Vismodegib – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 41 min read
Vismodegib - Uses, Dosage, Side Effects, Interaction
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Article Summary

Vismodegib is an orally bioavailable, small molecule inhibitor of SMO and the Hedgehog (Hh) pathway, with potential antineoplastic activity. Upon oral administration, vismodegib targets binds to, and inhibits the cell membrane-spanning G-protein coupled receptor SMO, which may result in the suppression of Hh pathway signaling and a decrease in tumor cell proliferation and survival. SMO is activated upon binding of the Hh ligand to the...

Key Takeaways

  • This article explains Mechanism of Action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
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Definition

Vismodegib is an orally bioavailable, small molecule inhibitor of SMO and the Hedgehog (Hh) pathway, with potential antineoplastic activity. Upon oral administration, vismodegib targets binds to, and inhibits the cell membrane-spanning G-protein coupled receptor SMO, which may result in the suppression of Hh pathway signaling and a decrease in cell proliferation and survival. SMO is activated upon binding of the Hh ligand to the cell surface receptor Patched (PTCH); inappropriate activation of Hh signaling and uncontrolled cellular proliferation may be associated with SMO mutations.

Vismodegib is a kinase inhibitor actively used in the therapy of unresectable or metastatic basal cell . Vismodegib therapy is associated with a low rate of transient elevations in serum aminotransferase during therapy and has been linked to rare cases of clinically apparent injury.

Vismodegib is a benzamide obtained by formal condensation between the carboxy group of 2-chloro-4-(methylsulfonyl)benzoic acid and the aniline group of 4-chloro-3-(pyridine-2-yl)aniline. Used for the treatment of metastatic basal cell carcinoma. It has a role as an antineoplastic agent, an SMO receptor antagonist, a Hedgehog signaling pathway inhibitor, and a teratogenic agent. It is a sulfone, a member of benzamides, a member of pyridines, and a member of monochlorobenzenes.

Mechanism of Action

Mutations of the Hedgehog pathway may results in uncontrolled proliferation of skin basal cells. Vismodegib binds to and inhibits the transmembrane protein Smoothened homologue (SMO) to inhibit the Hedgehog signalling pathway. Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

Recent evidence from in vitro and in vivo studies has demonstrated that aberrant reactivation of the Sonic Hedgehog (SHH) signaling pathway regulates genes that promote cellular proliferation in various human cancer stem cells (CSCs). Therefore, the chemotherapeutic agents that inhibit activation of Gli transcription factors have emerged as promising novel drugs for pancreatic cancer. GDC-0449 (Vismodegib), orally administrable molecule belonging to the 2-arylpyridine class, inhibits SHH signaling pathway by blocking the activities of Smoothened. The objectives of this study were to examine the molecular mechanisms by which GDC-0449 regulates human pancreatic CSC characteristics in vitro. GDC-0499 inhibited cell viability and induced apoptosis in three pancreatic cancer cell lines and pancreatic CSCs. This inhibitor also suppressed cell viability, Gli-DNA binding and transcriptional activities, and induced apoptosis through caspase-3 activation and PARP cleavage in pancreatic CSCs. GDC-0449-induced apoptosis in CSCs showed increased Fas expression and decreased expression of PDGFRa. Furthermore, Bcl-2 was down-regulated whereas TRAIL-R1/DR4 and TRAIL-R2/DR5 expression was increased following the treatment of CSCs with GDC-0449. Suppression of both Gli1 plus Gli2 by shRNA mimicked the changes in cell viability, spheroid formation, apoptosis and gene expression observed in GDC-0449-treated pancreatic CSCs. Thus, activated Gli genes repress DRs and Fas expressions, up-regulate the expressions of Bcl-2 and PDGFRa and facilitate cell survival. These data suggest that GDC-0499 can be used for the management of pancreatic cancer by targeting pancreatic CSCs.

or

Hedgehog (Hh) signaling is involved in the pathogenesis of liver . It has been previously shown that Hh-inhibitor cyclopamine (CYA) can reduce liver fibrosis in rats. However, CYA is not stable in vivo, which limits its application. This study compares the antifibrotic potential of two known Hh antagonists, vismodegib (GDC-0449, abbreviated to GDC) and CYA. GDC is a synthetic molecule presently in clinical cancer trials and has been reported to be safe and efficacious. These drugs attenuated early liver fibrosis in common ligated rats, improved liver function, and prevented hepatic stellate cell (HSC) activation, thereby suppressing epithelial to mesenchymal transition (EMT). While both CYA and GDC increased the number of proliferating cell nuclear antigen positive liver cells in vivo, only CYA increased Caspase-3 expression in HSCs in rat livers, suggesting that while GDC and CYA effectively attenuate early liver fibrosis, their hepatoprotective effects may be mediated through different modes of action. Thus, GDC has the potential to serve as a new therapeutic agent for treating early liver fibrosis.

