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.”

Nerlynx (neratinib)

General Description:

Nerlynx (neratinib) is prescribed as an adjuvant treatment for adults with early-stage breast cancer that overexpresses or has amplified HER2.”

Getting Nerlynx (neratinib) in India

Nerlynx (neratinib) is approved in the U.S., Europe, and other countries but it is not yet sold in India commercially. Still, patients in India can get this important medicine for their treatment through a special program called the Named Patient Program (NPP).

MitoGENE helps eligible patients get Nerlynx legally and safely, with the support of their treating physician. We take care of all the necessary paperwork, import process, and delivery—while making sure everything follows Indian regulations.

If you or someone you care about require Nerlynx, MitoGENE is here to guide and support you every step of the way.

Disease Indications:Breast Cancer

Manufacturer:Puma Biotechnology

Usage:Oral

Medicine Approved by:

  • Food and Drug Administration (FDA)
  • European Medical Agency (EMA)
  • Therapeutic Goods Administration (TGA)
  • Health Canada

Available Dosage Form& Package

  • 180 Capsules of 40 mg

Shipping: Room Temperature Shipping. This medication is shipped using standard delivery methods, ensuring it remains within a controlled room temperature range of 15°C to 25°C throughout transit.

What is Nerlynx (neratinib)?

Nerlynx is a prescription medicine used as extended adjuvant treatment for adults with early-stage HER2-positive breast cancer. It is intended for use after patients have completed a previous adjuvant treatment with trastuzumab-based therapy.

Nerlynx helps reduce the risk of cancer returning and is typically used within one year of completing trastuzumab therapy.

How does Nerlynx work?

Nerlynx contains neratinib, a type of kinase inhibitor that targets HER2 receptors on breast cancer cells. HER2 is a protein that, when overexpressed, can cause uncontrolled cancer cell growth. By blocking the HER2 pathway, Nerlynx helps to prevent the growth and spread of cancer cells.

Where is Nerlynx approved?

Nerlynx has been approved in several regions for the treatment of early-stage HER2-positive breast cancer:

  • U.S. FDA – Approved in July 2017
  • European Medicines Agency (EMA) – Approved in August 2018
  • Health Canada – Approved in December 2019
  • Therapeutic Goods Administration (Australia) – Approved in March 2019

Note: Nerlynx may also be approved in other countries. Speak to your doctor or pharmacist for country-specific availability.

What are the possible side effects?

Common side effects of Nerlynx include:

  • Diarrhea
  • Nausea
  • Abdominal pain
  • Fatigue
  • Vomiting
  • Mouth sores (stomatitis)

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

Note

Always talk to your doctor to see if Nerlynx is appropriate for your treatment. They will consider your treatment history and discuss possible benefits and risks.

References

Therapeutic Goods Administration (TGA), Australia. Nerlynx Approval Overview. March 2019.

  1. U.S. Food and Drug Administration (FDA). Nerlynx Prescribing Information. FDA Website. Accessed May 2025.
  2. European Medicines Agency (EMA). Nerlynx: EPAR – Product Information. EMA Website. Accessed May 2025.
  3. FDA News Release. FDA Approves Nerlynx for Extended Adjuvant Treatment of HER2-Positive Breast Cancer. July 2017.
  4. BreastCancer.org. HER2-Positive Breast Cancer and Neratinib. https://www.breastcancer.org/. Accessed May 2025.
  5. National Cancer Institute. Neratinib (Nerlynx) – Drug Information. https://www.cancer.gov/about-cancer/treatment/drugs/neratinib. Accessed May 2025.
  6. Health Canada. Nerlynx – Drug Product Database. December 2019.
  7. Therapeutic Goods Administration (TGA), Australia. Nerlynx Approval Overview. March 2019.

How to Access Nerlynx (neratinib) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)?

If Nerlynx (neratinib) is not yet approved or commercially available in India, MitoGENE can assist you in accessing it legally through the Named Patient Program (NPP). Here’s how the process works:

    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.