Neratinib Tablets

What is this medication?

NERATINIB (ner A ti nib) treats breast cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Take products for stomach acid at a different time of day than this medication. Take this medication at least 3 hours after antacids. Take this medication 2 hours before or 10 hours after H2 blockers, such as cimetidine or famotidine.

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 care team about the use of this medication 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, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• Aprepitant
• Bosentan
• Calcium channel blockers, such as diltiazem or verapamil
• Certain antibiotics, such as clarithromycin, erythromycin, troleandomycin, ciprofloxacin
• Certain antivirals for HIV or AIDS
• Certain medications for fungal infections, such as clotrimazole, fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabigatran
• Digoxin
• Dronedarone
• Enzalutamide
• Fexofenadine
• Fluvoxamine
• Grapefruit juice
• Idelalisib
• Imatinib
• Mitotane
• Modafinil
• Nefazodone
• Rifampin
• St. John's wort
• Stomach acid blockers, such as cimetidine, famotidine, lansoprazole, ranitidine, 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?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work while taking this medication.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 1 month after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 1 month after the last dose. Talk to your care team about reliable forms of contraception. Do not father a child while taking this medication or for 3 months after the last dose. Use a condom while having sex during this time period.

Do not breast-feed while taking this medication and for 1 month after the last dose.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Severe or prolonged diarrhea

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

• Change in nail shape, thickness, or color
• Fatigue
• Loss of appetite with weight loss
• Muscle spasms
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Stomach pain

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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.