BOSULIF® Full Patient Information

(bosutinib)

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

•
Dosage and Administration

Instruct patients to take BOSULIF exactly as prescribed, not to change their dose or to stop taking BOSULIF unless they are told to do so by their doctor. If patients miss a dose beyond 12 hours, they should be advised to take the next scheduled dose at its regular time. A double dose should not be taken to make up for any missed dose. Advise patients to take BOSULIF with food. Patients should be advised: “Swallow tablets whole. Do not crush, break, or cut tablet. Do not touch or handle crushed or broken tablets.” Patients should be advised: “Capsules may be swallowed whole. For those that cannot swallow the capsule whole, the capsule can be opened and the contents mixed with applesauce or yogurt.”

•
Gastrointestinal Toxicity

Advise patients that they may experience diarrhea, nausea, vomiting, abdominal pain, or blood in their stools with BOSULIF and to seek medical attention promptly for these symptoms [see Warnings and Precautions (5.1)].

•
Myelosuppression

Advise patients of the possibility of developing low blood cell counts and to immediately report fever, any suggestion of infection, or signs or symptoms suggestive of bleeding or easy bruising [see Warnings and Precautions (5.2)].

•
Hepatic Toxicity

Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice [see Warnings and Precautions (5.3)].

•
Cardiovascular Toxicity

Advise patients that cardiac failure, left ventricular dysfunction, and cardiac ischemic events have been reported. Advise patients to seek immediate medical attention if any symptoms suggestive of cardiac failure and cardiac ischemia occur, such as shortness of breath, weight gain, or fluid retention [see Warnings and Precautions (5.4)].

•
Fluid Retention

Advise patients of the possibility of developing fluid retention (swelling, weight gain, or shortness of breath) and to seek medical attention promptly if these symptoms arise [see Warnings and Precautions (5.5)].

•
Renal Toxicity

Advise patients of the possibility of developing renal problems and to immediately report frequent urination, polyuria or oliguria [see Warnings and Precautions (5.6)].

•
Adverse Reactions

Advise patients that they may experience other adverse reactions such as respiratory tract infections, rash, fatigue, loss of appetite, headache, dizziness, back pain, arthralgia, pruritus or constipation with BOSULIF and to seek medical attention if symptoms are significant. There is a possibility of anaphylactic shock [see Contraindications (4) and Adverse Reactions (6)].

•
Embryo-Fetal Toxicity

Advise females to inform their healthcare provider if they are pregnant or become pregnant. Advise female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)].

Advise females of reproductive potential, to use effective contraception during treatment and for 2 weeks after receiving the last dose of BOSULIF [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1, 8.3)].

Advise lactating women not to breastfeed during treatment with BOSULIF and for 2 weeks after the last dose [see Use in Specific Populations (8.2)].

•
Drug Interactions

Advise patients that BOSULIF and certain other medicines, including over the counter medications or herbal supplements (such as St. John's wort) can interact with each other and may alter the effects of BOSULIF [see Drug Interactions (7)].

PATIENT INFORMATION

BOSULIF (BAH-su-lif)

(bosutinib)

tablets

BOSULIF (BAH-su-lif)

(bosutinib)

capsules

What is BOSULIF?
BOSULIF is a prescription medicine used to treat:

•
adults and children 1 year of age and older who have a certain type of leukemia called chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who are newly-diagnosed or who no longer benefit from or did not tolerate other treatment.
•
adults with accelerated phase (AP), or blast phase (BP) Ph+ CML who can no longer benefit from or did not tolerate other treatment.

It is not known if BOSULIF is safe and effective in children less than 1 year of age with CP Ph+ CML who are newly‑diagnosed or who no longer benefit from or did not tolerate other treatment or in children with AP Ph+ CML or BP Ph+ CML.

Do not take BOSULIF if you are allergic to bosutinib or any of the ingredients in BOSULIF. See the end of this leaflet for a complete list of ingredients of BOSULIF.

Before taking BOSULIF, tell your doctor about all of your medical conditions, including if you:

•
have liver problems
•
have heart problems
•
have kidney problems
•
have high blood pressure
•
have diabetes
•
are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with BOSULIF. Tell your doctor right away if you become pregnant during treatment with BOSULIF.
o
Females who are able to become pregnant should use effective birth control (contraception) during treatment with BOSULIF and for 2 weeks after the last dose. Talk to your doctor about birth control methods that may be right for you.
•
are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. Do not breastfeed during treatment with BOSULIF and for 2 weeks after the last dose.

