GLEEVEC® (imatinib mesylate) tablets and TASIGNA® (nilotinib) 150-mg and 200-mg capsules are available only by prescription.
About half of all Ph+ CML patients do not have symptoms at the time the disease is diagnosed, and no standard screening process exists for detecting early-stage leukemia. A physician may find Ph+ CML during a routine blood test. Blood tests are done to count the different types of blood cells in your blood. A blood sample is looked at under the microscope, and if an abnormally high number of mature and maturing white blood cells are noted, a bone marrow biopsy may be done. In this procedure, a small bone marrow sample is taken by a needle inserted into your hip bone. This bone marrow is looked at and evaluated under a microscope.
Confirmation of Ph+ CML: A diagnosis of Ph+ CML is suggested by the finding of the Philadelphia chromosome in cells of the bone marrow. At the time of diagnosis, Ph+ CML patients typically have a significantly elevated white blood cell count. If the Ph chromosome is also present, the diagnosis is strengthened. Approximately 95% of patients with CML test positive for the Ph chromosome. However, a finding of Ph+ is not sufficient by itself to confirm a diagnosis, as there are other forms of leukemia in which the Philadelphia chromosome appears. But it is an important piece of the diagnostic puzzle.
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)
What is the most important information to know about prescription 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 electrocardiogram (ECG):
TASIGNA is a prescription medicine used to treat adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The efficacy of TASIGNA is based on major molecular response and cytogenetic response rates. The study is on-going and more data will be needed to determine long-term outcomes.
TASIGNA is also used to treat chronic phase or accelerated phase Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who are no longer benefiting from previous other treatments, including imatinib (Gleevec®), or have taken other treatments, including imatinib (Gleevec) but cannot tolerate them. The efficacy of TASIGNA is based on hematologic response and cytogenetic response rates.
GLEEVEC® (imatinib mesylate) tablets are indicated for:
For full Important Information about TASIGNA and GLEEVEC, click here.
TASIGNA is a prescription medicine used to treat adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The efficacy of TASIGNA is based on major molecular response and cytogenetic response rates. The study is on-going and more data will be needed to determine long-term outcomes.
TASIGNA is also used to treat chronic phase or accelerated phase Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who are no longer benefiting from previous other treatments, including imatinib (Gleevec), or have taken other treatments, including imatinib (Gleevec) but cannot tolerate them. The efficacy of TASIGNA is based on hematologic response and cytogenetic response rates.
What is the most important information to know about prescription 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 electrocardiogram (ECG):
Before starting TASIGNA
7 days after starting TASIGNA
With any dose changes
Regularly during TASIGNA treatment
You may lower your chances for having QT prolongation with TASIGNA if you:
Who should not take TASIGNA?
Do not take if you have:
Taking TASIGNA:
- Do not use more than 1 teaspoon of applesauce
- Only use applesauce. Do not sprinkle TASIGNA onto other foods
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.
Tell your doctor if:
Also tell your doctor if you are pregnant, breast-feeding, or lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA.
Serious side effects
TASIGNA may cause serious side effects including:
Your doctor may do blood tests to check you for TLS
Call your doctor immediately if you experience any of these symptoms. Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it.
Common side effects
Most patients experience side effects at some time. Some common side effects you may experience include:
Be sure to tell your doctor or pharmacist if you have any side effects during treatment with TASIGNA. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
It is not known if TASIGNA is safe or effective in children.
Tell your doctor if you are pregnant or planning to become pregnant. TASIGNA may harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment with TASIGNA. Talk to your doctor about the best birth control methods to prevent pregnancy while you are taking TASIGNA.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breast-feed. You should not do both.
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 2 weeks for the first 2 months and then monthly thereafter, or as considered necessary by your doctor.
Please see the full prescribing information including the Boxed WARNING, and the TASIGNA Medication Guide.
Click here for full Prescribing Information
GLEEVEC® (imatinib mesylate) is available only by prescription.
GLEEVEC® (imatinib mesylate) tablets are indicated for:
Who should NOT take GLEEVEC
Sexually active females should use highly effective birth control while taking GLEEVEC.
Be sure to talk to your doctor and/or healthcare professional about these issues before taking GLEEVEC.
Warnings and precautions
Additional important safety information
The following serious side effects have been reported by patients taking GLEEVEC:
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 (a small hole or tear).
If you are experiencing any of the above-mentioned side effects, please be sure to speak with your doctor immediately.
Common side effects of GLEEVEC
Almost all patients treated with GLEEVEC experience side effects at some time. Most side effects are mild to moderate in severity. Some common side effects that you may experience include:
If you are experiencing any of the above-mentioned side effects, please be sure to speak with your doctor immediately.
The severity of some side effects may be reduced with the help of other medicines and advice from your doctor, while others may require stopping GLEEVEC therapy for a while or changing the dose. However, in some cases, GLEEVEC therapy may need to be discontinued.
Tell your doctor if you have a history of heart disease or risk factors for heart disease or if you experience side effects, including fever, shortness of breath, blood in your stools, jaundice (yellowing of the skin and/or eyes), sudden weight gain, or symptoms of heart failure during therapy with GLEEVEC. After the approval of GLEEVEC, the following adverse events have been reported in patients treated with GLEEVEC: compression of the heart due to increased fluid, swelling of the brain, GI perforation (holes in the stomach or intestine), and sudden lung failure. These events, including some fatalities, may or may not have been drug related.
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.
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); or prescription medications including Coumadin® (warfarin sodium); rifampin; erythromycin; metoprolol; ketoconazole; 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.
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.
Click here for full Prescribing Information.
A very sensitive test to count the number of cells containing the BCR-ABL gene (which is located on the Philadelphia chromosome). It can be done on either blood or bone marrow cells and can detect the presence of a single abnormal cell in one million cells.
A very sensitive test to count the number of cells containing the BCR-ABL gene (which is located on the Philadelphia chromosome). It can be done on either blood or bone marrow cells and can detect the presence of a single abnormal cell in one million cells.
A primary resistance means not getting a complete hematologic response within 3 months on treatment, not getting a cytogenetic response within 6 months on treatment, or not getting a major cytogenetic response at 12 months on treatment.
A secondary resistance means that a prior hematologic or cytogenetic response that was obtained while on treatment is lost.
A complete molecular response means that, using currently available tests, there are no detectable BCR-ABL cells found in the bone marrow sample or blood sample. However, this does not mean that your Ph+ CML is cured.
A major molecular response means that the amount of BCR-ABL found in the bone marrow sample or blood sample is very low.
A complete cytogenetic response means that, using currently available tests, no cells with the Philadelphia chromosome are found in the patient's bone marrow sample or blood sample. However, this does not mean that your Ph+ CML is cured.
A major cytogenetic response means that no more than 35% of the cells in the patient's bone marrow sample or blood sample have the Philadelphia chromosome.
A slowly progressing blood and bone marrow disease that usually occurs during or after middle age, and rarely occurs in children. Most types of CML have a genetic defect called the Philadelphia chromosome that causes the constant production of abnormal white blood cells.
Some CML patients have already been provided with a Co-Pay Card from their doctor that can be activated on this site. But if you haven't received one yet, don't worry. During registration for My CML Circle you will have a chance to verify your eligibility and have one mailed to you.