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GLEEVEC® (imatinib mesylate) tablets and TASIGNA® (nilotinib) 150-mg and 200-mg capsules are available only by prescription.
About CML
Ph+ CML Prognosis and Disease Progression
Understanding the phases of a Ph+ CML diagnosis.
Ph+ CML Prognosis: Your Ph+ CML prognosis depends on the phase of the disease, your blood counts, and whether you have an enlarged spleen. Most patients are diagnosed in the chronic phase, which is the initial phase of the disease. With currently available treatments, continued follow-up monitoring, and patient compliance in taking their medication as prescribed, most patients are able to remain in the chronic phase.
Disease Progression: Once Ph+ CML has been diagnosed, it is described by the extent of disease progression. The description of Ph+ CML by its phase helps the patient's healthcare team to develop an appropriate treatment plan. Ph+ CML typically progresses in three phases:
Chronic Phase: Too many white blood cells are produced with few immature white blood cells (blasts) in the blood and bone marrow. Patients may have an abnormal number of red blood cells and platelets. Symptoms may or may not be present.
Accelerated Phase: An increasing number of white blood cells and more blast cells are present in the blood and bone marrow with fewer normal cells. Platelets and red blood cells may begin to decrease. Symptoms are often present.
Blast Phase: A greater number of blast cells are found in the blood or bone marrow compared with the accelerated phase. Large numbers of white blood cells continue to crowd out the production of red blood cells and platelets. Patients may develop bleeding, bone tenderness, and gouty arthritis.
IMPORTANT SAFETY INFORMATION
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 electrocardiogram (ECG):
- Before starting TASIGNA
- 7 days after starting TASIGNA
- With any dose change
- Regularly during TASIGNA treatment
TASIGNA Indications
TASIGNA is a prescription medicine used to treat Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who are:
- Newly diagnosed. The effectiveness of TASIGNA is based on major molecular response and cytogenetic response rates. The study is ongoing and more data will be needed to determine long-term outcomes
- No longer benefiting from previous other treatments, including imatinib (GLEEVEC®), or have taken other treatments, including imatinib (GLEEVEC), but cannot tolerate them. The effectiveness of TASIGNA is based on hematologic response and cytogenetic response rates
GLEEVEC Indications
GLEEVEC® (imatinib mesylate) tablets are indicated for:
- Newly diagnosed adult and pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase
- Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy
For full Important Information about TASIGNA and GLEEVEC, click here.
TASIGNA Indications
TASIGNA is a prescription medicine used to treat Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who are:
- Newly diagnosed. The effectiveness of TASIGNA is based on major molecular response and cytogenetic response rates. The study is ongoing and more data will be needed to determine long-term outcomes
- No longer benefiting from previous other treatments, including imatinib (GLEEVEC®), or have taken other treatments, including imatinib (GLEEVEC), but cannot tolerate them. The effectiveness of TASIGNA is based on hematologic response and cytogenetic response rates
Important Safety Information
Important Information about TASIGNA® (nilotinib)
It is not known if TASIGNA is safe or effective in children.
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 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:
- Take TASIGNA on an empty stomach
- DO NOT TAKE TASIGNA WITH FOOD
- Food can affect the levels of TASIGNA in your body, which can lead to serious side effects
- Taking TASIGNA on an empty stomach may lower your chances of having a possibly life-threatening heart problem called QT prolongation
- QT prolongation causes an irregular heartbeat, which may lead to sudden death
Taking TASIGNA:
- TASIGNA at least 2 hours after eating any food
- 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 the amount of TASIGNA in your body
- Avoid taking other medicines or other supplements with TASIGNA that can also cause QT prolongation
Who should not take TASIGNA?
Do not take if you have:
- Low levels of potassium or magnesium in your blood
- Long QTc syndrome
TASIGNA is a prescription medication. TASIGNA comes in 150 mg and 200 mg capsules. Your doctor will prescribe 300 mg of TASIGNA to be taken twice a day for a total daily dose of 600 mg or 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. If you cannot swallow TASIGNA capsules whole, tell your doctor.
- If you cannot swallow TASIGNA capsules whole:
- Open the TASIGNA capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple).
- Swallow the mixture right away (within 15 minutes).
- 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.
- 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:
- 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 have liver problems
- You know that you suffer from low blood levels of electrolytes, such as potassium, magnesium, or calcium
- You have a pancreas disorder
- You have had a surgical procedure involving the removal of the entire stomach (total gastrectomy)
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.
