Safety

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

In ExteNET, antidiarrheal prophylaxis was not protocol mandated1

Prophylaxis reduces incidence and severity of diarrhea1

  • Incidence of hospitalization due to diarrhea was 1.4% with NERLYNX vs 0.1% with placebo2

  • Discontinuation due to diarrhea was 16.8% with NERLYNX vs 0.2% with placebo2

Diarrhea categorized according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 4.03).20

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

*Further follow-up is necessary in the ongoing colestipol cohort.

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 dosing 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.