Torisel is an mtor inhibitor administered once a week as an iv infusion. Torisel may be used in a variety of settings including the following sites of care. Temsirolimus torisel temsirolimus torisel is a chemotherapy regimen for renal cell carcinoma kidney cancer. This should be considered during the preparation and administration of torisel, including storage time elapsed when in direct contact with pvc following constitution. Torisel temsirolimus injection side effects, images.
The nccn compendium is a derivative work of the nccn guidelines. The fda approved torisel for the treatment of patients with advanced renal cell carcinoma rcc. Current guidelines from the national comprehensive cancer network nccn. Highlights of prescribing information tafinlar with. Absolute neutrophil count greater than the upper limit of normal vi. This document contains confidential and proprietary information of cvs. 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. Torisel temsirolimus reimbursement and billing guide. Torisel temsirolimus is indicated for the treatment of advanced renal cell carcinoma.
If vinblastine is swallowed, activated charcoal in a water slurry may be given by mouth along with a cathartic. Arterial occlusion has occurred in at least 35% of iclusig treated patients including fatal myocardial infarction. Docetaxel injection this product information is intended only for residents of the united states. Renal cell carcinoma a type of kidney cancer that is advanced. It is usually given once a week over 30 to 60 minutes or as directed by your doctor. Torisel, when diluted, contains polysorbate 80, which is known to increase the rate of dehp extraction from pvc. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database.
This medication is given by injection into a vein by a health care professional. 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. Monitor for the development of severe diarrhea or colitis. Patients and their partners should be advised to avoid pregnancy throughout treatment and for 3 months after torisel therapy has stopped. Pfizer oncology field reimbursement managers frms are trained to help address specific access issuesin person or over the phone. It is chemically designated as 4,41,5pentanediylbisoxybisbenzenecarboximidamid with the following structural formula.
Afinitor or afinitor disperz may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Torisel medication page for healthcare professionals to search for scientific information on pfizer medications. New patients who have been prescribed ibrance can start a free 1month 21day trial with this voucher, regardless of insurance coverage. Dacarbazine is an anticancer agent designated chemically. Arterial occlusion has occurred in at least 35% of iclusig treated patients including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain. Highlights of prescribing information wounds have adequately. What are the possible side effects of temsirolimus torisel.
Dailymed pentam 300 pentamidine isethionate injection. In addition, each kit includes a singledose sterile vial containing 2. 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. Appropriate administration materials should be composed of glass, polyolefin, or polyethylene to avoid excessive loss of product and. In some people, these infections may be severe and can even lead to death. Temsirolimus torisel for kidney cancer chemoexperts. Dec 31, 2019 vinblastine sulfate in the dry state is irregularly and unpredictably absorbed from the gastrointestinal tract following oral administration. Sep 12, 2019 pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether, acetone, and chloroform. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. Highlights of prescribing information when administering. Torisel temsirolimus injection worldwide fact sheet. Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether. See full prescribing information for temsirolimus injection.
Official site for healthcare professionals nexavar. Torisel temsirolimus binds with specific and high affinity to immunophilin fkbp 12. Temsirolimus is also being studied in the treatment of other types of cancer. Torisel may also be used for purposes not listed in this medication guide. Reference number 20 81a torisel 2081a sgm p2019 2019 cvs caremark. Temsirolimus is a white to offwhite powder with a molecular formula of c 56 h 87 no 16 and a molecular weight of 1030. To report an adverse event, please call 18004381985. Torisel kit temsirolimus injection, for intravenous infusion only.
Viral infections may include reactivation of hepatitis b in people who have had hepatitis b in the past. If you are a consumer or patient please visit this version. Highlights of prescribing information perforation can occur. Temsirolimus, an inhibitor of mtor, is an antineoplastic agent. May 01, 2020 torisel temsirolimus is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Torisel is administered as an intravenous infusion over a 30 to 60minute period once weekly. Torisel 30 mg concentrate and solvent for solution for infusion temsirolimus. Temsirolimus torisel is an intravenous chemotherapeutic agent in the. 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. Istodax is supplied as a kit which includes a sterile, lyophilized powder in a 10 mg singledose vial containing 11 mg of romid epsin and 22 mg of the bulking agent, povidone, usp. Apr 05, 2018 what are the possible side effects of temsirolimus torisel.
