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Monitoring during therapy | BOSULIF® (bosutinib) Tablets | Safety Info

Monitoring during therapy

Monitoring during therapy

Ongoing communication can help you and your doctor work together to best manage your CML. Make sure you are following up with your doctor regularly, regardless of how you are feeling. Frequent monitoring and blood tests are very important, so ask your doctor about getting tests that gauge the status of your disease and how you are responding to treatment.

Monitoring with quantitative polymerase chain reaction (QPCR) every 3 months is recommended for all patients after initiating therapy, including those who meet response milestones at 3, 6, and 12 months, and beyond. After complete cytogenetic response has been achieved, molecular monitoring is recommended every 3 months for 2 years and every 3 to 6 months thereafter.

Common laboratory tests done during CML treatmenta

Test What it measures What is needed
Quantitative polymerase chain reaction (QPCR) The presence of very low levels of specific genetic material—in CML, QPCR measures the number of cells that have the BCR-ABL cancer gene Blood or bone marrow sample
Fluorescence in situ hybridization (FISH) Abnormal changes in a cell’s genes and chromosomes, such as the presence of BCR-ABL and the Philadelphia (Ph) chromosome Blood or bone marrow sample
Bone marrow cytogenetics Cells carrying the Ph chromosome Bone marrow sample

aAdapted with permission from the NCCN Guidelines for Patients®: Chronic Myelogenous Leukemia V.1.2016. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed August 11, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. The NCCN Guidelines for Patients® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.

Other health issues to monitor

It is very common for people to develop different kinds of health issues as they grow older, and it is important that you watch out for certain types of changes that could affect your health or your treatment.

If you have multiple medical conditions (called comorbidities), it is very important to have regular checkups to monitor these medical conditions and your overall health. These medical conditions may include:

  • Heart disease
  • Kidney disease
  • Lung disease
  • Diabetes
  • Other illnesses that may affect your body's ability to fight infection

Remember, the more information your doctor has, the better he or she will be able to make decisions about what the best course of treatment is to manage your CML.

Other tests during treatment with BOSULIF® (bosutinib)

A blood test called a complete blood count (CBC) is often done as part of a regular office visit to monitor your treatment with BOSULIF. A CBC counts the number of different kinds of cells in the blood.

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.

Your doctor should also 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.

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, rash, vomiting, stomach pain, respiratory tract infection, fever, abnormal liver function, tiredness or weakness, cough, and headache

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

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, rash, vomiting, stomach pain, respiratory tract infection, fever, abnormal liver function, tiredness or weakness, cough, and headache

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