TORISEL 25 mg/ml concentrate and diluent for solution for infusion
Temsirolimus
Read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What TORISEL is and what it is used for
2. Before you receive TORISEL
3. How TORISEL is given
4. Possible side effects
5. How to store TORISEL
6. Further information
What Torisel Is And What It Is Used For
Your doctor has prescribed TORISEL because you have one of the following types of cancer:
- Advanced cancer of the kidney (renal cancer).
- Previously treated mantle cell lymphoma, a type of cancer affecting the lymph nodes
TORISEL is a selective inhibitor of mTOR (mammalian target of rapamycin) that blocks tumour cell growth and division.
Before You Receive Torisel
Do not use TORISEL
- If you are allergic (hypersensitive) to temsirolimus, to polysorbate 80 or any of the other ingredients of TORISEL
- If you are allergic (hypersensitive) to sirolimus (used to prevent the body from rejecting transplanted kidneys) since sirolimus is released from temsirolimus in the body
- If you have mantle cell lymphoma and liver problems please tell your doctor.
Take special care with TORISEL
- If you are allergic (hypersensitive) to antihistamines or cannot take antihistamines for other medical reasons.
- If you have high cholesterol, TORISEL may elevate triglycerides and/or cholesterol. This may require treatment with lipid-lowering agents (medicine used to reduce cholesterol in the blood).
- If you are going to have an operation, if you have had recent major surgery, or if you still have an unhealed wound following surgery, you should tell your doctor before receiving this medicine, as TORISEL may increase the risk of problems with wound healing.
- If you are planning to have a vaccination during treatment with TORISEL, the vaccination may be less effective. The use of certain vaccinations should be avoided during treatment with TORISEL.
- If you have a history of kidney failure or kidney problems.
- If you have a history of liver problems.
- If you are a child or adolescent under 18 years of age, your doctor will consider the potential benefit to you in relation to any risk.
- If you are over 65 years of age, you may be more likely to have certain side effects, including swelling of your face, diarrhoea, pneumonia, anxiety, depression, shortness of breath, decreased number of white cells in the blood, muscle pain, change in the sense of taste, upper respiratory infection, fluid around the lungs, sores and inflammation in the mouth and/or the digestive tract and runny nose, dizziness and infections.
- If you have tumours in your brain or spinal cord, or are taking medicines to prevent your blood from clotting (such as warfarin), you may be more likely to have bleeding into your brain.
TORISEL may also
- increase blood glucose levels and worsen diabetes mellitus. This may result in the need for insulin and/or oral antidiabetic agent therapy. Tell your doctor if you experience any excessive thirst or increased frequency and quantity of urination.
- weaken your immune system; therefore, you may be at risk of getting an infection while you are taking TORISEL.
- cause shortness of breath, cough, and fever. Tell your doctor if you experience new or worsening symptoms.
- increase the risk of cerebral haemorrhage (bleeding in the brain).
- cause cataracts when taken with interferon-alpha (a medicine used in the treatment of hepatitis and cancer).
- cause serious allergic reactions. Tell your doctor if you experience difficulty in breathing and/or swelling of the face.
- cause a decrease in the number of cells that help blood to clot, which may increase the risk of bleeding.
Using TORISEL with other medicines
Some medicines can interfere with the breakdown or metabolism of TORISEL. In particular, you should inform your doctor if you are taking any of the following:
- protease inhibitors used in the treatment of HIV
- antibiotics (including rifampicin) or antifungal medicines (including ketoconazole) used to treat infections
- nefazodone or selective serotonin re-uptake inhibitors used to treat depression
- anti-epileptic medicines, including carbamazepine, phenytoin and phenobarbital
- rifabutin used to treat infection in people with HIV and other diseases
- herbal medicines or natural remedies containing St. John’s Wort (Hypericum perforatum) used to treat mild depression
- Angiotensin converting enzyme (ACE) inhibitors used to treat high blood pressure or other cardiovascular problems (such as enalapril, ramipril, lisinopril), amphiphilic medicines used to treat heart arrhythmias (such as amiodarone), or statins used to treat high cholesterol
Using TORISEL with food and drink
- Grapefruit juice may increase blood concentrations of TORISEL and should be avoided.
Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
TORISEL has not been studied in pregnant women, and it must not be used during pregnancy. It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving TORISEL.
Women of childbearing potential must avoid pregnancy by using an effective method of birth control during treatment with TORISEL. Men with partners of childbearing potential should use medically acceptable contraception while receiving TORISEL.
Women should not breast-feed during treatment with TORISEL, as this medicine may interfere with the growth and development of the baby. Ask your doctor for advice before breast-feeding your baby, as it is not known if TORISEL passes into breast milk.
Driving and using machines
No studies on the ability to drive and use machines have been performed. However, the very common side effects include feeling or being sick (nausea and vomiting) and difficulty falling or staying asleep. It is recommended you do not drive immediately after treatment.
For patients receiving the higher dose of TORISEL for the treatment of mantle cell lymphoma, the amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Important information about some of the ingredients of TORISEL
This medicine contains ethanol (alcohol), equivalent to 17.6 ml beer, 7.3 ml wine per 25 mg dose. Patients receiving the higher dose of 175 mg of TORISEL for the initial treatment of mantle cell lymphoma may receive a dose of ethanol equivalent to up to 123 ml beer or 51 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines.