Accelerated approval was granted for fl and sll based on. Dacarbazine for injection is reconstituted and administered intravenously ph 34. Each vial contains 200 mg of dacarbazine the active ingredient, citric acid monohydrate and mannitol. Torisel temsirolimus injection requires two dilutions prior to intravenous infusion.
Torisel temsirolimus injection, 25 mgml, is a clear, colorless to light yellow, nonaqueous, ethanolic, sterile solution. Torisel is used to treat cancer of the kidneys, also called renal cell carcinoma. Ixempra, a microtubule inhibitor, in combination with capecitabine is indicated for the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline and a taxane 1. These highlights do not include all the information needed to use. 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. Torisel temsirolimus torisel 25 mg concentrate for injection. Indication and usage is recognized in nccn drugs and biologics compendium as a category 1 or 2a recommendation approval duration. Torisel temsirolimus torisel reimbursement support program. See full prescribing information for complete boxed warning.
Torisel temsirolimus pfizer medical information us. In study 1, grade 3 peripheral neuropathy occurred in 8% 40503 of patients, and grade 4 in 0. Torisel temsirolimus injection should be diluted only with the supplied diluent for torisel. Dacarbazine for injection is a colorless to an ivory colored solid which is light sensitive. Torisel is contraindicated in patients with bilirubin 1. Torisel concentrate for injection before adding to infusion solutions. Product monograph prtorisel temsirolimus concentrate. 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 involvement.
Always combine torisel concentrate for injection with diluent for. Torisel kit te msirolimus injection, for intr avenous infusion only. Authorization of 3 months may be granted for members with intraabdominal disease. Highlights of prescribing information monitor for symptoms. Fatal andor serious and severe diarrhea or colitis occurred in 14% to 19% of zydeligtreated patients. Afinitor is a prescription medicine used to treat advanced hormone receptorpositive, her2negative breast cancer along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer. Highlights of prescribing information these highlights. Dailymed vinblastine sulfate vinblastine sulfate injection. Torisel fda prescribing information, side effects and uses. Torisel temsirolimus injection side effects, images, uses. Torisel kit temsirolimus injection, for intravenous infusion only initial u.
If torisel must be given to patients with mild hepatic impairment, reduce the dose of torisel to 15 mgweek. Full prescribing information 1 indications and usage zaltrap, in combination with. Apr 05, 2018 torisel kit temsirolimus injection, for intravenous infusion only. Temsirolimus is designed to slow the growth of kidney cancer cells by inhibiting several mechanisms that the cell uses to grow and survive. Please see full prescribing information for torisel temsirolimus. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Highlights of prescribing information these highlights do not include all the information needed to use torisel safely and effectively. Authorization of 3 months may be granted for members prescribed torisel as a single agent as. Platelet count greater than the upper limit of normal b. Ixempra as monotherapy is indicated for the treatment of metastatic or locally.
The use of an infusion pump is the preferred method of administration to ensure accurate delivery of the product. Torisel kit temsirolimus is a cancer antineoplastic medication used to treat cancer of the kidneys, also called renal cell carcinoma. Pentam 300 pentamidine isethionate for injection, an antiprotozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular im or intravenous iv routes see dosage and administration. Food and drug administration fda in may 2007 for the treatment of advanced renal cell carcinoma in adults. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Side effects of torisel temsirolimus injection, warnings. Temsirolimus is the 2,2bis hydroxymethyl propionic acid ester of sirolimus, a macrocyclic lactone produced by streptomyces hygroscopicus. Highlights of prescribing information monitor for symptoms or. Torisel temsirolimus dosing, indications, interactions. Soft tissue sarcoma authorization of 12 months may be granted to members prescribed torisel as a single agent for the. Authorization of 12 months may be granted to members who are prescribed torisel as a single agent for the treatment of recurrent or metastatic endometrial carcinoma that has progressed after prior cytotoxic chemotherapy.