Dosing

Supportive medications

Together with dose modifications, anti-diarrheal prophylaxis may also help reduce diarrhea4

If the patient experiences breakthrough diarrhea, consider modifying, adding, or replacing one of the anti-diarrheals1

  • Diarrhea management should be started with the first dose of NERLYNX1

  • Medications that help manage diarrhea have different mechanisms of action; if one doesn't work, another might1,2

  • Dietary changes or NERLYNX dose modifications may also help manage side effects1

Studied prophylaxis regimens4

  MEDICATION   ADMINISTRATION
  Loperamide
Anti-diarrheal
 
  • 4 mg initial dose

  • 4 mg TID on days 1-14

  • 4 mg BID on days 15-56

  Budesonide
Anti-inflammatory
 
  • 9 mg QD (extended-release) for 28 days

  • Administer in combination with loperamide (4 mg initial dose, 4 mg TID on days 1-14, 4 mg BID on days 15-56)

  Colestipol
Bile acid sequestrant
 
  • 2 g BID for 28 days

  • Taken either 4 hours before or 2 hours after neratinib

  • Administer in combination with loperamide, either 4 mg initial dose, 4 mg TID on days 1-14, 4 mg BID on days 15-28; or PRN

BID: twice daily; PRN: as needed; QD: once daily; TID: three times daily

Voucher program for a FREE 3-month supply of anti-diarrheals is available to eligible patients

In order to best support the patient's experience on NERLYNX, our service program has been expanded to include coverage of products used for anti-diarrheal prophylaxis.

This support can be accessed by your patient through a voucher, which can be obtained from your Puma sales representative or from one of the Puma network specialty pharmacies. The voucher can be used at any retail pharmacy to provide your patient a FREE 3-month supply of product(s) that you prescribe for anti-diarrheal treatment.

Qualifying guidelines and additional utilization instructions are provided in the voucher.

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

Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.

Please see additional IMPORTANT SAFETY INFORMATION below.

Learn about dose modifications

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.