GLEEVEC® (imatinib mesylate) tablets and TASIGNA® (nilotinib) 150-mg and 200-mg capsules are available only by prescription.
The purpose of the caregiver is straightforward—to help a loved one, friend, or family member cope with their cancer treatment. This simple definition, however, only begins to describe how essential a caregiver is to a patient's well being.
Some people don't think of themselves of being an "official caregiver." Caring for a loved one is just something that they do, a natural extension of their commitment to friends and family. But the caregiver is an essential part of the patient's team, the one who is with them day in, day out to help them cope with the myriad concerns that are bound to arise. They are a constant source of strength and support.
If you find yourself caring for someone with Ph+ CML, you're probably already involved in the treatment process—taking your loved one to the doctor, picking up medications and supporting them when they feel overwhelmed. Sometimes listening is what they need most. Having someone by their side helps patients feel that they're not alone.
When at the doctor's office, let your doctor or oncology nurse know any concerns or questions you may have. It might be helpful to write them down before you go. Also, many caregivers help loved ones maintain a folder with their health information and share that with their doctors and nurses on a regular basis.
Cancer is a life-altering event in which everyone suddenly finds themselves in a new, unexpected, and often frightening situation. Naturally, it impacts caregivers as well, which is why taking care of yourself is vital.
While providing care, it's okay to set aside your own needs from time to time. But keep it in perspective: a caregiver who's stressed out or overwhelmed might not be able to care for a loved one as well as they want to. These could lead to feelings of anger, sadness, grief, or guilt. Understanding that this is normal is the first step to working through them.
If you need help, ask—doing so helps both you and your loved one. Delegate tasks to others for a little while, or ask someone to pitch in. You might be surprised how willing others can be to lend a helping hand.
The goal is to not feel that you're doing too much on your own, or that you regret not asking for help. The sooner you can reestablish balance in your life, the sooner you can go back to being a source of strength and support. If you're interested in joining a caregiver support group, ask a nurse or social worker about one in your area.
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.