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This is an international website for NERLYNX® dedicated to Healthcare professionals ​​

IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

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NERLYNX® has a well-understood and predictable safety and tolerability profile2,3,5

Adverse reactions reported in ≥6% of patients in the ExteNET study5

System Organ Class Adverse Reaction All Grades (%) ≥ Grade 3 (%)
General Disorders Fatigue 27.3 -
Metabolic and Nutritional Disorders Decreased appetite 13.7 -
Hepatobiliary Disorders ALT increased 8.5 1.3
AST increased 7.4 0.7
Gastrointestinal Disorders




Nausea 42.5 -
Abdominal pain* 35.9 -
Vomiting 26.8 3.5
Stomatitis 11.2  
Skin and Subcutaneous Tissue Disorders Rash 15.4 0.4
Nail disorders 7.8 0.2
Musculoskeletal and Connective Tissue Disorders Muscle spasms 10.0 -

Table adapted from NERLYNX SmPC.
ALT, alanine aminotransferase; AST, aspartate transaminase.
*Includes abdominal pain, abdominal pain upper.
Incidence of grade ≥ 3 is only reported for the most common adverse reactions and selected adverse reactions according to NERLYNX® SmPC.

The most frequent adverse event experienced by patients is diarrhoea:

  • In the ExteNET study, primary prophylaxis for diarrhoea was not protocol-specified.1

Other than diarrhoea, there is a low incidence of severe adverse events.1

No evidence of cardiac or pulmonary toxicity, nor increased risk for secondary malignancy is observed.1

WARNING: Patients may also experience side effects related to associated treatment, such as hormone therapy.

See Risk Management Plan

NERLYNX® associated diarrhoea is the most common adverse reaction, it must be monitored and managed

It is recommended to take anti-diarrhoeal prophylaxis with the very first dose of NERLYNX®.5

Nerlynx - Diarrhoea management - Prophylaxis

Dietary recommendations24,25

Diet and lifestyle changes play an important role in the management of NERLYNX® associated diarrhoea. It is important to have a proactive discussion about diet modifications.

Things to do:


Drink more clear liquids
Try to drink ~2L of clear fluids per day.
These include water, sports drinks, broth, weak decaffeinated tea,
caffeine-free soft drinks, clear juices, and gelatin.



Eat small, frequent meals


Choose foods that are easy to digest (low-residue diet).
These include bananas, rice, applesauce and toast.

Things to avoid:


Medicines such as laxatives or stool softeners




Caffeine, alcohol, dairy, fat, fibre, orange juice, grapefruit juice, pomegranate juice, prune juice, and spicy foods






Dose adjustments according to the severity of diarrhoea and based on patient individual safety and tolerability5

The overall management of diarrhoea is based upon its grade as measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).27

Contenu de la pop in (ici, un H3)

A noter que le contenu de la pop in est prise en compte pour le SEO.

Il est donc nécessaire de bien baliser les titres. Nous conseillons d'utiliser un H2 ou un H3 (pas de H1).

NCI CTCAE: Grading for diarrhoea27


NCI CTCAE: Grading for diarrhoea

Grade 1

Increase of <4 stools per day over baseline
Mild increase in ostomy output compared to baseline

Grade 2

Increase of 4-6 stools per day over baseline
Moderate increase in ostomy output compared to baseline

Grade 3

Increase of ≥7 stools per day over baseline
Incontinence, hospitalisation indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL)

Grade 4

Life threatening consequences
Urgent intervention indicated

Dose adjustments according to the severity of diarrhoea and based on patient individual safety and tolerability5


*Complicated features include dehydration, fever, hypotension, renal failure, or Grade 3 or 4 neutropenia.
†Despite being treated with optimal medical therapy.