg orally once daily on days 1 to 28 in combination with...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
DAURISMO 100 mg tablets: round, pale orange film-coated tablet debossed with "Pfizer" on one side and "GLS 100" on the other.
DAURISMO 25 mg tablets: round, yellow film-coated tablet...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Embryo-Fetal Toxicity
Based on its mechanism of action and findings from animal embryo-fetal developmental toxicity studies, DAURISMO...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- •
- QTc Interval Prolongation [see Warnings and...
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Drug Interactions
7 DRUG INTERACTIONS
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its mechanism...
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Overdosage
10 OVERDOSAGE
There is no specific antidote for DAURISMO. Management of DAURISMO overdose should include symptomatic treatment and ECG monitoring.
Glasdegib has been administered in clinical studies up to a dose of 640...
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Description
11 DESCRIPTION
DAURISMO (glasdegib) is a hedgehog pathway inhibitor. It is formulated with the maleate salt of glasdegib. The molecular formula for glasdegib maleate is C25H26...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Glasdegib is an inhibitor of the Hedgehog pathway. Glasdegib binds to and inhibits Smoothened, a transmembrane...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been performed with glasdegib.
Glasdegib...
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Clinical Studies
14 CLINICAL STUDIES
The efficacy of DAURISMO in combination with low-dose cytarabine was evaluated in a multicenter, open-label, randomized study (Study BRIGHT AML 1003, NCT01546038) that included 115 patients age 55 years...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
DAURISMO is supplied in the following strengths and package configurations:
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Medication Guide
This Medication Guide has been approved by the U.S. Food and Drug Administration. | ... |
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Other
This product's label may have been updated. For current full prescribing information, please visit www.DAURISMO.com.
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