Import Nerlynx (neratinib) in India

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.”

MitoGENE helps Indian patients access Nerlynx (neratinib) legally and safely under their doctor’s supervision.

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.

Nerlynx (neratinib)

Access Nerlynx (neratinib) in India

Nerlynx (neratinib) has been approved in countries like the U.S. and Europe but is not yet available for commercial sale in India. However, it is accessible through the Named Patient Program (NPP) for eligible patients.

MitoGENE helps Indian patients access Nerlynx (neratinib) legally and safely under their doctor’s supervision. We handle the documentation, regulatory approvals, and logistics to ensure compliance with Indian regulations.

If you or your loved one may benefit from Nerlynx (neratinib), MitoGENE is here to support your journey to access this treatment.

Product Description:

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

Disease Indications: Lung Cancer

Manufacturer: Amgen GmbH (DE)

Medicine Approved by:

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

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

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

Disclaimer: Nerlynx (neratinib) is not approved for commercial sale in India. Access is provided strictly for personal use under physician supervision in accordance with Indian regulatory guidelines through the Named Patient Program (NPP). MitoGENE does not market, advertise, or sell unapproved drugs. All content is for informational purposes and not a substitute for professional medical advice.

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: