Erivedge (Vismodegib)
Hedgehog pathway inhibitor for advanced basal cell carcinoma
Quick Facts About Erivedge
Key Takeaways About Erivedge
- Targeted therapy: Erivedge specifically blocks the Hedgehog signaling pathway, which drives the growth of basal cell carcinoma
- Simple daily dosing: One 150 mg capsule taken once daily by mouth, with or without food
- Severe pregnancy risk: Erivedge can cause severe birth defects or fetal death – strict pregnancy prevention measures are mandatory for 24 months after the last dose
- Common side effects: Muscle spasms, hair loss, taste changes, and fatigue are very common and should be discussed with your doctor
- No blood or sperm donation: Blood donation is prohibited during treatment and for 24 months after; sperm donation is prohibited for 2 months after the last dose
What Is Erivedge and What Is It Used For?
Erivedge (vismodegib) is an anticancer medicine that treats advanced basal cell carcinoma (BCC) in adults. It is used when the cancer has spread to other parts of the body (metastatic BCC) or when it has spread to surrounding areas (locally advanced BCC) and your doctor determines that surgery or radiation therapy is not appropriate.
Basal cell carcinoma is the most common type of skin cancer worldwide, accounting for approximately 80% of all non-melanoma skin cancers. While most cases of BCC are slow-growing and can be effectively treated with surgery or radiation, a small proportion of cases progress to an advanced stage where these conventional treatments are no longer feasible. This is where Erivedge plays a critical role as a systemic therapy option.
The active substance in Erivedge is vismodegib, a small-molecule drug that belongs to a class of medicines known as Hedgehog pathway inhibitors. Vismodegib was the first drug in this class to receive regulatory approval, initially granted by the U.S. Food and Drug Administration (FDA) in 2012 and subsequently by the European Medicines Agency (EMA) in 2013. It represented a significant advance in the treatment of advanced BCC, which previously had very limited systemic treatment options.
Erivedge is prescribed for two specific clinical scenarios. First, it is indicated for metastatic basal cell carcinoma, where the cancer has spread beyond the skin to other organs such as the lungs, bones, or lymph nodes. Second, it is used for locally advanced basal cell carcinoma that has grown extensively into surrounding tissues, making surgical removal impractical or inappropriate, and where radiation therapy is not a suitable alternative. Your oncologist or dermatologist will assess your individual situation to determine if Erivedge is the right treatment for you.
How Erivedge Works
To understand how Erivedge works, it is helpful to understand the role of the Hedgehog signaling pathway in cancer development. The Hedgehog pathway is a cellular communication system that is essential during embryonic development, where it guides cell growth, differentiation, and tissue formation. In healthy adults, this pathway is largely inactive. However, in more than 90% of basal cell carcinomas, the Hedgehog pathway becomes abnormally reactivated due to genetic mutations.
The most common mutations in BCC affect a gene called PTCH1 (Patched 1), which normally acts as a brake on the Hedgehog pathway. When PTCH1 is mutated, it can no longer inhibit a transmembrane protein called Smoothened (SMO). With SMO unrestrained, it sends continuous growth signals into the cell through downstream transcription factors known as GLI1 and GLI2. These signals drive uncontrolled cell proliferation, which is the hallmark of cancer.
Vismodegib works by binding directly to the Smoothened protein and blocking its activity. By inhibiting SMO, vismodegib effectively shuts down the aberrant Hedgehog signaling cascade. This interruption of the growth signal can slow down or stop the proliferation of cancer cells, and in many cases leads to tumor shrinkage. The pivotal ERIVANCE BCC trial demonstrated an objective response rate of 30% in patients with metastatic BCC and 43% in patients with locally advanced BCC, with many patients experiencing durable responses lasting several months or longer.
Erivedge is a targeted therapy that specifically addresses the molecular driver of basal cell carcinoma. Unlike traditional chemotherapy, which kills rapidly dividing cells indiscriminately, vismodegib acts on a specific signaling pathway. However, because the Hedgehog pathway also plays roles in hair follicle growth, taste bud maintenance, and muscle function, side effects related to these tissues are common during treatment.
What Should You Know Before Taking Erivedge?
Before starting Erivedge, you must understand the serious risk of birth defects. Women of childbearing potential must have negative pregnancy tests and use two forms of contraception. Erivedge must not be taken during pregnancy, while breastfeeding, or together with St. John's Wort.
