ROZLYTREK 200 Mg Entrectinib Capsules User Guide

ROZLYTREK 200 Mg Entrectinib Capsules User Guide

This Instructions for Use contains information on how to prepare and take or give ROZLYTREK capsules.

Before Starting

Read this Instructions for Use before giving ROZLYTREK capsules for the first time and each time you get a refill. There may be new information.
ROZLYTREK capsules can be swallowed whole or prepared as a suspension and taken or given by mouth or through a nasogastric tube (NG tube) or gastrostomy tube (G tube) feeding tube.

Important Information You Need to Know Before Taking or Giving ROZLYTREK Capsules

• Your healthcare provider or pharmacist should show you how to correctly prepare and take or give a dose of ROZLYTREK capsules. Always take or give ROZLYTREK capsules exactly as your healthcare provider tells you.
• Do not take or give ROZLYTREK to someone else until you have been shown how to properly prepare and take or give ROZLYTREK.
• Wash your hands before and after preparing, taking, or giving ROZLYTREK.
• Check the expiration date and check the product for damage before use. Do not use if expired or damaged.

Dosing of ROZLYTREK capsules to be swallowed whole

• Your healthcare provider will decide the right dose of ROZLYTREK for you or your child.
• Your healthcare provider will tell you what your daily dose of ROZLYTREK is.
• Swallow ROZLYTREK capsules whole, with or without food.
• Swallow whole capsules with drinking water, as directed by your healthcare provider.
• Do not crush or chew the capsules.

Dosing of ROZLYTREK capsules prepared as a suspension to be taken by

mouth or through a feeding tube

If you or your child cannot swallow capsules whole, ROZLYTREK capsules can be prepared as a suspension and taken or given by mouth or through a feeding tube. For doses of 3 mL or higher, a NG or G feeding tube size 8 French or larger should be used.
Your healthcare provider or pharmacist will show you how to prepare and take or give a dose of ROZLYTREK capsules prepared as a suspension.
Table 1 shows the prescribed dose, the number and strength of capsules needed, the amount of water or milk needed to mix the capsules, and the amount of suspension needed to give for the prescribed dose.
Your healthcare provider will tell you the number of capsules to use, the amount of liquid needed to mix the capsules, and the amount of suspension (mL) to take or give to get the correct dose of ROZLYTREK.
You may need to measure a smaller amount of suspension than you prepared to take or give the correct prescribed dose of ROZLYTREK.

Supplies needed to prepare and take or give ROZLYTREK as a suspension:

• the number of capsules needed for your prescribed dose
• a clean empty cup
• a paper towel
• a cup of room temperature drinking water or milk
• an oral syringe (provided by your healthcare provider or pharmacist)

Preparing ROZLYTREK capsules as a suspension

Giving ROZLYTREK capsules prepared as a suspension by mouth

Giving ROZLYTREK capsules prepared as a suspension through a gastrostomy

tube (G tube)

Giving ROZLYTREK capsules prepared as a suspension through a nasogastric

tube (NG tube)

Cleaning up and disposing of ROZLYTREK

Step D1

• Wash your hands and all the items used to give ROZLYTREK.
• Remove the syringe plunger from the syringe barrel.
• Use only clean water to rinse the syringe parts and the cup used to prepare the suspension. Let all items dry before the next use.
• Put the syringe plunger back into the syringe barrel when dry.
• Throw away (discard of) the disposable items in your household trash.

Storing ROZLYTREK

• Store ROZLYTREK capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not store ROZLYTREK prepared as a suspension for more than 2 hours at room temperature below 86°F (30°C). Throw away any unused suspension if it is not used within 2 hours of preparation.
• Store ROZLYTREK capsules in the original container and keep the bottle tightly closed to protect from moisture.

Keep ROZLYTREK and all medicines out of the reach of children.

Distributed by: Genentech USA, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990
ROZLYTREK® is a registered trademark of Genentech, Inc.
©2023 Genentech, Inc.
For more information, go to www.ROZLYTREK.com or call 1-877-436-3683.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.

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