A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Torisel temsirolimus is indicated for the treatment of advanced renal cell carcinoma rcc. Temsirolimus comes as a solution liquid to be given by infusion slow injection into a vein over 30 to 60 minutes. Temsirolimus safety data sheet supersedes revision. Follow applicable special handling and disposal procedures 1. This may stop or slow the growth or spread of cancer cells.
Torisel temsirolimus is fda approved for the treatment of advanced renal cell carcinoma. Torisel should be used with caution in persons with known hypersensitivity to temsirolimus or its metabolites including sirolimus, polysorbate 80, or to any other component including the excipients of torisel. Torisel fda prescribing information, side effects and uses. Temsirolimus torisel is an intravenous chemotherapeutic agent in the. Temsirolimus torisel, cci779 temsirolimus brand name torisel, previously called cci779 is an inhibitor of mtor that is fdaapproved for renal cell carcinoma, and it could therefore be.
Temsirolimus is the 2,2bis hydroxymethyl propionic acid ester of. Temsirolimus side effects, dosage, interactions drugs. Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor net of the stomach and intestine gastrointestinal or lung that has progressed and cannot be treated with surgery. Mar 16, 2010 vorinostat is designed to prevent or slow down the growth of cancer cells by blocking proteins. Comparison of ep2006, a filgrastim biosimilar, to the reference. Highlights of prescribing information monitor for symptoms or. Torisel, inntemsirolimus european medicines agency. Temsirolimus binds to and inhibits the mammalian target of rapamycin mtor, resulting in decreased expression of mrnas necessary for cell. Apr 05, 2018 torisel kit temsirolimus injection, for intravenous infusion only. Temsirolimus binds to and inhibits the mammalian target of rapamycin mtor, resulting in decreased expression of mrnas necessary for cell cycle progression and arresting cells in the g1 phase of the cell cycle. Temsirolimus is the 2,2bis hydroxymethyl propionic acid ester of sirolimus, a macrocyclic lactone produced by streptomyces hygroscopicus. Temsirolimus injection requires two dilutions prior to. The recommended dose of torisel for advanced renal cell carcinoma is 25 mg. Highlights of prescribing information when administering.
You should tell your health care provider before taking afinitor or afinitor. This file contains additional information such as exif metadata which may have been added by the digital camera, scanner, or software program used to create or digitize it. Some patients were asymptomatic or had minimal symptoms. Temsirolimus is an inhibitor of mtor mammalian target of rapamycin. Torisel temsirolimus torisel 25 mg concentrate for injection. Federal usa law restricts this drug to use by or on the order of a licensed veterinarian.
Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flatdosing schedule in patients with cancer. Torisel temsirolimus injection, 25 mgml, is a clear, colorless to light yellow, nonaqueous, ethanolic, sterile solution. Hospital outpatient medicare only hospital outpatient facilities may use ccodes to report drugs and procedures provided to medicare patients. The recommended dose of torisel is 25 mg infused over a. Torisel temsirolimus torisel reimbursement support program. The torisel temsirolimus vial contains an overfill of 0. Temsirolimus has shown efficacy as firstline treatment of patients with metastatic renal cell carcinoma and poor prognostic features. All trials on the list are supported by nci ncis basic information about clinical.
If the file has been modified from its original state, some details such as the timestamp may not fully reflect those of the original file. Food and drug administration fda in may 2007 for the treatment of. Temsirolimus infusion should be interrupted in all patients with severe infusion reactions and appropriate medical therapy administered. Patients enrolled in the study had advanced disease and three or more factors indicating a poor prognosis.
Cases of ild, some resulting in death, have occurred. Appropriate studies performed to date have not demonstrated pediatricspecific problems that. Vorinostat is designed to prevent or slow down the growth of cancer cells by blocking proteins. Temsirolimus intravenous route before using mayo clinic. Use this medicine temsirolimus as ordered by your doctor. Each kit is supplied in a single carton containing one singleuse vial of 25 mgml of temsirolimus and one diluent vial which includes a deliverable volume of 1. The clinical trials on this list are studying temsirolimus. The recommended dose of torisel is 25 mg administered as an intravenous infusion over a 3060 minute period once a. Torisel is contraindicated in patients with bilirubin 1.
