XALKORI® What is the most important information I should know about XALKORI?

(crizotinib)

What is the most important information I should know about XALKORI?

XALKORI may cause serious side effects, including:
•
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 1 time a month and as recommended by your healthcare provider during treatment. Tell your healthcare provider right away if you develop any of the following new or worsening symptoms:
o
yellowing of your skin or the white part of your eyes
o
severe tiredness
o
dark or brown (tea color) urine
o
nausea or vomiting
o
decreased appetite
o
pain on the right side of your stomach
o
bleed or bruise more easily than normal
o
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:
o
trouble breathing or shortness of breath
o
cough with or without mucous
o
fever
•
Heart problems. XALKORI may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your pulse rate and blood pressure regularly 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 permanently stop your treatment with XALKORI and refer you to an eye specialist if any vision problems develop 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:
o
double vision
o
seeing flashes of light
o
blurry vision
o
light hurting your eyes
o
new or increased floaters

In addition, for children or young adults taking XALKORI to treat anaplastic large cell lymphoma (ALCL) or children taking XALKORI to treat inflammatory myofibroblastic tumor (IMT):
Your healthcare provider may refer you to an eye specialist before starting XALKORI, and within 1 month of starting XALKORI to check for vision problems. You should have an eye examination every 3 months during treatment with XALKORI and more often if there are any new vision problems.

•
Severe stomach, intestine, and mouth (gastrointestinal) problems in children or young adults with ALCL or children with IMT. XALKORI may cause severe diarrhea, nausea, vomiting, or mouth sores. Tell your healthcare provider right away if problems with swallowing, vomiting, or diarrhea develop during treatment with XALKORI.
o
Your healthcare provider may give medicines as needed to prevent or treat diarrhea, nausea, and vomiting.
o
Your healthcare provider may recommend drinking more fluids or may prescribe electrolyte supplements or other kinds of nutritional support if severe symptoms develop.

See "What are possible side effects of XALKORI?" for more information about side effects.

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What is the most important information I should know about XALKORI?

What is the most important information I should know about XALKORI?

XALKORI may cause serious side effects, including:
•
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 1 time a month and as recommended by your healthcare provider during treatment. Tell your healthcare provider right away if you develop any of the following new or worsening symptoms:
o
yellowing of your skin or the white part of your eyes
o
severe tiredness
o
dark or brown (tea color) urine
o
nausea or vomiting
o
decreased appetite
o
pain on the right side of your stomach
o
bleed or bruise more easily than normal
o
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:
o
trouble breathing or shortness of breath
o
cough with or without mucous
o
fever
•
Heart problems. XALKORI may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your pulse rate and blood pressure regularly 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 permanently stop your treatment with XALKORI and refer you to an eye specialist if any vision problems develop 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:
o
double vision
o
seeing flashes of light
o
blurry vision
o
light hurting your eyes
o
new or increased floaters

In addition, for children or young adults taking XALKORI to treat anaplastic large cell lymphoma (ALCL) or children taking XALKORI to treat inflammatory myofibroblastic tumor (IMT):
Your healthcare provider may refer you to an eye specialist before starting XALKORI, and within 1 month of starting XALKORI to check for vision problems. You should have an eye examination every 3 months during treatment with XALKORI and more often if there are any new vision problems.

•
Severe stomach, intestine, and mouth (gastrointestinal) problems in children or young adults with ALCL or children with IMT. XALKORI may cause severe diarrhea, nausea, vomiting, or mouth sores. Tell your healthcare provider right away if problems with swallowing, vomiting, or diarrhea develop during treatment with XALKORI.
o
Your healthcare provider may give medicines as needed to prevent or treat diarrhea, nausea, and vomiting.
o
Your healthcare provider may recommend drinking more fluids or may prescribe electrolyte supplements or other kinds of nutritional support if severe symptoms develop.

See "What are possible side effects of XALKORI?" for more information about side effects.
Prescribing Information
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Health Professional Information

What is the most important information I should know about XALKORI?

What is the most important information I should know about XALKORI?

XALKORI may cause serious side effects, including:
•
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 1 time a month and as recommended by your healthcare provider during treatment. Tell your healthcare provider right away if you develop any of the following new or worsening symptoms:
o
yellowing of your skin or the white part of your eyes
o
severe tiredness
o
dark or brown (tea color) urine
o
nausea or vomiting
o
decreased appetite
o
pain on the right side of your stomach
o
bleed or bruise more easily than normal
o
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:
o
trouble breathing or shortness of breath
o
cough with or without mucous
o
fever
•
Heart problems. XALKORI may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your pulse rate and blood pressure regularly 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 permanently stop your treatment with XALKORI and refer you to an eye specialist if any vision problems develop 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:
o
double vision
o
seeing flashes of light
o
blurry vision
o
light hurting your eyes
o
new or increased floaters

In addition, for children or young adults taking XALKORI to treat anaplastic large cell lymphoma (ALCL) or children taking XALKORI to treat inflammatory myofibroblastic tumor (IMT):
Your healthcare provider may refer you to an eye specialist before starting XALKORI, and within 1 month of starting XALKORI to check for vision problems. You should have an eye examination every 3 months during treatment with XALKORI and more often if there are any new vision problems.

•
Severe stomach, intestine, and mouth (gastrointestinal) problems in children or young adults with ALCL or children with IMT. XALKORI may cause severe diarrhea, nausea, vomiting, or mouth sores. Tell your healthcare provider right away if problems with swallowing, vomiting, or diarrhea develop during treatment with XALKORI.
o
Your healthcare provider may give medicines as needed to prevent or treat diarrhea, nausea, and vomiting.
o
Your healthcare provider may recommend drinking more fluids or may prescribe electrolyte supplements or other kinds of nutritional support if severe symptoms develop.

See "What are possible side effects of XALKORI?" for more information about side effects.

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