Neratinib tablets

What is this medication?

NERATINIB (ner A ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat breast cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Nerlynx

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• dehydration
• liver disease
• an unusual or allergic reaction to neratinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Do not take with grapefruit juice. Avoid taking this medicine within 3 hours of taking an antacid. Take this medicine with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, then do not replace the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS
• aprepitant
• bosentan
• calcium channel blockers like diltiazem and verapamil
• certain antibiotics like clarithromycin, erythromycin and troleandomycin
• certain medicines for fungal infections like clotrimazole, fluconazole, ketoconazole, itraconazole, posaconazole, and voriconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• ciprofloxacin
• conivaptan
• crizotinib
• cyclosporine
• dabigatran
• digoxin
• dronedarone
• enzalutamide
• fexofenadine
• fluvoxamine
• grapefruit juice
• idelalisib
• imatinib
• mitotane
• modafinil
• nefazodone
• rifampin
• St. John's Wort
• stomach acid blockers like cimetidine, famotidine, lansoprazole, ranitidine, or omeprazole
• tofisopam

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not become pregnant while taking this medicine or for 1 month after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 1 month after stopping it.

Check with your doctor or health care professional if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

You may need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• diarrhea
• nausea, vomiting
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• dry mouth
• loss of appetite
• mouth sores
• muscle cramps
• red spots on the skin
• sore throat
• stomach pain
• upset stomach
• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.