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Manufacturer Pfizer
Distributor Zuellig
Contents Sunitinib malate
Indications Treatment of GI stromal tumor (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance & metastatic renal cell carcinoma (MRCC).
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Dosage 50 mg/day for 4 consecutive wk, followed by a 2-wk rest period (schedule 4/2) to complete a 6-wk cycle.
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Overdosage View Sutent overdosage for action to be taken in the event of an overdose.
Administration May be taken with or without food
Contraindications [Click for Sutent detailed prescribing infomation]
Special Precautions Perform complete blood count & physical exam, liver & renal function assessment. Concomitant treatment w/ potent CYP3A4 inhibitors & inducers. Risk of osteonecrosis of the jaw (ONJ) when given w/ IV bisphosphonates. Avoid invasive dental procedures. Impaired liver & hepatic function. Childn. Pregnancy & lactation.
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Adverse Drug Reactions Pulmonary embolism, thrombocytopenia, tumor hemorrhage, febrile neutropenia, HTN, fatigue, GI disorders, skin discoloration, dysgeusia, anorexia, increased lipase, ONJ. Hypothyroidism, QT prolongation, HFS, decrease LVEF, pancreatic function.
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Drug Interactions CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, clarithromycin). CYP3A4 inducers (rifampicin, dexamethasone, phenytoin, carbamazepine, phenobarb, St. John's wort).
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Pregnancy Category (US FDA)
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Description View Sutent description for details of the chemical structure and excipients (inactive components).
Mechanism of Action View Sutent mechanism of action for pharmacodynamics and pharmacokinetics details.
Presentation/Packing
Form Packing Photo
Sutent capsule Sutent 12.5 mg x 28's
Manufacturer: Pfizer
Distributor: Zuellig