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DAURISMO™ (glasdegib)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
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 reaction is described elsewhere in the labeling:
- QT Interval Prolongation [see
6.1 Clinical Trials...
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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 potent small molecule inhibitor of Smoothened (SMO) for oral use. It is formulated with the maleate salt of glasdegib. The molecular formula for glasdegib maleate is C...
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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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Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.