MedeliX
Start asking

neratinib

Nerlynx · ATC code L01EH02

Key facts
Active substance
neratinib
ATC code
L01EH02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Nerlynx 40 mg film-coated tablets
Marketing authorisation holder
Pierre Fabre Medicament
Information as of
2026-10-29

Key facts

Neratinib (Nerlynx) is an oral HER2 tyrosine kinase inhibitor used for extended adjuvant treatment of early-stage hormone receptor-positive, HER2-positive breast cancer after trastuzumab-based therapy.

What it is used for

  • Extended adjuvant treatment of adults with early-stage hormone receptor-positive HER2-overexpressed/amplified breast cancer who completed adjuvant trastuzumab-based therapy less than one year ago.

Dosing

  • 240 mg (six 40 mg tablets) orally once daily with food, preferably in the morning, continuously for one year; started within 1 year after completing trastuzumab.
  • Dose reductions for adverse reactions: 200 mg, then 160 mg, then 120 mg daily; discontinue if 120 mg daily is not tolerated or toxicity delays treatment > 3 weeks.
  • Anti-diarrhoeal prophylaxis is started with the first dose; see the full text for diarrhoea and hepatotoxicity dose tables.
  • If a strong or moderate CYP3A4/P-gp inhibitor cannot be avoided: 40 mg once daily, increased stepwise up to 160 mg if tolerated.
  • H2-receptor antagonists: take neratinib at least 2 hours before or 10 hours after; antacids: separate by at least 3 hours.
  • No adjustment in mild to moderate renal or hepatic (Child-Pugh A or B) impairment; not recommended in severe renal impairment or dialysis.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.
  • Co-administration with strong CYP3A4/P-gp inducers: carbamazepine, phenytoin, St John's wort, rifampicin.
  • Severe hepatic impairment (Child-Pugh C).

Important warnings

  • Diarrhoea, which may be severe with dehydration, usually starts in the first or second week; anti-diarrhoeal prophylaxis is maintained during the first 1-2 months. Elderly patients and those with renal impairment need careful monitoring.
  • Hepatotoxicity: liver tests at 1 week, monthly for the first 3 months and then every 6 weeks.
  • Left ventricular dysfunction is associated with HER2 inhibition; cardiac monitoring in patients with risk factors.
  • Proton pump inhibitors are not recommended because they lower neratinib absorption.

Side effects

  • Most common: diarrhoea (93.6%), nausea (42.5%), fatigue (27.3%), vomiting (26.8%), abdominal pain (22.7%), rash (15.4%), decreased appetite (13.7%), stomatitis (11.2%), muscle spasms (10.0%).
  • Grade 3 diarrhoea occurred in 36.9% of patients.
  • Common: urinary tract infection.

Interactions

  • Strong CYP3A4/P-gp inducers are contraindicated; moderate inducers (e.g. bosentan, efavirenz, phenobarbital, dexamethasone) are not recommended.
  • Strong or moderate CYP3A4/P-gp inhibitors are not recommended; if unavoidable, the dose is reduced.
  • Medicines increasing gastric pH reduce absorption.

Pregnancy and breastfeeding

  • May cause foetal harm; women must use highly effective contraception during treatment and for 1 month after (adding a barrier method if using hormonal contraceptives); men use a barrier method for 3 months after.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • NerlynxPierre Fabre Medicament · EMEA/H/C/004030

Source: European Medicines Agency (EMA), product information

Turkey

  • NerlynxPIERRE FABRE İLAÇ A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Nerlynx
Liechtenstein
Nerlynx
Norway
Nerlynx

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Nerlynx – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.