Diarrhea and antidiarrheal prophylaxis1

  • Prophylaxis with loperamide has been shown to lower the incidence and severity of diarrhea

  • Start loperamide with the first dose of NERLYNX and continue during the first two cycles (56 days) of treatment. Continue loperamide as shown below, titrating to 1-2 bowel movements per day

Loperamide prophylaxis guidance1

loperamide-proph-guidance-chart Created with Sketch.
  • Additional antidiarrheal agents may be required to manage diarrhea in patients with loperamide-refractory diarrhea

  • NERLYNX dose interruptions and dose reductions may also be required (please see Full Prescribing Information)

  • Please see additional guidelines for the management of adverse events, including hepatotoxicity, in the Full Prescribing Information

Voucher program for a 3-month supply of antidiarrheals 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 antidiarrheal treatment, as based on findings from CONTROL.

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 antidiarrheal treatment.

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

NEW APPROACHES FOR MANAGING NERLYNX-INDUCED DIARRHEA
Adding colestipol to loperamide prophylaxis may help to manage diarrhea, as shown in the CONTROL study.3
Colestipol Regimen
DOSING AND ADMINISTRATION GUIDE
Learn about dose modifications, antidiarrheal prophylaxis, and drug interactions with NERLYNX.
DOWNLOAD

Select IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

Lactation: Advise women not to breastfeed.

Please see additional IMPORTANT SAFETY INFORMATION below.

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, epistaxis, 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.