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. When taken together, BOSULIF and certain other medicines can affect each other.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take BOSULIF?

•
Take BOSULIF exactly as prescribed by your doctor.
•
Do not change your dose or stop taking BOSULIF without first talking with your doctor.
•
If your child takes BOSULIF, your healthcare provider will change the dose as your child grows.
•
Take BOSULIF with food.
•
Swallow BOSULIF tablets whole. Do not crush, break, chew or cut BOSULIF tablets. Do not touch or handle crushed or broken BOSULIF tablets.
•
Swallow BOSULIF capsules whole. If you cannot swallow BOSULIF capsules whole, tell your healthcare provider.
•
If you cannot swallow BOSULIF capsules whole, see the “Instructions for Use” for detailed instructions on how to prepare and give a dose of BOSULIF capsules by opening the capsules and mixing the capsule contents with applesauce or yogurt.
•
If you take an antacid or H2 blocker medicine, take it at least 2 hours before or 2 hours after BOSULIF. If you take a Proton Pump Inhibitor (PPI) medicine, talk to your doctor or pharmacist.
•
You should avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract during treatment with BOSULIF. Grapefruit products increase the amount of BOSULIF in your body.
•
If you miss a dose of BOSULIF, take it as soon as you remember. If you miss a dose by more than 12 hours, skip that dose and take your next dose at your regular time. Do not take 2 doses at the same time.
•
If you take too much BOSULIF, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of BOSULIF?
BOSULIF may cause serious side effects, including:

•
Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, vomiting, or blood in your stools. Get medical help right away for any stomach problems.
•
Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection.
•
Liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark "tea color" urine.
•
Heart problems. BOSULIF may cause heart problems, including heart failure and decreased blood flow to the heart which can lead to heart attack. Get medical help right away if you get shortness of breath, weight gain, chest pain, or swelling in your hands, ankles or feet.
•
Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Get medical help right away if you get any of the following symptoms during your treatment with BOSULIF:
o
shortness of breath and cough
o
chest pain
o
swelling in your hands, ankles, or feet
o
swelling all over your body
o
weight gain
•
Kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
o
you urinate more often than normal
o
you urinate less often than normal
o
you make a much larger amount of urine than normal
o
you make a much smaller amount of urine than normal

The most common side effects of BOSULIF in adults and children with CML include:

•
diarrhea
•
stomach (abdominal) pain
•
vomiting
•
nausea
•
rash
•
tiredness
•
liver problems
•
headache
•
fever
•
decreased appetite
•
respiratory tract infections (infections in nose, throat or lungs)
•
constipation
•
changes in certain blood tests. Your doctor may do blood tests during treatment with BOSULIF to check for changes

Tell your doctor or get medical help right away if you get respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, rash or itching while taking BOSULIF. These may be symptoms of a severe allergic reaction.
Your doctor may change your dose, temporarily stop, or permanently stop treatment with BOSULIF if you have certain side effects.
BOSULIF may cause fertility problems in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of BOSULIF.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BOSULIF?

•
Store BOSULIF tablets and capsules at room temperature between 68°F to 77°F (20°C to 25°C).
•
The BOSLUIF tablets and capsules bottle has a child-resistant closure.
•
The BOSULIF tablets bottle contains a desiccant to help keep your medicine dry (protect it from moisture). Keep the desiccant in the bottle. Do not eat the desiccant.
•
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.

General information about the safe and effective use of BOSULIF.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BOSULIF for a condition for which it is not prescribed. Do not give BOSULIF to other people even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about BOSULIF that is written for health professionals.

What are the ingredients in BOSULIF?
Active ingredient: bosutinib.
Inactive ingredients:Tablets: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. Capsules: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.

logo



LAB-0639-12.0
For more information, go to www.Bosulif.com or www.pfizermedicalinformation.com or call 1-800-438-1985.

