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

Note: We can assist only if the medicine is unavailable in your country.”

PEMAZYRE (Pemigatinib)

General Description

Pemazyre (pemigatinib) is an oral targeted therapy used to treat adults with specific types of cholangiocarcinoma (bile duct cancer) that have a fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement, and whose cancer has progressed after at least one prior treatment.

Getting Pemazyre (pemigatinib) in India

Pemazyre is approved in the U.S., Europe, and other countries, but it is not yet commercially available in India. However, eligible patients in India may access this important therapy through the Named Patient Program (NPP).

MitoGENE helps patients obtain Pemazyre legally and safely, in collaboration with their treating doctor. We assist with documentation, import coordination, and delivery—ensuring full compliance with Indian regulatory guidelines.

If you or a loved one needs Pemazyre, MitoGENE is here to guide you through every step of the process.

Disease Indications:Cholangiocarcinoma (bile duct cancer)

Manufacturer:Incyte Corporation

Usage:Oral

Medicine Approved by:

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

Available Dosage Form & Package:

  • 4.5 mg, 9 mg, 13.5 mg tablets – Packaged in 14- or 28-day supplies

Shipping:

Room Temperature Shipping. Pemazyre is shipped under controlled room temperature conditions (15°C to 25°C) using standard logistics procedures.

What is Pemazyre (pemigatinib)?

Pemazyre is a prescription medication used for treating adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with an FGFR2 fusion or rearrangement.

It is typically prescribed after prior systemic treatment has failed. Before prescribing Pemazyre, doctors will use a diagnostic test to confirm FGFR2 gene alteration.

How does Pemazyre work?

Pemazyre contains pemigatinib, a selective FGFR inhibitor. FGFR2 gene alterations can drive the growth of cancer cells in bile duct tumors. Pemigatinib blocks these abnormal receptors, thereby inhibiting tumor cell growth and survival.

Where is Pemazyre approved?

Pemazyre has been approved for treating FGFR2-positive cholangiocarcinoma in several countries:

  • U.S. FDA – Approved in April 2020
  • European Medicines Agency (EMA) – Approved in March 2021
  • Health Canada – Approved in April 2022
  • Therapeutic Goods Administration (Australia) – Approved in 2022

Note: For country-specific availability, consult your treating doctor or pharmacist.

What are the possible side effects?

Common side effects of Pemazyre include:

  • Hyperphosphatemia (high phosphate levels in blood)
  • Hair loss
  • Fatigue
  • Diarrhea
  • Dry mouth
  • Nail disorders
  • Loss of appetite
  • Constipation

Important: Pemazyre may harm an unborn baby. Pregnancy and breastfeeding should be avoided during treatment.

Note

Always speak with your healthcare provider to determine if Pemazyre is right for your treatment plan. Your doctor will consider your mutation profile and treatment history before prescribing.

References

U.S. Food and Drug Administration (FDA). Pemazyre Prescribing Information. Accessed May 2025.

European Medicines Agency (EMA). Pemazyre: EPAR – Product Overview. Accessed May 2025.

FDA News Release. FDA Approves Pemazyre for Cholangiocarcinoma with FGFR2 Fusion. April 2020.

Incyte Corporation. Pemazyre Official Product Website. Accessed May 2025.

Health Canada. Pemazyre – Drug Product Database. April 2022.

TGA, Australia. Pemazyre Approval Summary. 2022.

National Cancer Institute. FGFR Gene Mutations and Targeted Therapy. https://www.cancer.gov/. Accessed May 2025.

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

If Pemazyre is not yet approved or available commercially in India, MitoGENE can help you access it through a legal pathway. Here’s how:

    Upload Prescription

    Upload Patient Consent Form

    Patient Consent Form
    Download

    Please download and complete this form, including your signature, and attach it to the request form or email it to info@mitogene.org along with the patient details.