Erivedge is a potent medication with specific safety requirements that must be understood before beginning treatment. Your doctor will provide you with a patient information booklet as part of the Erivedge Pregnancy Prevention Programme, which outlines the critical safety measures you need to follow. Read these instructions carefully and follow them throughout your treatment and for an extended period after your last dose.
Contraindications
You must not take Erivedge if any of the following apply:
- You are allergic to vismodegib or any of the other ingredients in the capsule (including lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, and magnesium stearate)
- You are pregnant, think you may be pregnant, or plan to become pregnant during treatment or within 24 months after your last dose – Erivedge can cause severe birth defects or fetal death
- You are breastfeeding or plan to breastfeed during treatment or within 24 months after your last dose – it is not known whether vismodegib passes into breast milk
- You are a woman of childbearing potential who cannot or will not comply with the required pregnancy prevention measures outlined in the Erivedge Pregnancy Prevention Programme
- You are taking St. John's Wort (Hypericum perforatum), an herbal remedy used for mild depression, as it may reduce the effectiveness of Erivedge
Erivedge causes severe birth defects and can lead to the death of an unborn baby. If you are a woman who could become pregnant, you must use two reliable methods of contraception during treatment and for 24 months after your last dose. If you are a man, you must always use a condom (with spermicide if available) during treatment and for 2 months after your last dose, even if you have had a vasectomy. Monthly pregnancy testing is required throughout treatment.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Erivedge if you have questions about the following important precautions:
- Blood donation: You must not donate blood at any time during treatment or for 24 months after your last dose of Erivedge
- Sperm donation: Men must not donate sperm during treatment or for 2 months after the last dose
- Serious skin reactions: Severe and potentially life-threatening skin reactions have been reported with Erivedge treatment. Stop taking Erivedge and seek immediate medical attention if you develop widespread rashes, blisters, skin peeling, sores in the mouth or on the genitals, or fever with rash
- Sharing medication: Never give Erivedge to anyone else. Return any unused capsules to your pharmacy after treatment has ended
Children and Adolescents
Erivedge is not recommended for use in children and adolescents under 18 years of age. This is because the safety and effectiveness of vismodegib have not been established in this age group. The Hedgehog signaling pathway plays a critical role in normal bone growth and pubertal development. Use of Erivedge in children could cause bones to stop growing prematurely (premature epiphyseal closure) and lead to early onset of puberty (before age 8 in girls and before age 9 in boys). These effects may persist even after treatment is stopped. Animal studies have also shown problems with tooth and bone development.
Pregnancy and Breastfeeding
The effects of Erivedge on the developing fetus are well-documented and severe. Vismodegib inhibits the Hedgehog signaling pathway, which is essential for normal embryonic development. In animal studies, vismodegib caused severe structural abnormalities including craniofacial defects, absent digits, and other skeletal malformations, as well as embryo-fetal death.
For women taking Erivedge: Before starting treatment, your doctor will verify that you are not pregnant through a pregnancy test performed within 7 days before the first dose. You must use two methods of contraception simultaneously: one highly effective method (such as a hormonal implant, intrauterine device, or surgical sterilization) and one barrier method (such as a condom or diaphragm with spermicide). Monthly pregnancy tests are required throughout treatment. You must continue contraception for 24 months after your last dose because vismodegib can remain in the body for an extended period.
For men taking Erivedge: Vismodegib can pass into seminal fluid. You must always use a condom (with spermicide if available) when having sex with a female partner, even if you have had a vasectomy. This precaution applies during treatment and for 2 months after the last dose.
Fertility: Erivedge may affect a woman's ability to become pregnant. Some women have experienced amenorrhea (absence of menstrual periods) during treatment. It is not known whether fertility returns in all cases after stopping treatment. If you wish to have children in the future, discuss this with your doctor before starting Erivedge.
Driving and Operating Machinery
Erivedge is not expected to significantly affect your ability to drive or operate machinery. However, if you experience fatigue or other side effects that could impair your alertness, you should avoid these activities until you feel well enough to do so safely. Consult your doctor if you are uncertain.
How Does Erivedge Interact with Other Drugs?
Erivedge can interact with several medications, including certain antibiotics, anti-epileptics, cholesterol-lowering drugs, and herbal remedies. St. John's Wort (Hypericum perforatum) is contraindicated and must never be taken with Erivedge. Always inform your doctor about all medications you are taking.
