"Oct. 29, 2012 -- The FDA has approved Teva's Synribo (omacetaxine mepesuccinate) for treating adults with chronic myelogenous leukemia (CML).
The fast-track approval is for people for whom at least two of the most common treatments ha"...
(dasatinib) Tablets for Oral Use
SPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6 -methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S • H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:
Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. SPRYCEL tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.
What are the possible side effects of dasatinib (Sprycel)?
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.
Stop taking dasatinib and call your doctor right away if you have any symptoms of pulmonary arterial hypertension (PAH), such as:
- feeling tired or short of breath (even with mild exertion);
- swelling in your feet or lower legs;
- rapid weight gain;
- blue-colored lips and skin; and
- feeling light-headed or fainting.
Stop using dasatinib and call your doctor at once if...
What are the precautions when taking dasatinib (Sprycel)?
Before taking dasatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose), 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., irregular heartbeat), liver problems, a certain lung problem (pulmonary arterial hypertension).
Dasatinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right...
Last reviewed on RxList: 7/1/2013
This monograph has been modified to include the generic and brand name in many instances.
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