Temsirolimus belongs to the class of medications used to treat cancer called antineoplastics and specifically to the family of antineoplastics called mTOR kinase inhibitors. It prevents growth of the tumour cells, slowing the growth of tumours. It is used to treat kidney cancer that has spread to other areas of the body.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended adult dose of temsirolimus is 25 mg given intravenously (into a vein) once a week. It is usually infused over 30 to 60 minutes into a specially prepared site in the skin.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Very careful handling of this medication is required. Temsirolimus should be given under the direct supervision of a doctor who is experienced in prescribing and administering chemotherapy. It should also be given in a hospital or similar setting with access to sterile equipment for preparation. It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive temsirolimus, contact your doctor as soon as possible to reschedule your appointment.

This medication will be stored at the hospital or clinic in the refrigerator and protected from light.

Each mL of sterile concentrate for injection contains 25 mg of temsirolimus. Nonmedicinal ingredients: dehydrated alcohol, d,l-alpha-tocopherol, propylene glycol, anhydrous citric acid. Diluent for temsirolimus concentrate for injection: polysorbate 80, polyethylene glycol 400 macrogol, dehydrated alcohol (anhydrous ethanol).

Do not take temsirolimus if you:

• are allergic to temsirolimus, sirolimus or any ingredients of the medication
• have a high level of bilirubin

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• acne
• change in the ways things taste
• diarrhea
• dry skin
• itching
• loss of appetite
• nausea
• rash
• trouble sleeping
• vomiting
• weakness
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal, back or chest pain
• increased blood cholesterol levels
• increased blood pressure
• joint pain
• mouth sores
• redness and swelling around the eye
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, pain and swelling in one leg muscle
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, lack of coordination, thirst, confusion)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of kidney failure (e.g., decreased urine production, swelling, fatigue, abdominal pain)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of respiratory or lung infection (e.g., fever, chills, shortness of breath, cough)
• swelling (due to fluid retention)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: Temsirolimus may cause a heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, heart attack, heart disease, are taking other medications known to cause QT prolongation, or have a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Anemia: This medication may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Birth Control: Temsirolimus may cause birth defects in children if either the mother or father are being treated with this medication at the time of conception. If either partner is using temsirolimus, a reliable method of birth control should always be used throughout the course of treatment and for at least 12 weeks after stopping the medication.

Bleeding: Temsirolimus can cause a reduced number of platelets in the blood, which makes it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Cerebral bleeding: People who have tumours in the brain and those who are taking medications to thin the blood may be at an increased risk of developing bleeds in the brain. This is a serious condition that can be fatal. Symptoms are similar to those of a stroke: confusion, difficulty speaking, loss of coordination, sudden headache or vision changes, or collapse. If you experience any of these symptoms, get immediate medical attention.

Diabetes: Temsirolimus may cause a loss of control of diabetes by increasing blood glucose (sugar). People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: Temsirolimus can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Infusion Reactions: This medication can cause a hypersensitivity or infusion reaction. Symptoms of this type of reaction generally appear during the infusion of the medication and may include flushing, chest pain, shortness of breath and a dramatic drop in blood pressure. These reactions can cause death if a health care provider is not informed immediately. If you experience any of these symptoms, or notice them happening to someone, let your nurse or doctor know immediately.

Kidney function: The effects of decreased kidney function on how temsirolimus works in the body have not been established. There have been reports of people developing who were using temsirolimus developing kidney failure. Report any signs of decreased kidney function, such as decreased urine production, swelling, fatigue, or abdominal pain to your doctor as soon as possible.

If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Temsirolimus is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Temsirolimus has also been reported to cause liver failure which has in cases, led to death. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately. Your doctor should test your liver function regularly with blood tests while you are taking this medication.

People with moderately to severely reduced liver function appear to have an increased risk of side effects and death while being treated with temsirolimus.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking this medication. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are being treated with temsirolimus, contact your doctor immediately.

Second cancers: Although studies have not been done to determine if there is any risk of developing other cancers due to the use of temsirolimus, the medication breaks down in the body to sirolimus, a medication that can cause skin cancer, and lymphoma, a cancer of the blood. Your doctor will monitor you for these conditions while you are taking this medication. Talk to your doctor if you have any concerns.

Vaccines: Vaccines should not be given while you are taking temsirolimus. Some vaccines should not be given to people who are in close contact with people being treated with temsirolimus.

Pregnancy: There is a possibility of birth defects if either the father or mother is using temsirolimus at the time of conception, or if it is taken during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if temsirolimus passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Women are generally advised to avoid breast-feeding if they are being treated with temsirolimus.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between temsirolimus and any of the following:

• amiodarone
• angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• BCG vaccine
• bosentan
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• carbamazepine
• carvedilol
• clozapine
• cobicistat
• conivaptan
• crizotinib
• cyclosporine
• dabrafenib
• dasatinib
• deferiprone
• deferasirox
• denosumab
• dexamethasone
• diabetes medications (e.g., glyburide, metformin, saxagliptin, insulin)
• dronedarone
• Echinacea
• enzalutamide
• fingolimod
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• imatinib
• lapatinib
• leflunomide
• lomitapide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• mitotane
• modafinil
• natalizumab
• nefazodone
• nilotinib
• nivolumab
• phenobarbital
• phenytoin
• pimecrolimus
• primidone
• quinidine
• quinine
• reserpine
• rifabutin
• rifampin
• roflumilast
• St. John's wort
• simeprevir
• sunitinib
• tacrolimus
• tocilizumab
• tofacitinib
• trastuzumab
• vinblastine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.