Leaflet NERLYNX 40mg film-coated tablets

Product code:
W71654001
Quantity:
180
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