XALKORI^® (crizotinib) may cause serious side effects, some of which may include:

Liver problems — XALKORI may cause life-threatening liver injury that may lead to death. Your healthcare provider should do blood tests to check your liver every 2 weeks during the first 2 months of treatment with XALKORI, then one time a month. Tell your healthcare provider right away if you get any of the following new or worsening symptoms:

• yellowing of your skin or the white part of your eyes
• severe tiredness
• dark or brown (tea color) urine
• nausea or vomiting

• decreased appetite
• pain on the right side of your stomach
• bleed or bruise more easily than normal
• itching

Lung problems (pneumonitis) — XALKORI may cause life-threatening lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

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

Heart problems — XALKORI may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your pulse rate and blood pressure during treatment with XALKORI. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. Tell your healthcare provider if you take any heart or blood pressure medicines.

Severe vision problems — Vision problems are common with XALKORI. These problems usually happen within 1 week of starting treatment with XALKORI. Vision problems with XALKORI can be severe and may cause partial or complete loss of vision in one or both eyes. Your healthcare provider may hold or stop XALKORI and refer you to an eye specialist if you develop any vision problems during treatment with XALKORI. Tell your healthcare provider right away if you have any new vision problems, loss of vision or any change in vision, including:

• double vision
• seeing flashes of light
• blurry vision

• light hurting your eyes
• new or increased floaters

Before you take XALKORI, tell your healthcare provider about all of your medical conditions including if you:

• have liver or kidney problems
• have lung problems
• have heart problems, including a condition called long QT syndrome
• have vision or eye problems

• are pregnant, or plan to become pregnant. XALKORI can harm your unborn baby
  • Females who are able to become pregnant should use effective birth control during treatment with XALKORI and for 45 days after the last dose of XALKORI.
  • Your healthcare provider will check to see if you are pregnant before starting treatment with XALKORI
  • Males who have female partners who can become pregnant should use condoms during treatment with XALKORI and for 90 days after the last dose of XALKORI.
  • Talk to your healthcare provider about birth control methods that may be right for you.
  • If you or your partner becomes pregnant, tell your healthcare provider right away.
• are breastfeeding or plan to breastfeed. It is not known if XALKORI passes into your breast milk. Do not breastfeed during treatment with XALKORI and for 45 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about the medicines you take, including prescription, and over-the-counter medicines, vitamins, and herbal supplements. XALKORI can affect the way other medicines work, and other medicines can affect how XALKORI works.

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

The most common side effects of XALKORI in adults with NSCLC include:

• vision problems
• nausea, diarrhea, or vomiting
• swelling of your hands, feet, face, or eyes
• constipation
• increased liver function blood test results

• tiredness
• decreased appetite
• upper respiratory infection
• dizziness
• feeling of numbness or tingling in your arms or legs

XALKORI can cause changes in vision, dizziness, and tiredness. Do not drive or operate machinery if you have any of these symptoms.

Avoid spending prolonged time in sunlight. XALKORI can make your skin sensitive to the sun (photosensitivity), and you may burn more easily. You should use sunscreen and wear protective clothing that covers your skin to help protect against sunburn if you have to be in the sunlight during treatment with XALKORI.

XALKORI may cause fertility problems in females and males, which may affect the ability to have children.

These are not all of the possible side effects of XALKORI.

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

Please see Full Prescribing Information and Medication Guide.