Vismodegib

Pronunciation: vis-moe-DEG-ib.

Generic name
vismodegib
Drug class
Hedgehog pathway inhibitor (Smoothened/SMO antagonist); antineoplastic agent
Form
Capsule, 150 mg
Route
Oral
Legal status
Prescription-only, oncologist/specialist-initiated, in every market reviewed

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Erivedge (6) · Full directory

What vismodegib is and how it works

Vismodegib is a targeted cancer medicine that blocks the Hedgehog signalling pathway by inhibiting a protein called SMO (Smoothened), which basal cell carcinoma tumours rely on to grow and spread. It is used for adults with basal cell carcinoma that has spread to other parts of the body (metastatic), or that is locally advanced and not suitable for surgery or radiotherapy. (1) (2)

Vismodegib carries a serious, genuine FDA boxed warning -- the strongest safety warning the FDA issues -- because it can cause embryo-fetal death or severe birth defects if taken during pregnancy. Because of this, pregnancy testing, strict contraception, and blood/semen donation restrictions are required before, during, and for a long period after treatment. This is a specialist oncology treatment that must only be started, continued, or stopped under the direction of the cancer care team managing your treatment.

Mechanism of action: how vismodegib works

Vismodegib is a first-in-class, small-molecule inhibitor of Smoothened (SMO), a transmembrane protein central to Hedgehog pathway signal transduction. By blocking SMO, vismodegib inhibits the Hedgehog signalling pathway implicated in the pathogenesis of basal cell carcinoma, slowing tumour growth and spread. (1) (2) (3)

What vismodegib is used for

Metastatic basal cell carcinoma

Used to treat adults whose basal cell carcinoma has spread to other parts of the body. (1) (3)

Locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy

Used to treat adults with locally advanced basal cell carcinoma that has recurred after surgery, or who are not candidates for surgery or radiation therapy. (1) (2)

Before taking vismodegib

Do not take / not appropriate for

  • Must not be used during pregnancy, because of the risk of embryo-fetal death or severe birth defects. Pregnancy status must be confirmed within 7 days before starting treatment. (all countries) (1) (2) (3)
  • Women of childbearing potential must not take vismodegib unless using effective contraception during treatment and for 24 months after the final dose (two reliable methods, including a barrier method, are required per the UK and New Zealand labels). (all countries) (2) (3)
  • Must not be used while breastfeeding, or for 24 months after the final dose, because of the potential for serious developmental defects in breastfed infants. (United Kingdom, New Zealand (and reflected in the US label's Nursing Mothers guidance)) (2) (3)
  • Do not take if you have a known hypersensitivity to vismodegib or any excipient. (all countries) (2)
  • Avoid St. John's Wort while taking vismodegib. (United Kingdom) (2)

Tell your clinician about

  • Whether you are pregnant, could become pregnant, or are breastfeeding -- this determines whether treatment can be started at all.
  • Whether you or your partner could conceive during treatment, so the correct contraception and donation restrictions can be explained clearly for your specific situation.
  • All other medicines and supplements you take, including herbal products such as St. John's Wort.
  • Any history of kidney or liver problems, though no dose adjustment has been shown to be needed for renal or hepatic impairment.
  • Your age, particularly if you are 65 or older, since a lower response rate or higher rate of severe side effects could not be ruled out in this age group based on the clinical trial data reviewed.
(1) (2) (3)

How to take vismodegib

  • Take one 150 mg capsule by mouth once a day, with or without food, at around the same time each day.
  • Swallow the capsule whole with water -- do not open or crush it.
  • Continue treatment for as long as your oncology team directs, typically until the disease progresses or side effects become unacceptable; do not stop or change your dose without their guidance.
  • If you miss a planned dose, do not take the missed dose -- simply resume with the next scheduled dose, per the New Zealand data sheet's explicit missed-dose instruction.
(1) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a planned dose, do not take the missed dose -- simply resume dosing with your next scheduled dose. Do not double up. Contact your oncology team if you are unsure or have missed several doses.

Overdose

If you think you or someone else has taken too much vismodegib, contact your oncology team, a doctor, or emergency services immediately for guidance. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Muscle spasms and joint pain (arthralgia).

