patients of the possibility of developing liver function abnormalities and to immediately report jaundice.
• 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.
• Other 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, or pruritus with Bosulif and to seek medical attention if symptoms are significant. There is a possibility of anaphylactic shock.
• Pregnancy and Breast-feeding
Advise patients that Bosulif can cause fetal harm when administered to a pregnant woman. Advise women of the potential hazard to the fetus and to avoid becoming pregnant. If Bosulif is used during pregnancy, or if the patient becomes pregnant while taking Bosulif, the patient should be apprised of the potential hazard to the fetus. Because a potential risk to the nursing infant cannot be excluded, women that are taking Bosulif should not breast-feed or provide breast milk to infants.
Counsel females of reproductive potential to use effective contraceptive measures to prevent pregnancy during and for at least 30 days after completing treatment with Bosulif. Instruct patients to contact their physicians immediately if they become pregnant during treatment. Advise patients not to take Bosulif treatment while pregnant or breastfeeding. If a patient wishes to restart breastfeeding after treatment, advise her to discuss the appropriate timing with her physician.
• 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 Dosage and Administration (2.5) and Drug Interactions (7)].
LAB-0443-1.0
September 2012
PATIENT INFORMATION
Bosulif® (BAH-su-lif)
(bosutinib)
tablets
Read the Patient Information that comes with Bosulif before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.
What is Bosulif?
Bosulif is a prescription medicine used to treat adults who have a certain type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who no longer benefit from or did not tolerate other treatment.
It is not known if Bosulif is safe and effective in children less than 18 years of age.
Who should not take Bosulif?
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.
What should I tell my doctor before taking Bosulif?
Before you take Bosulif, tell your doctor if you:
•have liver problems
•have heart problems
•have any other medical conditions
•are pregnant or plan to become pregnant. Bosulif can harm your unborn baby. You should not become pregnant while taking Bosulif. Tell your doctor right away if you become pregnant while taking Bosulif.
•are a woman who may become pregnant. Use effective contraception (birth control) during and for at least 30 days after completing treatment with Bosulif. Talk to your doctor about forms of birth control.
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