NOW APPROVED

In early-stage HER2+ breast cancer NERLYNX is your next step to further reduce the risk of recurrence following trastuzumab-based therapy

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.

Up to 31% of early-stage HER2+ patients
experience a disease-free survival
event or death* within 11 years as
observed in the HERA trial. A substantial unmet need still exists.1

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NERLYNX Results

reduction in risk of
recurrence with NERLYNX
vs placebo at 2 years2,†

5-year exploratory analysis NERLYNX iDFS results were consistent with the 2-year data3,‡

Study design Efficacy Safety

MANAGING ADVERSE EVENTS

Prophylaxis reduces incidence and severity of diarrhea3

Loperamide prophylaxis guidance

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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.

Please see additional IMPORTANT SAFETY INFORMATION below.

Disease-free survival, defined as time from randomization to the first occurrence of any of the following disease-free survival events: recurrence of breast cancer at any site; the development of ipsilateral or contralateral breast cancer, including ductal carcinoma in situ but not lobular carcinoma in situ; second nonbreast malignant disease other than basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix; or death from any cause without documentation of a cancer-related event.4

Recurrence is defined as an invasive disease event or death.

Results of ExteNET are supported by an exploratory analysis of 5-year follow-up with 74.5% (2,117/2,840) of patients re-consented.

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.