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XALKORI® (crizotinib) is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1. It is not known if XALKORI is safe and effective in children.
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Important Safety Information
XALKORI 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 once 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
dark or brown (tea color) urine
nausea or vomiting
pain on the right side of your stomach
bleed or bruise more easily than normal
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
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:
seeing flashes of light
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 the 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.
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 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 the 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 the baby during this time
Tell your healthcare provider about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
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 include:
nausea, diarrhea, or vomiting
swelling of your hands, feet, face, and eyes
increased liver function blood test results
upper respiratory infection
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.
XALKORI may cause decreased 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.
XALKORI is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1. It is not known if XALKORI is safe and effective in children.