"Oct. 29, 2012 -- The FDA has approved Teva's Synribo (omacetaxine mepesuccinate) for treating adults with chronic myelogenous leukemia (CML).
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Dosing and Administration
Patients should be informed to take Gleevec exactly as prescribed, not to change their dose or to stop taking Gleevec unless they are told to do so by their doctor. If patients miss a dose they should be advised to take their dose as soon as possible unless it is almost time for their next dose in which case the missed dose should not be taken. A double dose should not be taken to make up for any missed dose. Patients should be advised to take Gleevec with a meal and a large glass of water.
Pregnancy and Breast-Feeding
Patients should be advised to inform their doctor if they are or think they may be pregnant. Women of reproductive potential should be advised to avoid becoming pregnant while taking Gleevec. Sexually active female patients taking Gleevec should use highly effective contraception. Patients should also be advised not to breast feed while taking Gleevec.
Patients should be advised to tell their doctor if they experience side effects during Gleevec therapy including fever, shortness of breath, blood in their stools, jaundice, sudden weight gain, symptoms of cardiac failure, or if they have a history of cardiac disease or risk factors for cardiac failure.
Patients should be advised not to take any other medications, including over-the-counter medications such as herbal products without talking to their doctor or pharmacist first. Examples of other medications that should not be taken with Gleevec are warfarin, erythromycin, and phenytoin. Patients should also be advised to tell their doctor if they are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods known to inhibit CYP3A4 while taking Gleevec.
Patients should be advised that growth retardation has been reported in children and pre-adolescents receiving Gleevec. The long term effects of prolonged treatment with Gleevec on growth in children are unknown. Therefore, close monitoring of growth in children under Gleevec treatment is recommended.
Driving and Using Machines
Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with Gleevec. Therefore, caution patients about driving a car or operating machinery.
Last reviewed on RxList: 2/21/2013
This monograph has been modified to include the generic and brand name in many instances.
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