Safety Information
The following safety information is based on the complete prescribing information and clinical trials with Gleevec® in patients with chronic phase, accelerated phase and blast crisis in CML and GIST. Because follow-up of adult patients treated with Gleevec for Kit+ GIST and for newly diagnosed Ph+ CML in chronic phase is relatively short, there is no long-term safety data available for Gleevec in these patient groups.
Side Effects
Gleevec may cause side effects. Gleevec is occasionally associated with serious side effects, including severe fluid retention in different parts of the body including the lungs and heart, heart failure, low levels of certain blood cells (including children), liver problems, abnormal bleeding, or skin blistering. There have also been reports, including deaths, from increased pressure on the heart or brain, swelling of the brain, swelling inside the eye, and holes in the walls of the intestinal tract. Your doctor will monitor you closely for these reactions to prevent more serious complications from occurring. Patients with heart failure or risk factors for heart failure should also be monitored carefully. Gleevec should not be used in patients with a known allergic reaction to Gleevec or any of its ingredients. The majority of patients who received Gleevec in clinical studies experienced side effects, but they were usually mild or moderate.
Of the approximately 1700 adult patients who received Gleevec in clinical studies, the most common side effects were fluid retention (usually swelling around the eyes or legs) (59%-81%), diarrhea (39%-70%), nausea (47%-74%), vomiting (21%-58%), fatigue (30%-53%), muscle cramps (28%-62%), muscle or bone pain (30%-49%), abdominal pain (30%-40%), and rash (36%-53%)†. In some cases, these side effects were managed with other medications without having to reduce the dose of Gleevec or stop treatment. In a small percentage of patients with side effects, the dose of Gleevec was reduced or treatment was stopped temporarily. Discontinuation of Gleevec therapy because of side effects occurred in 3%-5% of patients.
Side effects in children were similar to the side effects in adults except muscle pain was less frequent and there was no fluid retention. The most common side effects were nausea and vomiting.
Gleevec should not be given to women who are or could be pregnant, or who are breastfeeding. Women should avoid becoming pregnant and be aware of the potential risk to the unborn child if Gleevec is used during pregnancy.
Nausea and Vomiting
(Click here to read more)
Nausea was reported in up to 73% of CML patients and 74% of patients with GIST. Nausea is one of the most common side effects with Gleevec therapy, sometimes accompanied by vomiting, which was seen in up to 58% of CML patients and 38% in GIST, or upper abdominal pain. Taking Gleevec with a meal and a large glass of water may greatly reduce these effects. Avoid taking Gleevec with grapefruit juice to avoid unwanted side effects.
Close
Fluid Retention
(Click here to read more)
Swelling around the eyes (periorbital edema) and/or of the lower legs has been reported in up to 76% of CML patients and 81% of GIST patients participating in clinical trials. If you notice these symptoms, or swelling of other areas while taking Gleevec, notify your physician. You may be given a diuretic, a drug that makes you pass more urine than usual to reduce the amount of fluid in your body, or your dose of Gleevec may be reduced. Your doctor should monitor and weigh you regularly to prevent more serious complications from occurring, such as water retention in different parts of the body including the heart.
Close
Muscle Cramps
(Click here to read more)
Muscle cramps were reported in up to 62% of CML patients and 58% in GIST patients. If you develop muscle cramps during therapy with Gleevec, contact your physician. Muscle cramps are usually mild and can be easily managed with calcium supplements which are available from your local pharmacy. Talk to your doctor before taking any new medication.
Close
Diarrhea
(Click here to read more)
In clinical trials, diarrhea was reported in up to 57% of CML patients and 70% of GIST patients. If you experience diarrhea during Gleevec therapy, contact your physician before taking any other drugs. Diarrhea is usually mild and can be managed with over-the-counter medications.
Close
Bleeding
(Click here to read more)
Bleeding was reported in up to 53% of patients with CML. In GIST patients, up to 34% reported bleeding in the clinical trials. Most bleeding in GIST was in the gastrointestinal tract. Consult your physician immediately if you suspect any abnormal bleeding or symptoms such as blood in stool or bruising easily.
