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Temsirolimus (Injection)

Temsirolimus (tem-sir-OH-li-mus)

Treats late-stage kidney cancer.

Brand Name(s):


There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not receive this medicine if you have had an allergic reaction to temsirolimus, or if you are pregnant. Do not receive this medicine if you have moderate to severe liver disease.

How to Use This Medicine:


  • Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
  • You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
  • Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
  • You will receive a medicine to prevent allergic reactions (such as diphenhydramine, Benadryl®) before you receive this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using St. John's wort, a blood thinner (such as warfarin, Coumadin®), medicine to treat a fungus infection (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), medicine to treat depression (such as nefazodone, Serzone®), or medicine to treat HIV or AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, Reyataz®, or Viracept®). Tell your doctor if you are using a steroid medicine (such as dexamethasone, Decadron®, or Hexadrol®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Carbatrol®, Dilantin®, or Tegretol®), or medicine to treat an infection (such as clarithromycin, telithromycin, rifabutin, rifampicin, rifampin, Biaxin®, Ketek®, Mycobutin®, Rifadin®, or Rimactane®).
  • Make sure your doctor knows if you are also using other medicines to treat kidney cancer (such as sunitinib, Sutent®).
  • This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

  • This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant.Use an effective form of birth control while being treated with this medicine and for at least 3 months after stopping treatment.
  • Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, bleeding problems, bowel problems, a brain tumor, diabetes, high cholesterol or fats in the blood, any type of infection, or lung disease. Tell your doctor if you have had an allergic reaction to sirolimus or polysorbate 80.
  • This medicine may cause allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you receive the injection.
  • This medicine may cause flushing, headaches, and lightheadedness or faintness, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.
  • This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. Your doctor may give you insulin or other medicines that can lower the amount of sugar in your blood.
  • This medicine lowers the number of some types of blood cells in your body. Because of this, you may get infections more easily. To help with this problem, avoid being near people who are sick or have infections. If you think you are getting a cold or other infection, check with your doctor.
  • This medicine may cause a serious lung problem. Check with your doctor immediately if you are having tightness in the chest, shortness of breath, difficulty with breathing, or wheezing.
  • This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.
  • Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; diarrhea; fever; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.
  • This medicine may increase your chance of having acute kidney disease that is not related to the worsening of your kidney cancer. Talk to your doctor about this risk.
  • This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several weeks before and after having surgery.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Change in how much or how often you urinate, or painful urination.
  • Chest pain, shortness of breath, or coughing up blood.
  • Fever, chills, cough, headache, sore throat, runny or stuffy nose, and body aches.
  • Increased hunger or thirst.
  • Lightheadedness, dizziness, or fainting.
  • Nosebleeds.
  • Pain in your lower leg (calf).
  • Severe stomach pain, vomiting of blood or material that looks like coffee grounds, or red or black stools.
  • Sores or white patches on your lips, mouth, or throat.
  • Swelling in your hands, ankles, or feet.
  • Tearing, or red, itchy, painful, or irritated eyes.
  • Unusual bleeding, bruising, or weakness.
  • Warmth or redness in your face, neck, arms, or upper chest.

If you notice these less serious side effects, talk with your doctor:

  • Back, muscle, or joint pain.
  • Change in taste.
  • Depression or trouble sleeping.
  • Diarrhea, constipation, nausea, vomiting, or mild stomach pain.
  • Dry skin, pimples, skin rash or itching, or nail changes.
  • Loss of appetite or weight loss.
  • Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
  • Tiredness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

Last Updated: 4/4/2014

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