What is NERLYNX® (neratinib) tablets?
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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.
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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
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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.
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.
Always take antidiarrheals exactly as your healthcare provider tells you.
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.
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Liver problems: Tell your healthcare provider if you have liver problems. Changes in liver function tests are common with NERLYNX. Your healthcare provider should do blood tests before and during treatment with NERLYNX. Your healthcare provider will stop your treatment if your liver tests show severe problems. Call your healthcare provider right away if you experience:
- tiredness
- nausea
- vomiting
- pain in the right upper stomach-area (abdomen)
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- fever
- rash
- itching
- yellowing of your skin or whites of your eyes
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Pregnancy: NERLYNX can harm your unborn baby. Female patients should tell their healthcare providers if they are pregnant or plan to become pregnant. They should use effective birth control (contraception) during treatment and for at least 1 month after their last dose of NERLYNX. Male patients with female partners who can become pregnant should use effective birth control during treatment and for 3 months after the last dose of NERLYNX.
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Breastfeeding: Tell your healthcare provider if you 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.
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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 (PPIs). You should avoid taking these medicines during treatment with NERLYNX.
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You should avoid eating products that contain grapefruit during treatment with NERLYNX.
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
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- muscle spasms
- upset stomach
- nail problems including color change
- dry skin
- swelling of your stomach-area
- nosebleed
- weight loss
- urinary tract infection
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The most common side effects of NERLYNX when used with capecitabine include:
- diarrhea
- nausea
- vomiting
- decreased appetite
- constipation
- tiredness/weakness
- weight loss
- dizziness
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- back pain
- joint pain
- urinary tract infection
- upper respiratory tract infection
- swelling of your stomach-area
- kidney problems
- muscle spasms
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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.
