"The US Food and Drug Administration (FDA) has approved lenvatinib (Lenvima, Eisai), in combination with everolimus, for the treatment of patients with advanced renal cell carcinoma who were previously treated with an anti-angiogenic ther"...
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,7E,9R,10R,12R,14S,15E,17E,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-6,8,12,14,20,26hexamethyl-23, 27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine1,5,11,28,29 (4H,6H,31H)-pentone 4'-[2,2-bis (hydroxymethyl)propionate]; or Rapamycin, 42-[3hydroxy-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.
Temsirolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox,...
Last reviewed on RxList: 3/18/2015
This monograph has been modified to include the generic and brand name in many instances.
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