When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to ceritinib or if you are pregnant.

How to Use This Medicine:
Capsule

• 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 tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine on an empty stomach. Take it at least 2 hours before or after a meal.
• Swallow the capsule whole. Do not crush, break, chew, or open it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  
  • Less than 12 hours until next regular dose: Skip the missed dose and take your next dose at the regular time.
  • More than 12 hours until next regular dose: Take the missed dose as soon as possible, and then go back to your regular schedule.
  • Do not take extra medicine to make up for a missed dose. Do not take extra medicine if you vomit.
• 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.

• Some foods and medicines can affect how ceritinib works. Tell your doctor if you are using any of the following:
  
  • Carbamazepine, clonidine, digoxin, fentanyl, nefazodone, phenytoin, pimozide, quinidine, rifampin, ritonavir, St John's wort, dihydroergotamine, ergotamine, or warfarin
  • Cyclosporine, sirolimus, tacrolimus
  • Blood pressure medicine or heart medicine
  • Antibiotic, including telithromycin
  • Medicine to treat fungus infection, including ketoconazole
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use effective birth control during treatment and for at least 2 weeks after the last dose.
• Tell your doctor if you are breastfeeding, or if you have liver disease, diabetes, heart failure, or heart rhythm problems (such as long QT syndrome).
• This medicine may cause the following problems:
  
  • Liver problems
  • Pneumonitis or interstitial lung disease, which may be life-threatening
  • Heart rhythm problems, including QT prolongation
  • High blood sugar
  • Pancreatitis
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, or lightheadedness
• Fast, slow, pounding, or uneven heartbeat
• Increased hunger or thirst, increase in how much or how often you urinate, confusion
• Severe diarrhea, nausea, vomiting, or stomach pain
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness
• Trouble breathing, chest pain, fever, chills, cough

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

• Constipation
• Heartburn, trouble swallowing
• 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