Torisel

DRUG DESCRIPTION

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-dimethoxy6,8,12,14,20,26-hexamethyl-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[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate].

TORISEL Kit (temsirolimus) Structural Formula Illustration

TORISEL (temsirolimus) injection, 25 mg/mL, is a clear, colorless to light yellow, nonaqueous, 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 (temsirolimus injection) .

DILUENT for TORISEL (temsirolimus injection) 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 (temsirolimus injection)

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 (temsirolimus injection) , in accordance with the instructions in section 2.5, the solution contains 35.2% alcohol.

TORISEL (temsirolimus) injection and DILUENT for TORISEL (temsirolimus injection) are filled in clear glass vials with butyl rubber stoppers.

What are the possible side effects of temsirolimus (Torisel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • cough, feeling short of breath;
  • warmth, redness, or tingly feeling under your skin;
  • increased thirst, hunger, or urination;
  • black, bloody, or tarry stools;
  • fever, severe stomach pain;
  • urinating less than usual or...

Read All Potential Side Effects and See Pictures of Torisel

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...

Read All Potential Precautions of Torisel


Torisel Consumer (continued)

SIDE EFFECTS: Pain/sores in the mouth or throat, nausea, vomiting, diarrhea, headache, changes in taste, weakness, and loss of appetite may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: flushing, slow wound healing, swelling ankles/feet, eye redness/itching, easy bruising/bleeding, unusual tiredness, muscle cramps, fast/pounding heartbeat, pain/redness/swelling of arms or legs.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Temsirolimus may cause your cholesterol/triglycerides or blood sugar to increase. You may be required to have your cholesterol/triglycerides or blood sugar checked periodically. You may need medication to control your cholesterol/triglycerides or blood sugar. Tell your doctor or pharmacist if you experience symptoms of high blood sugar, including increased thirst/hunger, frequent urination.

This medication can infrequently cause serious (rarely fatal) lung, kidney, or intestinal problems. Tell your doctor immediately if you notice any symptoms of lung, kidney, or intestinal problems, including: shortness of breath, cough, change in the amount of urine, severe abdominal pain, black/bloody stool.

This drug increases the risk of a possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, difficulty speaking.

Infrequently a very serious allergic reaction to this drug might occur, especially while your dose is being given (infusion reaction). Get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash/flushing, itching/swelling (especially of the face/tongue/throat), severe dizziness, chest pain, trouble breathing.

Temsirolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 infections.

Before having surgery, tell your doctor or dentist that you are using this medication.

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

This drug is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. It is recommended that both men and women receiving this medication use at least 2 reliable forms of birth control (e.g., condoms, birth control pills) during treatment with this medication and for at least 3 months afterwards. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor immediately.

It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Torisel Patient Information Including Side Effects

Brand Names: Torisel

Generic Name: temsirolimus (Pronunciation: TEM sir OH li mus)

  • What is temsirolimus (Torisel)?
  • What are the possible side effects of temsirolimus (Torisel)?
  • What is the most important information I should know about temsirolimus (Torisel)?
  • What should I discuss with my doctor before receiving temsirolimus (Torisel)?
  • How is temsirolimus given (Torisel)?
  • What happens if I miss a dose (Torisel)?
  • What happens if I overdose (Torisel)?
  • What should I avoid while receiving temsirolimus (Torisel)?
  • What other drugs will affect temsirolimus (Torisel)?
  • Where can I get more information?

What is temsirolimus (Torisel)?

Temsirolimus is a cancer medication. It slows the growth and spread of cancer cells in the body.

Temsirolimus is used to treat cancer of the kidneys, also called renal cell carcinoma.

Temsirolimus may also be used for other purposes not listed in this medication guide.

What are the possible side effects of temsirolimus (Torisel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • cough, feeling short of breath;
  • warmth, redness, or tingly feeling under your skin;
  • increased thirst, hunger, or urination;
  • black, bloody, or tarry stools;
  • fever, severe stomach pain;
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, loss of appetite, nausea and vomiting;
  • swelling, weight gain; or
  • pale skin, easy bruising or bleeding, weakness.

Less serious side effects include:

  • minor skin rash; or
  • white patches or sores inside your mouth or on your lips.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about temsirolimus (Torisel)?

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive temsirolimus without telling your doctor if you are pregnant. Use an effective form of birth control while you are using this medication and for at least 3 months after your treatment ends.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using temsirolimus.

Temsirolimus can lower the blood cells that help your body fight infections. Avoid contact with people who have colds, the flu, or other contagious illnesses. Do not receive any vaccines. Contact your doctor immediately if you develop signs of infection.

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