This medication requires a valid prescription. Please refer to the ‘Prescription Guide’ for details.

ERIVEDGE (Vismodegib)

General Description

Erivedge (vismodegib) is prescribed for the treatment of adults with advanced forms of basal cell carcinoma (BCC), including metastatic or locally advanced BCC that has recurred after surgery or cannot be treated with surgery or radiation.

Getting Erivedge (vismodegib) in India

Erivedge (vismodegib) is approved in the U.S., Europe, and other countries but is not yet commercially available in India. However, patients in India can legally access this medicine through the Named Patient Program (NPP).
MitoGENE supports eligible patients and their treating physicians by facilitating safe and legal access to Erivedge, managing the required paperwork, import coordination, and delivery—all in compliance with Indian regulations.

If you or a loved one has been prescribed Erivedge, MitoGENE is here to assist and guide you throughout the process.

Disease Indications

  • Basal Cell Carcinoma (BCC) – metastatic or locally advanced

Manufacturer: Genentech (a member of the Roche Group)
Usage: Oral

Medicine Approved by:

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Therapeutic Goods Administration (TGA)
  • Health Canada

Available Dosage Form & Package

  • 150 mg capsules (packaged as per manufacturer specifications)

Shipping: Room Temperature Shipping. This medication is shipped under standard controlled conditions (15°C to 25°C) to preserve product integrity.

What is Erivedge (vismodegib)?

Erivedge is a prescription medication used to treat adults with advanced basal cell carcinoma (BCC) that has spread (metastatic) or relapsed after surgery, or cannot be treated with surgery or radiation. It is the first FDA-approved treatment that specifically targets the Hedgehog signaling pathway, which plays a key role in the development of BCC.

How does Erivedge work?

Erivedge contains vismodegib, a Hedgehog pathway inhibitor. The Hedgehog signaling pathway is crucial in cell growth and differentiation. In certain cancers like BCC, this pathway becomes abnormally activated. Erivedge binds to and inhibits the SMO (Smoothened) protein, a component of this pathway, to slow or stop cancer cell growth.

Where is Erivedge approved?

Erivedge has received regulatory approval in multiple countries for the treatment of advanced BCC:

  • U.S. FDA – Approved in January 2012
  • European Medicines Agency (EMA) – Approved in July 2013
  • Health Canada – Approved in February 2013
  • TGA (Australia) – Approved in March 2013

Note: Approvals may also exist in other regions. Please consult your physician or contact MitoGENE for more information.

What are the possible side effects?

Common side effects of Erivedge include:

  • Muscle spasms
  • Hair loss (alopecia)
  • Altered taste (dysgeusia)
  • Weight loss
  • Fatigue
  • Nausea
  • Decreased appetite
  • Diarrhea

Important Warning:
Erivedge can cause serious birth defects or fetal death. It must not be used during pregnancy. Effective contraception is essential during treatment and for a period after discontinuation.

Note: Please consult your doctor to determine if Erivedge is appropriate for your specific condition.

References

  1. Therapeutic Goods Administration (TGA), Australia. Approval Details for Erivedge. Accessed May 2025.
  2. U.S. Food and Drug Administration (FDA). Erivedge Prescribing Information. FDA Website. Accessed May 2025.
  3. European Medicines Agency (EMA). Erivedge: EPAR – Product Information. EMA Website. Accessed May 2025.
  4. FDA News Release. FDA Approves Erivedge for Advanced Basal Cell Carcinoma. January 2012.
  5. National Cancer Institute. Vismodegib – Drug Information. https://www.cancer.gov/about-cancer/treatment/drugs/vismodegib. Accessed May 2025.
  6. Health Canada Drug Database. Erivedge Approval. Accessed May 2025.

How to Access Erivedge (vismodegib) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)

If Erivedge (vismodegib) is not commercially available in India, MitoGENE can assist you in accessing it legally under NPP. Here’s the step-by-step process: