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Manufacturer / Innovator:
France
Regulatory Approval:
N/A
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Nerlynx (neratinib) is a kinase inhibitor approved for two indications in HER2-positive breast cancer: as extended adjuvant treatment for adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens in the metastatic setting.
Nerlynx is an irreversible pan-HER tyrosine kinase inhibitor that blocks signaling through HER1, HER2, and HER4 receptors, helping to suppress the growth of HER2-positive breast cancer cells.
Nerlynx is used in two distinct HER2-positive breast cancer settings: as extended adjuvant therapy after initial trastuzumab-based treatment, or as later-line therapy in combination with capecitabine for advanced or metastatic disease.
For extended adjuvant treatment, the dose is 240 mg orally once daily with food for up to one year. For metastatic disease in combination with capecitabine, the dose is 240 mg orally once daily on Days 1-21, with capecitabine 750 mg/m² twice daily on Days 1-14 of a 21-day cycle.
Nerlynx does not carry a formal FDA boxed warning. However, patients and prescribers should be aware of the following important safety information.
Diarrhea is the most commonly reported side effect and can be severe. Antidiarrheal prophylaxis, such as loperamide, is recommended during the initial months of treatment, with dose escalation strategies used to improve tolerability. Treatment should be withheld or reduced for severe or persistent diarrhea.
Liver function tests should be monitored monthly for the first three months of treatment, then every three months and as clinically indicated thereafter.
Nerlynx may cause fetal harm. Effective contraception should be used during treatment and for one month after the final dose.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
Nerlynx is marketed by Pierre Fabre Medicament. It is sourced through authorized distribution channels for patients seeking named-patient import into India.
Patients typically need a valid prescription from a treating oncologist confirming HER2-positive breast cancer diagnosis and treatment history. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an approved therapy for HER2-positive breast cancer, Nerlynx is sourced through authorized channels and imported under GDP-compliant logistics to preserve product quality throughout transit.
NPP sources Nerlynx directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.
Nerlynx should be stored at 20°C to 25°C, with excursions permitted between 15°C and 30°C, and this condition is maintained throughout transit.
Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile logistics to the patient's city.
Patients across India can access Nerlynx through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.
Leading hospitals in Mumbai support oncology care coordination and documentation for Nerlynx access.
Delhi's major hospitals assist patients with prescription support and documentation for Nerlynx.
Bangalore's specialist network offers access coordination for eligible HER2-positive breast cancer patients seeking Nerlynx.
Chennai-based oncology specialists coordinate Nerlynx access alongside comprehensive breast cancer care.
Hyderabad's care institutions support patients pursuing Nerlynx therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Nerlynx.
Pune-based specialists assist with prescription support and Nerlynx treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Nerlynx.
Kochi's specialist units assist patients with the documentation needed for Nerlynx access.
Chandigarh's care centers support Nerlynx treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Nerlynx access process.
Lucknow-based centers assist patients pursuing Nerlynx therapy.
Bhubaneswar's institutions support access to Nerlynx for eligible patients.
Guwahati's specialists help coordinate Nerlynx access for patients across the Northeast.
Patients in other cities across India can also access Nerlynx through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026
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