(temsirolimus)
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 INDICATIONS 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)To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION. Revised: 4/2023 |
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