1. Nerlynx
  2. Dosing

EU Healthcare Professionals​

This is an international website for NERLYNX® dedicated to EU Healthcare professionals ​​(outside the UK and ROI).

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 a Healthcare Professional in the EU (outside the UK and ROI) and I have read the information above​, the Legal Notice and the Privacy Policy

Patients / Non EU Healthcare Professionals

This is an international website for NERLYNX® dedicated to EU Healthcare Professionals (outside the UK and ROI)

I am a patient or a Healthcare Professional outside the EU.

https://www.pierre-fabre.com/en
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heading-Nerlynx-Neratinib--HER2-Breast-Cancer

Dosing

Reading time: 4 min

NERLYNX® is to be taken orally, once a day, as six 40 mg tablets, continuously for one year5

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Nerlynx dosing

 

 

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NERLYNX® should be taken with food, preferably in the morning every day, continuously for 1 year

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If a dose of NERLYNX® is missed or vomited, inform patients that the missed dose should not be replaced and to resume NERLYNX® with the next scheduled daily dose

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Tablets should not be chewed, crushed, dissolved or split prior to swallowing

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Grapefruit or pomegranate may inhibit CYP3A4 and/or P-gp and should be avoided during treatment with NERLYNX®

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Nerlynx-Neratinib--HER2-Breast-Cancer-Dosing-illustration

NERLYNX® does not require any special temperature storage conditions

 

See support materials

Adjusting daily dose can improve tolerability and adherence5

Management of some adverse reactions may require dose interruption and/or dose reduction.5

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Nerlynx-Neratinib--HER2-Breast-Cancer-Dosing-adjusting

 

In case of Grade 3 toxicity:

Stop NERLYNX® until recovery to Grade ≤ 1 or baseline within 3 weeks. Then resume NERLYNX® at the next lower dose level. If Grade 3 toxicity does not recover within 3 weeks, discontinue permanently. NERLYNX® should be discontinued for patients that are unable to tolerate 120 mg daily or who fail to recover to Grade 0–1 from treatment toxicity, or for toxicities resulting in a treatment delay >3 weeks.5

See dose adjustment for

general adverse events

Dose adjustments for specific populations5

  • Elderly

No dose adjustment is required.

There is no data in patients ≥85 years of age.

  • Renal impairment

No dose adjustment is required for patients with mild to moderate renal impairment.

NERLYNX® has not been studied in patients with severe renal impairment (eGFR ≤29 mL/ min/1.73 m2) including patients on dialysis. Treatment is not recommended for these patients.

  • Hepatic impairment

No dose adjustment is required for patients with Child-Pugh A or B (mild to moderate).

See Child-Pugh score &

Prognostic sub-groups  

Dose adjustments for general hepatotoxicity5

Hepatotoxicity has been reported in patients treated with NERLYNX®.

Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin should be monitored at 1 week, then monthly for the first 3 months and every 6 weeks thereafter while on treatment or as clinically indicated.5

See dose adjustment for hepatotoxicity

hepatotoxicity & action

Learn about…

NERLYNX
Efficacy

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Nerlynx-Neratinib--Read-Also

NERLYNX
Safety

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Nerlynx-Neratinib--Read-Also

NERLYNX
Mechanism of action

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Nerlynx-Neratinib--Read-Also

General adverse events management according to the severity of adverse reactions and based on patient individual safety and tolerability5

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General adverse events management

 

Child-Pugh score28

Variable Points
1 2 3
Hepatic encephalopathy None Stage I-II Stage III-IV
Acites Absent Controlled Refractory
Bilirubin (mg/dL) <2 2-3 >3
Albumin (g/L) >35 28-35 <28
Prothrombin time (seconds) <4 4-6 >6

Prognostic sub-group28

Sum of points 5-6 7-9 10-15
Class A (mild) B (moderate) C (severe)
Severity of hepatotoxicity* Action

Grade 3 ALT

(>5-20 x ULN)

OR

Grade 3 bilirubin

(>3-10 x ULN)
  • Stop NERLYNX® until recovery to Grade 0-1    
  • Evaluate alternative causes    
  • Resume NERLYNX® at the next lowest level if recovery to Grade 0-1 occurs within 3 weeks. If Grade 3 ALT or bilirubin occurs again despite one dose reduction, permanently discontinue NERLYNX®    
  • If Grade 3 hepatotoxicity persists longer than 3 weeks, discontinue NERLYNX® permanently

Grade 4 ALT

(>20 x ULN)

OR

Grade 4 bilirubin

(>10 x ULN)
  • Permanently discontinue NERLYNX®    
  • Evaluate alternative causes

 ULN, Upper Limit Normal; ALT, Alanine Aminotransferase.

*Per CTCAE v5.0