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Xalkori is the brand name for crizotinib and is available as oral capsules and pellets.

Xalkori is available as 200 mg and 250 mg oral capsules and 20 mg, 50 mg, and 150 mg oral pellets.

Xalkori is a tyrosine kinase inhibitor that is used to treat:

• Metastatic non-small-cell lung cancer (NSCLC) with an ALK or ROS1 mutation
• Advanced anaplastic large cell lymphoma (ALCL) with an ALK mutation
• Advanced inflammatory myofibroblastic tumor (IMT) with an ALK mutation

Xalkori works by targeting cells that have genetic changes (mutations) in specific receptors, such as anaplastic lymphoma kinase (ALK) and ROS1. These genetic changes cause cells to become cancer cells. When Xalkori blocks the activity of these receptors, cancer cells can’t grow and spread as well.

Xalkori is dosed as follows:

NSCLC

• Adults: The usual dose is 250 mg by mouth twice a day

ALCL

• Children and young adults: Your provider will determine your dose based on body surface area (BSA), which is a measurement of body size that takes into account weight and height. The usual dose ranges from 200 mg to 500 mg twice a day, depending on body size

IMT

• Adults: The usual dose is 250 mg by mouth twice a day
• Children: Your child’s provider will determine your child’s dose based on their body size, taking into account their weight and height. The usual dose ranges from 200 mg to 500 mg twice a day, depending on body size

Xalkori is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Xalkori:

• Vomiting
• Diarrhea
• Nausea
• Higher liver labs, suggesting liver irritation
• Vision changes
• Runny nose, sore throat, and other symptoms of an upper respiratory infection
• Headache
• Muscle pain
• Fever
• Swelling in the legs and feet
• Lower blood cell counts
• Mouth sores

Serious side effects are rare with Xalkori. Contact your healthcare provider immediately if you experience any of the following.

• Serious lung problems: sudden cough, fever, and difficulty breathing
• Heart rhythm problems: lightheadedness, blurry vision, fainting, seizures, loss of consciousness
• Serious liver problems: nausea, vomiting, tiredness, stomach pain or swelling, pale-colored stool, dark-colored urine, yellowing of the whites of the eyes or skin

The following medications may interact with Xalkori:

• Strong CYP3A Inhibitors: Avoid concomitant use
• Strong CYP3A Inducers: Avoid concomitant use
• CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious adverse reactions

Pfizer

Xalkori can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before starting treatment with Xalkori.
  Effective birth control (contraception) should be used during treatment with Xalkori and for 45 days after the last dose of Xalkori
• Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Xalkori

Males who have female partners who can become pregnant:

• You should use condoms during treatment with Xalkori and for 90 days after the last dose of Xalkori

• Crizotinib