Temsirolimus, an inhibitor of mammalian target of rapamycin. Temsirolimus is a targeted therapy and is classified as a mtor inhibitor. Torisel temsirolimus injection requires two dilutions prior to intravenous infusion. For nonprescription products, read the label or package ingredients carefully. Highlights of prescribing information these highlights do not include all the information needed to use afinitor safely and effectively. Torisel medication page for healthcare professionals to search for scientific information on pfizer medications. Jan 21, 2020 along with its needed effects, temsirolimus the active ingredient contained in torisel may cause some unwanted effects. See full prescribing information for complete boxed warning. This file contains additional information, probably added from the digital camera or scanner used to create or digitize it. Temsirolimus, interferon alfa, or both for advanced renalcell carcinoma. The efficacy of temsirolimus in other clinical settings, such as secondline therapy, is unclear. It is usually given by a doctor or nurse in a doctors office or infusion center. Temsirolimus is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Temsirolimus is degraded by both acids and bases, and thus combinations of temsirolimus with agents capable of modifying solution ph should be avoided. Opdivo nivolumab information for healthcare professionals. Torisel temsirolimus how suppliedstorage and handling. Due to the intentional overfill in the torisel injection vial. Temsirolimus tem sir oh li mus is a drug that alters immune system response in the body. Soliris is not for use in treating people with shiga toxin e. Temsirolimus is designed to slow the growth of kidney cancer cells by inhibiting several mechanisms that the cell uses to grow and survive.
Authorization of 3 months may be granted for members prescribed torisel as primary therapy for disease not suitable for primary surgery in members with suspected or gross cervical. Temsirolimus torisel temsirolimus torisel is a chemotherapy regimen for renal cell carcinoma kidney cancer. Background renal cell carcinoma rcc is the most common form of kidney cancer and the eighth most common cancer in adults worldwide1 rcc commonly metastasizes to the brain. Apr 05, 2018 what are the possible side effects of temsirolimus torisel. Product monograph prtorisel temsirolimus concentrate.
Torisel patients on average received 92% torisel is indicated. Temsirolimus binds to an intracellular protein fkbp12, and the proteindrug complex inhibits the activity of mtor that controls cell division. The study reported that median overall survival was longer in patients treated with standalone temsirolimus than those treated with standalone. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. Afinitor is not for use in people with carcinoid tumors that actively produce hormones. The recommended dose of temsirolimus for advanced rcc is 25 mg administered by intravenous. Temsirolimus solutions that have been diluted to 10 mgml initial dilution may be stored for. Temsirolimus is used to treat cancer of the kidneys, also called renal. Check with your doctor or nurse immediately if any of the following side effects occur while taking temsirolimus.
Torisel patients on average received 92% torisel is. Temsirolimus is also being studied in the treatment of other types of cancer. Torisel kit temsirolimus injection, for intravenous infusion only initial u. Temsirolimus for patients with metastatic renal cell. Several payment sources exist for cancer drugs in ontario. Torisel temsirolimus injection should be diluted only with the supplied diluent for torisel. In some cases, health care professionals may use the trade name torisel when referring to the generic drug. Temsirolimus is an intravenous drug for the treatment of renal cell carcinoma rcc, developed by wyeth pharmaceuticals and approved by the fda in late may 2007, and was also approved. Ncis basic information about clinical trials explains the types and phases of trials and how they are carried out. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Temsirolimus torisel for kidney cancer chemoexperts.
Patients should undergo baseline radiography prior to torisel therapy and periodically thereafter, even in the absence of clinical respiratory symptoms. Soliris is a prescription medicine that is used to treat patients with a disease called paroxysmal nocturnal hemoglobinuria pnh. Also find the package insert, announcements, resources, and ways to connect. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling. Torisel temsirolimus injection worldwide fact sheet. Temsirolimus was approved by the fda in 2007 based on results of a multicenter, international, randomized. Mar 23, 2010 temsirolimus is a prodrug of sirolimus, which is marketed as rapamune wyeth pharmaceuticals, inc. Food and drug administration fdas approval of temsirolimus torisel, on may 30, 2007, for the treatment. Clinical trials using temsirolimus national cancer institute. Worley and others published eculizumab and temsirolimus find, read and cite all the research you need on researchgate. Soliris is a prescription medicine that is used to treat adults.
Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively. The efficacy of temsirolimus in other clinical settings. These highlights do not include all the information needed to use temodar safely and effectively. Temsirolimus, an inhibitor of mtor, is an antineoplastic agent.
Temsirolimus safety profile and management of toxic effects in. Cci779 is an ester derivative of rapamycin and has improved pharmaceutical properties. Torisel patients on average received 92% of the planned weekly 25 mg dose17 please see accompanying full prescribing information. Torisel temsirolimus is supplied as a kit consisting of the following. Pdf cancer chemotherapy update eculizumab and temsirolimus. It is given as an infusion into a vein over a period of. Temsirolimus binds to an intracellular protein fkbp12, and the proteindrug complex inhibits the activity of mtor. Cci779 is a potent inhibitor of mtor with ic50 values of 0. Temsirolimus is an anticancer agent used to treat some types of solid tumours.
Light chain myeloma pdf file download light chain myeloma pdf file read online kyrtsonis mc, vassilakopoulos tp, kafasi n, et al. Clinical trials are research studies that involve people. Temsirolimus is a white to offwhite powder with a molecular formula of c 56 h 87 no 16 and a molecular weight of 1030. Any relevant documentation to support medical necessity package insert, chart or lab notes, letter of medical necessity consult with the payer regarding specific claim and documentation requirements. Torisel temsirolimus pfizer medical information us. Pfizer seeks to stymie sandoz, accords generic torisel law360. Temsirolimus torisel, wyeth pharmaceuticals is an inhibitor of mammalian target of rapamycin mtor, a molecule implicated in multiple tumorpromoting intracellular. If torisel must be given to patients with mild hepatic impairment, reduce the dose of torisel to 15 mgweek. Sirolimus or everolimus or temsirolimus and vorinostat in. Highlights of prescribing information these highlights do not include all the information needed to use torisel safely and effectively.
For current package insert and further product information, please visit. Temsirolimus uses, dmf, dossier, manufacturer, supplier. Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Torisel temsirolimus is an intravenous inhibitor of mammalian target of rapamycin mtor, an intracellular protein that has been implicated in multiple growth related cellular functions. At least 3 of the following 6 prognostic risk factors based on the torisel pivotal trial. We use cookies to offer you a better experience, personalize content, tailor advertising, provide social media features, and better understand the use of our services. Do not take afinitor or afinitor disperz if you have had a severe allergic reaction to everolimus. Phase iii study to evaluate temsirolimus compared with investigators choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. If the file has been modified from its original state, some details may not fully reflect the modified file. Torisel is indicated for the treatment of advanced renal cell carcinoma. Pfizer seeks to stymie sandoz, accords generic torisel. Inhibition of mtor activity resulted in a g1 growth arrest in treated tumor cells.
Renal cell carcinoma a type of kidney cancer that is advanced. Temsirolimus is the generic name for the trade name chemotherapy drug torisel. Temsirolimus results in cell cycle arrest and reduces the synthesis of vegf 47. In some cases, health care professionals may use the trade name torisel when referring to the generic drug name temsirolimus. Everolimus is designed to stop cells from dividing. Temsirolimus is used in the treatment of advanced renal cell.
Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use rapamune for prophylaxis of organ. Temsirolimus binds to an intracellular protein fkbp12, and the proteindrug complex inhibits. Highlights of prescribing information monitor for symptoms. If the file has been modified from its original state, some details may not. Temsirolimus is considered experimental and investigational for all other indications. Temsirolimus is designed to block a protein called mtor a protein that is thought to cause cancer cells to grow inside the cancer cell. Although not all of these side effects may occur, if they do occur they may need medical attention. Highlights of prescribing information these highlights.
Temsirolimus injection, 25 mgml, is a clear, colorless to light yellow, nonaqueous, ethanolic, sterile solution. Torisel temsirolimus injection side effects, images, uses. Read the package leaflet before use and for dilution instructions. Torisel 30 mg concentrate and solvent for solution for infusion temsirolimus.