Product image of Nerlynx (Neratinib) supplied by GNH India

Nerlynx

Active Ingredient:
Neratinib
Origin:
EU

Nerlynx (Neratinib)

Neratinib, the active ingredient in Nerlynx, is a tyrosine kinase inhibitor presented as a 240 mg capsule for oral use. It treats HER2‑positive breast cancer in patients who have completed trastuzumab‑based therapy and in those with metastatic disease.

GNH India supplies Nerlynx as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Pierre Fabre Medicament

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Nerlynx is used in HER2‑positive breast cancer management, targeting both early‑stage and metastatic disease.

  • Extended adjuvant treatment of HER2‑positive breast cancer: reduces risk of recurrence after trastuzumab‑based therapy.
  • HER2‑positive metastatic breast cancer: helps control tumor progression in advanced disease.

How It Works

  • Neratinib irreversibly binds to the ATP‑binding pocket of the pan‑HER family receptors HER1, HER2 and HER4. This covalent inhibition blocks downstream signaling through the PI3K/AKT and MAPK pathways, preventing cellular proliferation and survival signals that drive HER2‑positive breast cancer growth.

Side Effects

Nerlynx may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Diarrhea: frequent, may be severe.
  • Nausea and vomiting: gastrointestinal upset.
  • Fatigue: reduced energy levels.
  • Rash or skin irritation: mild to moderate.

Serious or Rare Side Effects

  • Severe or persistent diarrhea leading to dehydration.
  • Hepatotoxicity: elevated liver enzymes or hepatitis.
  • Interstitial lung disease or pneumonitis: respiratory symptoms.

Precautions & Warnings

When prescribing Nerlynx, clinicians should observe several safety precautions to minimize risks.

  • Monitor for diarrhea: initiate antidiarrheal prophylaxis and assess hydration status.
  • Assess liver function: perform baseline and periodic transaminase testing.
  • Evaluate cardiac status: obtain baseline ejection fraction and monitor for dysfunction.
  • Avoid use in pregnancy: teratogenic risk; ensure effective contraception.
  • Review concomitant medications: check for CYP3A4 inhibitors or inducers.
  • Store at ambient temperature: keep below 25 °C, protect from moisture, retain original packaging.

Avoid Interactions

Neratinib interacts with several drug classes; awareness of these interactions helps optimize therapy.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase neratinib exposure and toxicity.
  • Antacids containing aluminum or magnesium: reduce oral absorption of neratinib.
  • Co‑administration with other HER‑targeted TKIs: may amplify adverse effects.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): decrease neratinib effectiveness.
  • Antidiarrheal agents (e.g., loperamide): may mask severity of neratinib‑related diarrhea.
  • Warfarin: may require more frequent INR monitoring.

Frequently Asked Questions

Nerlynx contains the active ingredient neratinib and is indicated for the extended adjuvant treatment of HER2‑positive breast cancer after trastuzumab‑based therapy, as well as for the treatment of HER2‑positive metastatic breast cancer.

Neratinib irreversibly binds to the ATP‑binding sites of HER1, HER2 and HER4 receptors, blocking downstream signaling pathways such as PI3K/AKT and MAPK. This inhibition stops cell proliferation and promotes cancer cell death in HER2‑positive tumors.

The prescribed dose of Nerlynx is determined by the treating physician. The product is supplied as a 240 mg oral capsule, typically taken once daily with food, but the exact regimen is individualized for each patient.

Nerlynx is classified as pregnancy category D, indicating evidence of fetal risk. It should not be used during pregnancy and is not recommended while breastfeeding because it may pass into breast milk and affect the infant.

To order Nerlynx, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and necessary import documentation.

Nerlynx (neratinib) is an oral irreversible pan‑HER tyrosine kinase inhibitor, whereas alternatives such as trastuzumab are intravenous monoclonal antibodies and lapatinib is a reversible HER2 TKI. Neratinib offers a convenient oral route but has a distinct safety profile, especially a higher incidence of diarrhea.

Nerlynx capsules should be stored at ambient temperature, below 25 °C, in the original container. Protect them from moisture and direct sunlight. No refrigeration is required.

Nerlynx is taken orally as a whole capsule with food. Patients should swallow the capsule whole and should not crush, split, or chew it to maintain proper absorption.

The most serious risks include severe or persistent diarrhea that can lead to dehydration, hepatotoxicity manifested by elevated liver enzymes or hepatitis, and interstitial lung disease or pneumonitis presenting with respiratory symptoms. Prompt medical attention is required if these occur.

Nerlynx should not be used by patients who are pregnant, are breastfeeding, have known hypersensitivity to neratinib, or have severe hepatic impairment. Caution is also advised for patients with pre‑existing cardiac conditions or significant lung disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Related Products

Other formulations containing Neratinib

A

A
A

A
A

A
A

A

Browse all products →

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Regulatory recognitions

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.

SGS GSDP Certification

GSDP Compliant from SGS

URS ISO 9001

URS ISO 9001 Certification

FDA Maharashtra

Licensed by FDA Maharashtra

IEC License DGFT

IEC License issued by DGFT