(temsirolimus) Injection, for Intravenous Infusion Only
Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent.
Temsirolimus is a white to off-white powder with a molecular formula of C56H87NO16 and a molecular weight of 1030.30. It is non-hygroscopic. Temsirolimus is practically insoluble in water and soluble in alcohol. It has no ionizable functional groups, and its solubility is independent of pH.
The chemical name of temsirolimus is (3S,6R,1E,9R, 10R, 12R, 14S,15E, 11E, 19E, 21S, 23S, 26R, 27R,34aS)- 9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2- [(1S,3R,4R)-4-hydroxy-3 -methoxycyclohexyl] -1 -methylethyl] -10,21 -dimethoxy-6,8,12,14,20,26- hexamethyl-23, 27-epoxy-3H-pyrido[2,1 -c][ 1,4]oxaazacyclohentriacontine- 1,5,11,28,29(4H,6H,31H)-pentone 4'-[2,2-bis(hydroxymethyl)propionate]; or Rapamycin, 42-[3- hydroxy-2-(hydroxymethyl)-2-methylpropanoate].
TORISEL (temsirolimus) injection, 25 mg/mL, is a clear, colorless to light yellow, non-aqueous, ethanolic, sterile solution. TORISEL (temsirolimus) injection requires two dilutions prior to intravenous infusion. TORISEL (temsirolimus) injection should be diluted only with the supplied DILUENT for TORISEL®.
DILUENT for TORISEL® is a sterile, non-aqueous solution that is supplied with TORISEL injection, as a kit.
TORISEL (temsirolimus) injection, 25 mg/mL: Active ingredient: temsirolimus (25 mg/mL)
Inactive ingredients: dehydrated alcohol (39.5% w/v), dl-alpha-tocopherol (0.075% w/v), propylene glycol (50.3% w/v), and anhydrous citric acid (0.0025% w/v).
DILUENT for TORISEL®
Inactive ingredients: polysorbate 80 (40.0% w/v), polyethylene glycol 400 (42.8% w/v) and dehydrated alcohol (19.9% w/v).
After the TORISEL (temsirolimus) injection vial has been diluted with DILUENT for TORISEL®, in accordance with the instructions in section 2.5, the solution contains 35.2% alcohol.
TORISEL (temsirolimus) injection and DILUENT for TORISEL® are filled in clear glass vials with butyl rubber stoppers.
What are the possible side effects of temsirolimus (Torisel)?
Some people receiving a temsirolimus injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, warm, tingly, light-headed, short of breath, or have chest pain or trouble breathing during the injection.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- fever, chills, body aches, flu symptoms, sores in...
What are the precautions when taking temsirolimus injection (Torisel)?
Before receiving temsirolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, high cholesterol/triglyceride levels, liver disease, kidney disease, recent/current infections or wounds, recent surgery, brain cancer.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of...
Last reviewed on RxList: 6/21/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Torisel Information
Torisel - User Reviews
Torisel User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.