ABOUT Ph+ CML
ABOUT Ph+ CML

What is CML?

CML is chronic myelogenous leukemia. It is a type of cancer in your blood and bone marrow.

When you have CML, irregular white blood cells (WBCs) grow uncontrollably in your bone marrow and collect in your blood. These are called leukemia cells. Over time, the leukemia cells crowd out healthy WBCs, red blood cells, and platelets.

What Causes CML?

CML can be caused by an abnormal chromosome called the Philadelphia chromosome. If your CML is caused by this chromosome, it may also be referred to as Ph+ CML. This abnormal chromosome produces an abnormal protein called BCR-ABL. BCR-ABL causes the bone marrow to produce the leukemia cells.

What Are Some of the Signs and Symptoms of Ph+ CML?

Some people may experience 1 or more of these symptoms before being diagnosed with Ph+ CML:

Ph_tired

Feeling very tired

ph_weight

Weight loss for no known reason

Ph_pain

Pain or feeling of fullness below your ribs on the left side

ph_sweat

Night sweats

ph_fever

Fever

ph_weakness

Weakness

These are not all the symptoms of Ph+ CML. You may experience others. Call your doctor or HCP if you have any of the symptoms above or have any questions or concerns.

Most people are diagnosed in the earliest phase, known as the chronic phase (CP). Symptoms are milder or not noticeable in the CP compared with later phases.

What Are the CML Phases?

CML has 3 phases:

ph-phases-mob

The phase definitions above are from the World Health Organization (WHO). Some doctors or HCPs may use different definitions. Talk to your doctor or HCP about any questions or concerns you may have about the different phases.

Most patients are diagnosed in the CP, so the goal of treatment is to control the disease in CP and keep it from getting worse for as long as possible. By blocking BCR-ABL, medicines called tyrosine kinase inhibitors (TKIs), like BOSULIF® (bosutinib), help slow the growth of CML cells.

Some patients being treated for Ph+ CML may need to switch to another therapy. This can be due to resistance, intolerance (side effects), or both. However, everyone’s disease is different, so it’s important to take your medicine as directed to get the most out of treatment. Read on to find out more about the difference between resistance and intolerance, as well as learn about monitoring and treatment goals.
Talk to your doctor or HCP if you have questions about your medicine for CML.

Monitoring During Therapy

How do my doctor and I know if my CML is responding to treatment?

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.

In CML, qPCR measures the number of cells that have the BCR-ABL cancer gene.*
qPCR-International Scale (IS) is how many 
BCR-ABL cells you have in your blood compared to baseline. After BCR-ABL >0.1%-1% has been achieved, molecular monitoring
is recommended every 3 months for 2 years and every 3 to 6 months thereafter.*

*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia V.2.2020. © National
Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed September 19, 2019. To view the most recent and complete version of the guideline, go online to
NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in
any way.

Measures of response in CML
ph_cml_responce-mob.png
Below are qPCR-IS molecular response milestones that your doctor or healthcare professional will try to achieve with treatment
P_milestone
Two types of responses your doctor may mention are EMR and MMR
  • EMR is early molecular response, which means that at
    3 and 6 months, the amount of BCR-ABL in your
    blood is ≤10% of when you started treatment
  • MMR is major molecular response, which means the
    amount of BCR-ABL is ≤0.1% of what it was
    at baseline
What else should be monitored during treatment?

Your doctor may also order blood tests:

  • To monitor 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
  • To monitor 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
Other health issues to monitor

If you have multiple medical conditions, 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
  • Pregnancy

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

Ph+CML_Beach_Graphic
Ph+CML_Beach_Graphic

Resistance and Intolerance

What is resistance?

Resistance is when the disease fails to respond or stops responding to a given therapy. Your
doctor or HCP will schedule regular check-ups to measure your response to therapy. This will
be done using blood and bone marrow tests.

Resistance can occur at any time during treatment, even if you have been taking your
medicine successfully for several years. Because of this, resistance may be a possible cause
for not meeting treatment goals.

What is intolerance?

Intolerance is when a patient can no longer take his or her current medicine due to side
effects. If your side effects are severe, occur too often, or are damaging to your health, your
doctor or HCP may switch you to another medicine.

However, having side effects does not always mean that treatment should be switched. Often,
your doctor or HCP will be able to treat or manage side effects (for example, by reducing your
dose) without having to switch your medicine for Ph+ CML. Always tell your doctor or HCP if
you have side effects, even if you think they aren’t serious.

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