Gleevec

DRUG DESCRIPTION

Imatinib is a small molecule kinase inhibitor. Gleevec film-coated tablets contain imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is

GLEEVEC (imatinib mesylate) Structural Formula Illustration

Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O CH4SO3 and its molecular weight is 589.7. Imatinib mesylate is soluble in aqueous buffers ? pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol and ethanol, but is insoluble in n-octanol, acetone and acetonitrile.

Inactive Ingredients: colloidal silicon dioxide (NF); crospovidone (NF); hydroxypropyl methylcellulose (USP); magnesium stearate (NF); and microcrystalline cellulose (NF). Tablet coating: ferric oxide, red (NF); ferric oxide, yellow (NF); hydroxypropyl methylcellulose (USP); polyethylene glycol (NF) and talc (USP).

What are the possible side effects of imatinib (Gleevec)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • black,...

Read All Potential Side Effects and See Pictures of Gleevec

What are the precautions when taking imatinib mesylate (Gleevec)?

Before taking imatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., heart failure), kidney problems, liver problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with...

Read All Potential Precautions of Gleevec


Gleevec Consumer (continued)

SIDE EFFECTS: Upset stomach, nausea, vomiting, diarrhea, headache, joint pain, or muscle cramps/pain may occur. If any of these effects persist or worsen, notify your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, fast/pounding heartbeat, extreme tiredness, sudden/unexplained weight gain, swelling (especially of lower legs/the area around eyes), increasing trouble breathing (shortness of breath).

Tell your doctor immediately if any of these rare but very serious side effects occur: black/bloody stools, dark urine, stomach/abdominal pain, vomit that looks like coffee grounds, yellowing eyes/skin.

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking imatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., heart failure), kidney problems, liver problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

The elderly may be more sensitive to the side effects of this drug (e.g., swelling). Also, the manufacturer recommends a routine heart test (LV ejection fraction) in the elderly before treatment.

This medication is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. To avoid pregnancy, both males and females using this drug must use reliable form(s) of birth control (e.g., condoms, birth control pills) during treatment with this drug. Talk with your doctor about effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Gleevec Patient Information Including Side Effects

Brand Names: Gleevec

Generic Name: imatinib (oral) (Pronunciation: im MA ta nib)

  • What is imatinib (Gleevec)?
  • What are the possible side effects of imatinib (Gleevec)?
  • What is the most important information I should know about imatinib (Gleevec)?
  • What should I discuss with my healthcare provider before taking imatinib (Gleevec)?
  • How should I take imatinib (Gleevec)?
  • What happens if I miss a dose (Gleevec)?
  • What happens if I overdose (Gleevec)?
  • What should I avoid while taking imatinib (Gleevec)?
  • What other drugs will affect imatinib (Gleevec)?
  • Where can I get more information?

What is imatinib (Gleevec)?

Imatinib interferes with the growth of some cancer cells.

Imatinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML). It is also used to treat certain tumors of the stomach and digestive system.

Imatinib may also be used for other purposes not listed in this medication guide.

What are the possible side effects of imatinib (Gleevec)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • urinating more or less than usual, or not at all; or
  • sudden, severe headache or pain behind the eyes.

Less serious side effects may include:

  • mild nausea, diarrhea, upset stomach, gas;
  • muscle or joint pain;
  • skin rash;
  • headache, dizziness;
  • stuffy nose, cough, sore throat;
  • depression, sleep problems (insomnia); or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about imatinib (Gleevec)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have liver disease, kidney disease, congestive heart failure, a history of stomach ulcer or bleeding, or if you are receiving chemotherapy.

Take this medicine with a large glass of water.

Imatinib should be taken with a meal. Do not take the medicine on an empty stomach.

If you miss a dose, take the medicine as soon as you remember, making sure you also eat a meal and drink a large glass of water. If it is almost time for your next meal, skip the missed dose and take the medicine when you eat your next meal. Do not take extra medicine to make up the missed dose.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

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