Close
Rash
(Click here to read more)
Some patients taking Gleevec develop a skin rash. Rash has been reported in up to 47% of CML patients and 53% of patients with GIST. If you notice any red patches, itchiness, or blistering, contact your physician. You may be given an additional medication, such as an antihistamine or a topical corticosteroid, to reduce the signs and symptoms of rash. If additional treatment does not help and the rash grows severe, your physician may find it necessary to interrupt or even discontinue your therapy.
Close
Indigestion
(Click here to read more)
Another side effect experienced by some patients receiving Gleevec is indigestion, which was reported in up to 27% of CML patients and 15% of GIST patients. To reduce the chance of getting indigestion, you should take Gleevec with a meal and a large glass of water. If indigestion persists, contact your physician. Indigestion is usually mild and can be managed with over-the-counter medications. Talk to your physician before beginning any new medication.
Close
Headache
(Click here to read more)
Headache has been reported in up to 36% of CML patients and 39% of patients with GIST. Headaches were usually mild to moderate. Caution is advised when taking Gleevec with acetaminophen (Tylenol®). Talk to your doctor before beginning any new medication.
Close
Joint Pain
(Click here to read more)
Joint pain (arthralgia) has been reported in 40% of CML and 15% of GIST patients. Caution is advised when taking Gleevec with acetaminophen (Tylenol®). Consult your physician or pharmacist.
Close
If You Are Pregnant or Nursing
(Click here to read more)
Gleevec should not be taken by women who are or could be pregnant, or who are breastfeeding. Please discuss these issues with your physician or nurse before beginning therapy with Gleevec.
Close
Blood and Liver Monitoring
(Click here to read more)
During treatment with Gleevec, you will need to have frequent blood tests to help your physician monitor your condition. These tests are for measuring your blood counts and checking your liver function since Gleevec has been associated with low levels of certain blood cells as well as liver problems. Symptoms of low levels of certain blood cells can include bruising, infection, and shortness of breath. Signs of liver problems can include yellowing of the skins or eyes.
Close
Heart Monitoring
(Click here to read more)
Patients with heart disease or risk factors for heart failure should be monitored carefully. Any patients with signs or symptoms of heart failure should be evaluated and treated. Symptoms may include shortness of breath and fatigue.
Close
Gleevec and Other Medications
(Click here to read more)
The body metabolizes, or breaks down, many drugs in the liver with a specific group of proteins known as enzymes. When Gleevec is taken at the same time as other drugs, these enzymes may be forced to put the other drugs aside while they break down Gleevec. This can result in higher- or lower-than-expected levels of the other drugs in the bloodstream. Similarly, certain drugs may force the enzymes to put Gleevec aside, which can result in higher- or lower-than-expected levels of Gleevec in the bloodstream. These effects are known as drug-drug interactions. In particular, Tylenol® (acetaminophen)*, birth control pills (oral contraceptives), blood thinners (especially warfarin, Coumadin®+), herbal products (e.g., St. John's Wort), erythromycin, phenytoin (e.g., Dilantin®‡, and anticonvulsants, are all broken down by the same enzymes that metabolize Gleevec. Drug-drug interactions may therefore occur with these medications.
Since drug-drug interactions can be complex, and they may occur with Gleevec and other medications, you must tell your doctor if you are taking any other medication. Your doctor may be able to predict the results of certain drug-drug interactions and will tell you which drugs to avoid during Gleevec therapy.
Gleevec should not be taken by patients with an allergy to imatinib or to any other component of Gleevec.
Because follow-up of adult patients treated with Gleevec for Kit+ GIST are for newly diagnosed pH+ CML in chronic phase is relatively short, there are no long-term safety data available for Gleevec in these patient groups.
Please click here to view complete Prescribing Information.
Close
Return to Top
*Tylenol® (acetaminophen) is a registered trademark of McNeil Consumer Healthcare.
+Coumadin® (warfarin sodium) is a registered trademark of Bristol-Myers Squibb.
‡Dilantin® (phenytoin) is a registered trademark of Parke-Davis, a Division of Pfizer, Inc.
