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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 at least every month to check your liver during treatment with XALKORI. 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 mucous
• fever

Heart problems — XALKORI may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your heart 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.

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 stop XALKORI and refer you to an eye healthcare provider if you develop severe vision problems during treatment with XALKORI. Tell your healthcare provider right away if you have any 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 if you:

• have heart problems, including a condition called long QT syndrome
• have liver or kidney problems
• have vision or eye problems
• have any other medical conditions

• 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 at least 45 days after the final dose of XALKORI.
  • Males who have female partners who can become pregnant should use condoms during treatment with XALKORI and for at least 90 days after the final 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 final 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 medicines, over-the-counter medicines, vitamins, and herbal supplements.

You should 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.

The most common side effects of XALKORI include:

• vision problems
• nausea
• diarrhea
• vomiting
• swelling of your hands, feet, face, and eyes
• constipation

• increased liver function blood test results
• tiredness
• decreased appetite
• upper respiratory infection
• dizziness
• feeling of numbness or tingling in the extremities

XALKORI can cause changes in your vision, dizziness, and tiredness. If you have these symptoms avoid driving a car, using machinery or doing anything that needs you to be alert.

XALKORI may cause decreased fertility. In females, this could affect your ability to become pregnant. In males, this could affect your ability to father a child.

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

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 Patient Information.