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

How Is BOSULIF Prescribed?

If you are an adult, your doctor or HCP most likely started you on a dosing schedule of 400 mg a day with food if you are newly diagnosed or 500 mg a day with food if you were resistant or intolerant to prior therapy. This can vary, though, depending on your individual needs. Your doctor or HCP may adjust your dose or tell you to stop taking BOSULIF if there are issues or concerns about tolerability.

ONLY YOUR DOCTOR OR HCP CAN TELL YOU IF CHANGING YOUR DOSE IS APPROPRIATE IN MANAGING YOUR THERAPY

What is a dose adjustment?

BOSULIF is available in 400–mg, 500–mg, and 100–mg tablets, and 100-mg and 50-mg capsules to allow for dose adjustments. A dose adjustment is when your doctor or HCP changes the amount of BOSULIF you’re taking, in order to best tailor your therapy to your individual needs. Your doctor or HCP may change your dose of BOSULIF or tell you to stop taking BOSULIF depending on how you are doing on treatment, as it may help manage side effects and response to treatment.

If your child takes BOSULIF, your healthcare provider will change the dose as your child grows.

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