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About CML

About CML

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Ph+ CML diagnostic and monitoring tests

What kinds of tests are used to diagnose Ph+ CML?

There are several tests that examine blood and bone marrow cells to diagnose Ph+ CML. The Ph chromosome is detected in the bone marrow of approximately 95% of patients with CML and is one of the main indicators of the disease. At the time of diagnosis, Ph+ CML patients typically have a significantly elevated white blood cell count.

Complete Blood Count (CBC): This is a test that measures the number and type of cells in your blood. Individuals with Ph+ CML have an increased white blood cell count, often to very high levels. Examination of blood cells under a microscope shows a pattern of white cells characteristic of this disease: a small proportion of very immature cells (leukemic blast cells and promyelocytes) and a larger proportion of maturing and fully matured white cells (myelocytes and neutrophils). Blast cells, promyelocytes, and myelocytes are not present in the blood of healthy individuals.

Your doctor may recommend you have blood tests every week or every other week for the first few months after starting treatment, followed by periodic blood tests when indicated.

Cytogenetic analysis: This test measures the number and structure of your chromosomes. A sample of blood or bone marrow is examined to determine if there is a chromosomal abnormality. The presence of the Ph chromosome in the bone marrow cells, a high white blood cell count, and other characteristic blood and marrow test findings help confirm the diagnosis of Ph+ CML.

Once diagnosed, these cytogenetic analyses may be performed at 6, 12, and 18 months following treatment. If a complete cytogenetic response (CCyR) is achieved at any of the earlier time points, then conventional cytogenetics do not need to be repeated, or may be performed as clinically indicated. (See Ph+ CML Remission)

Fluorescence In Situ Hybridization (FISH): This chromosome test for Ph+ CML is more sensitive than standard cytogenetics (also called karyotyping) that are used to detect the BCR-ABL gene within the Ph+ CML chromosome. This method identifies cells in which the nucleus contains chromosomes that have the BCR-ABL translocation (chromosome 9;22) that is characteristic of Ph+ CML.

FISH can detect chromosomal abnormality via blood cells and does not require a bone marrow examination. For that reason, it is also useful for following the effects of Ph+ CML treatment. FISH can determine whether a considerable number of Ph+ CML cells have decreased in the blood.

Laboratory monitoring may need to be done more or less frequently depending on your doctor's discretion.

Polymerase Chain Reaction (PCR): This is a sensitive test of blood cells. The PCR test can detect the alteration in DNA caused by the chromosome 9;22 translocation found in Ph+ CML. This testing method is more sensitive than FISH. It is capable of finding one BCR-ABL cell out of one million normal cells, and it can be done on either blood or bone marrow cells. Quantitative PCR is used to determine the amount of BCR-ABL in the blood.

PCR may also be used to quantify the decrease in the amount of BCR-ABL after therapy and to measure if Ph+ CML cell counts are stable during patient follow-up after treatment.

Some doctors may recommend a PCR test in order to get a baseline reading of the number of Ph+ cells in order to track treatment progress. PCR is recommended every 3 months when a patient is responding to therapy, and every 3 to 6 months when a CCyR is reached, or as recommended by your doctor. (See Cytogenetic response)

Next: Ph+ CML prognosis and disease progression

SAFETY: Important Product Information

Important information

GLEEVEC is available only by prescription.

Indication

GLEEVEC® (imatinib mesylate) tablets are indicated for:

  • Newly diagnosed adult patients with Philadelphia chromosome– positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP)
  • Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP after failure of interferon-alpha therapy

Who should NOT take GLEEVEC

  • Women who are or could be pregnant should not take GLEEVEC. Fetal harm can occur when administered to pregnant women; therefore, women should not become pregnant, as well as be advised of the potential risk to the unborn child if GLEEVEC is used during pregnancy.
  • Women who are breast-feeding should not take GLEEVEC because of the potential for serious adverse reactions in nursing infants.
  • Sexually active females should use adequate birth control while taking GLEEVEC.

Be sure to talk to your doctor and/or nurse about these issues before taking GLEEVEC.

