Fatal andor serious and severe diarrhea or colitis occurred in 14% to 19% of zydeligtreated patients. Care champions at pfizer oncology together are ready to listen to patients and connect them to resources that may help with some of their daytoday challenges. Among 208 patients, the most common temsirolimusrelated grades 34 aes. These highlights do not include all the information needed to use halaven safely and effectively. Temsirolimus safety profile and management of toxic effects in. Torisel, inntemsirolimus european medicines agency. Torisel kit te msirolimus injection, for intr avenous infusion only. Accelerated approval was granted for fl and sll based on. Temsirolimus torisel is an inhibitor of mammalian target of rapamycin mtor.
Store diluted solutions of halaven for up to 4 hours at room temperature or up to 24 hours under refrigeration. Temsirolimus is designed to slow the growth of kidney cancer cells by inhibiting several mechanisms that the cell uses to grow and survive. Inhibition of mtor activity resulted in a g1 growth arrest in treated tumor cells. If thrombocytopenia does occur, it usually reverses within a few days after termination of treatment. Platelet count greater than the upper limit of normal b.
Torisel kit temsirolimus injection, for intravenous infusion only initial u. Temsirolimus is considered experimental and investigational for all other indications. Do not remove the oral syringe adapter from the bottle once inserted. Torisel is contraindicated in patients with bilirubin 1. Hypersensitivityinfusion reactions, including flushing, chest pain, dyspnea, hypotension, apnea, loss of consciousness, hypersensitivity, and anaphylaxis, may occur very early in the first infusion or with subsequent infusions.
Torisel temsirolimus is being used concurrently with other chemotherapy. Highlights of prescribing information these highlights do not include all the information needed to use torisel safely and effectively. Torisel kit temsirolimus injection, for intravenous use. Torisel 30 mg concentrate and solvent for solution for infusion temsirolimus. Torisel temsirolimus injection requires two dilutions prior to intravenous infusion. Some of the dosage forms listed on this page may not apply to the brand name torisel for the consumer. Wellstat therapeutics corporation 2017 vistogard uridine triacetate oral granules package insert garcia r et al. Severe mucocutaneous reactions, some with fatal outcomes 5.
Temsirolimus torisel for kidney cancer chemoexperts. Ixempra as monotherapy is indicated for the treatment of metastatic or locally. Authorization of 3 months may be granted for members prescribed torisel as a single agent. Torisel package insert, wyeth pharmaceuticals, inc. Among 208 patients, the most common temsirolimusrelated grades 34 aes were anemia %, hyperglycemia 9%. Matthias behrend, in side effects of drugs annual, 2010. Read the package leaflet before use and for dilution instructions. Torisel temsirolimus injection, 25 mgml, is a clear, colorless to light yellow, nonaqueous, ethanolic, sterile solution. Temsirolimus torisel medical clinical policy bulletins. Do not take afinitor or afinitor disperz if you have had a severe allergic reaction to everolimus. Allow sufficient time for the air bubbles to subside. Phase i study combining treatment with temsirolimus and.
This document contains side effect information about temsirolimus. Torisel kit temsirolimus injection, for intravenous infusion only. Insert the oral syringe adapter plastic tube with stopper tightly into the bottle until it is even with the top of the bottle figure 2. Docetaxel injection this product information is intended only for residents of the united states. Temsirolimus binds to an intracellular protein fkbp. Indication and usage is recognized in nccn drugs and biologics compendium as a category 1 or 2a recommendation approval duration. Authorization of 3 months may be granted for members prescribed torisel as a single agent as. Torisel medication page for healthcare professionals to search for scientific information on pfizer medications. Dailymed pentam 300 pentamidine isethionate injection. Temsirolimus is a specific inhibitor of rapamycin mtor kinase, a component of intracellular signaling pathways involved in the growth and proliferation of cells and the response of such cells to hypoxic stress. Food and drug administration fda in may 2007 for the treatment of. Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether.
Torisel is indicated for the treatment of advanced renal cell carcinoma. 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. See full prescribing information for complete boxed warning. After reconstitution, it should be administered by intramuscular im or intravenous iv routes see dosage and administration. What is the role of temsirolimus torisel in the treatment of renal cell. Compared with the interferons, temsirolimus improves overall survival among patients with. Pharmacist information sheet important dispensing information for every patient, temodar must be dispensed in a separate vial or in its original package making sure each container lists the strength per capsule and. Highlights of prescribing information these highlights. Temsirolimus torisel is an intravenous chemotherapeutic agent in the. Monitor for the development of severe diarrhea or colitis. Torisel infusion should be interrupted in patients with infusion reactions and appropriate. Cci779 is an ester derivative of rapamycin and has improved pharmaceutical properties. Cci779 is a potent inhibitor of mtor with ic50 values of 0.
Torisel fda prescribing information, side effects and uses. Hycamtin for injection,in combination with cisplatin,is indicated for the treatment of patients with stage ivb, recurrent, or persistent cervical cancernot amenable to curative treatment. It also results in reduced levels of certain cell growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor vegf. After a pa request is submitted, well follow up with the payer on behalf of the patientto track the progress of the request until a final outcome is determined. Table 1patients reporting drugrelated grade 3 or 4 adverse events. The ndc for torisel is 0008117901 coded as 00008117901 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. You should tell your health care provider before taking afinitor or afinitor disperz if you are allergic to sirolimus rapamune or temsirolimus torisel afinitor or afinitor disperz can cause serious side effects. Use the resources here to stay supported during chemotherapy and informed about a common but serious side effect called severe neutropenia. Highlights of prescribing information monitor for symptoms. Torisel temsirolimus is being used without pretreatment medications i. Member has disease progression while taking torisel temsirolimus. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. 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. Torisel temsirolimus injection worldwide fact sheet.
Dispense enclosed patient package insert to each patient. Prior authorizations pa we can coordinate with a patients insurer to determine the pa requirements, where and how to submit requests, and typical turnaround times. Temsirolimus torisel inhibits mammalian target of rapamycin mtor, which is a serinethreonine kinase important in the regulation of cell. Dosing exceeds single dose limit of torisel temsirolimus. Each vial of torisel temsirolimus must first be mixed with 1. The recommended dose of torisel for advanced renal cell carcinoma is 25 mg infused over a 3060 minute period once a week. Phase i study combining treatment with temsirolimus and sunitinib.
Monitor patients and discontinue rituxan infusion for severe reactions 5. Please see indication and important safety information. Vinblastine generally has an insignificant effect on. Find patient medical information for torisel intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. At the starting dose, temsirolimus 15 mg was administered by intravenous i. Diluent for torisel is a sterile, nonaqueous solution that is supplied with torisel injection, as a kit. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Highlights of prescribing information tafinlar with. Vinp03 vinblastine sulfate for injection usp warning caution this preparation should be administered by individuals experienced in the administration of vinblastine sulfate.
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