HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use TORISEL® safely and effectively. See full prescribing information for TORISEL. TORISEL Kit (temsirolimus) injection, for intravenous use Initial U.S. Approval: 2007 RECENT MAJOR CHANGESINDICATIONS AND USAGETORISEL® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSTORISEL injection, 25 mg/mL supplied with DILUENT for TORISEL. (3) CONTRAINDICATIONSTORISEL is contraindicated in patients with bilirubin > 1.5×ULN. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe most common adverse reactions (incidence ≥30%) are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common laboratory abnormalities (incidence ≥30%) are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, elevated alkaline phosphatase, elevated serum creatinine, lymphopenia, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia. (6) DRUG INTERACTIONSUSE IN SPECIFIC POPULATIONSLactation: Do not breastfeed. (8.2) See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2018 |

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TORISEL®Highlights (temsirolimus)
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