Gleevec

Generic Name: imatinib (Oral route)

i-ma-TIN-ib

Commonly used brand name(s):

In the U.S.

• Gleevec

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Gleevec

Imatinib 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 Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) or gastrointestinal stromal tumors (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 to feel weak or tired. Imatinib helps your body stop making these abnormal white blood cells. GIST is a group of cancer cells that start growing in the wall of the stomach, intestines, or rectum. Imatinib helps your body stop making these abnormal cells. Imatinib is also used as an additional treatment in adult patients that have their GIST tumors completely removed.

Imatinib is also used to treat other conditions such as Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), myelodysplastic syndrome (MDS) or myeloproliferative diseases (MPD), aggressive systemic mastocytosis (ASM), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), and dermatofibrosarcoma protuberans (DFSP).

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

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, imatinib is used in certain patients with the following medical condition:

• Acute lymphoblastic leukemia, Philadelphia chromosome-positive, newly diagnosed, as part of combination chemotherapy.

Importance of Diet

Grapefruits and grapefruit juice may increase the effects of imatinib by increasing the amount of Gleevec in your body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

Before Using This Medicine

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of imatinib in children below 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of imatinib in the elderly. However, serious side effects (e.g., swelling of the face, hands, fingers, feet, and/or lower legs, and unusual weight gain) may be more likely to occur in elderly patients, who may be more sensitive than younger adults to the effects of imatinib.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant
• Carbamazepine
• Dexamethasone
• Fosaprepitant
• Phenobarbital
• Phenytoin
• Rifampin
• St John's Wort
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole
• Levothyroxine
• Pimozide
• Rifabutin
• Simvastatin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. 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.

• Ascites (fluid in the abdomen) or
• Bleeding problems or
• Congestive heart failure or
• Pericardial effusion (fluid around the heart) or
• Pleural effusion (fluid around your lungs) or
• Pulmonary edema (fluid inside the lungs) or
• Underactive thyroid—Use with caution. May make these conditions worse.

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

• Heart disease—Patients with this condition should be monitored closely when using imatinib.

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

• Kidney disease or
• Liver disease—Drug effects may be increased because of slower removal of imatinib from the body.

Proper Use of Gleevec

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 to help prevent stomach irritation.

If you cannot swallow the tablet, you may dissolve the tablet in a glass of water or apple juice. If you are taking the 100 mg tablet, dissolve it in 2 ounces (1/4 cup) of water or juice. If you are taking the 400 mg tablet, dissolve it in 7 ounces (about 1 cup) of water or juice. Stir with a spoon and drink immediately after the tablet has dissolved.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablet):
  • For the treatment of ALL:
    • Adults—600 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of ASM:
    • Adults—400 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of CML:
    • Adults—400 milligrams (mg) or 600 mg once a day, as determined by your doctor. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of DFSP:
    • Adults—800 milligrams (mg) per day.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of GIST:
    • Adults—400 milligrams (mg) once a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For the additional treatment after complete removal of GIST:
    • Adults—400 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of HES or CEL:
    • Adults—400 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of MDS or MPD:
    • Adults—400 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Gleevec

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects. Be sure to keep all appointments.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Some serious side effects such as swelling of the face, hands, fingers, feet, and/or lower legs; severe stomach pain; black, tarry stools; vomiting of blood or material that looks like coffee grounds; or unusual weight gain can occur during treatment with this medicine. .

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.

Check with your doctor right away if you have symptoms of jaundice (yellow skin or eyes) because these may be signs of a serious liver condition.

This medicine may also cause serious heart conditions. Call your doctor right away if you start to have chest pain or discomfort; fast, irregular, or pounding heart beat; or shortness of breath.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Gleevec Side Effects

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 immediately if any of the following side effects occur:

• Abdominal pain, cramping, burning, or tenderness
• bleeding from wound after surgery
• bleeding gums
• bleeding problems
• bloating or swelling of the face, hands, lower legs, or feet
• blood in the urine
• bloody eye
• bloody nose
• blue lips and fingernails
• blurred vision
• body aches or pain
• chest pain or discomfort
• chills
• clay-colored stools
• cough
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• decrease in the amount of urine
• decreased appetite
• decreased urination
• diarrhea
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• dry mouth
• ear congestion
• fever
• general feeling of discomfort or illness
• headache
• inability to speak
• increased menstrual flow or vaginal bleeding
• increased thirst
• irregular heartbeat
• itching
• joint pain
• large, flat, blue, or purplish patches on the skin
• loss of appetite
• loss of voice
• mood changes
• muscle aches and pain
• muscle cramps
• nasal congestion
• nausea and vomiting
• noisy, rattling breathing
• nosebleed
• numbness or tingling in the hands, feet, or lips
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• prolonged bleeding from cuts
• rapid weight gain
• red, black, bloody, or tarry stools
• red or dark brown urine
• redness of the eye
• seizures
• shivering
• shortness of breath
• skin rash
• slurred speech
• small red or purple spots on the skin
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• sweating
• swelling in the legs and ankles
• swollen glands
• temporary blindness
• tightness in the chest
• trouble sleeping
• troubled breathing at rest
• troubled breathing when moving or walking
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weakness in the arm or leg on one side of the body, sudden and severe
• wheezing
• yellow eyes or skin

• Anxiety
• blistering, peeling, or loosening of the skin
• change in vision not present before treatment
• chest pain, possibly moving to the left arm, neck, or shoulder
• confusion
• irregular, fast or slow, or shallow breathing
• nausea, heartburn, and/or indigestion, severe and continuing
• red, irritated eyes
• red skin lesions, often with a purple center
• pain in bones
• seeing floaters, veil or curtain appearing across part of vision
• severe abdominal pain, cramping, or burning
• severe constipation
• severe vomiting
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• difficulty having a bowel movement (stool)
• difficulty with moving
• discouragement
• excess air or gas in the stomach or intestines
• fear or nervousness
• feeling sad or empty
• feeling unusually cold
• full or bloated feeling
• increased bowel movements
• irritability
• lack or loss of strength
• loose stools
• loss of interest or pleasure
• muscle stiffness
• night sweats
• passing gas
• sleeplessness
• stomach discomfort, upset, or pain
• swollen joints
• trouble concentrating
• unable to sleep
• weight loss

• Back pain
• bad, unusual or unpleasant (after) taste
• change in taste
• watering of the eyes

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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