BOSULIF® Instructions For Use

(bosutinib)

INSTRUCTIONS FOR USE

BOSULIF (BAH-su-lif)

(bosutinib)

capsules

This Instructions for Use contains information on how to prepare and give a dose of BOSULIF capsules by opening the capsules and mixing the contents with applesauce or yogurt for people who cannot swallow capsules whole. Read this Instructions for Use before you prepare or give the first dose of BOSULIF, and each time you get a refill. Ask your healthcare provider or pharmacist if you have any questions.

Important information you need to know before preparing a dose of BOSULIF capsules:

BOSULIF capsules can be opened and the capsules contents mixed with room temperature applesauce or yogurt.
Only use applesauce or yogurt. Do not mix BOSULIF with other foods.
Swallow all of the mixture right away, without chewing. Do not store the mixture for later use.
If you do not swallow the entire BOSULIF mixture, do not mix another dose. Wait until the next day to take your regularly scheduled dose.
Take the BOSULIF mixture with a full meal.

Preparing a dose of BOSULIF capsules:


Gather the following supplies:

BOSULIF capsules
small, clean container
yogurt or applesauce
teaspoon for mixing
disposable gloves

Giving a dose of BOSULIF capsules:

Step 1: Choose a clean, flat work surface. Place all supplies on the work surface.

Step 2: Wash and dry your hands well.

Step 3: Put on disposable gloves

Step 4: Get the prescribed number of BOSULIF capsule(s) needed to prepare the dose.

Step 5: Add the amount of applesauce or yogurt needed for the prescribed dose to the container.

Dose

Amount of Applesauce or Yogurt

100 mg

10 mL (2 teaspoons)

150 mg

15 mL (3 teaspoons)

200 mg

20 mL (4 teaspoons)

250 mg

25 mL (5 teaspoons)

300 mg

30 mL (6 teaspoons)

350 mg

30 mL (6 teaspoons)

400 mg

35 mL (7 teaspoons)

450 mg

40 mL (8 teaspoons)

500 mg

45 mL (9 teaspoons)

550 mg

45 mL (9 teaspoons)

600 mg

50 mL (10 teaspoons)

Step 6: Carefully open each of the BOSULIF capsule(s) needed for the dose and empty the entire contents into the applesauce or yogurt. Mix the entire capsule contents with the applesauce or yogurt in the container.

Step 7: Swallow all of the mixture right away, without chewing.

Step 8: Dispose of (throw away) the empty BOSULIF capsule shell(s) in the household trash.

Step 9: Wash teaspoon and the container with soap and warm water.

Step 10: Remove disposable gloves and throw them away in the household trash.

Step 11: Wash and dry your hands.

How should I store BOSULIF capsules?

Store BOSULIF at room temperature between 68°F to 77°F (20°C to 25°C).
Store the BOSULIF capsules in the original bottle.
Ask your doctor or pharmacist about the right way to throw away outdated or unused BOSULIF.

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

logo

LAB-0639-13.0

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

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

Issued: 9 2023

Find BOSULIF® medical information:

Find BOSULIF® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

BOSULIF® Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Instructions For Use

INSTRUCTIONS FOR USE

BOSULIF (BAH-su-lif)

(bosutinib)

capsules

This Instructions for Use contains information on how to prepare and give a dose of BOSULIF capsules by opening the capsules and mixing the contents with applesauce or yogurt for people who cannot swallow capsules whole. Read this Instructions for Use before you prepare or give the first dose of BOSULIF, and each time you get a refill. Ask your healthcare provider or pharmacist if you have any questions.

Important information you need to know before preparing a dose of BOSULIF capsules:

BOSULIF capsules can be opened and the capsules contents mixed with room temperature applesauce or yogurt.
Only use applesauce or yogurt. Do not mix BOSULIF with other foods.
Swallow all of the mixture right away, without chewing. Do not store the mixture for later use.
If you do not swallow the entire BOSULIF mixture, do not mix another dose. Wait until the next day to take your regularly scheduled dose.
Take the BOSULIF mixture with a full meal.

Preparing a dose of BOSULIF capsules:


Gather the following supplies:

BOSULIF capsules
small, clean container
yogurt or applesauce
teaspoon for mixing
disposable gloves

Giving a dose of BOSULIF capsules:

Step 1: Choose a clean, flat work surface. Place all supplies on the work surface.

Step 2: Wash and dry your hands well.

Step 3: Put on disposable gloves

Step 4: Get the prescribed number of BOSULIF capsule(s) needed to prepare the dose.

Step 5: Add the amount of applesauce or yogurt needed for the prescribed dose to the container.

Dose

Amount of Applesauce or Yogurt

100 mg

10 mL (2 teaspoons)

150 mg

15 mL (3 teaspoons)

200 mg

20 mL (4 teaspoons)

250 mg

25 mL (5 teaspoons)

300 mg

30 mL (6 teaspoons)

350 mg

30 mL (6 teaspoons)

400 mg

35 mL (7 teaspoons)

450 mg

40 mL (8 teaspoons)

500 mg

45 mL (9 teaspoons)

550 mg

45 mL (9 teaspoons)

600 mg

50 mL (10 teaspoons)

Step 6: Carefully open each of the BOSULIF capsule(s) needed for the dose and empty the entire contents into the applesauce or yogurt. Mix the entire capsule contents with the applesauce or yogurt in the container.

Step 7: Swallow all of the mixture right away, without chewing.

Step 8: Dispose of (throw away) the empty BOSULIF capsule shell(s) in the household trash.

Step 9: Wash teaspoon and the container with soap and warm water.

Step 10: Remove disposable gloves and throw them away in the household trash.

Step 11: Wash and dry your hands.

How should I store BOSULIF capsules?

Store BOSULIF at room temperature between 68°F to 77°F (20°C to 25°C).
Store the BOSULIF capsules in the original bottle.
Ask your doctor or pharmacist about the right way to throw away outdated or unused BOSULIF.

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

logo

LAB-0639-13.0

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

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

Issued: 9 2023

Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.