Indications

  • Vismodegib is used for treating locally advanced or metastatic basal cell carcinoma in patients whose carcinoma has recurred after surgery, and in patients who are not candidates for surgery or radiation.
  • Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or
  • Vismodegib is a kinase inhibitor active used in the therapy of unresectable or metastatic basal cell carcinoma.
  • Erivedge capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
  • Vismodegib is indicated for patients with basal cell carcinoma (BCC) which has metastasized to other parts of the body, relapsed after surgery, or cannot be treated with surgery or radiation.
  • Vismodegib is a hedgehog pathway inhibitor used to treat patients with locally advanced or metastatic basal cell carcinoma.
  • Vismodegib is used for treating locally advanced or metastatic basal cell carcinoma in patients whose carcinoma has recurred after surgery, and in patients who are not candidates for surgery or radiation.
  • Locally Advanced Basal Cell Carcinoma
  • Metastatic Basal cell carcinoma

Use in Cancer

Vismodegib is approved to treat:

  • Basal cell carcinoma (a type of skin cancer). It is used in adults whose disease has metastasized (spread to other parts of the body). It is also used in adults with locally advanced disease that has recurred (come back) after surgery or who cannot be treated with surgery or radiation.

Vismodegib is also being studied in the treatment of other types of cancer.

Contraindications

Vismodegib is in pregnant women or women who may become pregnant.

Boxed Warning of Embryofetal Toxicity

Embryotoxic effects include:

  • Craniofacial abnormalities
  • Anorectal defects
  • Fused or absent digits

Blood Donations – Patients should be advised not to donate blood or blood products during vismodegib treatment and at least 24 months after the last dose.

Important Special Warnings – Counseling of both males and females on vismodegib is necessary.

Women- Following a negative , initiate highly effective before the first dose of vismodegib and continue for seven months after treatment.

Men – During treatment, and for three months following treatment, men should not donate sperm and should use condoms with spermicide (even after vasectomy) as vismodegib may be present in seminal fluid. This precaution is to avoid exposure to patients that may be pregnant.

Strengths: 150 mg

Basal Cell Carcinoma

  • 150 mg orally once a day until or unacceptable toxicity
  • Withhold therapy for up to 8 weeks for intolerable adverse reactions until improvement or resolution.
  • Treatment durations shorter than 8 weeks prior to interruptions have not been studied.

EMBRYOFETAL TOXICITY:

  • This drug can cause embryofetal death or birth defects when administered to a pregnant woman.
  • This drug is embryotoxic, fetotoxic, and teratogenic in animals.
  • Teratogenic effects include severe midline defects, missing digits, and other irreversible malformations.
  • Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating therapy.
  • Advise pregnant women of the potential risks to a fetus.
  • Advise females of reproductive potential to use effective contraception during and after therapy.
  • Advise males of the potential risk of drug exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential.

Administration advice:

  • This drug may be taken with or without food.
  • Swallow capsules whole; do not open or crush.
  • If a dose of is missed, do not make it up; resume with the next scheduled dose.
  • Verify pregnancy status of females of reproductive potential within 7 days prior to initiating this drug.