This Patient Information has been approved by the U.S. Food and Drug Administration.        Revised 9 2023

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-0639-12.0

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

Medication Guide

Health Professional Information

Full Patient Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

•
Dosage and Administration

Instruct patients to take BOSULIF exactly as prescribed, not to change their dose or to stop taking BOSULIF unless they are told to do so by their doctor. If patients miss a dose beyond 12 hours, they should be advised to take the next scheduled dose at its regular time. A double dose should not be taken to make up for any missed dose. Advise patients to take BOSULIF with food. Patients should be advised: “Swallow tablets whole. Do not crush, break, or cut tablet. Do not touch or handle crushed or broken tablets.” Patients should be advised: “Capsules may be swallowed whole. For those that cannot swallow the capsule whole, the capsule can be opened and the contents mixed with applesauce or yogurt.”

•
Gastrointestinal Toxicity

Advise patients that they may experience diarrhea, nausea, vomiting, abdominal pain, or blood in their stools with BOSULIF and to seek medical attention promptly for these symptoms [see Warnings and Precautions (5.1)].

•
Myelosuppression

Advise patients of the possibility of developing low blood cell counts and to immediately report fever, any suggestion of infection, or signs or symptoms suggestive of bleeding or easy bruising [see Warnings and Precautions (5.2)].

•
Hepatic Toxicity

Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice [see Warnings and Precautions (5.3)].

•
Cardiovascular Toxicity

Advise patients that cardiac failure, left ventricular dysfunction, and cardiac ischemic events have been reported. Advise patients to seek immediate medical attention if any symptoms suggestive of cardiac failure and cardiac ischemia occur, such as shortness of breath, weight gain, or fluid retention [see Warnings and Precautions (5.4)].

•
Fluid Retention

Advise patients of the possibility of developing fluid retention (swelling, weight gain, or shortness of breath) and to seek medical attention promptly if these symptoms arise [see Warnings and Precautions (5.5)].

•
Renal Toxicity

Advise patients of the possibility of developing renal problems and to immediately report frequent urination, polyuria or oliguria [see Warnings and Precautions (5.6)].

•
Adverse Reactions

Advise patients that they may experience other adverse reactions such as respiratory tract infections, rash, fatigue, loss of appetite, headache, dizziness, back pain, arthralgia, pruritus or constipation with BOSULIF and to seek medical attention if symptoms are significant. There is a possibility of anaphylactic shock [see Contraindications (4) and Adverse Reactions (6)].

•
Embryo-Fetal Toxicity

Advise females to inform their healthcare provider if they are pregnant or become pregnant. Advise female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)].

Advise females of reproductive potential, to use effective contraception during treatment and for 2 weeks after receiving the last dose of BOSULIF [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1, 8.3)].

Advise lactating women not to breastfeed during treatment with BOSULIF and for 2 weeks after the last dose [see Use in Specific Populations (8.2)].

•
Drug Interactions

Advise patients that BOSULIF and certain other medicines, including over the counter medications or herbal supplements (such as St. John's wort) can interact with each other and may alter the effects of BOSULIF [see Drug Interactions (7)].

PATIENT INFORMATION

BOSULIF (BAH-su-lif)

(bosutinib)

tablets

BOSULIF (BAH-su-lif)

(bosutinib)

capsules

What is BOSULIF?
BOSULIF is a prescription medicine used to treat:

•
adults and children 1 year of age and older who have a certain type of leukemia called chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who are newly-diagnosed or who no longer benefit from or did not tolerate other treatment.
•
adults with accelerated phase (AP), or blast phase (BP) Ph+ CML who can no longer benefit from or did not tolerate other treatment.

It is not known if BOSULIF is safe and effective in children less than 1 year of age with CP Ph+ CML who are newly‑diagnosed or who no longer benefit from or did not tolerate other treatment or in children with AP Ph+ CML or BP Ph+ CML.

Do not take BOSULIF if you are allergic to bosutinib or any of the ingredients in BOSULIF. See the end of this leaflet for a complete list of ingredients of BOSULIF.

Before taking BOSULIF, tell your doctor about all of your medical conditions, including if you:

•
have liver problems
•
have heart problems
•
have kidney problems
•
have high blood pressure
•
have diabetes
•
are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with BOSULIF. Tell your doctor right away if you become pregnant during treatment with BOSULIF.
o
Females who are able to become pregnant should use effective birth control (contraception) during treatment with BOSULIF and for 2 weeks after the last dose. Talk to your doctor about birth control methods that may be right for you.
•
are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. Do not breastfeed during treatment with BOSULIF and for 2 weeks after the last dose.

