HIGHLIGHTS OF PRESCRIBING INFORMATION
These 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 CHANGES
INDICATIONS AND USAGE
TORISEL® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
TORISEL injection, 25 mg/mL supplied with DILUENT for TORISEL. (3)
TORISEL is contraindicated in patients with bilirubin > 1.5×ULN. (4)
WARNINGS AND PRECAUTIONS
The 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)
USE IN SPECIFIC POPULATIONS
Lactation: Do not breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
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