Neratinib

Generic name: Neratinib
Brand names: Nerlynx
Dosage form: oral tablet (40 mg)

Usage of 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.

Neratinib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Neratinib may cause serious side effects. Call your doctor at once if you have:

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 of neratinib 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.

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.

Neratinib can harm an unborn baby or cause birth defects if the mother or the father is using neratinib.

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.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

How to use Neratinib

Usual Adult Dose for Breast Cancer -- Adjuvant:

240 mg orally once a day continuously for 1 yearNOTE: Antidiarrheal prophylaxis is recommended during the first 2 cycles (56 days) of therapy and should be initiated with the first dose. Titrate loperamide to 1 to 2 bowel movements per day.MANUFACTURER SUGGESTED PROPHYLACTIC LOPERAMIDE DOSING:-Weeks 1 and 2 (days 1 through 14): 4 mg orally 3 times a day-Weeks 3 through 8 (days 15 through 56): 4 mg orally 2 times a day-Weeks 9 through 52 (days 57 through 365): 4 mg as needed (not to exceed 16 mg per day)Use: For the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer (to follow adjuvant trastuzumab-based therapy)

Warnings

Neratinib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may be given anti-diarrhea medications for the first 2 months of treatment with neratinib.

Call your doctor if you are sick with severe diarrhea, or you also have weakness, dizziness, or a fever.

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.

Disclaimer

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