Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
TEMSIROLIMUS (UNII: 624KN6GM2T) (TEMSIROLIMUS - UNII:624KN6GM2T)
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
TEMSIROLIMUS
TEMSIROLIMUS 25 mg in 1 mL
PRESCRIPTION DRUG
TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL is contraindicated in patients with bilirubin >1.5×ULN [see Warnings and Precautions (5.2)] . Risk Summary Based on findings in animal studies and its mechanism of action, temsirolimus can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Although there are no data on the use of TORISEL in pregnant women, there are limited data on the use of sirolimus, the active metabolite of temsirolimus, during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproductive studies, oral daily administration of temsirolimus to pregnant rats and rabbits during organogenesis caused adverse embryo-fetal effects at approximately 0.04 and 0.12 times the AUC in patients at the recommended dose, respectively (see Data) . Advise pregnant women of the potential hazard to a fetus. The estimated background risk of major birth defects and m
NDC 0008-1179-01 TORISEL (temsirolimus) injection, 25 mg/mL. Each kit is supplied in a single carton containing one single-use vial of 25 mg/mL of temsirolimus and one DILUENT vial which includes a deliverable volume of 1.8 mL, and must be stored at 2º–8º C (36º–46º F). Protect from light. TORISEL is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .
New Drug Application
TORISEL- TEMSIROLIMUS WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TORISEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TORISEL. TORISEL KIT (TEMSIROLIMUS) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2007 INDICATIONS AND USAGE TORISEL is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS TORISEL injection, 25 mg/mL supplied with DILUENT for TORISEL. (3) CONTRAINDICATIONS TORISEL is contraindicated in patients with bilirubin > 1.5×ULN. (4) WARNINGS AND PRECAUTIONS • • • • • • • • • • • • • ADVERSE REACTIONS THE MOST COMMON ADVERSE REACTIONS (INCIDENCE ≥30%) ARE RASH, ASTHENIA, MUCOSITIS, NAUSEA, EDEMA, AND ANOREXIA. THE MOST COMMON LABORATORY ABNORMALITIES (INCIDENCE ≥30%) ARE ANEMIA, HYPERGLYCEMIA, HYPERLIPIDEMIA, HYPERTRIGLYCERIDEMIA, ELEVATED ALKALINE PHOSPHATASE, ELEVATED SERUM CREATININE, LYMPHOPENIA, HYPOPHOSPHATEMIA, THROMBOCYTOPENIA, ELEVATED AST, AND LEUKOPENIA. (6)TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WYETH PHARMACEUTICALS INC. AT 1-800-934-5556 OR FDA AT 1-800-FDA- 1088 OR WWW.FDA.GOV/MEDWATCH ® ® The recommended dose of TORISEL is 25 mg administered as an intravenous infusion over a 30–60 minute period once a week. Treat until disease progression or unacceptable toxicity. (2.1) Antihistamine pre-treatment is recommended. (2.2) Dose reduction is required in patients with mild hepatic impairment. (2.4) TORISEL (temsirolimus) injection vial contents must first be diluted with the enclosed diluent before diluting the resultant solution with 250 mL of 0.9% Sodium Chloride Injection. (2.5) Hypersensitivity/Infusion Reactions (including some life-threatening and rare fatal reactions) can occur early in the first infusion of TORISEL. Patients should be monitored throughout the infusion. (5.1) To treat hypersensitivity read_full_document