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Daurismo

glasdegib
Hedgehog Pathway Inhibitor FDA Approved 2018 Pfizer
Route
Oral
Half-Life
17.4 hrs
FDA Approved
2018
Manufacturer
Pfizer
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1. Indications and Usage

AML: With low-dose cytarabine for newly diagnosed AML in patients ≥75 or unfit for intensive chemotherapy.

2. Dosage and Administration

100 mg daily D1-28 of 28-day cycles with cytarabine 20 mg SC BID D1-10.

3. Dosage Forms and Strengths

Tablets: 25 mg, 100 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • QTc Prolongation: Monitor ECGs.
  • Embryo-Fetal Toxicity: Can cause birth defects.
6. Adverse Reactions
Most Common Adverse Reactions

Anemia (75%), Fatigue (54%), Hemorrhage (49%), Febrile Neutropenia (29%), Nausea (26%), Musculoskeletal Pain (26%), Edema (21%), Mucositis (20%)

Anemia
75%
Fatigue
54%
Hemorrhage
49%
Febrile Neutropenia
29%
Nausea
26%
Musculoskeletal Pain
26%
Edema
21%
Mucositis
20%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inducers: Avoid.
QTc drugs: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Hedgehog pathway inhibitor binding Smoothened (SMO), reducing leukemic stem cell survival.

Pharmacokinetics

Tmax: 2h. Bioavailability: ~77%. t½: 17.4h. Urine 49%, feces 42%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Daurismo Trials on ClinicalTrials.gov ↗ 📚 PubMed: Daurismo Clinical Trials ↗
FDA-Approved Tumor Types

Daurismo has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Acute Myeloid Leukemia
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Daurismo. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Daurismo (glasdegib) approved for?

Daurismo (glasdegib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Daurismo (glasdegib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Daurismo (glasdegib) work?

Hedgehog pathway inhibitor binding Smoothened (SMO), reducing leukemic stem cell survival.

What are the most common side effects?

Anemia (75%), Fatigue (54%), Hemorrhage (49%), Febrile Neutropenia (29%), Nausea (26%), Musculoskeletal Pain (26%), Edema (21%), Mucositis (20%) Anemia 75% Fatigue 54% Hemorrhage 49% Febrile Neutropenia 29% Nausea 26% Musculoskeletal Pain 26% Edema 21% Mucositis 20%

← All Therapies Full Prescribing Information ↗