Warnings and precautions

  • Edema (swelling) and severe fluid retention have occurred. Your doctor will weigh you regularly and manage unexpected weight gain by drug interruption and diuretics.
  • Cytopenias (reduction or lack of certain cell elements in blood circulation), such as anemia, have occurred. Your doctor will perform complete blood counts weekly for the first month, every other week for the second month, and periodically thereafter. In most cases, your doctor will reduce or interrupt your therapy with GLEEVEC; in rare cases, your doctor may discontinue treatment.
  • Severe congestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors will be monitored and treated for the condition.
  • Hepatotoxicity (severe liver problems) may occur. Your doctor will check your liver function before beginning treatment and continue to monitor liver function as needed.
  • Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with newly diagnosed Ph+ CML.
  • GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported.
  • In patients with certain conditions associated with high eosinophil levels (eg, HES, MDS/MPD and ASM), beginning GLEEVEC has been associated with cardiogenic shock/ left ventricle dysfunction.
  • Skin reactions, such as fluid-filled blisters, have been reported with the use of GLEEVEC.
  • Clinical cases of hypothyroidism have been reported in patients taking levothyroxine replacement during treatment with GLEEVEC. Your doctor should closely monitor your TSH levels.
  • Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long- term use.
  • GLEEVEC can cause fetal harm when administered to a pregnant woman. Women should be aware of the potential harm to the fetus.

Important safety information

The following serious side effects have been reported in patients taking GLEEVEC:

  • Severe fluid retention, which can cause swelling around the eyes or swelling of the lower legs, lungs, and heart; fatal in rare cases
  • Low levels of certain blood cells Heart failure/cardiogenic shock Liver problems Skin blistering
  • Hemorrhage (abnormal bleeding)
  • Low levels of thyroid hormone

Your doctor will check you closely for any side effects to stop more serious complications from occurring. Patients with heart disease or risk factors for heart failure should also be monitored carefully.

GLEEVEC is sometimes associated with stomach or intestinal irritation. GLEEVEC should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including deaths, of stomach or intestinal perforation.

Common side effects of GLEEVEC

A majority of patients treated with GLEEVEC experience side effects at some time. Most side effects are mild to moderate in severity. Some common side effects you may experience include:

Fluid retention Nausea Fatigue Rash Abdominal pain Vomiting Diarrhea Muscle cramps or pain Hemorrhage (abnormal bleeding)

Some mild-to-moderate side effects can be managed with the help of other medicines and advice from your doctor. However, in some cases, your dose of GLEEVEC may be stopped for awhile or may be changed.

Take GLEEVEC exactly as prescribed. Do not change your dose or stop taking GLEEVEC unless you are told to do so by your doctor. If you miss a dose, take your dose as soon as possible, unless it is almost time for your next dose. In this case, your missed dose should not be taken.

A double dose should not be taken to make up for any missed dose. You should take GLEEVEC with a meal and a large glass of water.

Be sure to inform your doctor if you are or think you may be pregnant. You should not breast-feed while taking GLEEVEC.

Do not take any other medications without talking to your doctor or pharmacist first, including over-the-counter medications such as Tylenol® (acetaminophen), herbal products (St. John's Wort/hypericum perforatum), Coumadin® (warfarin sodium), rifampin, erythromycin, and Dilantin® (phenytoin). Taking these with GLEEVEC may affect how they work, or affect how GLEEVEC works.

You should also tell your doctor if you are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods that may affect how GLEEVEC works.

Tell your doctor if you experience side effects during therapy with GLEEVEC, including fever, shortness of breath, blood in your stools, jaundice (yellowing of the skin and/or eyes), sudden weight gain, symptoms of heart failure, or if you have a history of heart disease or risk factors for heart disease.

After GLEEVEC's approval, the following side effects have been reported in patients treated with GLEEVEC: compression of the heart due to increased fluid, swelling of the brain, GI perforation, and sudden lung failure. These events, including some fatalities, may or may not have been drug related.

Tylenol (acetaminophen) is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals a division of McNeil PPC, Inc. Coumadin (warfarin sodium) is a registered trademark of Bristol Myers Squibb Company. Dilantin (phenytoin) is a registered trademark of Parke-Davis, a division of Pfizer Inc.

Important Information about TASIGNA

TASIGNA (nilotinib) 200-mg capsules are indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of TASIGNA is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

WARNING:

QT PROLONGATION AND SUDDEN DEATHS

TASIGNA prolongs the QT interval. Sudden deaths have been reported in patients receiving nilotinib. TASIGNA should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Hypokalemia or hypomagnesemia must be corrected prior to TASIGNA administration and should be periodically monitored. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided. Patients should avoid food 2 hours before and 1 hour after taking dose. Use with caution in patients with hepatic impairment. ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.

