“This is a fighting chance to help reduce my risk...So I took it.”

—Sherry H, treated with NERLYNX

This was Sherry’s experience. Other patients may have a different experience.

How does NERLYNX work?

NERLYNX is a small molecule targeted therapy that works inside your cells and helps stop HER2 protein signals.

NERLYNX in women with early-stage and metastatic HER2+ breast cancer

In early-stage HER2+ breast cancer

What should I know about how NERLYNX was studied?

NERLYNX was studied in a phase 3 trial examining the safety and effectiveness of NERLYNX vs placebo. The clinical trial included 2,840 people who had early-stage HER2+ breast cancer.

In a clinical study, NERLYNX reduced the risk of recurrence by 34% at 2 years. This was the primary endpoint of the trial.

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 placebo: a difference of 2.3%.

NERLYNX was also studied in people with early-stage HER2+ breast cancer who were HR+ as well. In an additional analysis conducted after the clinical trial was completed, 75% of patients enrolled in the clinical trial (2,117 out of 2,840) agreed to remain in the study beyond the initial 2 years. Of the HER2+ and HR+ population, 95% were also treated with endocrine therapy.

In this analysis, NERLYNX reduced the risk of recurrence by 42% at 5 years.

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 taking placebo: a difference of 5.1%.

Talk to your doctor for more information on NERLYNX data. Your doctor will help you manage expectations.

Does NERLYNX impact the development of HER2+ breast cancer recurrence in the CNS?

In an additional analysis conducted after the clinical trial was completed, NERLYNX was shown to have an effect on CNS (central nervous system: brain and spinal cord) metastases in people with early-stage HER2+ breast cancer.

In absolute numbers, 98.4% of people given NERLYNX (n=670) did not experience a CNS recurrence, or death from any cause, compared to 95.7% of those given placebo (n=664): a benefit of 2.7%.

This translates to a 59% reduction in the risk of CNS recurrence or death in people with HER2+ and HR+ breast cancer given NERLYNX.

With NERLYNX, you may help further reduce the risk that your HER2+ breast cancer will return.

Mentor program*

If you are considering or already being treated with NERLYNX, our mentor program connects you with someone who currently takes or has taken NERLYNX.

We're ready to chat!

To talk to a mentor, call 1‑855‑816‑5421.

*The mentor program is here for you with support and resources. Your healthcare team should always be your primary source of information for treatment decisions.
Puma mentors are compensated for their time.

I have early-stage HER2+ breast cancer. How do I take my NERLYNX?

NERLYNX is an oral medicine that you take once a day at home. Talk to your doctor about the correct dosage for you. Your doctor may start you off with a lower dose of NERLYNX and then gradually increase to your full dosage.

Here’s an example of what dose escalation with NERLYNX may look like:

Your doctor may also prescribe you an antidiarrheal such as loperamide when you start treatment and then as needed. Talk to your doctor about how much and how often to take this medicine. Take a look at our Antidiarrheal Support Program to see if it could help you.

Limitations apply. Puma Biotechnology reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, call 1-855-816-5421.

§Take NERLYNX exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dosage of NERLYNX if needed.

For more information on the benefits of NERLYNX, download the patient brochure.

What side effects could I experience?

Common side effects

Diarrhea is the most common side effect of taking NERLYNX, and can be severe. Diarrhea may lead to loss of too much body salt and fluid, which can cause dehydration.

Talk to your doctor about how to best manage NERLYNX side effects, and call them right away if you have severe diarrhea or experience diarrhea along with weakness, dizziness, or fever.

Here are some other commonly reported side effects when NERLYNX is used alone to treat early-stage HER2+ breast cancer:

  • Nausea
  • Stomach-area (abdomen) pain
  • Tiredness
  • Vomiting
  • Rash
  • Dry or inflamed mouth, or mouth sores
  • Decreased appetite
  • Muscle spasms
  • Upset stomach
  • Nail problems including color change
  • Dry skin
  • Swelling of your stomach-area
  • Nosebleed
  • Weight loss
  • Urinary tract infection

These are not all of the possible side effects of NERLYNX. Tell your healthcare provider if you have any side effects that bother you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088.

Please see Important Safety Information below.

With metastatic HER2+ breast cancer

Take a stand against progression

“Metastatic” means that the cancer has spread beyond the breast and nearby lymph nodes to other parts of the body. NERLYNX plus capecitabine (an oral chemotherapy) can be taken to help prevent advanced or metastatic HER2+ breast cancer from spreading further.

Who is NERLYNX right for?

