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NERLYNX: The Power to Prevent Recurrence*

NERLYNX is an oral, extended adjuvant therapy, meaning it is designed to be taken after your adjuvant Herceptin® treatment (following surgery). With NERLYNX, you can help further reduce the risk that your breast cancer will return.

What is NERLYNX?

NERLYNX is a small-molecule, targeted therapy that enters and works inside the cell to permanently stop HER2 protein signals.

People with HER2+ breast cancer have a gene that causes their cells to make too much HER2 protein:

  • HER2 is a protein that signals cells to grow and divide
  • When a gene mutation causes too much HER2 protein, cells grow more aggressively than normal

By blocking HER2 protein signals with NERLYNX, breast cancer cells don't grow and divide as rapidly.

NERLYNX was shown in preclinical trials to possibly cross the blood-brain barrier and enter the brain. Up to 50% of women with HER2+ breast cancer will eventually have a recurrence in the brain.

Download a NERLYNX brochure

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The Benefits of NERLYNX

NERLYNX was studied in a clinical trial of 2,840 women who had early-stage HER2+ breast cancer and had undergone treatment with trastuzumab. The phase 3 trial examined the safety and effectiveness of NERLYNX by comparing women who took NERLYNX with women who were given a placebo (which did not contain the medicine in NERLYNX). Participants were selected to receive NERLYNX randomly and were not told whether they were receiving the medicine or a placebo.

In the clinical trial, NERLYNX reduced the risk of cancer returning by 34% at 2 years for all women studied with HER2+ breast cancer.

The clinical trial also looked at a subset of women with HER2+ breast cancer who were also hormone receptor positive (HR+) and found there was a 42% reduction in the risk of recurrence at 5 years.‡,§

By committing to NERLYNX, you can be confident in knowing you are doing everything you can to lower your risk of your cancer coming back.

*Recurrence is defined as the cancer coming back or resulting in death.

NERLYNX targets HER2+ cancer cells, but may also affect healthy cells.

These are relative benefits. In absolute numbers, 94.2% of all people studied who were HER2+ and took NERLYNX had no return of cancer after 2 years, compared to the 91.9% of people on a placebo who had no return of cancer. After 5 years, 90.8% of all people studied who were HER2+ and HR+ and took NERLYNX had no return of cancer, compared to the 85.7% of people on a placebo who had no return of cancer.

§5-year data are based on an exploratory analysis of people who were HR+ and had completed a trastuzumab-based treatment 1 year or less prior to treatment with NERLYNX. Of this HER2+, HR+ population, 95% were also on endocrine therapy.

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Select IMPORTANT SAFETY INFORMATION

What is the most important information I should know about NERLYNX (ner links)?

NERLYNX® (neratinib) may cause serious side effects, including:

  • Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. You may lose too much body salts and fluid, and get dehydrated. When you start NERLYNX, your healthcare provider should prescribe the medicine loperamide for you during your first 2 months (56 days) of NERLYNX and then as needed. Be sure that your healthcare provider prescribes anti-diarrheals with NERLYNX. Anti-diarrheals must be started with the first dose of NERLYNX.

Please see additional IMPORTANT SAFETY INFORMATION below.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about NERLYNX (ner links)?

NERLYNX® (neratinib) may cause serious side effects, including:

Your healthcare provider may change your dose of NERLYNX, temporarily stop or completely stop NERLYNX if needed to manage your diarrhea.

See "What are the possible side effects of NERLYNX?" for more information about side effects.

What is NERLYNX?

It is not known if NERLYNX is safe and effective in children.

Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines used to decrease stomach acid, called proton pump inhibitors or PPIs. You should avoid taking these medicines during treatment with NERLYNX.

What are the possible side effects of NERLYNX?

NERLYNX may cause serious side effects, including:
See "What is the most important information I should know about NERLYNX?"


The most common side effects of NERLYNX when used alone include:

The most common side effects of NERLYNX in combination with capecitabine include:

These are not all of the possible side effects of NERLYNX. For more information, ask your Healthcare Provider.

Tell your doctor if you have any side effects that bother you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For Patient Information, please click here.