Torisel

The recommended adult dose of Torisel (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 Torisel (Temsirolimus) is required. Torisel (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 Torisel (Temsirolimus) be given exactly as recommended by your doctor. If you miss an appointment to receive Torisel (Temsirolimus), contact your doctor as soon as possible to reschedule your appointment.

Torisel (Temsirolimus) will be stored at the hospital or clinic in the refrigerator and protected from light.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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

Do not take Torisel (Temsirolimus) if you:

• are allergic to Torisel (Temsirolimus), Sirolimus or any ingredients of the medication
• have a high level of bilirubin

There may be an interaction between Torisel (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 Torisel (Temsirolimus). 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.

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 Torisel (Temsirolimus).

Abnormal heart rhythms: Torisel (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 Torisel (Temsirolimus) may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of Torisel (Temsirolimus). Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Anemia: Torisel (Temsirolimus) 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: Torisel (Temsirolimus) may cause birth defects in children if either the mother or father are being treated with Torisel (Temsirolimus) at the time of conception. If either partner is using Torisel (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: Torisel (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: Torisel (Temsirolimus) 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 Torisel (Temsirolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Torisel (Temsirolimus), 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: Torisel (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 Torisel (Temsirolimus).

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

Infection: Torisel (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: Torisel (Temsirolimus) 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 Torisel (Temsirolimus) works in the body have not been established. There have been reports of people developing who were using Torisel (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 Torisel (Temsirolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Torisel (Temsirolimus), and whether any special monitoring is needed.

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

Torisel (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 Torisel (Temsirolimus).

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

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking Torisel (Temsirolimus). 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 Torisel (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 Torisel (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 Torisel (Temsirolimus). Talk to your doctor if you have any concerns.

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

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

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

Children: The safety and effectiveness of using Torisel (Temsirolimus) have not been established for children.