Drug interactions can affect how Erivedge works or increase the risk of side effects. Vismodegib is metabolized through multiple pathways and is a substrate for P-glycoprotein (P-gp) and CYP enzymes. Certain drugs can induce these metabolic pathways, potentially reducing vismodegib plasma concentrations and diminishing its anticancer activity. Conversely, vismodegib itself can affect the metabolism or transport of other drugs.
It is essential to tell your doctor about all medicines you are currently taking, have recently taken, or might take, including prescription drugs, over-the-counter medicines, vitamins, and herbal products. Your healthcare team will assess potential interactions and adjust your treatment plan if necessary.
Major Interactions
| Drug | Category | Effect | Action |
|---|---|---|---|
| St. John's Wort | Herbal remedy | May significantly reduce vismodegib levels through CYP/P-gp induction | Contraindicated – do not use together |
| Rifampicin | Antibiotic | Strong CYP3A4 and P-gp inducer that may reduce vismodegib efficacy | Avoid combination; discuss alternatives with doctor |
| Carbamazepine | Anti-epileptic | CYP3A4 inducer that may decrease vismodegib plasma concentrations | Use with caution; monitoring required |
| Phenytoin | Anti-epileptic | CYP3A4 inducer that may decrease vismodegib plasma concentrations | Use with caution; monitoring required |
Minor Interactions
The following drugs may interact with Erivedge to a lesser degree, but your doctor should still be informed if you are taking any of them:
| Drug | Category | Effect |
|---|---|---|
| Ezetimib & Statins (atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin) | Cholesterol-lowering | Vismodegib may affect statin metabolism; monitor for muscle symptoms |
| Bosentan | Pulmonary hypertension | May interact with vismodegib through shared metabolic pathways |
| Glibenclamide & Repaglinid | Diabetes medication | Vismodegib may affect glucose-lowering drug transport or metabolism |
| Valsartan | Blood pressure medication | May interact through shared transport proteins |
| Topotecan | Anticancer drug | Vismodegib may affect topotecan plasma levels through BCRP inhibition |
| Sulfasalazine | Anti-inflammatory | May interact through shared transport mechanisms |
What Is the Correct Dosage of Erivedge?
The recommended dose of Erivedge is one 150 mg capsule taken once daily by mouth, swallowed whole with water. It can be taken with or without food. Treatment continues as long as there is clinical benefit or until unacceptable side effects occur.
Erivedge has a straightforward dosing regimen compared to many other anticancer medications. The dose does not need to be adjusted based on body weight, age, or organ function in most patients. Always take Erivedge exactly as your doctor has prescribed. If you are unsure about any aspect of your dosing, consult your doctor or pharmacist.
Adults
Standard Adult Dose
150 mg once daily (one capsule), taken by mouth with a glass of water. The capsule should be swallowed whole – do not crush, open, or chew it, as this could lead to unintended exposure to the capsule contents. Erivedge may be taken with or without food at any convenient time of day. For consistency, try to take it at the same time each day.
Treatment with Erivedge is continued for as long as the cancer responds to therapy and you tolerate the medication. There is no predetermined maximum treatment duration. Your doctor will regularly assess your response through clinical examinations and imaging studies, and will advise you when to continue or stop treatment.
Children
Pediatric Use
Erivedge is not recommended for use in children and adolescents under 18 years of age. Safety and efficacy have not been established in this population. Due to the risk of premature bone growth plate closure and early puberty, vismodegib should not be used in growing individuals.
Elderly
Elderly Patients (65 years and older)
No dose adjustment is required for elderly patients. Clinical studies included patients over 65 years of age and no significant differences in safety or efficacy were observed compared to younger adults. However, elderly patients may be more susceptible to certain side effects such as fatigue and muscle spasms, so careful monitoring is recommended.
Missed Dose
If you forget to take a dose of Erivedge, do not take a double dose to make up for it. Simply skip the missed dose and take your next capsule at the regular scheduled time. Continue with your normal dosing schedule. If you frequently forget doses, speak with your doctor or pharmacist about strategies to help you remember.
Overdose
If you have taken more Erivedge than prescribed, contact your doctor immediately. There is limited experience with overdose of vismodegib in humans. In clinical studies, doses higher than 150 mg did not result in higher plasma concentrations due to the drug's saturable absorption and binding properties. Nevertheless, medical supervision should be sought following any suspected overdose.
Stopping Erivedge without consulting your doctor could make your cancer treatment less effective. Even if you experience side effects, talk to your doctor first, as they may be able to help manage symptoms while continuing your treatment. Your doctor will weigh the benefits of continued therapy against any adverse effects you are experiencing.
