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A new option for

metastatic HER2+ breast cancer

NERLYNX® (neratinib) is now approved for the treatment of adults with HER2+ breast cancer that has spread to other parts of the body (metastatic).

What is Nerlynx

NERLYNX is intended for adults with HER2+ breast cancer who have received 2 or more anti-HER2 therapies for metastatic breast cancer. These may include trastuzumab, T-DM1, and/or pertuzumab (Herceptin®, Kadcyla® and/or Perjeta®).

NERLYNX is taken with a medicine called capecitabine to help prevent metastatic breast cancer from progressing any further.

How Nerlynx was studied

NERLYNX was studied in a clinical trial of 621 people who had HER2+ metastatic breast cancer (mBC) and had undergone treatment with 2 or more HER2-directed therapies for mBC. The Phase 3 study examined the effectiveness of NERLYNX.

The study compared people who took NERLYNX plus capecitabine (a chemotherapy) with people who took lapatinib (Tykerb®) plus capecitabine. Participants were randomly selected to receive NERLYNX.

How Nerlynx was studied
The benefits of Nerlynx
24% reduction

In the clinical trial, NERLYNX reduced the risk of cancer progressing by 24% for all people studied who had undergone treatment with 2 or more HER2-directed therapies for mBC.

8.5 monthsThe trial also found that people taking NERLYNX responded to therapy for a median of 8.5 months compared to 5.6 months for those taking lapatinib (Tykerb®).*

*The 8.5 and 5.6 months durations were calculated only from the percentage of people that responded to therapy (32.8% in the NERLYNX group vs 26.7% in the lapatinib group).

How to take Nerlynx

NERLYNX is an oral medicine that you take once a day. You will take NERLYNX in combination with capecitabine (a chemotherapy). For 14 days, you will take 6 NERLYNX tablets once a day plus capecitabine twice a day. After 14 days, you will stop taking capecitabine for 7 days. You will continue taking NERLYNX during this time. After 7 days, you will add capecitabine back again for 14 days. The cycle keeps repeating.

Talk to your doctor about how to take NERLYNX and capecitabine. You will also take loperamide, an antidiarrheal, during the first two months and then as needed.

Planning for side effects

Working with your healthcare team from the beginning is the key to success. Be sure to let your doctor know about any side effects you experience and ask for help to manage them. Starting antidiarrheal medicines with the first dose of NERLYNX and continuing during the first 2 months may help minimize diarrhea.

Diet and lifestyle changes can also help

  • Choose foods that are low in fiber and high in protein and potassium.
  • Eat smaller, more frequent meals.
  • Stay well hydrated by drinking 8 to 10 large glasses of clear liquid daily.
  • Avoid dairy products (except for yogurt).
  • Eat bananas, rice, applesauce, and toast (the BRAT diet).
  • Try probiotics (found in yogurt or dietary supplements) to aid digestion.

We'll cover the cost of antidiarrheal medicines.

  • Eligible patients can receive up to a 3-month supply of products used for antidiarrheal treatment for free.
  • Get a voucher from your healthcare team.

This program benefit is offered based on the findings from the CONTROL trial, which show that using antidiarrheals can help to manage diarrhea that may be caused by NERLYNX. Limitations apply. Patient must have commercial insurance. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Puma Biotechnology reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, click here or call 1-855-816-5421 (when prompted, press 1).

Mentor Program

If you are considering or already on NERLYNX, the mentor program connects you with someone who currently takes NERLYNX or has recently completed treatment. To learn more, call 1-855-816-5421 (when prompted, press 3).

call 1-855-816-5421

Access Program

Puma is committed to ensuring that financial barriers do not prevent anyone from getting NERLYNX. Services are available to help support your experience and make NERLYNX more accessible for you.

Learn more


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

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

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.