Cci779 is a potent inhibitor of mtor with ic50 values of 0. In some cases, health care professionals may use the trade name torisel when referring to the generic drug name temsirolimus. Temsirolimus is considered experimental and investigational for all other indications. Torisel temsirolimus how suppliedstorage and handling.
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. Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Some patients were asymptomatic or had minimal symptoms. Pfizer seeks to stymie sandoz, accords generic torisel law360. Dosing should be titrated to attain trough concentrations of 5 to 10 ngml.
Patients enrolled in the study had advanced disease and three or more factors indicating a poor prognosis. The smpc and the package leaflet were updated to delete the. Torisel is indicated for the treatment of advanced renal cell carcinoma. Torisel temsirolimus injection vial contents must first be diluted with the enclosed diluent before diluting the resultant solution with 250 ml of 0. Torisel is contraindicated in patients with bilirubin 1. This is a pdf file of an unedited manuscript that has been accepted for publication. Nov 09, 2018 temsirolimus is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Temsirolimus also stops the cancer from making blood vessels, which the cells need to be able to grow. Pfizer seeks to stymie sandoz, accords generic torisel. No drug was detected in csf lower detection level 1ngml.
Temsirolimus torisel for kidney cancer chemoexperts. Inhibition of mtor activity resulted in a g1 growth arrest in treated tumor cells. May cause eye, skin, or respiratory system irritation. Files are available under licenses specified on their description page. Temsirolimus temsirolimus injection requires two dilutions prior to intravenous infusion. Sunitinib for advanced renal cell cancer amsterdam umc vrije. Temsirolimus in phase 0 full text view clinicaltrials. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively.
Other drugs may be given before this medicine temsirolimus to help avoid side effects. Temsirolimus is used in the treatment of advanced renal cell. May be harmful by inhalation, ingestion, or skin absorption. Temsirolimus is designed to block a protein called mtor a protein that is thought to cause cancer cells to grow inside the cancer cell. Temsirolimus is considered a firstline therapy for patients with poor risk features. Temsirolimus is used to treat cancer of the kidneys, also called renal cell carcinoma.
See full prescribing information for complete boxed warning. Have blood work checked as you have been told by the doctor. Clinical trials using temsirolimus national cancer institute. Temsirolimus is a type of targeted cancer drug treatment called an mtor inhibitor. This page was last edited on 19 february 2017, at 19. Follow applicable special handling and disposal procedures 1. Temsirolimus, an inhibitor of mtor, is an antineoplastic agent. Apr 05, 2018 what are the possible side effects of temsirolimus torisel.
Temsirolimus is also being studied in the treatment of other types of cancer. Highlights of prescribing information monitor for symptoms or. Temsirolimus is a white to offwhite powder with a molecular formula of c 56 h 87 no 16 and a molecular weight of 1030. If concentrations are between 10 to 15 ngml, and the patient has demonstrated adequate tolerability and tumor response, no dose reductions are needed. Torisel kit temsirolimus injection, for intravenous infusion only. Highlights of prescribing information these highlights do not include all the information needed to use torisel safely and effectively. The clinical trials on this list are studying temsirolimus. Safety and efficacy of targeted agents in metastatic kidney cancer. All structured data from the file and property namespaces is available under the creative commons cc0 license. Torisel temsirolimus injection and diluent for torisel are filled in clear glass vials with butyl rubber stoppers. Renal cell carcinoma a type of kidney cancer that is advanced. Definition from the nci drug dictionary detailed scientific definition and other names for this drug.
Temsirolimus torisel temsirolimus torisel is a chemotherapy regimen for renal cell carcinoma kidney cancer. Sirolimus or everolimus or temsirolimus and vorinostat in. Apr 05, 2018 torisel kit temsirolimus injection, for intravenous infusion only. The recommended dose of torisel for advanced renal cell carcinoma is 25 mg infused over a 3060 minute period once a week. It blocks the effects of a protein called mtor that is often over active in cancer cells. Highlights of prescribing information monitor for symptoms. It is usually given by a doctor or nurse in a doctors office or infusion center. Furthermore, adding bevacizumab significantly improved median pfs 8. Temsirolimus codenamed cci779 is an intravenous drug for the treatment of renal cell carcinoma rcc, developed by wyeth pharmaceuticals and approved by the u. Temsirolimus, an ester of sirolimus rapamycin, selectively inhibits the kinase mammalian target of rapamycin and consequently blocks the translation of cell cycle regulatory proteins and. Ncis basic information about clinical trials explains the types and phases of trials and how they are carried out.