Contraindications

You should not use TASIGNA if you have one of the following:

  • Hypokalemia
  • Hypomagnesemia
  • Long QT syndrome

What is the most important information to know about TASIGNA?

TASIGNA can cause a possible life-threatening heart problem called QT prolongation. QT prolongation causes an irregular heartbeat, which may lead to sudden death.

Your doctor should check your heart with a test called an "ECG:"

  • Before taking TASIGNA
  • Regularly during treatment
  • 7 days after starting TASIGNA
  • After any dose changes

You may lower your chances for having QT prolongation with TASIGNA if you:

  • Take TASIGNA on an empty stomach. DO NOT TAKE TASIGNA WITH FOOD

Take TASIGNA:

  • At least 2 hours after eating any food, and
  • After taking TASIGNA, wait at least 1 hour before eating any food
  • Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Food and grapefruit products increase blood levels of TASIGNA in your body
  • Avoid taking other medicines, vitamins, or herbal supplements with TASIGNA that can also cause QT prolongation

TASIGNA is a prescription medication.

TASIGNA comes in 200 mg capsules. Your doctor will prescribe 400 mg of TASIGNA to be taken twice a day for a total daily dose of 800 mg. Each dose should be taken approximately 12 hours apart.

Swallow TASIGNA capsules whole with water.

  • Do not open TASIGNA capsules.
  • Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract. It may affect the levels of TASIGNA in the blood.
  • If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a missed dose.

Before taking TASIGNA

Talk to your doctor or pharmacist about all other medication(s) you may be taking, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements, since they may affect how TASIGNA works and increase your chance of serious and life-threatening side effects.

Before taking TASIGNA, tell your doctor if:

  • You have a heart disorder or are taking medication for the heart
  • You have an irregular heartbeat
  • You have QT prolongation or a family history of it
  • You know that you suffer from low blood levels of electrolytes, such as potassium or magnesium; or you have a liver or pancreas disorder
  • Also tell your doctor if you are pregnant, breast feeding, or lactose-intolerant

Call your doctor right away if you faint or have an irregular heartbeat while taking TASIGNA.

These can be symptoms of QT prolongation.

Call your doctor immediately if you experience any of these symptoms.

Serious side effects

TASIGNA is sometimes associated with serious side effects, with symptoms that include:

  • Irregularity in heartbeat or fainting
  • Yellow skin and eyes
  • Unexplained bleeding or bruising
  • Shortness of breath
  • Blood in urine or stool
  • Swelling of hands, ankles, feet, or face
  • Unexplained weakness
  • Sudden stomach area pain with nausea and vomiting

Common side effects

Most patients experience side effects at some time. Some common side effects you may experience include:

Low blood count Rash Nausea and vomiting Headache Itching Tiredness Diarrhea Constipation

Be sure to tell your doctor or pharmacist if you have any side effects during treatment with TASIGNA.

Women taking TASIGNA should avoid becoming pregnant.

  • Tell your doctor if you are pregnant or planning to become pregnant. TASIGNA can harm a fetus (unborn baby).
  • Women who can get pregnant must use effective birth control during treatment with TASIGNA.

Women should not breast-feed while taking TASIGNA.

  • Tell your doctor if you are breast-feeding.

If you take too much TASIGNA, call your doctor or poison control center right away.

Your doctor will check your heart, do regular blood tests and take bone marrow samples during treatment with TASIGNA. These are done to check for side effects with TASIGNA and to see how well TASIGNA is working for you. Your doctor should check your blood to monitor the amount of blood cells (white blood cells, red blood cells, and platelets) during treatment. These should be checked every two weeks for the first two months and then monthly thereafter, or as considered necessary by your doctor. Your doctor may have you stop TASIGNA for some time or reduce your dose if you have side effects with it.

Gleevec Indication

GLEEVEC® (imatinib mesylate) tablets are indicated for:

  • Newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP)
  • Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP after failure of interferon-alpha therapy

Important Safety Information

What is the most important information I should know about Tasigna?

Tasigna can cause a possible life-threatening heart problem called QT prolongation. QT prolongation causes an irregular heart beat, which may lead to sudden death.

Your doctor should check your heart with a test called an "ECG":

  • Before taking Tasigna
  • 7 days after starting Tasigna
  • Regularly during treatment
  • After any dose changes

Tasigna Indication

Tasigna (nilotinib) 200-mg capsules is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.