Healthcare Professionals​

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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I am Healthcare Professional inside the EU and I have read the information above​.

Non Healthcare Professionals

This is an international website for NERLYNX® dedicated to Healthcare Professionals.

I am not a Healthcare Professional inside the EU.

https://www.pierre-fabre.com/en
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Risk Management Plan

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NERLYNX Risk Management Plan

Pierre Fabre is committed to make sure that patients can get the full benefit of their treatment. A Risk Management Plan (RMP) agreed with EMA has been set up in Europe to ensure that all treating physicians who are expected to prescribe NERLYNX and all patients who are expected to get treated with NERLYNX, have access and are provided with educational materials. Thus, educational materials were designed to increase awareness of diarrhoea-induced incidence and help with its management, to be offered to treating physicians and patients prior to treatment initiation.

Learn more on NERLYNX Risk Management Plan.

See support materials

 

In addition, the RMP includes the conduction of post-authorization safety studies (PASS) to observe the incidence of permanent discontinuation due to diarrhoea in the routine clinical practice and to evaluate if the upfront education of healthcare professionals and patients can impact on diarrhoea prevention and management. NERLYFE is a European, prospective, observational, PASS to investigate real-world incidence and management of diarrhoea under NERLYNX as extended adjuvant treatment.

 

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Nerlyfe logo

Ongoing study

Prospective observational safety study in adult breast cancer patients treated with neratinib
in extended adjuvant in a Real-World setting

 

To describe
the incidence of discontinuation due to diarrhoea within the first 3 months of treatment with neratinib.
 

To assess
the impact of the information provided in the educational materials according to Risk Management Plan engagement.
 

 

 

EU PAS Register number: EUPAS41584
For more information about Nerlyfe, please send an email to: nerlyfestudy@pierre-fabre.com

Nerlyfe study design

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Safety - Nerlyfe study design

SmPC, Summary of Product Characteristics; EM, Educational Material (Risk Management Plan materials). 

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