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Clinical Trial Results | BOSULIF® (bosutinib) Tablets | Safety Info

Clinical trial results for BOSULIF

Clinical trial results for BOSULIF

BOSULIF was studied in adult patients with Philadelphia chromosome–positive chronic myelogenous leukemia (Ph+ CML) in:

  • Chronic phase (CP) who had been treated with 1 prior tyrosine kinase inhibitor (TKI)
  • CP who had been treated with 2 or more prior therapies
  • Accelerated phase (AP) or blast phase (BP) who had been treated with at least 1 prior TKI

To see if BOSULIF worked in the clinical trial, doctors looked at patients’ blood and bone marrow samples regularly. In patients in CP, response was measured by the decrease in the number of white blood cells (WBCs) that had the Philadelphia chromosome. This is called cytogenetic response. A major cytogenetic response (MCyR) is when the medicine reduces the number of patients’ WBCs with the Philadelphia chromosome to less than or equal to 35%.

In patients in AP and BP, response was measured by overall hematologic response (OHR).

Patients in CP who had been treated with 1 prior TKI (Gleevec® [imatinib])

  • At 6 months from the start of therapy with BOSULIF, 34% of these patients had an MCyR
  • When these patients were followed for a longer period (at least 23 months), 53% of patients achieved an MCyR at some point during that period

Patients in CP who had been treated with 2 or more prior TKIs

  • By 6 months from the start of therapy with BOSULIF, 27% of these patients had an MCyR
  • When these patients were followed for a longer period (at least 13 months), 32% of patients achieved an MCyR at some point during that period

Patients in AP or BP who had been treated with at least 1 prior TKI

  • When patients were followed for 11 months, 55% of patients in AP achieved an OHR at some point during that period
  • When patients were followed for 11 months, 28% of patients in BP achieved an OHR at some point during that period

Gleevec is a registered trademark of Novartis AG.

Scroll for Important Safety Information for patients and Indication.

BOSULIF may cause serious side effects, including:

  • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, or vomiting. Tell your doctor about 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
  • 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. Call your doctor 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 include:
    • – diarrhea
    • – nausea
    • – low blood cell counts
    • – vomiting
    • – stomach pain
    • – rash
    • – fever
    • – tiredness or weakness

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. 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
  • are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. You and your doctor should decide if you will take BOSULIF or breastfeed. You should not do both

Scroll for Important Safety Information for patients and Indication.

BOSULIF may cause serious side effects, including:

  • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, or vomiting. Tell your doctor about 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
  • 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. Call your doctor 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 include:
    • – diarrhea
    • – nausea
    • – low blood cell counts
    • – vomiting
    • – stomach pain
    • – rash
    • – fever
    • – tiredness or weakness

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. 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
  • are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. You and your doctor should decide if you will take BOSULIF or breastfeed. You should not do both