Neratinib
Human Epidermal Growth Factor Receptor 2 (Her2) Tyrosine Kinase Inhibitors
Sold as Nerlynx
- Drug class
- Human Epidermal Growth Factor Receptor 2 (Her2) Tyrosine Kinase Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 4
Overview
Neratinib is an active pharmaceutical ingredient in the Human Epidermal Growth Factor Receptor 2 (Her2) Tyrosine Kinase Inhibitors group (L01EH). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| EU European Union | EMA | 1 | May 23, 2025 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
| GB United Kingdom | MHRA | 2 | February 20, 2026 |
EUEuropean Union· EMA
1 product
Uses
1 Therapeutic indication Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
How to take
CACanada· Health Canada
1 product
Uses
NERLYNX (neratinib) is indicated: For the extended adjuvant treatment of women with early-stage hormone receptor positive and HER2-overexpressed/amplified breast cancer, within one year after completion of trastuzumab-based adjuvant therapy.
In combination with capecitabine for the treatment of patients with metastatic HER2- overexpressed/amplified breast cancer, who have received two or more prior anti-HER2- based regimens in the metastatic setting. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
9% were ≥ 60 years of age. Lower magnitude of efficacy was noted in patients of ≥ 60 years when compared to patients of < 60 years of age. 4 Geriatrics). 5% were ≥ 65 years of age. No overall differences of efficacy were observed between patients ≥ 65 years when compared to patients of < 65 years of age.
4 Geriatrics).
GBUnited Kingdom· MHRA
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Drug interactions
Known interactions involving Neratinib. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]European Medicines Agency · EMEA/H/C/004030 · revised May 23, 2025
- [2]Health Canada (DPD) · 02490536 · revised March 22, 2025
- [3]MHRA (UK) · PLPI459850915 · revised December 27, 2024
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.