Sutent (Sunitinib Malate) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

Sutent

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Cancer is the uncontrolled growth of abnormal cells anywhere in a body. The abnormal cells are termed cancer cells, malignant cells, or tumor cells. Many cancers and the abnormal cells that compose the cancer tissue are further identified by the name of the tissue that the abnormal cells originated from (for example, breast cancer, lung cancer, colon cancer). Cancer is not confined to humans; animals and other living organisms can get cancer. Below is a schematic that shows normal cell division and how when a cell is damaged or altered without repair to its system, the cell usually dies. Also shown is what can occur when such damaged or unrepaired cells do not die and become cancer cells and proliferate with uncontrolled growth; a mass of cancer cells develop. Frequently, cancer cells can break away from this original mass of cells, travel through the blood and lymph systems, and lodge in other organs where they can again repeat the ...

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SUTENT®
(sunitinib malate) Capsules, Oral

WARNING: HEPATOTOXICITY

Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. [See WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION

SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-l,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C₂₂H₂₇FN₄O₂ • C₄H₆O₅ and the molecular weight is 532.6 Daltons.

The chemical structure of sunitinib malate is:

SUTENT®
(sunitinib malate) Structural Formula Illustration

Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2.

SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules containing sunitinib malate equivalent to 12.5 mg, 25 mg or 50 mg of sunitinib together with mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients.

The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide and black iron oxide. The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide.

What are the possible side effects of sunitinib (Sutent)?

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 using sunitinib and call your doctor at once if you have any of these serious side effects:

chest pain, general ill feeling;
uneven heart rate;
feeling short of breath, even with mild exertion;
swelling of your ankles or feet;
weakness, tired feeling, loss of appetite, weight loss;
sudden numbness or...

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What are the precautions when taking sunitinib malate (Sutent)?

Before taking sunitinib, 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., congestive heart failure), high blood pressure, liver problems, thyroid disease.

Sunitinib 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 require immediate medical attention. The risk of QT prolongation may...

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Last reviewed on RxList: 6/6/2011
This monograph has been modified to include the generic and brand name in many instances.