Neratinib (ne-RA-ti-nib)

Treats breast cancer.

Brand Name(s):

Nerlynx

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, or chew it. Take it at the same time each day.
• It is best to take this medicine with food or milk.
• Full Dose: You should start taking medicines to help prevent diarrhea (including loperamide) during your first dose of neratinib. Continue taking these medicines for the first 2 cycles (56 days) of treatment with neratinib.
• Lower starting dose: Your doctor may also give you a lower starting dose for the first 2 weeks of treatment and then increase you to a full dose to help prevent diarrhea.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and take your next dose at your usual time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take a proton pump inhibitor (including lansoprazole) together with this medicine. Ask your doctor which stomach medicines are safe for you to take.
• Some medicines can affect how neratinib works. Tell your doctor if you are using digoxin, efavirenz, fluconazole, ketoconazole, rifampin, or verapamil.
• If you are also using an antacid, take it 3 hours before using neratinib.
• Take neratinib at least 2 hours before or 10 hours after an H2 blocker (including ranitidine).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 3 months after the last dose.
• Do not breastfeed while you are using this medicine and for at least 1 month after your last dose.
• Tell your doctor if you have kidney disease, liver disease, low blood pressure, or dehydration.
• This medicine may cause liver problems.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, cloudy urine
• Dark urine, pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Lightheadedness or fainting
• Severe diarrhea

If you notice these less serious side effects, talk with your doctor:

• Muscle spasms
• Sores or white patches on your lips, mouth, or throat
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088