What Are the Side Effects of Erivedge?
Like all medicines, Erivedge can cause side effects, though not everyone gets them. The most common side effects include muscle spasms, hair loss, taste changes, fatigue, decreased appetite, diarrhea, and nausea. Serious skin reactions have been reported rarely. Erivedge can also cause severe birth defects if taken during pregnancy.
The side effects of Erivedge reflect the involvement of the Hedgehog signaling pathway in various normal body functions beyond cancer. For example, the Hedgehog pathway is involved in maintaining taste buds, hair follicle cycling, and muscle homeostasis, which explains why taste changes, hair loss, and muscle spasms are among the most frequent side effects. Most side effects are manageable and many improve or resolve after treatment is stopped, although some effects like hair regrowth may take considerable time.
Contact your doctor or pharmacist if any of these side effects become severe or if you notice any effects not listed below. It is important to report suspected side effects to help regulators continuously monitor the benefit-risk balance of the medicine.
Stop taking Erivedge and seek emergency medical attention if you experience: reddish target-like spots or round patches with central blisters on the trunk; skin peeling; sores in the mouth, throat, nose, genitals, or eyes; widespread rash with fever and swollen lymph nodes; or red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. These may be signs of Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, or acute generalized exanthematous pustulosis.
Very Common
- Absent menstrual periods (amenorrhea) in women of childbearing age
- Decreased appetite or weight loss
- Fatigue and tiredness
- Muscle spasms
- Diarrhea
- Hair loss (alopecia)
- Skin rash
- Taste changes (dysgeusia) or complete loss of taste (ageusia)
- Constipation
- Vomiting or nausea
- Upset stomach or indigestion (dyspepsia)
- Joint pain (arthralgia)
- General pain or pain in arms and legs
- Itching (pruritus)
Common
- Pain in chest, back, or side
- Lack of energy or weakness (asthenia)
- Dehydration (fluid loss)
- Pain in muscles, tendons, ligaments, or bones
- Abdominal pain
- Complete loss of taste
- Abnormal hair growth
- Loss of eyelashes (madarosis)
- Changes in blood tests including elevated liver enzymes and creatine phosphokinase levels
Not Known Frequency
- Premature closure of growth plates in bones (epiphyseal closure)
- Early onset puberty
- Liver damage (hepatotoxicity)
- Stevens-Johnson syndrome (severe skin and mucous membrane reaction)
- Toxic epidermal necrolysis (severe blistering and peeling of skin)
- DRESS syndrome (drug reaction with eosinophilia and systemic symptoms)
- Acute generalized exanthematous pustulosis (widespread pustular rash with fever)
Most of the very common side effects associated with Erivedge are linked to the Hedgehog pathway inhibition and are generally reversible after discontinuation of treatment. Hair loss, for example, typically begins within the first few months of treatment and hair regrowth usually occurs after stopping therapy, although it may take several months. Taste changes can significantly affect appetite and nutritional status, so patients are encouraged to work with their healthcare team to maintain adequate nutrition during treatment.
How Should You Store Erivedge?
Store Erivedge below 30°C in the original container with the lid tightly closed to protect from moisture. Keep out of sight and reach of children. Do not use after the expiry date printed on the packaging.
Proper storage of Erivedge is important to maintain the effectiveness and safety of the medicine. Follow these storage guidelines carefully:
- Temperature: Store at no more than 30°C (86°F). Do not freeze.
- Container: Keep the bottle tightly closed to protect the capsules from moisture.
- Children: Keep this medicine out of the sight and reach of children at all times.
- Expiry date: Do not use Erivedge after the expiry date shown on the bottle and carton (after “EXP”). The expiry date refers to the last day of that month.
- Disposal: Do not dispose of medicines via household waste or wastewater. After treatment has ended, return all remaining capsules to your pharmacy. These measures prevent accidental exposure and protect the environment.
Because Erivedge can cause severe birth defects, special care must be taken with unused capsules. Never leave capsules lying around where others – especially children or pregnant women – could accidentally come into contact with them. Return all unused medicine to a pharmacy for safe disposal.
What Does Erivedge Contain?
Each Erivedge hard capsule contains 150 mg of vismodegib as the active ingredient, along with excipients including microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, and magnesium stearate.
