CVS Caremark Specialty Programs 2969 Mapunapuna Place Honolulu, HI 96819 Phone:Fax:www. Do not torisel pdf have TORISEL if you have moderate or severe liver disease. 5×ULN or AST >ULN but bilirubin ≤ULN), reduce pdf the dose of TORISEL to 15 mg/week see Dosage and Administration (2.
The diluted solution must be administered by intravenous infusion. Food and Drug Administration (FDA) in May, and was also approved by the European Medicines Agency (EMA) in November. See full prescribing information for TORISEL. TORISEL (temsirolimus) injection requires two dilutions prior to intravenous infusion. Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent. Clinical Policy Title: Temsirolimus (Torisel) Policy Number: RxA. TORISEL® (temsirolimus) This product information is intended only for residents of the United States.
Torisel (temsirolimus) injection, torisel pdf 25 mg/mL, is a clear, colorless to light yellow, non-aqueous, ethanolic, sterile solution. The member has moderate to severe liver disease, bilirubin greater than 1. If request is for a dose increase, request meets one of the following (a or b):* a. TORISEL™ safely and effectively. This may result in the need for an increase in the dose of, or.
TORISEL 30 mg concentrate must first be diluted with 1. Pfizer Oncology Together can help you identify financial assistance resources for your prescribed TORISEL, regardless of torisel pdf your insurance coverage. If your blood levels are already high your doctor may start you on or increase the dose of, a blood fat lowering drug. torisel pdf Torisel Vial Side Effects by Likelihood and Severity COMMON side effects. The vial of concentrate must pdf first be diluted with 1.
Temsirolimus is a white to off-white powder with a molecular formula of C torisel pdf 56 H 87 NO 16 and a molecular weight of 1030. Temsirolimus (Torisel) is an intravenous chemotherapeutic agent in the. 1 Agents Inducing CYP3A Metabolism. torisel pdf Drugs & Medications Torisel Vial. The chemical name pdf is: (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-. 5 x ULN torisel pdf and should be used with torisel caution when treating patients with mild hepatic impairment (bilirubin >1-1.
Because there is a need for dosage adjustment based upon hepatic function, assessment of AST and bilirubin levels is recommended before. Torisel package insert. Pfizer Oncology Together.
This medication is given by injection into a vein by a health care professional. 509 Drug(s) Applied: Temsirolimus (Torisel ®) Last Review Date: 01/ Line of Business: Commercial, HIM, Medicaid Background Temsirolimus for injection (Torisel ®) is a kinase inhibitor. If TORISEL must be given in patients with mild hepatic impairment (bilirubin >1–1. Torisel is for intravenous use only. It is available in brand and generic form.
TORISEL™ safely and effectively. Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus C max (maximum concentration) and AUC (area under the concentration versus the time curve) after intravenous administration, but decreased sirolimus C max torisel pdf by 65% and AUC by 56% compared to TORISEL treatment alone. Temsirolimus, sold under the brand name Torisel, is an intravenous drug for the treatment of renal cell carcinoma (RCC), developed by Wyeth Pharmaceuticals and approved by the U. Temsirolimus is the 2,2bis( hydroxymethyl) propionic acid ester pdf of sirolimus, a macrocyclic lactone - produced torisel pdf by Streptomyces hygroscopicus. Torisel SGM – 10/ CVS Caremark Specialty Pharmacy 2211 Sanders Road NBT - 6 Northbrook, IL 60062 pdf Phone:Fax:www. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) temsirolimus.
UnitedHealthcare Group Medicare Advantage Base Plan; UnitedHealthcare Group Medicare torisel pdf Advantage Enhanced Plan. How to use Torisel Vial. torisel pdf It is usually given once a week (over 30 to 60 minutes) or as directed by your doctor. approval:INDICATIONS AND USAGE ----- TORISEL™ is a kinase inhibitor indicated for the treatment torisel pdf of advanced renal cell carcinoma. Torisel (temsirolimus) injection should be diluted only with the supplied DILUENT for Torisel. It is used to treat renal cell cancer. TORISEL ® (temsirolimus) NAME OF THE torisel pdf MEDICINE. Individual has a diagnosis of advanced Renal Cell Carcinoma torisel pdf and torisel the following torisel pdf are met: A.
It was approved by the U. It also results in reduced levels of certain torisel pdf cell torisel pdf growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor (VEGF). Torisel 25 mg/mL injection, single-use vial*:xx* *(No te: available generically hrou riou sm nufacturer ) VII.
