Brand Name
Torisel
Generic Name
Temsirolimus
View Brand Information FDA approval date: July 01, 2007
Form: Kit
What is Torisel (Temsirolimus)?
Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma. Temsirolimus injection is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
Approved To Treat
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Brand Information
Torisel (temsirolimus)
1INDICATIONS AND USAGE
TORISEL is indicated for the treatment of advanced renal cell carcinoma.
2DOSAGE FORMS AND STRENGTHS
TORISEL (temsirolimus) is supplied as a kit consisting of the following:
TORISEL (temsirolimus) injection (25 mg/mL). The TORISEL vial contains temsirolimus at a concentration of 25 mg/mL. The vial contains an overfill of 0.2 mL to ensure the ability to withdraw the recommended dose.
DILUENT for TORISEL. The DILUENT vial includes a deliverable volume of 1.8 mL. This vial contains an overfill in order to ensure that the appropriate volume can be withdrawn.
3CONTRAINDICATIONS
TORISEL is contraindicated in patients with bilirubin >1.5×ULN
4ADVERSE REACTIONS
The following serious adverse reactions have been associated with TORISEL in clinical trials and are discussed in greater detail in other sections of the label
- Hypersensitivity/Infusion Reactions
- Hepatic Impairment
- Hyperglycemia/Glucose Intolerance
- Infections
- Interstitial Lung Disease
- Hyperlipidemia
- Bowel Perforation
- Renal Failure
- Wound Healing Complications
- Intracerebral Hemorrhage
The most common (≥30%) adverse reactions observed with TORISEL are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common (≥30%) laboratory abnormalities observed with TORISEL are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, lymphopenia, elevated alkaline phosphatase, elevated serum creatinine, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia.
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.
In the phase 3 randomized, open-label study of interferon alfa (IFN-α) alone, TORISEL alone, and TORISEL and IFN-α, a total of 616 patients were treated. Two hundred patients received IFN-α weekly, 208 received TORISEL 25 mg weekly, and 208 patients received a combination of TORISEL and IFN-α weekly
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-α alone.
Table 1 shows the percentage of patients experiencing treatment emergent adverse reactions. Reactions reported in at least 10% of patients who received TORISEL 25 mg alone or IFN-α alone are listed. Table 2 shows the percentage of patients experiencing selected laboratory abnormalities. Data for the same adverse reactions and laboratory abnormalities in the IFN-α alone arm are shown for comparison
The following selected adverse reactions were reported less frequently (<10%).
Gastrointestinal Disorders – Gastrointestinal hemorrhage (1%), rectal hemorrhage (1%).
Eye Disorders – Conjunctivitis (including lacrimation disorder) (8%).
Immune System – Angioneurotic edema-type reactions (including delayed reactions occurring two months following initiation of therapy) have been observed in some patients who received TORISEL and ACE inhibitors concomitantly.
Infections – Pneumonia (8%), upper respiratory tract infection (7%), wound infection/post-operative wound infection (1%), sepsis (1%).
General Disorders and Administration Site Conditions - Diabetes mellitus (5%).
Respiratory, Thoracic and Mediastinal Disorders – Pleural effusion (4%).
Vascular – Hypertension (7%), venous thromboembolism (including deep vein thrombosis and pulmonary embolus [including fatal outcomes]) (2%), thrombophlebitis (1%), pericardial effusion (1%).
Nervous System Disorders – Convulsion (1%).
4.2Post-marketing and Other Clinical Experience
The following adverse reactions have been identified during post approval use of TORISEL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to readily estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been observed in patients receiving temsirolimus: angioedema, rhabdomyolysis, Stevens-Johnson Syndrome, complex regional pain syndrome (reflex sympathetic dystrophy), pancreatitis, cholecystitis, and cholelithiasis.
There are also post-marketing reports of temsirolimus extravasations resulting in swelling, pain, warmth, and erythema.
5OVERDOSAGE
There is no specific treatment for TORISEL intravenous overdose. TORISEL has been administered to patients with cancer in phase 1 and 2 trials with repeated intravenous doses as high as 220 mg/m
6DESCRIPTION
Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent.
