Drug Notebook

FDA Alerts

Special Alerts:

[Posted 10/19/2006] Novartis and FDA notified healthcare professionals about revisions to the PRECAUTIONS section of the prescribing information, describing the occasional occurrence of severe congestive heart failure and left ventricular dysfunction in patients taking imatinib (Gleevec). Most of the patients with reported cardiac events had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patients with signs or symptoms consistent with cardiac failure should be evaluated and treated. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Gleevec, http://www.fda.gov/medwatch/safety/2006/Gleevec_101906_HCPletter.pdf and http://www.fda.gov/medwatch/safety/2006/Gleevec_PI_Sep2006.pdf.

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imatinib
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(im MA ta nib)

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

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, or a history of stomach ulcer or bleeding.

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.

What is imatinib?

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 should I discuss with my healthcare provider before taking imatinib?

Do not use this medication if you are allergic to imatinib.

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; or

  • a history of stomach ulcer or bleeding.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use imatinib without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether imatinib passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone younger than 18 years old without a doctor's advice.

How should I take imatinib?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a large glass of water. Imatinib should be taken with a meal.

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.

Store imatinib at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose 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.

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