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. When taken together, BOSULIF and certain other medicines can affect each other.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take BOSULIF?

•
Take BOSULIF exactly as prescribed by your doctor.
•
Do not change your dose or stop taking BOSULIF without first talking with your doctor.
•
If your child takes BOSULIF, your healthcare provider will change the dose as your child grows.
•
Take BOSULIF with food.
•
Swallow BOSULIF tablets whole. Do not crush, break, chew or cut BOSULIF tablets. Do not touch or handle crushed or broken BOSULIF tablets.
•
Swallow BOSULIF capsules whole. If you cannot swallow BOSULIF capsules whole, tell your healthcare provider.
•
If you cannot swallow BOSULIF capsules whole, see the “Instructions for Use” for detailed instructions on how to prepare and give a dose of BOSULIF capsules by opening the capsules and mixing the capsule contents with applesauce or yogurt.
•
If you take an antacid or H2 blocker medicine, take it at least 2 hours before or 2 hours after BOSULIF. If you take a Proton Pump Inhibitor (PPI) medicine, talk to your doctor or pharmacist.
•
You should avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract during treatment with BOSULIF. Grapefruit products increase the amount of BOSULIF in your body.
•
If you miss a dose of BOSULIF, take it as soon as you remember. If you miss a dose by more than 12 hours, skip that dose and take your next dose at your regular time. Do not take 2 doses at the same time.
•
If you take too much BOSULIF, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of BOSULIF?
BOSULIF may cause serious side effects, including:

•
Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, vomiting, or blood in your stools. Get medical help right away for any stomach problems.
•
Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection.
•
Liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark "tea color" urine.
•
Heart problems. BOSULIF may cause heart problems, including heart failure and decreased blood flow to the heart which can lead to heart attack. Get medical help right away if you get shortness of breath, weight gain, chest pain, or swelling in your hands, ankles or feet.
•
Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Get medical help right away if you get any of the following symptoms during your treatment with BOSULIF:
o
shortness of breath and cough
o
chest pain
o
swelling in your hands, ankles, or feet
o
swelling all over your body
o
weight gain
•
Kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
o
you urinate more often than normal
o
you urinate less often than normal
o
you make a much larger amount of urine than normal
o
you make a much smaller amount of urine than normal

The most common side effects of BOSULIF in adults and children with CML include:

•
diarrhea
•
stomach (abdominal) pain
•
vomiting
•
nausea
•
rash
•
tiredness
•
liver problems
•
headache
•
fever
•
decreased appetite
•
respiratory tract infections (infections in nose, throat or lungs)
•
constipation
•
changes in certain blood tests. Your doctor may do blood tests during treatment with BOSULIF to check for changes

Tell your doctor or get medical help right away if you get respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, rash or itching while taking BOSULIF. These may be symptoms of a severe allergic reaction.
Your doctor may change your dose, temporarily stop, or permanently stop treatment with BOSULIF if you have certain side effects.
BOSULIF may cause fertility problems in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of BOSULIF.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BOSULIF?

•
Store BOSULIF tablets and capsules at room temperature between 68°F to 77°F (20°C to 25°C).
•
The BOSLUIF tablets and capsules bottle has a child-resistant closure.
•
The BOSULIF tablets bottle contains a desiccant to help keep your medicine dry (protect it from moisture). Keep the desiccant in the bottle. Do not eat the desiccant.
•
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.

General information about the safe and effective use of BOSULIF.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BOSULIF for a condition for which it is not prescribed. Do not give BOSULIF to other people even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about BOSULIF that is written for health professionals.

What are the ingredients in BOSULIF?
Active ingredient: bosutinib.
Inactive ingredients:Tablets: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. Capsules: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.

logo



LAB-0639-12.0
For more information, go to www.Bosulif.com or www.pfizermedicalinformation.com or call 1-800-438-1985.

