Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
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.”
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)].
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)].
Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice [see Warnings and Precautions (5.3)].
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)].
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)].
Advise patients of the possibility of developing renal problems and to immediately report frequent urination, polyuria or oliguria [see Warnings and Precautions (5.6)].
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)].
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)].
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?
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:
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. | ||
How should I take BOSULIF?
| ||
What are the possible side effects of BOSULIF?
| ||
|
| |
The most common side effects of BOSULIF in adults and children with CML include: | ||
|
| |
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. | ||
How should I store BOSULIF?
Keep BOSULIF and all medicines out of the reach of children. | ||
General information about the safe and effective use of BOSULIF. | ||
What are the ingredients in BOSULIF?
|
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 12/2024
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:
Preparing a dose of BOSULIF capsules:
Gather the following supplies:
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?
Keep BOSULIF and all medicines out of the reach of children.
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
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
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.”
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)].
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)].
Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice [see Warnings and Precautions (5.3)].
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)].
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)].
Advise patients of the possibility of developing renal problems and to immediately report frequent urination, polyuria or oliguria [see Warnings and Precautions (5.6)].
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)].
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)].
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?
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:
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. | ||
How should I take BOSULIF?
| ||
What are the possible side effects of BOSULIF?
| ||
|
| |
The most common side effects of BOSULIF in adults and children with CML include: | ||
|
| |
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. | ||
How should I store BOSULIF?
Keep BOSULIF and all medicines out of the reach of children. | ||
General information about the safe and effective use of BOSULIF. | ||
What are the ingredients in BOSULIF?
|
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 12/2024
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:
Preparing a dose of BOSULIF capsules:
Gather the following supplies:
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?
Keep BOSULIF and all medicines out of the reach of children.
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
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
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.”
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)].
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)].
Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice [see Warnings and Precautions (5.3)].
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)].
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)].
Advise patients of the possibility of developing renal problems and to immediately report frequent urination, polyuria or oliguria [see Warnings and Precautions (5.6)].
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)].
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)].
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?
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:
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. | ||
How should I take BOSULIF?
| ||
What are the possible side effects of BOSULIF?
| ||
|
| |
The most common side effects of BOSULIF in adults and children with CML include: | ||
|
| |
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. | ||
How should I store BOSULIF?
Keep BOSULIF and all medicines out of the reach of children. | ||
General information about the safe and effective use of BOSULIF. | ||
What are the ingredients in BOSULIF?
|
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 12/2024
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:
Preparing a dose of BOSULIF capsules:
Gather the following supplies:
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?
Keep BOSULIF and all medicines out of the reach of children.
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
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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:
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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.