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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