Side Effects

The Most Common

  • muscle spasms
  • joint
  • tiredness
  • hair loss
  • change in how things taste or loss of taste
  • decreased appetite
  • missed menstrual periods
  • Absent, missed, or irregular menstrual periods
  • change in taste
  • constipation
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement
  • difficulty with moving
  • hair loss or thinning
  • loss of taste
  • muscle or
  • pain in the joints
  • stopping of menstrual bleeding
  • weight loss

More Common

  • Bloody or cloudy urine
  • dry mouth
  • fast or irregular heartbeat
  • increased thirst
  • muscle pain or cramps
  • nausea
  • pain in the lower back or side
  • seizures
  • swelling of the face, ankles, or hands
  • thirst
  • unusual tiredness or weakness
  • vomiting

Rare

  • Black, tarry stools
  • blistering, peeling, loosening of the skin
  • chest pain
  • chills
  • cough
  • diarrhea
  • itching skin
  • joint or muscle pain
  • painful or difficult urination
  • red irritated eyes
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots in the mouth or on the lips
  • sore throat
  • swollen glands
  • trouble breathing
  • unusual bleeding or bruising
  • yellow eyes or skin

Drug interactions

Pregnancy and Lactation

FDA Pregnancy Category D

Pregnancy

Vismodegib capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Vismodegib is teratogenic in rats at doses corresponding to an exposure of 20% of the exposure at the recommended human dose (estimated AUC0-24hr steady-state exposure). In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Vismodegib is embryolethal in rats at exposures within the range achieved at the recommended human dose. If vismodegib is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the  potential hazard to the embryo or fetus. Encourage women who may have been exposed to vismodegib during pregnancy, either directly or through seminal fluid, to participate in the vismodegib pregnancy pharmacovigilance program by contacting the Genentech

Lactation

No information is available on the clinical use of vismodegib during breastfeeding. Because vismodegib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is 4 days and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during vismodegib therapy and for 24 months after the final dose.

How should this medicine be used?

Vismodegib comes as a capsule to take by mouth. It is usually taken once a day with or without food. To help you remember to take vismodegib, take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vismodegib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the capsules whole; do not split, chew, or crush them.

What special precautions should I follow?

Before taking vismodegib,

  • tell your doctor and pharmacist if you are allergic to vismodegib, any other medications, or any of the ingredients in vismodegib capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antacids; certain antibiotics such as azithromycin (Z-Pak, Zithromax), clarithromycin (Biaxin, in Prevpac), and erythromycin (E.E.S., Eryc, Ery-Tab, Erythrocin, PCE); a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), and ranitidine (Zantac); and proton-pump inhibitors such as dexlansoprazole (Dexilant), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), and rabeprazole (AcipHex). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with vismodegib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • do not breastfeed while you are taking vismodegib and for 7 months after your treatment.

References

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  9. Review prevention and self-care Explore prevention, healthy routines, and questions to discuss with a clinician.

Conditions & Diseases

Background, symptoms, causes, diagnosis, and care.

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Tests & Investigations

Laboratory, imaging, screening, and diagnostic education.

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Medicines

Uses, safety, monitoring, and related medicine knowledge.

Explore this library

Cancer Knowledge

Cancer types, screening, oncology, and treatment education.

Explore this library
Doctor visit helper

Prepare before seeing a doctor

A simple rural-patient checklist to help you explain symptoms clearly, ask better questions, and avoid unsafe self-treatment.

Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

Which doctor may help?

Start with a registered doctor or the nearest qualified health center.

What to tell the doctor

  • Write when the problem started and how it changed.
  • Bring old prescriptions, investigation reports, and current medicines.
  • Write allergies, pregnancy status, diabetes, kidney/liver disease, and major past illnesses.
  • Bring one family member if the patient is weak, elderly, confused, or a child.

Questions to ask

  • What is the most likely cause of my symptoms?
  • Which danger signs mean I should go to hospital quickly?
  • Which tests are necessary now, and which can wait?
  • How should I take medicines safely and what side effects should I watch for?
  • When should I come for follow-up?

Tests to discuss

  • Vital signs: temperature, pulse, blood pressure, oxygen saturation
  • Basic physical examination by a clinician
  • CBC, urine test, blood sugar, or imaging only when clinically needed

Avoid these mistakes

  • Do not use antibiotics, steroid tablets/injections, or strong painkillers without proper medical advice.
  • Do not hide pregnancy, kidney disease, ulcer, allergy, or blood thinner use.
  • Do not delay emergency care when danger signs are present.

Medicine safety and first-aid guide

This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

Doctor to discuss: Emergency care / cardiology / medicine doctor
Tests to discuss with doctor
  • ECG as early as possible when chest pain suggests heart risk
  • Troponin or cardiac blood tests if doctor suspects heart attack
  • Blood pressure, oxygen level, chest examination, and other tests as advised urgently
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Is this heart-related, and do I need emergency observation?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Vismodegib – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.