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, some symptoms of which include:
- Feeling lightheaded, fainting, or having an irregular heartbeat
- Unexplained bleeding or bruising
- Blood in urine or stool
- Unexplained weakness
- Yellow skin and eyes
- Shortness of breath
- Sudden stomach area pain with nausea and vomiting
- Sudden headache, changes in your eyesight, not being aware of what is going on around you, and becoming unconscious
Common side effects
Most patients experience side effects at some time. Some common side effects you may experience include:
- Low blood count
- Rash
- Nausea
- Fever
- Stomach (abdominal) pain
- Headache
- Itching
- Muscle and joint pain
- Tiredness
- Diarrhea
- Constipation
- Back pain
- Muscle spasms
- Weakness
- Hair loss
- Runny or stuffy nose, sneezing, sore throat
- Cough
Be sure to tell your doctor or pharmacist if you have any side effects during treatment with TASIGNA.
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.
Your doctor may have you stop TASIGNA for some time or reduce your dose if you have side effects with it.
Please see accompanying patient information, including Boxed WARNING, and the TASIGNA Medication Guide you received with your prescription.
Click here for full Prescribing Information.
Important information
GLEEVEC® is available only by prescription.
GLEEVEC® Indications
GLEEVEC® (imatinib mesylate) tablets are indicated for:
- Newly diagnosed adult and pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase
- Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy
SAFETY: Important product information (Click here for full Prescribing Information)
Who should NOT take GLEEVEC
- Women who are or could be pregnant. 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 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 healthcare professional about these issues before taking GLEEVEC.
Warnings and precautions
- GLEEVEC is often associated with edema (swelling) and serious fluid retention. It is important that patients be weighed and monitored regularly for signs and symptoms of serious fluid retention, or unexpected weight gain. Patients experiencing unexpected rapid weight gain should speak to their doctor about appropriate supportive care treatment. Studies have shown that edema (swelling) tended to occur more often among patients who are 65 and older or those taking higher doses of GLEEVEC. If you experience severe fluid retention, your doctor may treat you with diuretics and may stop your GLEEVEC treatment until the fluid retention has been managed
- 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, biweekly for the second month, and periodically thereafter. In most cases, your doctor will reduce or interrupt your GLEEVEC therapy; in rare cases, your doctor may discontinue treatment. If the cytopenia is severe, your doctor may reduce your dose or temporarily stop your treatment with GLEEVEC
- 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
- Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of GLEEVEC. Your doctor will check your liver function before beginning treatment and continue to monitor liver function as needed. If you experience severe liver problems, your doctor may stop your treatment with GLEEVEC until the liver problem has been managed
- Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with Ph+ CML
- In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell) and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) have been associated with the initiation of GLEEVEC therapy. Speak to your doctor regarding appropriate supportive care or discontinuing GLEEVEC
- Skin reactions, such as fluid-filled blisters, have been reported with the use of GLEEVEC
- Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement during treatment with GLEEVEC. Your doctor should closely monitor your thyroid hormone 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. Be sure to inform your doctor if you are or think you may be pregnant. You should not breast-feed while taking GLEEVEC
- GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported
- Growth retardation has been reported in children taking GLEEVEC. The long-term effects of extended treatment with GLEEVEC on growth in children are unknown. Growth retardation may be monitored in children receiving treatment
- Cases of tumor lysis syndrome (TLS), which refers to a metabolic and electrolyte disturbance caused by the breakdown of tumor cells, have been reported and can be life-threatening in some cases. The patients at risk of TLS are those that have a higher amount of tumor cells and whose tumors are fast-growing before beginning therapy. Your doctor should monitor you closely and take appropriate precautions
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
- Increased pressure in the heart or brain; fatal in rare cases
- Low levels of certain blood cells
- Heart failure/cardiogenic shock
- Liver problems
- Hemorrhage (abnormal bleeding)
- Skin blistering
- 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 (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 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 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 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); 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.
Use of website is governed by the Terms of Use and Privacy Statement. Copyright ©2012 Novartis Pharmaceuticals Corporation. All Rights Reserved. This site is intended for U.S. Residents only. Non-U.S. Residents click here.
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Acute leukemia
A quickly progressing cancer of the blood that makes the body produce too many cancerous white blood cells.
White blood cell
Type of blood cell that fights infection.
Bone marrow
The soft, spongy inner part of bones where blood cells are made.
Stem cell transplant
Another name for a bone marrow transplant.
Stem cell
An early cell that matures into various types of blood cells.
Spleen
An organ that is part of the vascular system; serves to store and filter blood.
Side effect
A side effect, also referred to as an adverse event, is a result of drug therapy which differs from the desired effect.
