neratinib

What is the most important information I should know about neratinib?

What is neratinib?

Neratinib is used alone or with other medicines to treat early-stage HER2-positive breast cancer. Neratinib is also used to treat HER2-positive breast cancer that is advanced or has spread to other parts of the body (metastatic).

Neratinib is used for breast cancer only if your tumor tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

Neratinib is given after you have received certain other cancer medicines.

Neratinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking neratinib?

Tell your doctor if you have ever had:

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

• If you are a woman, do not use neratinib if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using neratinib.

How should I take neratinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may need to take this medicine daily for up to one year. Neratinib is sometimes taken daily in 21-day treatment cycles until the medicine stops working or until you have serious side effects.

Your doctor will determine how long to treat you with this medicine. Follow your doctor's dosing instructions very carefully.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking neratinib. Take the anti-diarrhea medicine exactly as prescribed by your doctor.

To best control diarrhea, you may need to follow a special diet. Get familiar with the list of foods you should eat or avoid to help control diarrhea. You may also need to drink extra fluids to keep from getting dehydrated.

Tell your doctor if you have more than 2 bowel movements in 1 day.

You may need frequent blood tests.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include severe diarrhea or vomiting, stomach pain, increased thirst, decreased urination, dark urine, dizziness, or hot and dry skin.

What should I avoid while taking neratinib?

Grapefruit may interact with neratinib and lead to unwanted side effects. Avoid the use of grapefruit products.

Ask your doctor before using an antacid or stomach acid reducing medicine. Use only the type your doctor recommends.

What are the possible side effects of neratinib?

• severe or ongoing diarrhea;
• pain or burning when you urinate;
• kidney problems --little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• liver problems --right-sided upper stomach pain, vomiting, tiredness, fever, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• kidney problems;
• abnormal liver function tests;
• diarrhea, constipation;
• painful urination;
• nausea, vomiting, stomach pain, bloating;
• upset stomach, loss of appetite;
• dizziness, feeling weak or tired;
• nosebleed;
• rash, dry skin, problems with your fingernails or toenails;
• dry mouth, mouth sores;
• back pain, joint pain, muscle spasms;
• weight loss; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect neratinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

If you also take an antacid: Wait at least 3 hours after taking the antacid before you take neratinib.

If you also take a stomach acid reducer: Take your neratinib dose 2 hours before or 10 hours after you take the other medicine (this includes cimetidine, famotidine, nizatidine, ranitidine, Axid, Pepcid, Tagamet, Zantac, and others).

You should not use certain stomach acid reducers, such as esomeprazole, lansoprazole, omeprazole, pantoprazole Nexium, Prevacid, Prilosec, Protonix, and others.

Other drugs may affect neratinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about neratinib.