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Basal Cell Carcinoma
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Erivedge

vismodegib
Hedgehog Pathway Inhibitor FDA Approved 2012 Genentech / Roche
Route
Oral
Half-Life
12 days
FDA Approved
2012
Manufacturer
Genentech / Roche
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1. Indications and Usage

BCC: Metastatic or locally advanced BCC not candidates for surgery/radiation.

2. Dosage and Administration

150 mg orally once daily.

3. Dosage Forms and Strengths

Capsules: 150 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Embryo-Fetal Toxicity: Severe birth defects. Verify pregnancy.
  • Blood Donation: No donation for 24 months.
6. Adverse Reactions
Most Common Adverse Reactions

Muscle Spasms (72%), Alopecia (64%), Dysgeusia (55%), Weight Loss (45%), Fatigue (40%), Nausea (30%), Diarrhea (29%), Decreased Appetite (25%)

Muscle Spasms
72%
Alopecia
64%
Dysgeusia
55%
Weight Loss
45%
Fatigue
40%
Nausea
30%
Diarrhea
29%
Decreased Appetite
25%

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

7. Drug Interactions

P-gp 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). Hedgehog signaling is aberrantly activated in most BCC.

Pharmacokinetics

Bioavailability: 32%. Protein binding: >99%. t½: 12 days (steady state). Feces 82%.

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

Erivedge 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 Erivedge. 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 Erivedge (vismodegib) approved for?

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

How is Erivedge (vismodegib) administered?

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

How does Erivedge (vismodegib) work?

Hedgehog pathway inhibitor binding Smoothened (SMO). Hedgehog signaling is aberrantly activated in most BCC.

What are the most common side effects?

Muscle Spasms (72%), Alopecia (64%), Dysgeusia (55%), Weight Loss (45%), Fatigue (40%), Nausea (30%), Diarrhea (29%), Decreased Appetite (25%) Muscle Spasms 72% Alopecia 64% Dysgeusia 55% Weight Loss 45% Fatigue 40% Nausea 30% Diarrhea 29% Decreased Appetite 25%

← All Therapies Full Prescribing Information ↗