Created with sketchtool.

The FIRST AND only HER2-directed small molecule approved in both early and metastatic breast cancer

PREVENT

RECURRENCE1,2,*

(REDUCE THE RISK OF RECURRENCE IN eBC)

PROTECT

AGAINST PROGRESSION3

(INCREASE PFS IN mBC)

ACTUAL PATIENTS

DOSING AND ADMINISTRATION GUIDE

Learn about dose modifications, diarrhea management, and drug interactions with NERLYNX.

Patient Access and Support

See what services are available for your patients.

Resources

Helpful information and tools for you and your patients.

CI: confidence interval; eBC: early breast cancer; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor-positive; mBC: metastatic breast cancer; PFS: progression-free survival.

*In patients randomized to NERLYNX ≤1 year from completing trastuzumab-based therapy. Results of ExteNET are supported by an exploratory analysis of 5-year follow-up, with 74.5% (2117/2840) of patients reconsented. 95% of the HR+ study population received concurrent endocrine therapy. Recurrence is defined as an invasive-disease event or death.

4.7% absolute benefit in distant disease-free survival vs placebo at 5 years in HER2+, HR+ early breast cancer patients within 1 year of completing trastuzumab-based therapy. Distant disease-free survival was a secondary endpoint in the clinical trial.

Median PFS of 5.6 months with NERLYNX + capecitabine vs 5.5 months with lapatinib + capecitabine (HR=0.76; 95% CI: 0.63, 0.93; P=0.0059).

Select IMPORTANT SAFETY INFORMATION

The most common adverse reactions (reported in ≥5% of patients) were:

  • NERLYNX as a single agent: diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
  • NERLYNX in combination with capecitabine: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

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:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (reported in ≥5% of patients) were:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) 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.