This Patient Information has been approved by the U.S. Food and Drug Administration.        Revised 9 2023

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-0639-12.0

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
Prescribing Information
Download Prescribing Information

Health Professional Information

Full Patient Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

•
Dosage and Administration

Instruct patients to take BOSULIF exactly as prescribed, not to change their dose or to stop taking BOSULIF unless they are told to do so by their doctor. If patients miss a dose beyond 12 hours, they should be advised to take the next scheduled dose at its regular time. A double dose should not be taken to make up for any missed dose. Advise patients to take BOSULIF with food. Patients should be advised: “Swallow tablets whole. Do not crush, break, or cut tablet. Do not touch or handle crushed or broken tablets.” Patients should be advised: “Capsules may be swallowed whole. For those that cannot swallow the capsule whole, the capsule can be opened and the contents mixed with applesauce or yogurt.”

•
Gastrointestinal Toxicity

Advise patients that they may experience diarrhea, nausea, vomiting, abdominal pain, or blood in their stools with BOSULIF and to seek medical attention promptly for these symptoms [see Warnings and Precautions (5.1)].

•
Myelosuppression

Advise patients of the possibility of developing low blood cell counts and to immediately report fever, any suggestion of infection, or signs or symptoms suggestive of bleeding or easy bruising [see Warnings and Precautions (5.2)].

•
Hepatic Toxicity

Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice [see Warnings and Precautions (5.3)].

•
Cardiovascular Toxicity

Advise patients that cardiac failure, left ventricular dysfunction, and cardiac ischemic events have been reported. Advise patients to seek immediate medical attention if any symptoms suggestive of cardiac failure and cardiac ischemia occur, such as shortness of breath, weight gain, or fluid retention [see Warnings and Precautions (5.4)].

•
Fluid Retention

Advise patients of the possibility of developing fluid retention (swelling, weight gain, or shortness of breath) and to seek medical attention promptly if these symptoms arise [see Warnings and Precautions (5.5)].

•
Renal Toxicity

Advise patients of the possibility of developing renal problems and to immediately report frequent urination, polyuria or oliguria [see Warnings and Precautions (5.6)].

•
Adverse Reactions

Advise patients that they may experience other adverse reactions such as respiratory tract infections, rash, fatigue, loss of appetite, headache, dizziness, back pain, arthralgia, pruritus or constipation with BOSULIF and to seek medical attention if symptoms are significant. There is a possibility of anaphylactic shock [see Contraindications (4) and Adverse Reactions (6)].

•
Embryo-Fetal Toxicity

Advise females to inform their healthcare provider if they are pregnant or become pregnant. Advise female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)].

Advise females of reproductive potential, to use effective contraception during treatment and for 2 weeks after receiving the last dose of BOSULIF [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1, 8.3)].

Advise lactating women not to breastfeed during treatment with BOSULIF and for 2 weeks after the last dose [see Use in Specific Populations (8.2)].

•
Drug Interactions

Advise patients that BOSULIF and certain other medicines, including over the counter medications or herbal supplements (such as St. John's wort) can interact with each other and may alter the effects of BOSULIF [see Drug Interactions (7)].

PATIENT INFORMATION

BOSULIF (BAH-su-lif)

(bosutinib)

tablets

BOSULIF (BAH-su-lif)

(bosutinib)

capsules

What is BOSULIF?
BOSULIF is a prescription medicine used to treat:

•
adults and children 1 year of age and older who have a certain type of leukemia called chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who are newly-diagnosed or who no longer benefit from or did not tolerate other treatment.
•
adults with accelerated phase (AP), or blast phase (BP) Ph+ CML who can no longer benefit from or did not tolerate other treatment.

It is not known if BOSULIF is safe and effective in children less than 1 year of age with CP Ph+ CML who are newly‑diagnosed or who no longer benefit from or did not tolerate other treatment or in children with AP Ph+ CML or BP Ph+ CML.

Do not take BOSULIF if you are allergic to bosutinib or any of the ingredients in BOSULIF. See the end of this leaflet for a complete list of ingredients of BOSULIF.

Before taking BOSULIF, tell your doctor about all of your medical conditions, including if you:

•
have liver problems
•
have heart problems
•
have kidney problems
•
have high blood pressure
•
have diabetes
•
are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with BOSULIF. Tell your doctor right away if you become pregnant during treatment with BOSULIF.
o
Females who are able to become pregnant should use effective birth control (contraception) during treatment with BOSULIF and for 2 weeks after the last dose. Talk to your doctor about birth control methods that may be right for you.
•
are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. Do not breastfeed during treatment with BOSULIF and for 2 weeks after the last dose.

