Temsirolimus (Torisel)

Trade Name : Torisel

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Temsirolimus (Torisel) which is also known as Torisel and Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It is available in strength of per ml. Read more

Temsirolimus (Torisel) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

No data

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

No data

The recommended dose of TORISEL is 25 mg administered as an intravenous infusion over a 30u201360 minute period once a week. Treat until disease progression or unacceptable toxicity. ()
Antihistamine pre-treatment is recommended. ()
Dose reduction is required in patients with mild hepatic impairment. ()
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. ()

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 This vial contains an overfill in order to ensure that the appropriate volume can be withdrawn.
TORISEL injection, 25 mg/mL supplied with DILUENT for TORISEL. ()

TORISEL is contraindicated in patients with bilirubin >1.5u00d7ULN .
TORISEL is contraindicated in patients with bilirubin > 1.5u00d7ULN. ()

No data

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. ()
To treat hypersensitivity reactions, stop TORISEL and treat with an antihistamine. TORISEL may be restarted at physician discretion at a slower rate. ()
Hepatic Impairment: Use caution when treating patients with mild hepatic impairment and reduce dose. (, )
Hyperglycemia and hyperlipidemia are likely and may require treatment. Monitor glucose and lipid profiles. (, )
Infections may result from immunosuppression. ()
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. ()
Bowel perforation may occur. Evaluate fever, abdominal pain, bloody stools, and/or acute abdomen promptly. ()
Renal failure, sometimes fatal, has occurred. Monitor renal function at baseline and while on TORISEL. ()
Due to abnormal wound healing, use TORISEL with caution in the perioperative period. ()
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. ()
Live vaccinations and close contact with those who received live vaccines should be avoided. ()
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential hazard to the fetus and to use effective contraception. (, , )
Elderly patients may be more likely to experience certain adverse reactions, including diarrhea, edema and pneumonia. ()

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 .
The most common (u226530%) adverse reactions observed with TORISEL are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common (u226530%) laboratory abnormalities observed with TORISEL are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, lymphopenia, elevated alkaline phosphatase, elevated serum creatinine, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia.
The most common adverse reactions (incidence u226530%) are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common laboratory abnormalities (incidence u226530%) are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, elevated alkaline phosphatase, elevated serum creatinine, lymphopenia, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia. ()n n n

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. (, , )

Lactation: Do not breastfeed. ()

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. The risk of several serious adverse events, including thrombosis, bowel perforation, interstitial lung disease (ILD), seizure, and psychosis, is increased with doses of TORISEL greater than 25 mg.

Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent.
Temsirolimus is a white to off-white powder with a molecular formula of CHNO and a molecular weight of 1030.30. It is non-hygroscopic. Temsirolimus is practically insoluble in water and soluble in alcohol. It has no ionizable functional groups, and its solubility is independent of pH.
The chemical name of temsirolimus is (3,6,7,9,10,12,14,15,17,19,21,23,26,27,34a)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1)-2-[(1,3,4)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23, 27-epoxy-3-pyrido[2,1-][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4,6,31)-pentone 4'-[2,2-bis(hydroxymethyl)propionate]; or Rapamycin, 42-[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate].
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), -alpha-tocopherol (0.075% w/v), propylene glycol (50.3% w/v), and anhydrous citric acid (0.0025% 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.

No data

Carcinogenicity studies have not been conducted with temsirolimus. However, sirolimus, the major metabolite of temsirolimus in humans, was carcinogenic in mice and rats. The following effects were reported in mice and/or rats in the carcinogenicity studies conducted with sirolimus: lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.
Temsirolimus was not genotoxic in a battery of (bacterial reverse mutation in and , forward mutation in mouse lymphoma cells, and chromosome aberrations in Chinese hamster ovary cells) and (mouse micronucleus) assays.
In a fertility study in male rats, decreased number of pregnancies, decreased sperm concentration and motility, decreased reproductive organ weights, and testicular tubular degeneration were observed. These effects were observed at oral temsirolimus doses u22653 mg/m/day (approximately 0.2-fold the human recommended intravenous dose). Fertility was absent at 30 mg/m/day.
In a fertility study in female rats, an increased incidence of pre- and post-implantation losses occurred at oral doses u22654.2 mg/m/day (approximately 0.3-fold the human recommended intravenous dose), resulting in decreased numbers of live fetuses.

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-u03b1 to those receiving TORISEL or TORISEL plus IFN-u03b1. 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-u03b1 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 23u201386). 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 1u2013126 weeks). The median duration of treatment on the IFN arm was 8 weeks (range 1u2013124 weeks).
There was a statistically significant improvement in OS (time from randomization to death) in the TORISEL 25 mg arm compared to IFN-u03b1. The combination of TORISEL 15 mg and IFN-u03b1 did not result in a significant increase in OS when compared with IFN-u03b1 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.

No data

NDC 0008-1179-01
Each kit is supplied in a single carton containing one single-use vial of 25 mg/mL of temsirolimus and one DILUENT vial which includes a deliverable volume of 1.8 mL, and must be stored at 2u00bau20138u00ba C (36u00bau201346u00ba F). Protect from light.
TORISEL is a cytotoxic drug. Follow applicable special handling and disposal procedures.

No data

This product's label may have been updated. For full prescribing information, please visit www.torisel.com.
LAB-0461-10.0

TORISELn- (temsirolimus) injection
25 mg/mL*
*each vial contains 0.2 mL overfilln n 10 mg/mL after initial dilutionSingle Use - n n n
Rx only
LOT / EXP.:

NDC 0008-1125-01n- DILUENTn- TORISEL
2.2 mL
Not for direct administrationOnly for dilution of TORISEL(temsirolimus) injection vialSingle Use - Refrigerate
LOT / EXP.:

NDC 0008-1179-01
Pfizer
TORISELn n n- (temsirolimus) injection
25 mg/mL*
*each vial contains 0.2 mL overfill
CONCENTRATED - Requires two dilutionsbefore administration
10 mg/mL after initial dilutionFor intravenous infusion only
Each carton contains:1 vial TORISEL (temsirolimus) injection 25 mg/mL*1 vial DILUENT for TORISELn
Cytotoxic: Handle with caution
RefrigerateRx only

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Temsirolimus (Torisel)

Trade Name : Torisel

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Temsirolimus (Torisel)

Trade Name : Torisel

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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