If you've already been treated with 2 or more HER2-directed therapies for metastatic breast cancer (like trastuzumab, T-DM, and/or pertuzumab), NERLYNX plus capecitabine may be right for you.

What should I know about the benefits of NERLYNX plus capecitabine?

NERLYNX was studied in a phase 3 trial examining the safety and effectiveness of NERLYNX in combination with capecitabine vs lapatinib plus capecitabine. The clinical trial included 621 people with metastatic HER2+ breast cancer who had previously been treated with 2 or more HER2-directed therapies.

In a clinical study, NERLYNX plus capecitabine reduced the risk of progression by 24%.

These are relative benefits. In absolute numbers, at 12 months, the progression-free survival rate was 29% in the NERLYNX plus capecitabine group vs 15% in the lapatinib plus capecitabine group.

Talk to your doctor for more information on NERLYNX data. Your doctor will help you manage expectations.

In the clinical trial, NERLYNX also gave people a longer response to treatment compared with lapatinib plus capecitabine.*

*Median of 8.5 months compared to 5.6 months for those taking lapatinib. 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).

Mentor program

If you are considering or already being treated with NERLYNX, our mentor program connects you with someone who currently takes or has taken NERLYNX.

We're ready to chat!

To talk to a mentor, call 1‑855‑816‑5421.

The mentor program is here for you with support and resources. Your healthcare team should always be your primary source of information for treatment decisions.
Puma mentors are compensated for their time.

I have metastatic breast cancer. How do I take my NERLYNX?

NERLYNX is an oral medicine that you take once a day. Talk to your doctor about the correct dosage for you. Your doctor may start you off with a lower dose of NERLYNX and then gradually increase to your full dosage.

It's important to remember if you're taking NERLYNX for your metastatic breast cancer, you must take it in combination with capecitabine.

Here’s an example of what dose escalation with NERLYNX may look like:

Your doctor may also prescribe you an antidiarrheal such as loperamide when you start treatment and then as needed. Talk to your doctor about how much and how often to take this medicine. Take a look at our Antidiarrheal Support Program to see if it could help you.§

§Limitations apply. Puma Biotechnology reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, call 1-855-816-5421.

For more information on the benefits of NERLYNX, download the patient brochure.

What side effects could I experience?

Common side effects for NERLYNX plus capecitabine

Diarrhea is the most common side effect of taking NERLYNX, and can be severe. Diarrhea may lead to loss of too much body salt and fluid, which can cause dehydration.

Talk to your doctor about how to best manage NERLYNX side effects, and call them right away if you have severe diarrhea or experience diarrhea along with weakness, dizziness, or fever.

Here are some other commonly reported side effects when NERLYNX is used in combination with capecitabine to treat metastatic HER2+ breast cancer:

  • Nausea
  • Vomiting
  • Decreased appetite
  • Constipation
  • Tiredness/weakness
  • Weight loss
  • Dizziness
  • Back pain
  • Joint pain
  • Urinary tract infection
  • Swelling of your stomach-area
  • Kidney problems
  • Muscle spasms

These are not all of the possible side effects of NERLYNX. Tell your healthcare provider if you have any side effects that bother you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088.

Please see Important Safety Information below.

Tips for taking NERLYNX

Here are some tips and procedures for taking your NERLYNX from women and their caregivers who’ve been there:

Did you know there are educational programs and services that help make NERLYNX more accessible?

Check out Puma Patient Lynx™

How do I manage side effects?

If side effects arise, talk to your healthcare provider.

Diarrhea is a common side effect of NERLYNX, but it can also be severe. Diarrhea may lead to loss of too much body salts and fluid, which can cause dehydration.

For patients with early-stage HER2+ breast cancer, your doctor may start you with a lower dose and slowly increase the dose until you are taking the recommended dosage of 6 pills a day. This can help you adjust to NERLYNX by managing this side effect.

Working with your healthcare team

Side effects can occur with NERLYNX. But there are steps you can take to help manage the side effect of diarrhea and see your treatment through.

Working with your healthcare team from the beginning is the key to success. Here are some simple steps to help prepare you:

Antidiarrheal Support Program*

    Puma offers vouchers that include access to a free supply of certain antidiarrheal medicines.

  • With a prescription, patients can receive up to a 3-month supply of certain products used for antidiarrheal treatment for free
  • Ask your healthcare team or a Puma network Specialty Pharmacy for a voucher

*Limitations apply. Puma Biotechnology reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, call 1-855-816-5421.

    What is NERLYNX tablets?

