TAKING BOSULIF
 TAKING 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 are newly diagnosed. The approval of BOSULIF in these patients was based
    on molecular and cytogenetic response rates. There is an ongoing clinical study
    to confirm clinical benefit
  • Who no longer benefit from or did not tolerate other treatment

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?

BOSULIF is available in 400-mg, 500-mg, and 100-mg tablets and is taken once
a day with food.

Your doctor or HCP most likely started you on a dosing
schedule of taking one 400-mg tablet a day with food if you are newly diagnosed or one
500-mg tablet 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.

How is Prescribed Image

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 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.

How Should I Take BOSULIF?

It is important to take BOSULIF exactly as prescribed by your doctor. Follow the instructions below and talk
with your doctor or HCP for more information.

How should take-mob

Make Sure to Take BOSULIF as Prescribed

When you take BOSULIF... 

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REMINDERS TO MAKE THE MOST OF YOUR TREATMENT

Make sure to tell your doctor or healthcare professional (HCP) of any changes in: 

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Your prescription or over-the-counter medicines or any new ones you start taking.
Taking_SideEffect_Icon
Side effects, including ones that bother you or do not go away.
Taking_Feeling_Icon
How you are feeling, even if you think it is not related to your CML.
Taking_Lifestyle_Icon
Your lifestyle, including any new health issues that may arise.

Start a routine

  • Take your medicine at the same time every day. Consider taking BOSULIF in the morning with breakfast or in
    the evening with dinner.
  • Use alarms and calendars as reminders to take medicine.
  • Use a pill container to organize your medicines at home and when you travel.

Your doctor or HCP can help you with side effects

When you start treatment, consider asking your doctor how to prepare for possible episodes of diarrhea, the most
common side effect of BOSULIF.

About_Heart_Icon
Dose adjustments from your
doctor, lifestyle management, and
monitoring over time may help
you manage
side effects.

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 any other medical conditions
  • 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, 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

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 any other medical conditions
  • 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, nonprescription 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. BOSULIF may cause 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. Get medical help right away if you get shortness of breath, weight gain 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. BOSULIF may cause 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 for those patients who are newly diagnosed include: diarrhea, nausea, low platelet counts, rash, stomach pain, and changes in liver function tests.

The most common side effects of BOSULIF for those patients who no longer benefit from or did not tolerate other treatment include: diarrhea, nausea, stomach pain, rash, low platelet counts, vomiting, low red blood cell counts, tiredness, fever, cough, headache, changes in liver function tests, and swelling.

Tell your doctor or get medical help right away if you get respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, 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 who have a certain type of leukemia called Philadelphia chromosome–positive chronic myelogenous leukemia
(Ph+ CML):

  • Who are newly diagnosed. The approval of BOSULIF in these patients was based on molecular and cytogenetic response rates. There is an ongoing clinical study to confirm clinical benefit
  • Who no longer benefit from or did not tolerate other treatment

Pfizer Oncology