Tyrosine kinase
A protein that plays a role in certain forms of cancer, including Philadelphia chromosome-positive CML. Medicines called tyrosine kinase inhibitors target this enzyme as a treatment for Ph+ CML.
Translocation
A process in which two or more chromosomes break, and the broken parts of the chromosomes switch places. This forms new hybrid chromosomes, often with abnormal functions.
Platelets
Type of blood cell that helps blood to clot.
White blood cell
Type of blood cell that fights infection.
RT-PCR (reverse transcriptase-polymerase chain reaction)
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.
RT-PCR (reverse transcriptase-polymerase chain reaction)
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.
Resistance
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.
Remission
A disappearance of evidence of a disease, usually as a result of treatment.
Relapse
Return of cancer after it has been controlled by the initial treatment. Causes for a relapse can include not taking the therapy correctly as prescribed or changes in the cancer cells themselves.
Red blood cell
Type of blood cell that carries oxygen to other cells in the body.
Protein
An essential component of all living cells that is made up of amino acids.
Promyelocyte
A cell in bone marrow that is in an intermediate stage of development between a myeloblast and a myelocyte.
Philadelphia (Ph) chromosome
An abnormal chromosome that is responsible for the constant production of abnormal white blood cells (myeloid cells) that are present in CML.
Myeloblast
A large cell of the bone marrow that is an immature myelocyte.
Myelocyte
A large cell of the bone marrow that is an immature leukocyte.
Molecular testing
The use of PCR (polymerase chain reaction) to find the number of cells expressing BCR-ABL in either blood or bone marrow.
Molecular response
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.
Karyotyping
A cytogenetic test to identify chromosome abnormalities as the cause of a disease. This test looks at a small number of cells (about 20).
Interferon Treatment
Interferon medication is a man-made version of a protein that is involved in the immune system. The body produces interferons to help fight against disease and infection. These proteins stimulate immune cells to destroy body cells that have been infected with viruses or cancer.
Interferon alpha
The body's natural substance often used to fight cancer cells.
Hydroxyurea
A chemotherapy agent often used to treat Ph+ CML.
Hematologic testing
A simple blood test to measure levels of white blood cells, red blood cells, and platelets.
Hematologic response
A complete hematologic response means white blood cell, platelet, and red blood cell counts have returned to a normal range. However, this does not mean that your Ph+ CML is cured.
Gene
The basic unit of heredity passed from parent to child. Genes are made of DNA and carry instructions for making proteins.
FISH (fluorescence in situ hybridization)
A sensitive test done on either blood or bone marrow cells to look for abnormal cells that contain the BCR-ABL gene (which is located on the Philadelphia chromosome). This test can find one abnormal cell out of 200 to 500 normal cells.
DNA
The chemical inside the nucleus of a cell that carries the genetic instructions for making proteins. Genes are made of DNA.
Cytogenetic testing
Tests done on bone marrow cells or white blood cells to see if they contain the Philadelphia chromosome There are two types of cytogenetic testing: karyotyping and FISH (fluorescence in situ hybridization).
Cytogenetic response
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.
Chemotherapy
The use of drugs to destroy rapidly dividing cancer cells throughout the body. It may also destroy healthy cells that divide rapidly.
Chromosome
Part of the nucleus of the cell that contains the genes.
Chronic myeloid leukemia (CML)
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.
Complete blood count
A test of the blood that includes red blood cell count, white blood cell count, erythrocyte indices, hematocrit, differential blood count, and sometimes platelet count.
BCR-ABL
An abnormal gene that is formed when two specific chromosomes combine. This gene directs the production of a protein, called BCR-ABL—the underlying cause of Ph+ CML.
Bone marrow
The soft, spongy inner part of bones where blood cells are made.
Bone marrow transplant (BMT)
A procedure to replace bone marrow destroyed by high doses of anticancer drugs with healthy bone marrow.
Acute leukemia
A quickly progressing cancer of the blood that makes the body produce too many cancerous white blood cells.
Allogeneic transplant
A procedure in which a donor's stem cells are removed, stored, and placed into a patient's bone marrow after receiving high-dose drug therapy.
Anticonvulsant
A drug or treatment that prevents seizures or makes them less severe.
Antihistamine
A medicine used to reduce an allergic rash.
Autologous transplant
A procedure in which a patient's own stem cells are removed, stored, and eventually replaced after the patient receives high-dose drug therapy. This type of transplant is rarely used to treat CML.
What Is the My CML Circle Co-Pay Card?
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.