In ExteNET, diarrhea generally occurred early and was of short duration

In ExteNET, antidiarrheal prophylaxis was not protocol mandated1

  • 93% of patients had diarrhea in the first month

  • Median cumulative duration of Grade ≥ 3 diarrhea was 5 days

  • Median onset of diarrhea of any grade was 2 days8

  • Median number of episodes of Grade 3 diarrhea was 28

AVERAGE DAILY DIARRHEA GRADE OVER TIME IN ExteNET8

Artboard 1

Prophylaxis reduces incidence and severity of diarrhea1
  • Incidence of hospitalization due to diarrhea was 1.4% with NERLYNX vs 0.1% with placebo8

  • Discontinuation due to diarrhea was 16.8% with NERLYNX vs 0.2% with placebo8

Diarrhea categorized according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 4.03).9

NEW APPROACHES FOR MANAGING NERLYNX-INDUCED DIARRHEA
Adding colestipol to loperamide prophylaxis may help to manage diarrhea, as shown in the CONTROL study.3
Learn more

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.

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.