Xalkori is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Xalkori is used to treat non-small cell lung cancer 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. 

Xalkori is used to treat anaplastic large cell lymphoma (ALCL) in young adults and children 1 year of age and older whose cancer is ALK-positive. It is used when the ALCL has returned or when a treatment has been tried and it did not work or is no longer working.

Xalkori is also used to treat ALK-positive inflammatory myofibroblastic tumors (IMT) in adults and pediatric patients 1 year of age and older. It is used when the IMT cannot be surgically removed, or has returned, or when a treatment has been tried and it did not work or is no longer working.

 Xalkori may also be used for purposes not listed in this medication guide.

It is not known if Xalkori is safe and effective in older adults with ALCL or in children younger than 1 year of age with ALCL or IMT. 

Xalkori can cause serious heart or liver problems. Call your doctor at once if you have: fast or pounding heartbeats, sudden dizziness, shortness of breath, tiredness, itching, upper stomach pain, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Do not use Xalkori if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 3 months after your treatment ends, whether you are a man or a woman.

Before you take Xalkori, tell your doctor if you have liver or kidney disease, a heart rhythm disorder, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.

Take Xalkori exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Before you start treatment, your doctor may perform tests to make sure Xalkori is the best treatment for your type of lung cancer.

Xalkori is usually taken twice per day, with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

You should not stop taking Xalkori without your doctor's advice.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

250 mg orally twice a day

Use: For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test

Comments:
-Select patients for the treatment of metastatic NSCLC based on the presence of ALK or ROS1 positivity in tumor specimens.
-Continue treatment until disease progression or unacceptable toxicity.

Usual Pediatric Dose for Lymphoma:

280 mg/m² orally twice a day

Use: For the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

Usual Adult Dose for Inflammatory Myofibroblastic Tumor:

250 mg orally twice a day

Use: For the treatment of adults with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.

Usual Pediatric Dose for Inflammatory Myofibroblastic Tumor:

280 mg/m² orally twice a day

Use: For the treatment of pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.

You should not use Xalkori if you are allergic to crizotinib.

To make sure Xalkori is safe for you, tell your doctor if you have:

• liver or kidney disease;

• a heart rhythm disorder;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• long QT syndrome (in you or a family member); or

• if you take any heart or blood pressure medicines.

Crizotinib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

You may need to have a negative pregnancy test before starting this treatment.

• If you are a woman, do not use Xalkori if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 45 days after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 90 days after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Xalkori.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because crizotinib can harm an unborn baby.

You should not breastfeed while you are taking Xalkori and for at least 45 days after your last dose.

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with crizotinib and lead to unwanted side effects. Avoid the use of grapefruit products.

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Crizotinib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Xalkori: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• increased sensitivity of your eyes to light, seeing flashes of light or "floaters";

• blurred vision, double vision, or vision loss;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• very slow heartbeats;

• a light-headed feeling, like you might pass out;

• sudden chest pain or discomfort, wheezing, dry cough or cough with mucus, feeling short of breath;

• fever, swollen gums, painful mouth sores, pain when swallowing, cold or flu symptoms;

• easy bruising or bleeding (nosebleeds, bleeding gums); or

• liver problems - nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Xalkori side effects may include:

• nausea, vomiting, decreased appetite;

• diarrhea, constipation;

• abnormal liver function tests;

• swelling in your hands, feet, or eyes;

• numbness or tingling in your hands or feet;

• muscle weakness, trouble walking;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• dizziness, tiredness; or

• vision problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Crizotinib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can interact with crizotinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.