NERLYNX 40mg film-coated tablets medication leaflet

L01EH02 neratinib • Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors

Neratinib is an oral anti-cancer medicine used in certain adults with early-stage HER2-positive, hormone receptor-positive breast cancer after treatment with trastuzumab. Its aim is to lower the risk of the cancer coming back. In some countries it may also be used for advanced disease in combinations chosen by an oncology specialist.

It works by blocking growth signals inside cancer cells. Neratinib is usually taken once daily with food for the period prescribed by your doctor, and tablets should be swallowed whole. Follow the schedule exactly, including any anti-diarrhoea prevention medicine you are given. Grapefruit and some acid-reducing medicines can interact with neratinib.

The most important side effect is diarrhoea, which can be severe and may cause dehydration. Other possible effects include nausea, vomiting, abdominal pain, tiredness, reduced appetite, rash, mouth sores and changes in liver blood tests. Contact your care team quickly if diarrhoea continues, or if you feel dizzy, weak or unable to drink enough fluids.

Blood tests, especially liver tests, are needed before and during treatment. Neratinib can harm an unborn baby, so effective contraception is required and pregnancy must be reported immediately. Do not breastfeed during treatment unless your doctor says it is safe. Fever, jaundice, severe abdominal pain or signs of dehydration need urgent assessment.

General data about NERLYNX 40mg

Substance: neratinib

Date of last drug list: 01-05-2026

Commercial code: W71654001

Concentration: 40mg

Pharmaceutical form: film-coated tablets

Quantity: 180

Product type: generic

Price: 19507.58 RON

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: PIERRE FABRE MEDICAMENT PRODUCTION - FRANTA

Holder: MAGNAPHARM MARKETING & SALES ROMANIA S.R.L. - ROMANIA

Number: 1164/2026/01

Shelf life: 3 years

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