Vismodegib
ERIVEDGE
What it isHedgehog-pathway inhibitor blocking Smoothened; metastatic or unresectable basal-cell carcinoma.
Why this oneUnlike sonidegib, it is labeled for metastatic as well as locally advanced basal-cell carcinoma.
What limits itEmbryo-fetal death and birth defects require pregnancy precautions; muscle spasms, alopecia, taste loss, and weight loss are common.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Advanced basal cell carcinoma | Adults | 150 mg QD | 150 mg QD until progression or unacceptable toxicity | 150 mg QD |
Renal No adjustment needed
Hepatic No adjustment needed
Instructions
- With or without food; swallow capsules whole - do not open or crush
- Missed dose: skip; resume with next scheduled dose
- May withhold up to 8 weeks for intolerable adverse reactions until improvement/resolution
- Permanently discontinue for SCARs (SJS, TEN, DRESS); interrupt for severe/intolerable musculoskeletal reactions and permanently discontinue if recurrent
- Verify pregnancy status within 7 days before initiation
- Do not donate blood or blood products during treatment and for 24 months after final dose; males: do not donate semen during and for 3 months after final dose
Cautions
- Embryo-fetal toxicity (boxed): female contraception during and for 24 months after final dose; male condom use (even post-vasectomy) during and 3 months after - drug present in semen
- Severe cutaneous adverse reactions (SJS, TEN, DRESS), may be life-threatening or fatal - permanently discontinue
- Musculoskeletal adverse reactions with CPK elevation (78% of patients; muscle spasms 72%): obtain baseline CPK and creatinine; recheck if muscle symptoms
- Premature fusion of the epiphyses reported with pediatric exposure (may progress after discontinuation); not indicated in pediatric patients
- No blood donation during treatment and for 24 months after final dose
Adverse reactions
- Muscle spasms (72%), alopecia (64%), dysgeusia (55%), weight loss (45%), fatigue (40%)
- Nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, ageusia (>=10%)
- Amenorrhea in 30% of pre-menopausal women; Grade 3 hyponatremia, azotemia, hypokalemia; postmarketing: drug-induced liver injury, SJS/TEN, DRESS
Pregnancy Can cause embryo-fetal death or severe birth defects (teratogenic in rats at 0.2x human exposure); pregnancy registry 1-888-835-2555
Lactation Breastfeeding not recommended during treatment and for 24 months after final dose
⚠ BOXED WARNING
- Embryo-fetal toxicity
Principal riskBoxed warning: can cause embryo-fetal death and severe birth defects.
Cost, est. cash$5,000–$30,000+/month or cycle
Generic entry2028 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryD
Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.
Mechanism of action: Vismodegib ballicule
