Reduce the risk of recurrence* in early-stage HER2+ breast cancer with Nerlynx1
5.1%ABSOLUTE BENEFIT IN iDFS2,†
4.7%ABSOLUTE BENEFIT IN DDFS2,‡
IN HER2+, HR+ PATIENTS WITHIN 1 YEAR OF COMPLETING TRASTUZUMAB-BASED THERAPY VS PLACEBO AT 5 YEARS2

THE FIRST AND ONLY HER2-DIRECTED SMALL MOLECULE APPROVED IN EARLY-STAGE BREAST CANCER3

DOSING AND ADMINISTRATION GUIDE

Learn about dose modifications, prophylaxis options, and drug interactions with NERLYNX.

Download

Patient Management

Simple dose reductions may help manage side effects so patients remain on therapy.4

Learn more

Quick links

Full Prescribing Information Puma Patient Lynx
Enrollment Form
Specialty Pharmacy List

Select IMPORTANT SAFETY INFORMATION

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.

Please see additional IMPORTANT SAFETY INFORMATION below.

DDFS: distant disease-free survival; HER2: human epidermal growth factor receptor 2; HR+: hormone receptor-positive; iDFS: invasive disease-free survival

*Recurrence is defined as an invasive disease event or death.

95% of the HR+ study population received concurrent endocrine therapy.

Results of ExteNET are supported by an exploratory analysis of 5-year follow-up with 74.5% (2117/2840) of patients reconsented.5

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.