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DAURISMO™ (glasdegib)

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DAURISMO™ Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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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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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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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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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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4 CONTRAINDICATIONS

None.

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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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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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7 DRUG INTERACTIONS

...
Table 5. Drug Interactions with DAURISMO
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on its mechanism...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with glasdegib.

Glasdegib...

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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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16 HOW SUPPLIED/STORAGE AND HANDLING

DAURISMO is supplied in the following strengths and package configurations:

...
DAURISMO film-coated tablets
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This Medication Guide has been...
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This product's label may have been updated. For current full prescribing information, please visit www.DAURISMO.com.

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