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DAURISMO Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

Λέξεις κλειδιά

0069-0298 0069-1531

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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 ...

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 cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each ...

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 debossed with Pfizer on ...

4. Contraindications

None.

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 can cause embryo-fetal death or severe birth defects when administered ...

6. Adverse Reactions

The following clinically significant adverse reaction is described elsewhere in the labeling: QT Interval Prolongation <em>[see Warnings and Precautions (5.2)]</em>

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

Table 5. Drug Interactions with DAURISMO: Strong CYP3A Inhibitors Clinical Impact • Co-administration of DAURISMO with strong CYP3A inhibitors increased glasdegib plasma concentrations <em>[see Clinical ...

8.1. Pregnancy

Risk Summary Based on its mechanism of action and findings in animal embryo-fetal developmental toxicity studies, DAURISMO can cause fetal harm when administered to a pregnant woman <em>[see Clinical Pharmacology ...

8.2. Lactation

Risk Summary There are no data on the presence of glasdegib or its active metabolites in human milk, the effects of the drug on the breastfed child, or its effect on milk production. Because of the potential ...

8.3. Females and Males of Reproductive Potential

DAURISMO can cause fetal harm when administered to a pregnant woman <em>[see Use in Specific Populations (8.1)]</em>. Pregnancy Testing Conduct pregnancy testing in females of reproductive potential within ...

8.4. Pediatric Use

The safety and effectiveness of DAURISMO have not been established in pediatric patients. In repeat-dose toxicity studies in rats, oral administration of DAURISMO resulted in adverse changes in growing ...

8.5. Geriatric Use

Of the total number of subjects in clinical studies of DAURISMO with low-dose cytarabine (N=88), 98% of the patients were age 65 years or older and 60% of the patients were age 75 years or older. There ...

8.6. Renal Impairment

No dosage modification is recommended for patients with mild to severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 89 mL/min). Monitor patients with severe renal impairment (eGFR ...

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 ...

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<sub>25 ...

12.1. Mechanism of Action

Glasdegib is an inhibitor of the hedgehog pathway. Glasdegib binds to and inhibits Smoothened, a transmembrane protein involved in hedgehog signal transduction. In a murine xenotransplant model of human ...

12.2. Pharmacodynamics

Cardiac Electrophysiology The effect of glasdegib administration on corrected QT interval (QTc) was evaluated in a randomized, single-dose, double-blind, 4-way crossover, placebo- and open-label moxifloxacin-controlled ...

12.3. Pharmacokinetics

DAURISMO at 5 mg to 600 mg once daily (0.05 to 6 times the recommended dose) result in a dose proportional increase in glasdegib peak concentrations (C<sub>max</sub>) and area under the curve over the ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with glasdegib. Glasdegib was not mutagenic <em>in vitro</em> in the bacterial reverse mutation (Ames) assay and was not clastogenic in the <em>in vitro ...

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 ...

16.1. How Supplied

DAURISMO is supplied in the following strengths and package configurations: <b>DAURISMO film-coated tablets:</b> Package Configuration Tablet Strength (mg) NDC Print (description) 30 count bottle ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity Advise female patients of the potential risk to a fetus and to inform their healthcare provider of ...

BOXED WARNING SECTION

<b>WARNING: EMBRYO-FETAL TOXICITY</b> <b>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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