TAKING BOSULIF
TAKING 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.

The importance of taking BOSULIF as prescribed by your doctor or healthcare professional (HCP)

  • Not taking your medicine as prescribed can impact how it works. It is important to take your medicine exactly as prescribed by your doctor or HCP
  • Only your doctor or HCP can tell you if changes to your dosage are appropriate in managing your therapy

What Should I Tell My Doctor?

Your doctor or HCP needs to know about any other medical conditions or diseases that you have.

Before you take BOSULIF, tell your doctor or HCP 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. Tell your doctor or HCP right away if you become pregnant while taking BOSULIF
    • Females who are able to become pregnant should have a pregnancy test before starting treatment with BOSULIF and should use effective birth control (contraception) during treatment with BOSULIF and for at least 2 weeks after the last dose. Talk to your doctor or HCP 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 at least 2 weeks after the last dose

Tell your doctor or HCP 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 or HCP and pharmacist when you get a new medicine.

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.

Also let your doctor or HCP know about:

  • any changes in your medicines or any new medicines you start taking.
  • any side effect that bothers you or that does not go away
  • changes in your lifestyle, including any new health issues that may arise
  • how you are feeling, even if you think it is not related to your CML

Ongoing communication can help you and your doctor or HCP work together to best manage your CML. Make sure you are following up with your doctor or HCP regularly, regardless of how you are feeling.

Frequent monitoring and blood tests are very important, so ask your doctor or HCP about getting tests that assess the status of your disease and how you are responding to treatment.

If you have diarrhea, call your doctor or HCP. Your doctor or HCP may recommend you take medicine to treat diarrhea. Always talk to your doctor or HCP before taking any over-the-counter medicines. Your doctor or HCP may change your dose, temporarily stop, or permanently stop treatment with BOSULIF to help manage diarrhea.

Tell your doctor or HCP if you have any side effect that bothers you or that does not go away. For more information, ask your doctor, HCP, or pharmacist.

Important Information: Embedded Bottom

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR PATIENTS

Do not take BOSULIF if you are allergic to bosutinib or any of the ingredients in BOSULIF.
Before you take BOSULIF, tell your doctor 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. Tell your doctor right away if you become pregnant while taking BOSULIF
    • Females who are able to become pregnant should have a pregnancy test before starting treatment with BOSULIF and should use effective birth control (contraception) during treatment with BOSULIF and for at least 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 at least 2 weeks after the last dose

Tell your doctor about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. BOSULIF and certain other medicines can affect each other.

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:
  • shortness of breath and cough
  • chest pain
  • swelling in your hands, ankles, or feet
  • swelling all over your body
  • 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:
  • you urinate more or less often than normal
  • you make a much larger or 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, and 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 both female and male patients. 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. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

INDICATIONS

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.

Please see Patient Information and full Prescribing Information.

Pfizer Oncology