Neratinib (By mouth)

Nerlynx

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) or H2 blocker (including cimetidine) together with this medicine. Ask your doctor which stomach medicines are safe for you to take.
• Some foods and medicines can affect how neratinib works. Tell your doctor if you are using any of the following:
  • Aprepitant, boceprevir, bosentan, carbamazepine, ciprofloxacin, clarithromycin, clotrimazole, cobicistat, conivaptan, crizotinib, cyclosporine, dabigatran, danoprevir/ritonavir, digoxin, diltiazem, dronedarone, efavirenz, elvitegravir/ritonavir, enzalutamide, erythromycin, etravirine, fexofenadine, fluconazole, fluvoxamine, idelalisib, imatinib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, mitotane, modafinil, nefazodone, nelfinavir, paritaprevir/ritonavir and (ombitasvir and/or dasabuvir), phenytoin, posaconazole, rifampin, ritonavir, saquinavir/ritonavir, St John's wort, tipranavir/ritonavir, tofisopam, troleandomycin, verapamil, voriconazole
• If you are also using an antacid, take it 3 hours before using neratinib.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Tablet

• 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.
• 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.
• 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.
• 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.

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

Neratinib (ne-RA-ti-nib)

Treats breast cancer.

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

• 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. 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 taking this medicine and for at least 1 month after your last dose.
• Tell your doctor if you have liver disease, kidney disease, low blood pressure, or dehydration.
• This medicine may cause liver problems.
• 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.