  • NERLYNX is a prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and who have previously been treated

IMPORTANT SAFETY INFORMATION

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

    NERLYNX may cause serious side effects, including:

  • Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. Diarrhea may lead to loss of too much body salts and fluid, which can cause dehydration. Your healthcare provider will prescribe NERLYNX in one of two ways to help manage diarrhea:

IMPORTANT SAFETY INFORMATION

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

    NERLYNX may cause serious side effects, including:

  • Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. Diarrhea may lead to loss of too much body salts and fluid, which can cause dehydration. Your healthcare provider will prescribe NERLYNX in one of two ways to help manage diarrhea:

    What is NERLYNX tablets?

  • NERLYNX is a prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and who have previously been treated with trastuzumab-based therapy.
  • NERLYNX is also used with a medicine called capecitabine to treat adults with HER2-positive breast cancer that has spread to other parts of the body (metastatic) and who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer.

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

IMPORTANT SAFETY INFORMATION

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

NERLYNX may cause serious side effects, including:

  • Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. Diarrhea may lead to loss of too much body salts and fluid, which can cause dehydration. Your healthcare provider will prescribe NERLYNX in one of two ways to help manage diarrhea:

      Full dose of NERLYNX:

    • Your healthcare provider will prescribe the antidiarrheal medicine loperamide for you during your first 2 months (56 days) of treatment with NERLYNX and then as needed. Your healthcare provider will tell you exactly how much and how often to take this medicine.
    • If you are prescribed the full dose of NERLYNX from the start of your treatment, be sure that your healthcare provider also prescribes antidiarrheals with NERLYNX. You should start taking loperamide with your first dose of NERLYNX.
    • After 2 months (56 days) of treatment with NERLYNX, follow your healthcare provider’s instructions about taking loperamide as needed to control diarrhea.
      • A lower starting dose of NERLYNX:

      • Your healthcare provider will start you on a lower dose of NERLYNX for the first 2 weeks of treatment and then increase you to a full dose NERLYNX regimen. Tell your healthcare provider right away if you develop diarrhea; you may be prescribed loperamide as needed.

      To help prevent or reduce diarrhea during treatment with NERLYNX:

    • Your healthcare provider may also need to give you additional antidiarrheals, fluids, and electrolytes to manage diarrhea when you start treatment with NERLYNX. Follow your healthcare provider’s instructions on how to take antidiarrheal medicines.
    • Always take antidiarrheals exactly as your healthcare provider tells you.
    • While taking antidiarrheals, you and your healthcare provider should try to keep the number of bowel movements that you have at 1 or 2 bowel movements each day.
    • Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or you have diarrhea that does not go away.
    • Call your healthcare provider right away if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever.

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.

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

  • have liver problems. You may need a lower dose of NERLYNX.
  • are pregnant or plan to become pregnant. NERLYNX can harm your unborn baby. If you are a female who can become pregnant:
    • Your healthcare provider should do a pregnancy test before you start taking NERLYNX.
    • You should use effective birth control (contraception) during treatment and for at least 1 month after your last dose of NERLYNX.
    • Talk with your healthcare provider about forms of birth control that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant during treatment with NERLYNX.
    • Males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after the last dose of NERLYNX.
  • are breastfeeding or plan to breastfeed. It is not known if NERLYNX passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after your last dose of NERLYNX.

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 should I avoid while taking NERLYNX?

You should avoid eating products that contain grapefruit 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?”

  • Liver problems. Changes in liver function tests are common with NERLYNX. Your healthcare provider should do blood tests before you begin treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. Your healthcare provider will stop your treatment with NERLYNX if your liver tests show severe problems. Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
    • tiredness
    • nausea
    • vomiting
    • pain in the right upper stomach-area (abdomen)
    • fever
    • rash
    • itching
    • yellowing of your skin or whites of your eyes
    The most common side effects of NERLYNX when used alone include:
  • diarrhea
  • nausea
  • stomach-area (abdomen) pain
  • tiredness
  • vomiting
  • rash
  • dry or inflamed mouth, or mouth sores
  • decreased appetite
  • muscle spasms
  • upset stomach
  • nail problems including color change
  • dry skin
  • swelling of your stomach-area
  • nosebleed
  • weight loss
  • urinary tract infection
    The most common side effects of NERLYNX when used with capecitabine include:
  • diarrhea
  • nausea
  • vomiting
  • decreased appetite
  • constipation
  • tiredness/weakness
  • weight loss
  • dizziness
  • back pain
  • joint pain
  • urinary tract infection
  • upper respiratory tract infection
  • swelling of your stomach-area
  • kidney problems
  • muscle spasms

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

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

Please see Patient Information.