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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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-Neratinib--HER2-Breast-Cancer-dosign-illustration

NERLYNX must be taken with food, preferably in the morning

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

If a dose is missed or regurgitated due to vomiting, NERLYNX is to be resumed the next day

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

Tablets should be swallowed whole, and should not be crushed or dissolved

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

Grapefruit and pomegranate in any form should be avoided

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

NERLYNX does not require any special temperature storage conditions

 

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 0–1 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. Discontinue NERLYNX for patients 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). Treatment of patients with Child-Pugh C hepatic impairment is contraindicated.

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 details on severity of
hepatotoxicity & action

General adverse events management according to the severity and based on 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

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