|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: September 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.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients to immediately report symptoms of hepatotoxicity [see Warnings and Precautions (5.1)].
Interstitial Lung Disease (Pneumonitis)
Advise patients to immediately report any new or worsening pulmonary symptoms [see Warnings and Precautions (5.2)].
Advise patients to report any symptoms of bradycardia and to inform their healthcare provider about the use of any heart or blood pressure medications [see Warnings and Precautions (5.4)].
Severe Visual Loss
Inform patients of the potential risk of severe visual loss and to immediately contact their healthcare provider if they develop severe visual loss. Inform patients that visual changes such as perceived flashes of light, blurry vision, light sensitivity, and floaters are commonly reported adverse reactions and may occur while driving or operating machinery. The onset of visual disorders most commonly occurs during the first week of treatment [see Warnings and Precautions (5.5), Adverse Reactions (6)].
Gastrointestinal Toxicity in Patients with ALCL
Inform patients with ALCL of the risk of severe nausea, vomiting, diarrhea, and stomatitis. Advise patients to immediately inform their healthcare provider of problems with swallowing, vomiting, or diarrhea [see Warnings and Precautions (5.6)].
Inform patients to avoid grapefruit or grapefruit juice while taking XALKORI. Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7)].
Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure and to use sunscreen or protective clothing during treatment with XALKORI [see Adverse Reactions (6.1)].
Dosage and Administration
Advise patients to take XALKORI with or without food and to swallow XALKORI capsules whole. If a patient misses a dose, advise the patient to take it as soon as remembered unless it is less than 6 hours until the next dose, in which case, advise the patient not to take the missed dose. If a patient vomits after taking a dose of XALKORI, advise the patient not to take an extra dose, but to take the next dose at the regular time.
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.7), Use in Specific Populations (8.1)].
Females and Males of Reproductive Potential
Advise females of reproductive potential to use effective contraception during treatment with XALKORI and for at least 45 days after the final dose [see Use in Specific Populations (8.3)].
Advise males with female partners of reproductive potential to use condoms during treatment with XALKORI and for at least 90 days after the final dose [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Advise females not to breastfeed during treatment with XALKORI and for 45 days after the final dose [see Use in Specific Populations (8.2)].