Erivedge capsules have a distinctive appearance to aid identification. Each capsule has a pink opaque body marked with “150 mg” and a grey cap marked with “VISMO” in black edible ink. The capsules are supplied in bottles with child-resistant closures containing 28 capsules per bottle.
Active Ingredient
Each hard capsule contains 150 mg of vismodegib.
Inactive Ingredients
The other components of Erivedge include:
- Capsule contents: Microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone (K29/32), sodium starch glycolate (Type A), talc, and magnesium stearate
- Capsule shell: Red iron oxide (E172), black iron oxide (E172), titanium dioxide, and gelatin
- Printing ink: Shellac and black iron oxide (E172)
Erivedge contains lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per capsule, meaning it is essentially sodium-free.
Frequently Asked Questions About Erivedge
Erivedge (vismodegib) is used to treat adults with advanced basal cell carcinoma (BCC), the most common type of skin cancer. It is specifically indicated for metastatic BCC (cancer that has spread to other parts of the body) and locally advanced BCC when surgery or radiation therapy is not appropriate. Erivedge works by blocking the Hedgehog signaling pathway, which is abnormally active in more than 90% of basal cell carcinomas.
Absolutely not. Erivedge can cause severe birth defects or death of an unborn baby. Women of childbearing potential must have a negative pregnancy test before starting treatment, use two effective forms of contraception during treatment, and continue contraception for 24 months after the last dose. Monthly pregnancy testing is mandatory throughout treatment. If you suspect you are pregnant, stop taking Erivedge immediately and contact your doctor.
The most common side effects, affecting more than 1 in 10 patients, include muscle spasms, hair loss (alopecia), taste changes or complete loss of taste, fatigue, decreased appetite and weight loss, diarrhea, nausea, constipation, joint pain, and absence of menstrual periods in women. These side effects are related to the Hedgehog pathway being blocked in normal tissues and are generally reversible after stopping treatment.
The duration of Erivedge treatment is determined by your doctor and depends on how well your cancer responds and how well you tolerate the medication. There is no fixed treatment length. Treatment continues for as long as there is clinical benefit. Some patients take Erivedge for several months, while others may need it for a longer period. Never stop taking Erivedge without discussing it with your doctor first, as this could reduce the effectiveness of your cancer treatment.
No. You must not donate blood at any time during treatment with Erivedge or for 24 months after your last dose. This restriction exists because vismodegib can remain in the body for an extended period and could potentially cause harm if the donated blood is given to a pregnant woman or a woman who may become pregnant. Similarly, men must not donate sperm during treatment or for 2 months after the last dose.
Yes. Erivedge can interact with several medications. St. John's Wort (Hypericum perforatum) is strictly contraindicated and must never be used together with Erivedge. Other drugs that may interact include rifampicin, carbamazepine, phenytoin, certain statins (cholesterol-lowering drugs), bosentan, glibenclamide, repaglinid, valsartan, topotecan, and sulfasalazine. Always tell your doctor about all medicines, vitamins, and herbal products you are taking.
References and Sources
All medical information on this page is based on peer-reviewed scientific sources and international regulatory documents. The following references were used:
- European Medicines Agency (EMA). Erivedge (vismodegib) – Summary of Product Characteristics. Last updated 2025. Available from: EMA Erivedge EPAR.
- U.S. Food and Drug Administration (FDA). Erivedge (vismodegib) capsules – Prescribing Information. Genentech, Inc. Available from: FDA Drug Label Database.
- Sekulic A, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012;366(23):2171–2179. doi:10.1056/NEJMoa1113713.
- Basset-Seguin N, et al. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial. Lancet Oncol. 2015;16(6):729–736.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer. Version 2.2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023.
- Rubin AI, et al. Basal-cell carcinoma. N Engl J Med. 2005;353(21):2262–2269.
- British National Formulary (BNF). Vismodegib. NICE Evidence Services. Available from: bnf.nice.org.uk.
Our Medical Editorial Team
This article was written, reviewed, and fact-checked by the iMedic Medical Editorial Team, which includes board-certified specialists in oncology, dermatology, and clinical pharmacology. All content follows the GRADE evidence framework and adheres to international clinical guidelines from the EMA, FDA, NCCN, and WHO.
Licensed physicians with specialization in oncology and dermatology, experienced in skin cancer management and targeted therapies. Content is reviewed against the latest EMA and FDA prescribing information.
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Conflict of interest: The iMedic Medical Editorial Team has no financial relationships with pharmaceutical companies. All content is independently produced without commercial funding or advertising influence.