Cases of ild, some resulting in death, have occurred. This indicates that patients with renal impairment tolerated the drug similarly to. 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. Temsirolimus is the generic name for the trade name chemotherapy drug torisel. There is limited safety experience with patients having trough concentrations 10 ngml. They can help educate your staff on our access and reimbursement resources and help address challenging or urgent pfizer oncology patient cases you have sent to pfizer oncology together. Check with your doctor or nurse immediately if any of the following side effects occur while taking temsirolimus. Torisel temsirolimus injection should be diluted only with the supplied diluent for torisel. Jan 21, 2020 along with its needed effects, temsirolimus the active ingredient contained in torisel may cause some unwanted effects. Temsirolimus torisel is an inhibitor of mammalian target of rapamycin mtor. Temsirolimus side effects, dosage, interactions drugs.
Treatmentrelated mortality increases with abnormal liver function, at higher doses, and in patients with nsclc and prior platinumbased therapy receiving docetaxel. Temsirolimus supplier cas 162635043 tocris bioscience. Temsirolimus is designed to slow the growth of kidney cancer cells by inhibiting several mechanisms that the cell uses to grow and survive. Although not all of these side effects may occur, if they do occur they may need medical attention. 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 torisel medical clinical policy bulletins. Effect of renal impairment on the pharmacokinetics and safety of.
Torisel kit temsirolimus injection, for intravenous use. Torisel temsirolimus injection worldwide fact sheet. Sep 26, 2019 use this medicine temsirolimus as ordered by your doctor. The peptides were inserted into capsid domains putatively involved in receptor binding. Hospital outpatient medicare only hospital outpatient facilities may use ccodes to report drugs and procedures provided to medicare patients. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use rapamune for prophylaxis of organ. Cci779 is an ester derivative of rapamycin and has improved pharmaceutical properties. Indications torisel is an inhibitor of mtor approved in the european union for the firstline treatment of patients with advanced renal cell carcinoma rcc who have at least three of six prognostic risk factors. Food and drug administration fda in late may 2007, and was also approved by the european medicines agency emea on november 2007. Temsirolimus comes as a solution liquid to be given by infusion slow injection into a vein over 30 to 60 minutes.
Temsirolimus monotherapy recipients experienced significantly fewer grade 3 or 4 adverse events and had fewer withdrawals for adverse events than patients receiving ifn. Everolimus is designed to stop cells from dividing. Torisel temsirolimus torisel 25 mg concentrate for injection. 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.
If torisel must be given to patients with mild hepatic impairment, reduce the dose of torisel to 15 mgweek. View and buy high purity temsirolimus from tocris bioscience. The following data is based on the product molecular weight 1030. Torisel medication page for healthcare professionals to search for scientific information on pfizer medications. Pfizer oncology field reimbursement managers frms are trained to help address specific access issuesin person or over the phone. Temsirolimus cancer information cancer research uk. Torisel fda prescribing information, side effects and uses. Temsirolimus binds to an intracellular protein fkbp.
Patients should undergo baseline radiography prior to torisel therapy and periodically thereafter, even in the absence of clinical respiratory symptoms. Temsirolimus torisel is an intravenous chemotherapeutic agent in the. Temsirolimus safety data sheet supersedes revision. It is given as an infusion into a vein over a period of time. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. Diluent for torisel is a sterile, nonaqueous solution that is supplied with torisel injection, as a kit. Torisel kit te msirolimus injection, for intr avenous infusion only. Torisel temsirolimus injection side effects, images, uses. Torisel temsirolimus injection worldwide fact sheet product description 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. 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 is a targeted therapy and is classified as a mtor inhibitor. Temsirolimus temsirolimus injection, 25 mgml, is a clear, colorless to light yellow, nonaqueous, ethanolic, sterile solution.
Patients with combined abnormalities of transaminase and alkaline phosphatase should, in general, not be treated with taxotere. 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. Temsirolimus temsirolimus injection should be diluted only with the supplied diluent for temsirolimus. As an oral drug, axitinib will not add or burden chemo chair time and will. Cabometyx, inncabozantinib european medicines agency. Aug 16, 2011 the goal of this clinical research trial is to study the effects of the fdaapproved drug, temsirolimus, using a new type of clinical study design called a phase 0. Clinical trials are research studies that involve people.
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