Vismodegib

ERIVEDGE

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Pronunciation: vis-moe-DEG-ib (E-ri-vej)

Vismodegib ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Vismodegib ballicule

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.

Vismodegib molecular structure (skeletal formula) — Molecular structure: Vismodegib

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Embryo-fetal toxicity: can cause embryo-fetal death or severe birth defects. Verify pregnancy status within 7 days before initiation; females use effective contraception during and after treatment; males use condoms with pregnant partners or female partners of reproductive potential.

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

Available strengths

cap 150 mg

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

Cost

Vismodegib (ERIVEDGE)

Strength		#/mo	generic $/mo	CostPlus
150 mg	cap	30 qd		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Vismodegib is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2028 est.

⚠ BOXED WARNING

Embryo-fetal toxicity

Principal riskBoxed warning: can cause embryo-fetal death and severe birth defects.

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Legacy pregnancy categoryD

Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.

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