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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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heading-Nerlynx-Neratinib--HER2-Breast-Cancer

Safety

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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 ExteNET2,3,5

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

Diarrhoea

93.6

37.1

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.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate transaminase.
*Includes abdominal pain, abdominal pain upper.

The most frequent AE experienced by patients is diarrhoea:

  • Primary prophylaxis for diarrhoea was not protocol-specified in the ExteNET study.1

Other than diarrhoea, there is a low incidence of severe AEs.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 of any grade is the most common adverse reaction, it must be monitored and managed

It is recommended to take antidiarrhoeal prophylaxis with the very first dose of NERLYNX.5

Proposed example of diarrhoea management with loperamide3

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Nerlynx - Diarrhoea management - Prophylaxis

Proactive management of diarrhoea is essential to help patients stay on their treatment3,21–23

Prophylaxis decreases severity and duration of diarrhoea over the course of NERLYNX treatment3,21–23

Median cumulative duration of diarrhoea days (IQR) for the whole treatment period*21-23

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Schema of Médian Cumulative duration of diarrhoea days (IQR) for the whole treatment period

Graph adapted from NERLYNX EPAR and Barcenas CH, et al. The CONTROL trial. Ann Oncol. 2020. Graph is created using data from 2 studies, the ExteNET study and the CONTROL study.
*Defined as the sum of the durations of all episodes of diarrhoea at that grade.

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:

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NERLYNX should be taken once daily with food, preferably in the morning.

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Drink 8 to 10 large glasses (a total of ~2 liters) of clear liquids every day

 

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Eat small, more frequent meals

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Choose low residue foods, easy to digest (like the BRAT diet: bananas, rice, applesauce, toast)


Things to avoid:

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Medicines such as laxatives or stool softeners

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Dairy products (except for yogurt)

 

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

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Do not chew, crush, or split tablets

 

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

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