Dosing

NERLYNX is an oral, once-daily therapy1

The recommended dose of NERLYNX is 240 mg daily, to be taken orally as a single dose of six 40 mg tablets, continuously for 1 year1

Start your patients on anti-diarrheal medications with their first dose of NERLYNX to limit the severity, frequency, and duration of diarrhea.2

Important things to tell your patients

IMPORTANT

Take NERLYNX at approximately the same time every day, preferably at mealtime

If a dose is missed or vomited, resume NERLYNX the next day

Do not chew, crush, or split tablets

Avoid grapefruit in any form

If your patients miss a dose

  • If a dose is missed or vomited, patients should resume NERLYNX the next day

  • Remind them to not try and make up for a missed dose by taking more than 1 dose (6 tablets) on any 1 day

  • They should keep track of any doses that they miss for any reason and share this with their healthcare team at their next appointment

Dosing options

Simple dose reductions to help manage side effects

Management of dose modifications, anti-diarrheal medications, and dietary changes may help patients remain on therapy1

NERLYNX dose modifications options1

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  • NERLYNX dose modifications are recommended based on individual safety and tolerability; adjust the dose as clinically indicated1
  • Some adverse reactions may require dose interruption, reduction, or discontinuation1,*
  • Patients who experienced dose holds and reductions maintained efficacy2,†

*Discontinue NERLYNX for patients who fail to recover to Grade 0-1 from treatment-related toxicity, for toxicities that result in a treatment delay > 3 weeks, or for patients that are unable to tolerate 120 mg daily.

As demonstrated in ExteNET, a pivotal phase 3, global, multicenter, randomized, double-blind, placebo-controlled study.1

DOSING AND ADMINISTRATION GUIDE

View the full dosing and administration guide to learn more about dose modifications, anti-diarrheal prophylaxis, and drug interactions with NERLYNX.

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Select IMPORTANT SAFETY INFORMATION

Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

Please see additional IMPORTANT SAFETY INFORMATION below.

Learn about proactive diarrhea management

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (>5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

For Full Prescribing Information, please click here.