Instructions for Use

INSTRUCTIONS FOR USE

XALKORI® [zal-KOR-ee]

(crizotinib)

oral pellets

This Instructions for Use contains information on how to give or take XALKORI oral pellets. Read this Instructions for Use each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider or pharmacist about your or your child’s medical condition or treatment.

Important information you need to know before giving or taking XALKORI oral pellets:

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XALKORI oral pellets come in a capsule “shell” that must be opened before giving or taking a dose. Do not swallow the shell containing the oral pellets. Do not chew or crush the oral pellets.

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XALKORI oral pellets come in 3 dosage strengths: 20 mg, 50 mg, and 150 mg. Your healthcare provider may combine different strengths for your prescribed dose. No more than 4 XALKORI oral pellet shells are to be used for a single dose.

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Your healthcare provider will decide the right dose of XALKORI oral pellets for you or your child. Follow your healthcare provider’s instructions for the dose of XALKORI oral pellets to give your child or for you to take.

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Empty XALKORI oral pellets from the shells as described in Steps 1 to 4 below.

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Check the expiration date on the bottle containing XALKORI oral pellets. Do not use XALKORI oral pellets after the expiration date on the bottle has passed.

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Ask your healthcare provider or pharmacist if you are not sure how to prepare and give or take the prescribed dose of XALKORI oral pellets.

Supplies needed to give or take XALKORI oral pellets:

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XALKORI oral pellet(s), as prescribed by your healthcare provider.

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Spoon or medicine cup (optional). See Step 4 “Giving or taking XALKORI oral pellets”.

Preparing XALKORI oral pellets (Steps 1 to 3):

Step 1	Remove the number of XALKORI oral pellet shell(s) needed for the prescribed dose from each bottle(s).
Step 2	• Hold the shell with the writing “Pfizer” at the top (see Figure A). • Tap the shell to make sure the oral pellets fall to the bottom. Gently squeeze the bottom of the shell to loosen the top of the shell from the bottom.
	Figure A
Step 3	Carefully hold and twist the top and bottom parts of the shell in opposite directions and pull apart to open the shell (see Figure B). Figure B

Giving or taking XALKORI oral pellets (Step 4): There are 2 options for giving or taking the oral pellets.

Step 4	Option 1 (Pour directly into the mouth)	• Pour all oral pellets from 1 shell directly into your or your child’s mouth (see Figure C). • Gently tap the shell body with a finger as needed to make sure all pellets come out. • Right after giving or taking XALKORI oral pellets, give or drink enough water to make sure all oral pellets are swallowed. • If more than 1 shell is required for the prescribed dose, repeat Steps 1 to 4 for giving or taking the oral pellets from each shell.
		Figure C
	Option 2 (Pour from a spoon or medicine cup)	• Empty the oral pellets from the shell(s) that make up the prescribed dose into a dry spoon or medicine cup (see Figure D). • Pour the oral pellets from the dry spoon or medicine cup into your or your child’s mouth. • Right after giving or taking XALKORI oral pellets, give or drink enough water to make sure all oral pellets are swallowed. • If the entire prescribed dose cannot be taken at one time, give or take the oral pellets in smaller portions followed by giving or drinking water until the entire prescribed dose is given or taken.
		Figure D
After Step 4 is completed, other drinks or foods can be given or taken, except grapefruit juice, grapefruit, or supplements containing grapefruit extract.

Storing XALKORI oral pellets:

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Store XALKORI oral pellets at room temperature between 68°F to 77°F (20°C to 25°C).

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Keep XALKORI oral pellets and all medicines out of the reach of children.

Disposing of empty XALKORI oral pellet shells:

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Dispose of (throw away) the empty XALKORI oral pellet shell(s) in the household trash.

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Ask your pharmacist how to throw away medicines you no longer use or are expired.

For more information, go to www.Pfizer.com or call 1-800-438-1985.

LAB-1526-1.0

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 09/2023