TORISEL When you must not be given TORISEL Do not have TORISEL if you torisel pdf have an allergy to temsirolimus or any pdf of the other ingredients in TORISEL. CVS Caremark Prior Authorization 1300 E. Torisel is used to treat cancer of the kidneys, also called renal cell carcinoma. Campbell Road Richardson, TX torisel pdf 75081 Phone:Fax:www. Food and Drug Administration (FDA) in May for the treatment of torisel advanced renal cell carcinoma in adults. TORISEL Kit (temsirolimus) Injection, for Intravenous Infusion Only. If TORISEL must be given to patients with mild hepatic impairment, reduce the dose of TORISEL to 15 mg/week. TORISEL will always be prepared and given to you by a torisel pdf doctor or another healthcare professional as an intravenous infusion (into your torisel pdf vein).
torisel LEARN MORE Please see TRAZIMERA full Prescribing Information, including BOXED WARNING, or visit TRAZIMERA. Torisel is an inhibitor of mTOR. We would like to show you a description here but the site won’t allow us.
Step 1: DILUTION OF TORISEL INJECTION 25 MG/ML WITH SUPPLIED DILUENT Each Vial of Torisel (temsirolimus) must first be mixed with 1. torisel pdf What are the possible side effects of temsirolimus (Torisel)? Torisel (temsirolimus) is being used without pretreatment medications (i.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. TORISEL Product Monograph Page 6 of 47 over 82% of patients receiving temsirolimus and was an adverse event (greater than 13. Requests for Torisel (temsirolimus) may be approved if the following criteria are met: I. mTOR inhibition blocks the translation of genes that regulate cancer cell proliferation. Signs of allergy include a skin rash, itching, shortness of torisel breath and/or a swollen face, lips, tongue or other parts of the body. member is currently receiving Torisel for a covered indication and has received this medication for at least 30 days; torisel pdf 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 or purple skin rash with torisel blistering and peeling). TORISEL™ Kit (temsirolimus) injection, for intravenous infusion only Initial U.
New dose does not exceed 25 mg per torisel pdf week. Torisel may also be used for purposes not listed in this medication guide. Authorization of 3 months may be granted for members with intra-abdominal disease. Torisel (temsirolimus) injection requires two dilutions prior to intravenous infusion.
Torisel-H-C-PSUSA: EPAR - Scientific conclusions and grounds torisel pdf recommending the variation to the terms of the marketing authorisation torisel pdf (PDF/67. Torisel HMSA – 12/. TORISEL has been known to increase pdf blood fat levels. 8 ml of withdrawn diluent to achieve a concentration of 10 mg/ml before administration in sodium chloride 9 torisel mg/ml (0. Medscape - Renal cell carcinoma dosing for Torisel (temsirolimus), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. torisel pdf for Consumers: Visit www.
Hepatic impairment: TORISEL is contraindicated in patients with bilirubin >1. Step 1: DILUTION OF TORISEL INJECTION torisel pdf 25 MG/ML WITH SUPPLIED DILUENT • Each Vial of Torisel (temsirolimus) must first be mixed with 1. 8 mL of the enclosed. Torisel (temsirolimus) is a cancer medicine that interferes with the growth and spread of cancer cells in the body. If experienced, these tend to have a Severe expression.
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. TORISEL (temsirolimus) injection should be diluted only with the supplied DILUENT for TORISEL. Please note that both the TORISEL injection and diluent vials contain an overfill to ensure the recommended volume can be withdrawn.
TORISEL (temsirolimus) injection, 25 mg/mL, is a clear, colorless torisel pdf to light yellow, non-aqueous, torisel pdf ethanolic, sterile solution. 9%) solution for injection(see dilution instructions at the end of the package. class mTOR inhibitor for the treatment of renal cell carcinoma. 8 ml of the supplied solvent to achieve a concentration of temsirolimus of 10 mg/ml. 5 x ULN or AST >ULN but bilirubin ≤ULN). Temsirolimus is used as first-line therapy as a single agent (monotherapy) for (either. Temsirolimus for injection (Torisel ®) torisel is a kinase inhibitor.
Torisel (Temsirolimus) is an expensive drug that alters immune system response in the body. The required amount of the temsirolimus-solvent mixture. TORISEL (temsirolimus) Torisel 25 mg concentrate for injection. It is pdf indicated for the treatment of advanced renal cell carcinoma (RCC).
Torisel is torisel pdf not considered medically necessary for when any of the following selection criteria is met: 1. Torisel ( temsirolimus) SGM - 11/. Philadelphia, PA; Wyeth Pharmaceuticals Inc; March. It is less popular than comparable drugs. Member is responding positively to therapy; 3. FDA Approved Indication(s) Torisel is indicated for the treatment of advanced renal cell carcinoma (RCC).
Follow this two-step dilution process in an aseptic manner. Current guidelines from the National Comprehensive Cancer Network (NCCN,.
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