Dosing

NERLYNX is an oral, once-daily therapy1

NERLYNX dose escalation may be used as a diarrhea management and prevention strategy1

Daily Schedule Chart
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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

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

NERLYNX dose modifications options
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  • Patients who experienced dose holds and reductions maintained efficacy2,*
  • 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,†

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

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.

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

Drug interactions: 1. Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. 2. Strong or moderate CYP3A4 inhibitors: Avoid concomitant use. 3. Strong or moderate CYP3A4 inducers: Avoid concomitant use. 4. P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.

Please see additional IMPORTANT SAFETY INFORMATION below.

Learn about prophylaxis options

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.