What to notice: Muscle spasms and joint pain (arthralgia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Hair loss (alopecia) and altered or loss of taste (dysgeusia/ageusia).

What to notice: Hair loss (alopecia) and altered or loss of taste (dysgeusia/ageusia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Weight loss and decreased appetite.

What to notice: Weight loss and decreased appetite.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Fatigue, nausea, diarrhoea, constipation, and vomiting.

What to notice: Fatigue, nausea, diarrhoea, constipation, and vomiting.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Suspected or confirmed pregnancy during treatment (patient or partner) — boxed_warning

Symptoms: Not applicable -- this is a risk-avoidance warning rather than a symptom to watch for.

Action: Contact your oncology team and the reporting line noted on your patient materials immediately -- vismodegib can cause embryo-fetal death or severe birth defects, and any suspected pregnancy during treatment (in the patient or a partner) needs urgent clinical assessment. (1) (2)

Signs of a severe allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.

Action: Seek emergency medical help immediately. (2)

Severe or persistent side effects (such as significant weight loss, muscle spasms, or gastrointestinal symptoms) — high caution

Symptoms: Significant unintentional weight loss, severe muscle cramps, persistent vomiting or diarrhoea, or an inability to eat or drink adequately.

Action: Contact your oncology team promptly -- these are common but potentially serious side effects that may require dose interruption (treatment can be paused for up to 8 weeks per the UK label) or additional supportive care, always under clinical direction. (1) (2)

Interactions

  • St. John's Wort should be avoided while taking vismodegib. (2)
  • Tell your oncology team about all other medicines and supplements you take, since drug interaction data specific to vismodegib should be reviewed by your treating clinician before starting or continuing treatment. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Contraindicated. Vismodegib can cause embryo-fetal death or severe birth defects; pregnancy status must be verified within 7 days before starting, and effective contraception is required for females of reproductive potential during treatment and for 24 months after the final dose. (1) (2) (3) (4) (5) (6)

Breastfeeding

Contraindicated during treatment and for 24 months after the final dose (per the UK and New Zealand labels), because of the potential for serious developmental defects in breastfed infants; the extent of excretion into breast milk is not known. (1) (2) (3) (4) (5) (6)

Children

Safety and efficacy have not been established in children or adolescents under 18. Premature fusion of the epiphyses (growth plates) and precocious puberty have been reported in paediatric patients exposed to vismodegib, in some cases progressing even after the drug was stopped. (1) (2) (3) (4) (5) (6)

Elderly

No dose adjustment is required based on age alone; however, roughly 40% of clinical trial patients were 65 or older, and there were not enough patients in this group to rule out a lower response rate or a higher rate of severe side effects compared with younger patients. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

No dose adjustment required for mild, moderate, or severe hepatic impairment, based on a dedicated clinical pharmacokinetic study. (1) (2) (3) (4) (5) (6)

Renal_impairment

No dose adjustment required for renal impairment, based on a population pharmacokinetic analysis; no dedicated clinical study has specifically evaluated renal impairment's effect. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-ERIVEDGE-2026,UK-EMC-ERIVEDGE-2026,NZ-MEDSAFE-ERIVEDGE-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Pregnancy test within 7 days before starting, for females of reproductive potential
  • Baseline assessment of disease extent and suitability for surgery/radiotherapy
  • Review of other medicines, including herbal products

During treatment

  • Monthly pregnancy testing during treatment for females of reproductive potential (minimum test sensitivity 25 mIU/mL per the UK label), continued even if periods stop.
  • Ongoing assessment for weight loss, muscle spasms, taste changes, and gastrointestinal side effects, with dose interruption available for up to 8 weeks to manage tolerability.
  • Regular oncology follow-up to assess disease response and decide when to continue, interrupt, or stop treatment.
(2)

Storage

Store capsules in their original packaging as directed on the label, out of reach of children. Do not use after the expiry date.

Professional information

Clinician-facing context only, sourced from the current live US DailyMed label, the UK EMC SmPC, and the New Zealand Medsafe data sheet; verify against the current full label before prescribing.

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Metastatic or locally advanced basal cell carcinoma inappropriate for surgery/radiotherapy

Dose summary: 150 mg orally once daily, continued until disease progression or unacceptable toxicity; treatment interruption of up to 8 weeks permitted to manage tolerability (UK label).

