Other drug names:	A-Am  An-Az  B  C-Ch  Ci-Cz  D-Dh  Di-Dz  E  F  G  H  I-J  K-L  M-Mh  Mi-Mz  N-Nh  Ni-Nz  O  P-Pl  Pm-Pz  Q-R  S-Sn  So-Sz  T-To  Tp-Tz  U-V  W-Z  0-9

In the U.S.—

Gleevec

In Canada—

Gleevec

• Antineoplastic

Imatinib ( i-MAT-in-ib) is a new type of medication that prevents and stops the growth of cancer cells. It helps your body fight against a type of cancer called chronic myeloid leukemia (CML) or gastrointestinal stromal tumor (GIST). CML is a disease in which your body makes too many abnormal white blood cells which can cause you to become sick more often and also to feel weak or tired. Imatinib helps your body to stop making these abnormal white blood cells. GIST is a group of cancer cells that started growing in the wall of the stomach, intestines, or rectum. Imatinib helps your body to stop making these abnormal cells.

Before you begin treatment with imatinib, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Capsules (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For imatinib, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to imatinib. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Imatinib has not been studied in pregnant women. However, studies in animals have shown that imatinib causes birth defects and other problems with pregnancy. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. This medicine may be needed in serious diseases or other situations that threaten the mother's life. Be sure you have discussed this with your doctor.

Breast-feeding—It is not known whether imatinib passes into human breast milk. However, imatinib is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of imatinib in children with use in other age groups. Safety and effectiveness have not been established in children under 18 years of age.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. Fluid retention may be more likely to occur in elderly patients, who may be more sensitive than younger adults to the effects of imatinib.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking imatinib, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicines) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Rheumatrex) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir)—Concurrent use of these medicines with imatinib increases the risk of infection.

• If you have ever been treated with x-rays or other cancer medicines—Imatinib may increase the effects of these medicines or radiation therapy on the blood.

• Carbamazepine (e.g., Tegretol) or
• Dexamethasone (e.g., Decadron) or
• Phenobarbital (e.g., Luminal) or
• Phenytoin (e.g., Dilantin) or
• Rifampicin (e.g., Rifampin) or
• St. John's Wort—These medications may decrease the amount of imatinib in your body.

• Clarithromycin (e.g., Biaxin) or
• Erythromycin (e.g., E-Mycin, Erythrocin) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral)—These medications may increase the amount of imatinib in your body.

• Cyclosporine (e.g., Sandimmune) or
• Pimozide (e.g., Orap)—Imatinib may increase the amount of these medications in your blood to possibly harmful levels.

• Warfarin (e.g., Coumadin)—Imatinib may interfere with the metabolism of warfarin, which can cause clotting problems.

• Grapefruit or
• Grapefruit juice or
• Grapefruit-containing food or vitamin—These foods or vitamins may increase the amount of imatinib in your body. This may increase the chance of side effects.

Other medical problems—The presence of other medical problems may affect the use of imatinib. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Platelet problems or
• White blood cell problems—May worsen and affect the decision to continue therapy

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Liver disease—Effects may be increased because of slower removal of imatinib from the body

• Infection—Imatinib may decrease your body's ability to fight infection

Take imatinib only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

This medicine should be taken with a tall glass of water and a meal.

Do not take imatinib with grapefruit, grapefruit juice, or grapefruit-containing foods or supplements.

Dosing—

The dose of imatinib will be different for different patients. The dose that is used may depend on a number of things, how you are responding to the medicine and whether or not it is affecting your blood cells. If you are taking imatinib at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of imatinib, ask your doctor.

Missed dose—

If you miss a dose of this medicine, do not take the missed dose at all and do not double the next one. Instead, go back to your regular dosing schedule and check with your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with imatinib, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Imatinib may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Imatinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Black, tarry stools;  bleeding problems ;  bloating or swelling of face, hands, lower legs, and/or feet;  chest pain;  chills;  cough;  decreased urination;  fever;  painful or difficult urination;  pale skin;  rapid weight gain;  shortness of breath;  sore throat;  sores, ulcers, or white spots on lips or in mouth;  swollen glands;  trouble breathing, exertional;  unusual bleeding or bruising;  unusual tiredness or weakness  
  
  

• Less common
  • Body aches or pain;  convulsions (seizures) ;  dry mouth;  ear congestion ;  general feeling of discomfort or illness;  headache sudden and severe;  increased thirst;  irregular heartbeat;  loss of appetite;  loss of voice;  mood changes;  muscle pain or cramps;  nausea and vomiting;  numbness or tingling in hands, feet, or lips;  runny nose;  shivering;  small red or purple spots on skin;  sneezing;  stuffy nose;  sweating;  tightness in chest;  wheezing 
  
  

• Rare
  • Bloody stools;  blurred vision;  inability to speak;  slurred speech;  temporary blindness;  vomiting of blood or material that looks like coffee grounds;  weakness in arm and/or leg on one side of the body, sudden and severe 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Bone pain;  increased bowel movements ;  joint pain;  loose stools ;  skin rash;  stomach pain  
  
  

• Less common
  • Acid indigestion;  back pain;  bad unusual or unpleasant (after)taste;  bloated full feeling;  bloody nose;  change in taste;  difficulty having a bowel movement (stool);  dizziness;  excess air or gas in stomach or intestines;  headache;  itching skin;  lack or loss of strength ;  large, flat, blue or purplish patches in the skin ;  loss of appetite;  night sweats;  passing gas;  sleeplessness ;  trouble sleeping;  unable to sleep;  upset stomach;  watering of eyes;  weight loss 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 06/08/2001

Revised: 12/04/2003