Temsirolimus is a white to off-white powder with a molecular formula of C
The chemical name of temsirolimus is (3
TORISEL (temsirolimus) injection, 25 mg/mL, is a clear, colorless to light yellow, non-aqueous, ethanolic, sterile solution. TORISEL (temsirolimus) injection requires two dilutions prior to intravenous infusion. TORISEL (temsirolimus) injection should be diluted only with the supplied DILUENT for TORISEL.
DILUENT for TORISEL is a sterile, non-aqueous solution that is supplied with TORISEL injection, as a kit.
TORISEL (temsirolimus) injection, 25 mg/mL:
Active ingredient: temsirolimus (25 mg/mL)
Inactive ingredients: dehydrated alcohol (39.5% w/v),
DILUENT for TORISEL:
Inactive ingredients: polysorbate 80 (40.0% w/v), polyethylene glycol 400 (42.8% w/v) and dehydrated alcohol (19.9% w/v).
After the TORISEL (temsirolimus) injection vial has been diluted with DILUENT for TORISEL, in accordance with the instructions in section 2.5, the solution contains 35.2% alcohol.
TORISEL (temsirolimus) injection and DILUENT for TORISEL are filled in clear glass vials with butyl rubber stoppers.
7CLINICAL STUDIES
A phase 3, multi-center, three-arm, randomized, open-label study was conducted in previously untreated patients with advanced renal cell carcinoma (clear cell and non-clear cell histologies). The objectives were to compare Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR), and safety in patients receiving IFN-α to those receiving TORISEL or TORISEL plus IFN-α. Patients in this study had 3 or more of 6 pre-selected prognostic risk factors (less than one year from time of initial renal cell carcinoma diagnosis to randomization, Karnofsky performance status of 60 or 70, hemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, lactate dehydrogenase >1.5 times the upper limit of normal, more than one metastatic organ site). Patients were stratified for prior nephrectomy status within three geographic regions and were randomly assigned (1:1:1) to receive IFN-α alone (n = 207), TORISEL alone (25 mg weekly; n = 209), or the combination arm (n = 210).
The ITT population for this interim analysis included 626 patients. Demographics were comparable between the three treatment arms with regard to age, gender, and race. The mean age of all groups was 59 years (range 23–86). Sixty-nine percent were male and 31% were female. The racial distribution for all groups was 91% White, 4% Black, 2% Asian, and 3% other. Sixty-seven percent of patients had a history of prior nephrectomy.
The median duration of treatment in the TORISEL arm was 17 weeks (range 1–126 weeks). The median duration of treatment on the IFN arm was 8 weeks (range 1–124 weeks).
There was a statistically significant improvement in OS (time from randomization to death) in the TORISEL 25 mg arm compared to IFN-α. The combination of TORISEL 15 mg and IFN-α did not result in a significant increase in OS when compared with IFN-α alone. Figure 1 is a Kaplan-Meier plot of OS in this study. The evaluations of PFS (time from randomization to disease progression or death) and ORR, were based on blinded independent radiologic assessment of tumor response. Efficacy results are summarized in Table 4.
8REFERENCES
- OSHA Hazardous Drugs.
9HOW SUPPLIED/STORAGE AND HANDLING
NDC 0008-1179-01 TORISEL (temsirolimus) injection, 25 mg/mL.
10PRINCIPAL DISPLAY PANEL - 25 mg/mL Vial Label
TORISEL®
(temsirolimus) injection
(temsirolimus) injection
25 mg/mL*
*each vial contains 0.2 mL overfill
Rx only
LOT / EXP.:
11PRINCIPAL DISPLAY PANEL - 2.2 mL Vial Label
NDC 0008-1125-01
DILUENT
for TORISEL®
DILUENT
for TORISEL®
2.2 mL
Not for direct administration
Only for dilution of TORISEL
(temsirolimus) injection vial
Single Use - Refrigerate
Only for dilution of TORISEL
(temsirolimus) injection vial
Single Use - Refrigerate
LOT / EXP.:
12PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 0008-1179-01
Pfizer
TORISEL
(temsirolimus) injection
(temsirolimus) injection
25 mg/mL*
*each vial contains 0.2 mL overfill
CONCENTRATED - Requires two dilutions
before administration
before administration
10 mg/mL after initial dilution
For intravenous infusion only
For intravenous infusion only
Each carton contains:
Cytotoxic: Handle with caution
Refrigerate
Rx only
Rx only