Renal context: No dose adjustment required for renal impairment (US, UK, NZ labels); no dedicated renal-impairment clinical study has been conducted. (1) (2) (3)

Mechanism of action

Hepatic guidance

No dose adjustment required for mild, moderate, or severe hepatic impairment, based on a dedicated clinical pharmacokinetic study.

Overdose note

No specific antidote identified in the sources reviewed; manage suspected overdose with supportive care under oncology/clinical direction. (1) (2) (3)

Frequently asked questions

Is vismodegib (Erivedge) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. It is authorised in all six markets under the same brand name, Erivedge: FDA-approved in the United States (2012), authorised by the European Medicines Agency (conditional approval 2013, later converted to full approval), MHRA/EMC-licensed in the United Kingdom, Health Canada-approved (2013), TGA-registered in Australia (ARTG 196234, 2013), and Medsafe-registered in New Zealand. (1) (2) (4) (5) (6) (3)

Why does vismodegib have a boxed warning?

Vismodegib can cause embryo-fetal death or severe birth defects if taken during pregnancy. It is embryotoxic, fetotoxic, and teratogenic in animal studies, causing severe midline defects, missing digits, and other irreversible malformations. Because of this, pregnancy testing before starting, strict contraception during and after treatment, and blood/semen donation restrictions are required for anyone who could become pregnant or who could cause a pregnancy while taking it. (1) (2) (3)

How long after stopping vismodegib do contraception and donation restrictions last?

For women of reproductive potential, effective contraception is required during treatment and for 24 months after the final dose in every market reviewed, and blood donation is restricted for the same 24-month period. For men, the current US label requires condom use and avoiding semen donation for 3 months after the final dose, while the UK and New Zealand labels specify 2 months after the final dose -- a genuine difference between these regulators' current label wording, so always follow the specific guidance given by your own prescriber and country's label. (1) (2) (3)

What is the mechanism of action of vismodegib?

Vismodegib is a first-in-class, small-molecule inhibitor of Smoothened (SMO), a transmembrane protein central to Hedgehog pathway signal transduction. By blocking SMO, vismodegib inhibits the Hedgehog signalling pathway implicated in the pathogenesis of basal cell carcinoma, slowing tumour growth and spread. (1) (2) (3)

What is the generic name of Vismodegib?

The generic name is vismodegib. (1) (2)

What class of drug is vismodegib?

Vismodegib is classed as: Hedgehog pathway inhibitor (Smoothened/SMO antagonist); antineoplastic agent. (1) (2)

References

  1. ERIVEDGE (vismodegib) capsules -- full prescribing information (current label)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Genentech, Inc. · United States · accessed 2026-07-30 · source 1
  2. Erivedge 150 mg hard capsules -- Summary of Product Characteristics (emc)electronic medicines compendium (emc), United Kingdom -- Roche Products Limited · United Kingdom · accessed 2026-07-30 · source 2
  3. ERIVEDGE (vismodegib) -- New Zealand Data SheetMedsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-30 · source 3
  4. Erivedge (vismodegib) -- EPAR medicine overviewEuropean Medicines Agency (EMA) -- EPAR for Erivedge · European Union · accessed 2026-07-30 · source 4
  5. ERIVEDGE (vismodegib) 150 mg capsule -- Canadian Product MonographHealth Canada -- Product Monograph, Hoffmann-La Roche Limited · Canada · accessed 2026-07-30 · source 5
  6. ERIVEDGE (vismodegib) 150 mg hard capsule -- ARTG entry 196234Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient vismodegib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • ERIVEDGE150 mg · genentech, inc.

United Kingdom

  • Erivedge (2)MHRA licensed emc smpc confirmed · 150 mg capsule · Roche Products Limited

Canada

  • ERIVEDGE

Australia

  • Erivedge (6)TGA ARTG registered 2013-05-09 confirmed · 150 mg capsule · Roche Products Pty Limited

New Zealand

  • Erivedge (3)Medsafe registered confirmed · 150 mg capsule · Roche Products (New Zealand) Limited
View brands in additional countries.

European Union

Erivedge (4)