When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it 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.
• 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: If your next dose is more than 6 hours away, take the missed dose as soon as you can. If your next dose is less than 6 hours away, wait until then to use the medicine and skip the missed dose. Do not take extra medicine to make up for the missed dose. If you vomit after you take a dose, do not take an extra dose. Take the next dose at the regular time.
• 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 crizotinib works. Tell your doctor if you are using St John's wort, alfentanil, arsenic trioxide, cisapride, clonidine, cyclosporine, digoxin, dofetilide, fentanyl, pimozide, quinidine, sirolimus, or tacrolimus.
• Also tell your doctor if you are using blood pressure medicine, medicine to treat HIV/AIDS, medicine to treat an infection or tuberculosis, medicine to treat seizures, medicine to treat depression or mental illness, or an ergot medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• 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 and for at least 3 months after the last dose of this medicine.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, congestive heart failure, heart rhythm problems, or a mineral imbalance.
• This medicine may cause the following problems:
  
  • Pneumonitis (may be life-threatening)
  • Liver problems
  • Heart rhythm problems
  • Slow heartbeat
• This medicine may cause dizziness, tiredness, or vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• 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.

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, or yellow skin or eyes
• Fainting, dizziness, or lightheadedness
• Fast, slow, pounding, or uneven heartbeat
• Trouble breathing, chest pain, fever, chills, cough

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

• Change or loss of taste
• Diarrhea, constipation, nausea
• Runny or stuffy nose, sore throat
• Swelling in your hands, ankles, or feet
• Tiredness
• Vision changes

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