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Overview: Nerlynx is an oral tablet that is used to treat certain types of breast cancer. It works by blocking certain signals that cause breast cancer cells to grow and spread. Common side effects may include diarrhea, nausea and vomiting, stomach pain, mouth sores, decreased appetite, weight loss, and tiredness. Tell your health care provider right away if you have severe diarrhea or diarrhea with a fever, dizziness, or weakness. Do not take Nerlynx if you are pregnant or plan to become pregnant. Talk to your health care provider about your birth control options.

Uses

What is Nerlynx used for?

Nerlynx (neratinib) is commonly used to treat a certain type of breast cancer called HER2-positive breast cancer. It may be used in early-stage breast cancer or in people who have cancer that is advanced or has spread to other parts of the body (metastatic).

Nerlynx may also be used for other conditions as determined by your health care provider.                   

How does Nerlynx work (mechanism of action)?

Nerlynx blocks certain signals that cause breast cancer cells to grow and spread. 

How is Nerlynx supplied (dosage forms)?

Nerlynx is available in 40 mg oral tablets.

How should I store Nerlynx?

Nerlynx should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place, in a tightly closed container.

Side Effects

What are the most common side effects of Nerlynx?

The most common side effects of Nerlynx are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea (see below)
  • Nausea or upset stomach
  • Stomach or belly pain
  • Tiredness or weakness
  • Vomiting
  • Constipation (when used with capecitabine)
  • Rash
  • Dry mouth or mouth sores
  • Decreased appetite and weight loss
  • Muscle spasms
  • Dizziness (when used with capecitabine)
  • Back pain (when used with capecitabine)
  • Nail problems, such as color change
  • Dry skin
  • Swelling of your stomach area
  • Nosebleed
  • Kidney or bladder infection
  • Infection in the nose or throat, sore throat, or common cold symptoms (when used with capecitabine)
  • Joint pain (when used with capecitabine)
  • Kidney problems (when used with capecitabine)

There may be other side effects of Nerlynx that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Nerlynx?

While less common, the most serious side effects of Nerlynx are described below, along with what to do if they happen.

Diarrhea. Diarrhea is common with Nerlynx, but it can sometimes be severe. Follow any instructions from your health care provider about how to take Nerlynx to lessen the effect of diarrhea. If you are given medicine to prevent or treat diarrhea, take it exactly as your health care provider tells you. Call your health care provider right away if you have any of the following.

  • Severe diarrhea
  • Diarrhea that does not go away
  • Diarrhea with weakness, dizziness, or fever  

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Nerlynx. Keep all appointments with your health care provider for blood tests to check the health of your liver. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color, also called jaundice

Severe Allergic Reactions. Nerlynx may cause allergic reactions, which can be serious. Stop taking Nerlynx and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not take Nerlynx?

Allergies to Ingredients. People who are allergic to any of the following should not take Nerlynx.

  • Neratinib
  • Nerlynx
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Nerlynx.

What should I know about Nerlynx before using it?

Do not take Nerlynx unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Nerlynx with other people, even if they have the same condition as you. It may harm them.

Keep Nerlynx out of the reach of children.

Do not cut, chew, or crush Nerlynx tablets. Swallow Nerlynx tablets whole.

Take Nerlynx with food at about the same time every day.

If you can get your partner pregnant, you should use effective birth control while taking Nerlynx and for 3 months after your last dose. See the Pregnancy section for more details.

What should I tell my health care provider before using Nerlynx?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Nerlynx is right for you.

In particular, make sure that you discuss any of the following.

Liver Problems. Tell your health care provider if you have any problems with your liver. If there is a concern about the health of your liver, your health care provider may do tests to find the best dose of Nerlynx for you.

Other Medicines and Supplements. Nerlynx may interact with other medicines and supplements. Before taking Nerlynx, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Do not take Nerlynx if you are pregnant. Nerlynx may cause harm to a fetus. Tell your health care provider right away if you are pregnant or plan to become pregnant. You will need a negative pregnancy test before starting Nerlynx. If you can become pregnant, use effective birth control while you are taking Nerlynx and for at least 1 month after your last dose. Talk to your health care provider about your birth control options. Tell your health care provider right away if you have unprotected sex or if you think your birth control has failed. 

Breastfeeding. Do not breastfeed while you are taking Nerlynx and for at least 1 month after your last dose. It is not known if Nerlynx passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Nerlynx?

For more information about Nerlynx, you can visit the drugmaker's website at www.nerlynx.com or call them at 844-637-5969. 

Interactions

Does Nerlynx interact with foods or drinks?

Do not take Nerlynx with grapefruit or grapefruit juice.

It is unknown if drinking alcohol will affect Nerlynx.

Does Nerlynx interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Nerlynx.

  • An antacid 
  • An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid, Zantac), or nizatidine (Axid)
  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)

Some other medicines may alter the blood levels of Nerlynx, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Nerlynx. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Nerlynx?

If you or someone else has used too much Nerlynx, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Nerlynx?

Nerlynx is usually taken once a day, at about the same time each day. If you miss a dose, skip the missed dose and only take your next usual dose. Do not take double or extra doses.