IMPORTANT SAFETY INFORMATION

XALKORI may cause serious side effects, some of which may include:

Liver problems —XALKORI may cause life-threatening and/or fatal liver injury. Your doctor should do blood tests every month to check your liver while you are taking XALKORI. Tell your doctor right away if you get any of the following:

• your skin or the whites of your eyes turn yellow
• you feel tired
• your urine turns dark or brown (tea color)
• you have nausea or vomiting
• you have a decreased appetite
• you have pain on the right side of your stomach
• you bleed or bruise more easily than normal
• you have itching

Swelling of the lungs (pneumonitis) — XALKORI may cause life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you get any new or worsening symptoms, including:

• trouble breathing or shortness of breath
• cough with or without mucous
• fever

Changes in heartbeat (called QT interval prolongation), very fast or abnormal heartbeats — Your doctor may check your heart during treatment with XALKORI. Tell your doctor right away if you have abnormal heartbeats, or feel dizzy or faint. These may be symptoms related to QT interval prolongation.

Before you take XALKORI, tell your doctor if you:

• have heart problems, including a condition called long QT syndrome
• have liver or kidney problems
• have any other medical conditions
• are pregnant, or plan to become pregnant. XALKORI may harm your unborn baby.
  • > Women who are able to become pregnant and men who take XALKORI should use birth control during treatment and for 3 months after stopping XALKORI.
  • > Talk to your doctor about the birth control methods that may be right for you.
  • > If you or your partner becomes pregnant, tell your doctor right away.
• are breastfeeding or plan to breastfeed. It is not known if XALKORI® (crizotinib) passes into your breast milk. You and your doctor should decide if you will take XALKORI or breastfeed. You should not do both.

Especially tell your doctor if you take:

• St. John’s Wort (Hypericum perforatum)
• Medicines for:
  • > depression (antidepressants)
  • > fungal infections (antifungals)
  • > bacterial infections (antibiotics)
  • > tuberculosis (TB)
  • > HIV-AIDS
  • > heart conditions
  • > seizures

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

The most common side effects of XALKORI include:

• Vision problems
• These problems usually happen within 2 weeks of starting XALKORI. Tell your doctor right away if you have any change in vision, such as:
  • > flashes of light
  • > blurred vision
  • > light hurting your eyes
  • > new or increased floaters
• nausea
• diarrhea
• vomiting
• swelling of your hands or feet
• constipation

Use caution when driving or operating machinery if you have any change in vision, or feel tired or dizzy.

These are not all of the possible side effects of XALKORI. For more information, ask your doctor or pharmacist.

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

Do not drink grapefruit juice or eat grapefruit during treatment with XALKORI. It may increase the amount of XALKORI in your blood to a harmful level.

Please see full Prescribing and Patient Information