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Basal Cell Carcinoma
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Odomzo

sonidegib
Hedgehog Pathway Inhibitor FDA Approved 2015 Sun Pharma
Route
Oral
Half-Life
~4 days
FDA Approved
2015
Manufacturer
Sun Pharma
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1. Indications and Usage

BCC: Locally advanced BCC recurred after surgery/radiation.

2. Dosage and Administration

200 mg daily on empty stomach.

3. Dosage Forms and Strengths

Capsules: 200 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Musculoskeletal Reactions: Rhabdomyolysis. Monitor CPK.
  • Embryo-Fetal Toxicity: Severe birth defects.
6. Adverse Reactions
Most Common Adverse Reactions

Muscle Spasms (54%), Alopecia (51%), Dysgeusia (46%), Fatigue (41%), Nausea (39%), Musculoskeletal Pain (32%), Diarrhea (32%), Weight Loss (30%)

Muscle Spasms
54%
Alopecia
51%
Dysgeusia
46%
Fatigue
41%
Nausea
39%
Musculoskeletal Pain
32%
Diarrhea
32%
Weight Loss
30%

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

7. Drug Interactions

Strong CYP3A Inhibitors/Inducers: 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).

Pharmacokinetics

Bioavailability: <10%. t½: 28 days. Feces 70%.

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 Odomzo Trials on ClinicalTrials.gov ↗ 📚 PubMed: Odomzo Clinical Trials ↗
FDA-Approved Tumor Types

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

Basal Cell Carcinoma
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 Odomzo. 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 Odomzo (sonidegib) approved for?

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

How is Odomzo (sonidegib) administered?

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

How does Odomzo (sonidegib) work?

Hedgehog pathway inhibitor binding Smoothened (SMO).

What are the most common side effects?

Muscle Spasms (54%), Alopecia (51%), Dysgeusia (46%), Fatigue (41%), Nausea (39%), Musculoskeletal Pain (32%), Diarrhea (32%), Weight Loss (30%) Muscle Spasms 54% Alopecia 51% Dysgeusia 46% Fatigue 41% Nausea 39% Musculoskeletal Pain 32% Diarrhea 32% Weight Loss 30%

← All Therapies Full Prescribing Information ↗