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Sutent

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Sutent

SUTENT®
(sunitinib malate) Capsules

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- 1,2-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 a serious side effect such as:

  • chest pain, general ill feeling;
  • severe dizziness, fainting, fast or pounding heartbeat;
  • swelling of your ankles or feet, feeling short of breath (even with mild exertion);
  • sudden numbness or weakness, especially on one side of the body;
  • sudden and severe headache, confusion, problems with...

Read All Potential Side Effects and See Pictures of Sutent »

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 need medical attention right away.

The risk of QT...

Read All Potential Precautions of Sutent »

Last reviewed on RxList: 10/7/2013
This monograph has been modified to include the generic and brand name in many instances.

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