Temsirolimus

Temsirolimus is a prescription medication used to treat advanced renal cell carcinoma (RCC). RCC is a type of cancer that begins in the kidney. Temsirolimus belongs to a group of drugs called kinase inhibitors. These work by blocking the action of the abnormal protein that tells the cancer cells to multiply. This may help slow the growth of tumors.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include rash, weakness, nausea, and swelling.

Temsirolimus is a prescription medication used to treat advanced renal cell carcinoma (RCC). RCC is a type of cancer that begins in the kidney.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

Temsirolimus may be found in some form under the following brand names:

• Torisel

Common side effects include the following:

• rash
• weakness
• nausea
• swelling
• inflammation of the mucus membranes (such as the nostrils, lips of the mouth, eyelids, and the ears)
• low blood counts
• elevated blood sugar levels
• elevated cholesterol levels

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• certain antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• clarithromycin (Biaxin)
• dexamethasone (Decadron)
• certain medications used to treat HIV/AIDS such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• certain medications for seizures such as carbamazepine (Equetro, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek)
• medications to lower cholesterol and lipids
• nefazodone
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rifamate, Rifiter)
• selective serotonin reuptake inhibitors such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)
• sirolimus (Rapamune, Rapamycin)
• sunitinib (Sutent)
• telithromycin (Ketek)
• St. John's wort

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with temsirolimus including the following:

• Allergic (Hypersensitivity/Infusion) Reactions. Temsirolimus could cause serious allergic reactions, including anaphylaxis (including life threatening and fatal reactions). Immediately report any facial swelling or difficulty breathing.
• Increased Blood Glucose Levels. You are likely to experience increased blood glucose levels. This may result in the need to start, or increase in the dose of, insulin and/or antidiabetic agents. Report any excessive thirst or frequency of urination to your doctor.
• Infections. You may be more susceptible to infections while being treated with temsiroliums.
• Interstitial Lung Disease. Temsiroliums could lead to the development of interstitial lung disease, a chronic inflammation of the lungs, which may rarely result in death. Report promptly any new or worsening respiratory symptoms to your doctor.
• Increased Blood Triglycerides and/or Cholesterol. You are likely to experience elevated triglycerides and/or cholesterol during temsiroliums treatment. This may require the start of, or increase in the dose of, lipid-lowering agents.
• Bowel Perforation. Temsirolimus may cause bowel perforation. Report promptly any new or worsening stomach pain or blood in your stools.
• Kidney Failure
• Wound Healing Complications. Anormal wound healing may occur if you have surgery within a few weeks of starting therapy or during therapy with temsirolimus.
• Intracerebral Bleeding. There is an increased risk of developing intracerebral bleeding (including fatal outcomes) while on temsiroliums. This risk is greater if you have CNS tumors and/or are receiving blood thinners.
• Vaccinations may be less effective while being treated with temsirolimus. In addition, the use of live vaccines, and close contact with those who have received live vaccines, while on temsirolimus should be avoided.
• Elderly patients may be more likely to experience certain adverse reactions including diarrhea, edema and pneumonia.

Do not take temsirolimus if you

• are allergic to temsirolimus or any of its inactive ingredients
• have a bilirubin level greater than 1.5 × upper normal limit (a measure of liver dysfuntion)

Grapefruit and grapefruit juice may interact with this medication and can lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking temsirolimus,

• tell your doctor if you are allergic to temsirolimus, sirolimus, antihistamines, any other medications, polysorbate 80, or any of the ingredients in the temsirolimus solution.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take.
• tell your doctor what herbal products you are taking, especially St. John's Wort.
• tell your doctor if you have or have ever had diabetes, high cholesterol or triglycerides, a tumor in the central nervous system (brain or spinal cord), cancer, or kidney, liver, or lung disease.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving temsirolimus and for 3 months after treatment with temsirolimus has ended. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while taking temsirolimus, call your doctor immediately. Temsirolimus may harm the fetus.
• tell your doctor if you are breast-feeding. You should not breastfeed while receiving temsirolimus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving temsirolimus.
• you should know that you may be more at risk of getting an infection while you are receiving temsirolimus. Be sure to wash your hands frequently and avoid contact with people who are sick.
• do not have any vaccinations (e.g., measles, chicken pox, or flu shots) without talking to your doctor.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Temsirolimus can cause fetal (the unborn baby) harm. It is recommended to becoming pregnant throughout treatment and for 3 months after temsirolimus therapy has stopped. Men with partners of childbearing potential should use reliable contraception throughout treatment and are recommended to continue this for 3 months after the last dose of this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if temsirolimus crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using this medication.

Temsirolimus comes as a solution (liquid) to be given by infusion (slow injection into a vein) over 30 to 60 minutes. It is usually given by a doctor or nurse in a doctor's office or infusion center. Temsirolimus is usually given once every week.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of temsirolimus is 25 mg infused over a 30–60 minute period once a week.

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to temsirolimus.