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