TORISEL® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (1)

• The recommended dose of TORISEL is 25 mg administered as an intravenous infusion over a 30–60 minute period once a week. Treat until disease progression or unacceptable toxicity. (2.1)
• Antihistamine pre-treatment is recommended. (2.2)
• Dose reduction is required in patients with mild hepatic impairment. (2.4)
• TORISEL (temsirolimus) injection vial contents must first be diluted with the enclosed diluent before diluting the resultant solution with 250 mL of 0.9% Sodium Chloride Injection. (2.5)

TORISEL injection, 25 mg/mL supplied with DILUENT for TORISEL. (3)

TORISEL is contraindicated in patients with bilirubin > 1.5×ULN. (4)

• Hypersensitivity/Infusion Reactions (including some life-threatening and rare fatal reactions) can occur early in the first infusion of TORISEL. Patients should be monitored throughout the infusion. (5.1)
• To treat hypersensitivity reactions, stop TORISEL and treat with an antihistamine. TORISEL may be restarted at physician discretion at a slower rate. (5.1)
• Hepatic Impairment: Use caution when treating patients with mild hepatic impairment and reduce dose. (2.4, 5.2)
• Hyperglycemia and hyperlipidemia are likely and may require treatment. Monitor glucose and lipid profiles. (5.3, 5.6)
• Infections may result from immunosuppression. (5.4)
• Monitor for symptoms or radiographic changes of interstitial lung disease (ILD). If ILD is suspected, discontinue TORISEL, and consider use of corticosteroids and/or antibiotics. (5.5)
• Bowel perforation may occur. Evaluate fever, abdominal pain, bloody stools, and/or acute abdomen promptly. (5.7)
• Renal failure, sometimes fatal, has occurred. Monitor renal function at baseline and while on TORISEL. (5.8)
• Due to abnormal wound healing, use TORISEL with caution in the perioperative period. (5.9)
• Proteinuria and nephrotic syndrome may occur. Monitor urine protein prior to the start of TORISEL therapy and periodically thereafter. Discontinue TORISEL in patients with who develop nephrotic syndrome. (5.11)
• Live vaccinations and close contact with those who received live vaccines should be avoided. (5.14)
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential hazard to the fetus and to use effective contraception. (5.15, 8.1, 8.3)
• Elderly patients may be more likely to experience certain adverse reactions, including diarrhea, edema and pneumonia. (5.16)

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)

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

Strong inducers of CYP3A4/5 and inhibitors of CYP3A4 may affect concentrations of the primary metabolite of TORISEL. If alternatives cannot be used, dose modifications of TORISEL are recommended. (7.1, 7.2, 7.3)

Lactation: Do not breastfeed. (8.2)