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XALKORI is a prescription medicine used to treat adults 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 with NSCLC.
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:
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:
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:
Before you take XALKORI, tell your healthcare provider about all of your medical conditions including if you:
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:
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.
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.
