Leaflet NERLYNX 40mg film-coated tablets

Indicated for: breast cancer

Route of administration: oral

Substance: neratinib (tyrosine kinase inhibitor)

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

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Avoid grapefruit
Avoid grapefruit

Avoid grapefruit and grapefruit juice.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

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 latest medicines list: 01-06-2026
  • Product code: W71654001
  • Concentration: 40mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 180
  • Product type: Generic medicine
  • Price: 19507.58 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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