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TORISEL is a brand name for Temsirolimus, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TORISEL (temsirolimus for injection) is indicated for the treatment of metastatic renal cell carcinoma. 1.1 Pediatrics Pediatrics (1 year – 21 years): There is no indication for the use of TORISEL in the pediatric population. The effectiveness of TORISEL in 71 pediatric patients (aged 1 year to 21 years) with advanced…
Verbatim from this product's HC label. Tap a section to expand.
3 Reconstitution 07/2022 7 WARNINGS AND PRECAUTIONS, Concomitant use of cannabidiol and temsirolimus 07/2022 12 SPECIAL HANDLING INSTRUCTIONS 07/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
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). Drug-Drug Interactions Agents Inducing CYP3A Metabolism Agents such as carbamazepine, phenytoin, barbiturates, rifabutin, rifampicin, and St John’s Wort are strong inducers of CYP3A4/5 and may decrease composite exposures of the active moieties, temsirolimus and its metabolite, sirolimus.
Therefore, concomitant treatment with agents that have CYP3A4/5 induction potential should be avoided. The safety profile of temsirolimus at doses greater than 25 mg in the presence of a CYP3A4/5 inducer has not been evaluated in the context of compensation for the reduced sirolimus exposure (see 5 OVERDOSAGE).
8 ml per vial Dehydrated alcohol (anhydrous ethanol), polyethylene glycol 400 macrogol, polysorbate 80 Torisel (Temsirolimus) - Product Monograph Page 9 of 55 Agents Inhibiting CYP3A Metabolism Agents such as protease inhibitors, anti-fungals, macrolide antibiotics, nefazodone, and selective serotonin inhibitors are strong CYP3A4 inhibitors and may increase blood concentrations of the active moieties, temsirolimus and its metabolite, sirolimus.
Therefore, concomitant treatment with agents that have CYP3A4 inhibition potential should be avoided. Alternative treatments with agents that do not have CYP3A4 inhibition potential should be considered (see
, Concomitant use of cannabidiol and temsirolimus 07/2022 12 SPECIAL HANDLING INSTRUCTIONS 07/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Special Populations ..............................................................................................
14 8 ADVERSE REACTIONS..................................................................................................... 1 Adverse Reaction Overview ...................................................................................
2 Clinical Trial Adverse Reactions .............................................................................. 5 Post-Market Adverse Reactions.............................................................................. 21 9 DRUG INTERACTIONS ....................................................................................................
2 Drug Interactions Overview ................................................................................... 4 Drug-Drug Interactions ......................................................................................... 5 Drug-Food Interactions .........................................................................................
6 Drug-Herb Interactions ......................................................................................... 7 Drug-Laboratory Test Interactions .......................................................................... 23 10 CLINICAL PHARMACOLOGY ............................................................................................
1 Mechanism of Action ...................................................................................... 2 Pharmacodynamics......................................................................................... 3 Pharmacokinetics ...........................................................................................
25 11 STORAGE, STABILITY AND DISPOSAL ............................................................................... 27 12 SPECIAL HANDLING INSTRUCTIONS .................................................................................
28 PART II: SCIENTIFIC INFORMATION ............................................................................................. 29 13 PHARMACEUTICAL INFORMATION ..................................................................................
29 14 CLINICAL TRIALS............................................................................................................ 1 Trial Design and Study Demographics ................................................................
2 Study Results ................................................................................................. 31 15 MICROBIOLOGY ............................................................................................................
33 16 NON-CLINICAL TOXICOLOGY........................................................................................... 33 PATIENT MEDICATION INFORMATION ........................................................................................
48 Torisel (Temsirolimus) - Product Monograph Page 4 of 55 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TORISEL (temsirolimus for injection) is indicated for the treatment of […]
TORISEL (temsirolimus for injection) is contraindicated in patients who have a history of anaphylaxis after exposure to temsirolimus, sirolimus or any other component of TORISEL (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
5 x ULN (see 7 WARNINGS AND PRECAUTIONS,
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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