Full Adverse Event Profile
In the phase 3 randomized, open-label study of interferon-alpha (IFN-α) alone, TORISEL alone, and TORISEL and IFN-α, a total of 616 patients were treated. Two hundred patients received IFN-α, 208 received TORISEL 25 mg weekly, and 208 patients received a combination of TORISEL and IFN-α weekly.1
The most common laboratory abnormalities (incidence ≥ 30%) were1
- Anemia (94%)
- Hyperglycemia (89%)
- Hyperlipemia (87%)
- Hypertriglyceridemia (83%)
- Elevated alkaline phosphatase (68%)
- Elevated serum creatinine (57%)
- Lymphopenia (53%)
- Hypophosphatemia (49%)
- Thrombocytopenia (40%)
- Elevated AST (38%)
- Leukopenia (32%)
The most common (incidence ≥ 30%) adverse reactions observed with TORISEL were1
- Rash (47%)
- Asthenia (51%)
- Mucositis (41%)
- Nausea (37%)
- Edema (35%)
- Anorexia (32%)
- On average, patients receiving TORISEL received 92% of the planned weekly 25 mg dose2
- Treatment with the combination of TORISEL 15 mg and IFN-α was associated with an increased incidence of multiple adverse reactions and did not result in a significant increase in overall survival when compared with IFN-α1
- Fewer patients experienced Grade 3 or 4 adverse events (AEs) with TORISEL compared with IFN-α (67% vs 78%, respectively)1
- The incidence of certain metabolic abnormalities was higher with TORISEL compared with IFN-α, including hyperglycemia, hypophosphatemia, hypokalemia, hyperlipemia, increased creatinine, and elevated alkaline phosphatase1
Laboratory monitoring should be performed at the physician's discretion.1
Get information about managing TORISEL side effects in the Nurses' Guide to TORISEL.
Patient Education Materials
Give your patients and their caregivers information about renal cell carcinoma and TORISEL.
References:
- TORISEL® Kit (temsirolimus) Prescribing Information, Wyeth Pharmaceuticals Inc.
- Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell
carcinoma. N Engl J Med. 2007;356:2271-2281.
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