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. When taken together, BOSULIF and certain other medicines can affect each other.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take BOSULIF?

•
Take BOSULIF exactly as prescribed by your doctor.
•
Do not change your dose or stop taking BOSULIF without first talking with your doctor.
•
If your child takes BOSULIF, your healthcare provider will change the dose as your child grows.
•
Take BOSULIF with food.
•
Swallow BOSULIF tablets whole. Do not crush, break, chew or cut BOSULIF tablets. Do not touch or handle crushed or broken BOSULIF tablets.
•
Swallow BOSULIF capsules whole. If you cannot swallow BOSULIF capsules whole, tell your healthcare provider.
•
If you cannot swallow BOSULIF capsules whole, see the “Instructions for Use” for detailed instructions on how to prepare and give a dose of BOSULIF capsules by opening the capsules and mixing the capsule contents with applesauce or yogurt.
•
If you take an antacid or H2 blocker medicine, take it at least 2 hours before or 2 hours after BOSULIF. If you take a Proton Pump Inhibitor (PPI) medicine, talk to your doctor or pharmacist.
•
You should avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract during treatment with BOSULIF. Grapefruit products increase the amount of BOSULIF in your body.
•
If you miss a dose of BOSULIF, take it as soon as you remember. If you miss a dose by more than 12 hours, skip that dose and take your next dose at your regular time. Do not take 2 doses at the same time.
•
If you take too much BOSULIF, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of BOSULIF?
BOSULIF may cause serious side effects, including:

•
Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, vomiting, or blood in your stools. Get medical help right away for any stomach problems.
•
Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection.
•
Liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark "tea color" urine.
•
Heart problems. BOSULIF may cause heart problems, including heart failure and decreased blood flow to the heart which can lead to heart attack. Get medical help right away if you get shortness of breath, weight gain, chest pain, or swelling in your hands, ankles or feet.
•
Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Get medical help right away if you get any of the following symptoms during your treatment with BOSULIF:
o
shortness of breath and cough
o
chest pain
o
swelling in your hands, ankles, or feet
o
swelling all over your body
o
weight gain
•
Kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
o
you urinate more often than normal
o
you urinate less often than normal
o
you make a much larger amount of urine than normal
o
you make a much smaller amount of urine than normal

The most common side effects of BOSULIF in adults and children with CML include:

•
diarrhea
•
stomach (abdominal) pain
•
vomiting
•
nausea
•
rash
•
tiredness
•
liver problems
•
headache
•
fever
•
decreased appetite
•
respiratory tract infections (infections in nose, throat or lungs)
•
constipation
•
changes in certain blood tests. Your doctor may do blood tests during treatment with BOSULIF to check for changes

Tell your doctor or get medical help right away if you get respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, rash or itching while taking BOSULIF. These may be symptoms of a severe allergic reaction.
Your doctor may change your dose, temporarily stop, or permanently stop treatment with BOSULIF if you have certain side effects.
BOSULIF may cause fertility problems in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of BOSULIF.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BOSULIF?

•
Store BOSULIF tablets and capsules at room temperature between 68°F to 77°F (20°C to 25°C).
•
The BOSLUIF tablets and capsules bottle has a child-resistant closure.
•
The BOSULIF tablets bottle contains a desiccant to help keep your medicine dry (protect it from moisture). Keep the desiccant in the bottle. Do not eat the desiccant.
•
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.

General information about the safe and effective use of BOSULIF.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BOSULIF for a condition for which it is not prescribed. Do not give BOSULIF to other people even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about BOSULIF that is written for health professionals.

What are the ingredients in BOSULIF?
Active ingredient: bosutinib.
Inactive ingredients:Tablets: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. Capsules: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.

logo



LAB-0639-12.0
For more information, go to www.Bosulif.com or www.pfizermedicalinformation.com or call 1-800-438-1985.

This Patient Information has been approved by the U.S. Food and Drug Administration.        Revised 9 2023

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-0639-12.0

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

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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.