|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Issued: January 2021|
|What is the most important information I should know about XALKORI? |
XALKORI may cause serious side effects, including:
|In addition, for people taking XALKORI to treat anaplastic large cell lymphoma (ALCL): 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.|
|What is XALKORI?|
XALKORI is a prescription medicine that is used to treat:
|Before taking XALKORI, tell your healthcare provider about all of your medical conditions, including if you:|
|How should I take XALKORI? |
|What should I avoid while taking XALKORI?|
|What are the possible side effects of XALKORI?|
XALKORI may cause serious side effects, including:The most common side effects of XALKORI in people with NSCLC include:
|The most common side effects of XALKORI in people with ALCL include:|
|XALKORI may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.|
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 FDA at 1-800-FDA-1088.
|How should I store XALKORI? |
|General information about the safe and effective use of XALKORI.|
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XALKORI for a condition for which it was not prescribed. Do not give XALKORI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about XALKORI that is written for health professionals.
|What are the ingredients in XALKORI?|
Active ingredient: crizotinib
Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate, and magnesium stearate.
Pink opaque capsule shell contains: gelatin, titanium dioxide, and red iron oxide.
White opaque capsule shell contains: gelatin and titanium dioxide.
Printing ink contains: shellac, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide.
For more information, go to www.XALKORI.com or call 1-800-438-1985.
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