Erivedge (Vismodegib)

What it is and what it treats

Vismodegib, marketed as Erivedge, is a first-in-class small-molecule inhibitor of the Hedgehog signalling pathway. It is authorised in the United States and European Union for adults with symptomatic metastatic basal cell carcinoma (BCC), or locally advanced BCC that has recurred after surgery, or for whom surgery or radiotherapy is not appropriate. Basal cell carcinoma is the most common human cancer, and in the majority of cases aberrant Hedgehog signalling — typically from PTCH1 or SMO gene mutations — drives tumour growth.

The medicine works by binding to and inhibiting Smoothened (SMO), a transmembrane protein that transmits Hedgehog pathway signals inside the cell. By blocking SMO, vismodegib interrupts the abnormal signalling cascade that allows basal cell tumours to proliferate. It was the first targeted systemic therapy developed specifically for advanced BCC and remains restricted to specialist oncology and dermatology use.

Because Erivedge acts on a developmental signalling pathway that is also essential for foetal growth, it carries a well-documented teratogenic risk. Its use is therefore confined to patients for whom the specific advanced-BCC indication applies, under the supervision of a physician experienced in oncology, and within a formal pregnancy-prevention framework described below.

Presentations and dosage forms

• 150 mg hard capsules, supplied in blister packs for oral administration
• Single-strength presentation — no other dose forms are marketed
• Capsules must be swallowed whole and never opened, crushed or chewed

How it is administered

The approved label describes a dose of one 150 mg capsule taken orally once daily, with or without food, until disease progression, unacceptable toxicity, or a decision by the patient and physician to discontinue treatment. No dose adjustment is described for renal or mild-to-moderate hepatic impairment, reflecting the drug's elimination pathway.

If a dose is missed, the label describes resuming the normal once-daily schedule at the next planned dose rather than doubling up. Prescribers monitor patients periodically for tolerability, including musculoskeletal symptoms, weight and hydration status, since gastrointestinal and taste-related effects can affect nutritional intake over prolonged courses.

The most clinically important administration requirement is the pregnancy-prevention programme. Vismodegib is contraindicated in pregnancy and can cause severe foetal malformation or death. Female patients of reproductive potential must have a negative pregnancy test before starting, use highly effective contraception during treatment and for 24 months after the last dose, and avoid breastfeeding. Male patients are advised to use condoms during treatment and for a defined period after the last dose, even after vasectomy, because vismodegib has been detected in semen. Blood or blood-component donation is prohibited during treatment and for a specified period afterwards, and semen donation is prohibited during treatment and after discontinuation, consistent with the teratogenicity risk.

Storage and handling

• Store below 30 °C in the original blister packaging
• Keep out of the reach of children
• Do not use beyond the expiry date printed on the pack
• Handlers who are pregnant, or may become pregnant, should avoid direct contact with capsule contents

Side effects

The European and US prescribing information describe a consistent adverse-reaction profile drawn from clinical trials in advanced basal cell carcinoma. Most reactions are manageable, and some improve despite continued treatment; discussion of individual tolerability sits with the treating clinician.

Commonly reported

Serious effects requiring medical attention

Patients or carers should contact the prescribing team promptly if new or worsening symptoms occur, and should report suspected adverse reactions through their national reporting scheme (for example, the MHRA Yellow Card Scheme in the UK or FDA MedWatch in the US).

Availability and supply route

Erivedge is registered in a number of countries, but market authorisation status, pack sizes and named-brand availability differ from one national regulator to another. A country where the medicine is licensed for advanced basal cell carcinoma is not guaranteed to have continuous commercial supply, and clinicians managing rare or advanced skin cancers sometimes need to source authorised stock from outside their home market.

Where Erivedge is not registered or is temporarily unavailable locally, hospitals and specialist pharmacies may arrange named-patient supply: an import mechanism, permitted under most national frameworks, that allows an unlicensed-in-that-country but internationally authorised medicine to be dispensed for a specific, identified patient under direct physician responsibility. This route requires a valid prescription, documented clinical justification and compliance with the destination country's import regulations; it is not a route for general retail purchase.

Pharmacy Remedy is a licensed pharmaceutical wholesaler based in Turkey that supplies hospitals, oncology clinics and licensed pharmacies against valid prescriptions and the appropriate institutional documentation. It operates strictly business-to-business within licensed pharmaceutical supply chains and does not sell Erivedge, or any prescription oncology medicine, directly to members of the public.

Frequently asked questions

Primary sources

• EMA — Erivedge EPAR
• FDA — Erivedge prescribing information

Further reading and regulatory routes

• Which country Erivedge is sourced from, and why prices differ
• How to verify a medicine is genuine
• Why medicines cost less in Türkiye
• WHO falsified medicine alerts
• Named patient supply
• UAE import guide
• For healthcare professionals
• All medicine monographs

Related medicines

• Tasigna (nilotinib)
• Xospata (gilteritinib)
• Calquence (acalabrutinib)