Changes to Packaging for TORISEL Kit
Pfizer is pleased to announce changes to our TORISEL Kit (temsirolimus) injection 25 mg/mL.
NOTE: Appearance of product packaging may vary
*Category 1: The recommendation is based on high-level evidence (eg, randomized controlled trials) and there is uniform NCCN consensus.
TORISEL—Powerful 1st-line evidence in poor-risk patients with advanced RCC
Median overall survival (OS)* of nearly 11 months was achieved with TORISEL1,2
Results from a phase 3, multicenter, 3-arm, randomized, open-label study conducted in 626 previously untreated patients with advanced RCC.1 Patients had ≥ 3 of 6 preselected prognostic risk factors.1 Patients received TORISEL
(25 mg IV weekly) or IFN (maximum 18 MU SubC 3 times weekly).1,2
- 49% significant increase in median OS with TORISEL vs IFN1,2
- Median duration of treatment was 17 weeks (range 1-126 weeks) for TORISEL and 8 weeks (range 1-124 weeks) for IFN1
* Time from randomization to death.
† A comparison is considered statistically significant if the P-value is <0.0159 (O'Brien-Fleming boundary at 446 deaths).
‡ Based on log-rank test stratified by prior nephrectomy and region.
§ Based on Cox proportional hazard model stratified by prior nephrectomy and region.
TORISEL is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
Important Safety Information
- TORISEL is contraindicated in patients with bilirubin >1.5 x ULN and should be used with caution when treating patients with mild hepatic impairment (bilirubin >1 - 1.5 x ULN or AST > ULN but bilirubin ≤ ULN). If TORISEL must be given to patients with mild hepatic impairment, reduce the dose of TORISEL to 15 mg/week. In a phase 1 study, the overall frequency of ≥ grade 3 adverse reactions and deaths, including deaths due to progressive disease, was greater in patients with baseline bilirubin > 1.5 x ULN.
- Hypersensitivity/infusion reactions, including flushing, chest pain, dyspnea, hypotension, apnea, loss of consciousness, hypersensitivity and anaphylaxis, may occur very early in the first infusion or with subsequent infusions. Pretreat with an H1 antihistamine. TORISEL infusion should be interrupted in patients with infusion reactions and appropriate therapy given.
- Serum glucose, serum cholesterol, and triglycerides should be tested before and during TORISEL treatment.
- TORISEL is likely to result in hyperglycemia and hyperlipemia. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy and/or lipid-lowering agents, respectively.
- TORISEL may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections.
- Cases of interstitial lung disease, some resulting in death, have occurred. Some patients were asymptomatic or had minimal symptoms. Patients should undergo baseline radiography prior to TORISEL therapy and periodically thereafter, even in the absence of clinical respiratory symptoms. Follow patients closely and, if clinically significant respiratory symptoms develop, consider withholding TORISEL until recovery of symptoms and radiographic improvement of pneumonitis findings. Some patients required TORISEL discontinuation and/or treatment with corticosteroids and/or antibiotics.
- Cases of fatal bowel perforation occurred with TORISEL. These patients presented with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea, and/or acute abdomen.
- Cases of rapidly progressive and sometimes fatal acute renal failure not clearly related to disease progression occurred in patients who received TORISEL.
- Due to abnormal wound healing, use TORISEL with caution in the perioperative period.
- Patients with central nervous system tumors (primary CNS tumor or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including fatal outcomes) while receiving TORISEL.
- Live vaccinations and close contact with those who received live vaccines should be avoided.
- TORISEL may cause fetal harm. Patients and their partners should be advised to avoid pregnancy throughout treatment and for 3 months after TORISEL therapy has stopped.
- Elderly patients may be more likely to experience certain adverse reactions including diarrhea, edema and pneumonia.
- The most common (incidence ≥30%) adverse reactions observed with TORISEL are: rash (47%), asthenia (51%), mucositis (41%), nausea (37%), edema (35%), and anorexia (32%). The most common laboratory abnormalities (incidence ≥30%) are 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%), and leukopenia (32%).
- Most common grades 3/4 adverse events and laboratory abnormalities included asthenia (11%), dyspnea (9%), hemoglobin decreased (20%), lymphocytes decreased (16%), glucose increased (16%), phosphorus decreased (18%), and triglycerides increased (44%).
- Pleural effusion, hemodynamically significant pericardial effusions requiring intervention, convulsions, rhabdomyolysis, Stevens-Johnson Syndrome, complex regional pain syndrome and extravasations have been reported during postmarketing use.
- Strong inducers of CYP3A4/5 (eg, dexamethasone, rifampin) and strong inhibitors of CYP3A4 (eg, ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended.
- Avoid St. John's Wort which may decrease TORISEL plasma concentrations, and grapefruit juice which may increase plasma concentrations of the major metabolite of TORISEL.
- The combination of TORISEL and sunitinib resulted in dose-limiting toxicity (Grade 3/4 erythematous maculopapular rash, and gout/cellulitis requiring hospitalization).
Please see the full Prescribing Information for TORISEL.
- TORISEL® Kit (temsirolimus) Prescribing Information, May 2012.
- Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma.
N Engl J Med. 2007;356(22):2271-2281.
- National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: kidney cancer. V.2.2012.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Kidney Cancer V.2.2012. ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN content are trademarks owned by the National Comprehensive Cancer Network, Inc.