How Torisel Is Given
TORISEL will always be prepared and given to you by a doctor or another healthcare professional as an intravenous infusion (into your vein).
TORISEL 25 mg/ml concentrate must be diluted with 1.8 ml of withdrawn diluent before administration in sodium chloride 9 mg/ml (0.9%) solution for injection (see dilution instructions at the end of the package leaflet).
For renal cancer, the recommended dose is 25 mg infused (as a drip) over a 30- to 60-minute period once weekly.
For mantle cell lymphoma, the recommended dosing is 175 mg infused (as a drip) over a 30- to 60-minute period once weekly for 3 weeks followed by single weekly doses of 75 mg infused (as a drip) over a 30- to 60-minute period.
You should receive an injection of antihistamine (to try to prevent allergic reaction to TORISEL) directly into your vein approximately 30 minutes before your dose of TORISEL.
Treatment with TORISEL should continue until you are no longer benefiting from therapy or until unacceptable side effects occur.
If too much TORISEL is given or you miss a dose
As this medicine is prepared and given by a healthcare professional, it is unlikely you will be given too much.
If you are concerned about this, or think you may have missed a dose, tell your doctor immediately.
Possible Side Effects
Like all medicines, TORISEL can cause side effects, although not everybody gets them. Side effects may be more pronounced during the higher dose of 175 mg / week during initial treatment for mantle cell lymphoma.
Very common serious side effects observed in more than 1 in 10 patients treated with TORISEL are:
- Decreased number of white cells in the blood, which may increase your risk of infection.
- Increased blood glucose levels in diabetic and non-diabetic patients.
- Increased blood levels of cholesterol and triglycerides.
- Decreased number of cells in the blood that help the blood to clot, which may increase the risk of bleeding**.
Common serious side effects observed in more than 1 in 100 patients treated with TORISEL are:
- Blood clots in the veins.
- Allergic (hypersensitivity)/infusion reactions (including some life-threatening and rare fatal reactions [rare is less than 1 in 1,000 patients]). You should inform your doctor immediately if you have symptoms of angioedema, such as swollen face, tongue or pharynx, and difficulty in breathing.
- Perforation of the gut (mantle cell lymphoma)*.
- Inflammation of the lungs.
- Kidney failure or kidney problems.
- Problems with wound healing.
- Pleural effusion (fluid around the lungs).
The following side effects and frequencies are those that have been seen in patients treated with TORISEL:
Very Common side effects occurring in more than 1 in 10 patients are:
General feeling of weakness, chills**, swelling due to fluid retention, pain (including abdominal, back, chest and joint pain), feeling or being sick (nausea and vomiting), diarrhoea, fever, sore throat, sores and inflammation in the mouth and/or the digestive tract, cough, upper respiratory infections**, pneumonia**, nose bleed, runny nose, rash, itching, nail disorder, acne, dry skin, anorexia, shortness of breath, low levels of potassium in the blood (which may cause muscle weakness), low red blood cell count, decreased number of white blood cells**, decreased number of lymphocytes**, high blood sugar, high cholesterol and other blood fats, abscess, infections, urinary tract infections, abnormal kidney function (including kidney failure), change in the sense of taste, difficulty falling or staying asleep, anxiety**, muscle pain**.
Common side effects occurring in less than 1 out of 10 patients, but more than 1 per 100 patients, are:
Gum redness and swelling, mouth pain (including sores inside the mouth), stomach bloating, high blood pressure, redness and swelling of the tissues around the eye, including watery eye disorder, taste loss, redness and swelling of the follicles in the skin, allergic (hypersensitivity) reactions, severe scaling of the skin, and problems with healing after surgery, increased blood clotting (including thrombosis of the veins, embolism in the lung), inflammation of the lung, infection in the blood, dehydration, depression, sleepiness, numbness and tingling of the skin, dizziness, perforation of the gut*, bleeding from the stomach or intestines, inflammation of the lining of the stomach, trouble with swallowing, eye or skin bleeding (bruising), yeast infection, fungal infection of the skin, and blood tests that show changes in the way the liver or kidney are working, low levels of phosphate in the blood, low levels of calcium in the blood.
*occurred as uncommon for renal cell carcinoma
**occurred as common for renal cell carcinoma
Uncommon side effects occurring in less than 1 out of 100 patients, but more than 1 per 1,000 patients are:
Pericardial effusion (fluid around the heart that may require drainage and can affect the pumping of blood).
Bleeding into the brain in patients with brain tumours or who are on blood thinners.
Side effects for which frequency has not been determined are:
Swelling of the face, lips, tongue, and throat, possibly causing difficulty breathing.
Serious reactions of the skin and/or mucous membranes which may include painful blisters and fever (Stevens-Johnson syndrome).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Torisel
Keep out of the reach and sight of children.
Do not use TORISEL after the expiry date, which is stated on the vial label and carton. The first two numbers indicate the month; the next four numbers indicate the year.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vials in the outer carton in order to protect from light.
After first dilution of TORISEL 25 mg/ml concentrate with 1.8 ml of withdrawn diluent, the mixture may be stored for up to 24 hours below 25°C and protected from light prior to further dilution.
After further dilution of the concentrate-diluent mixture with sodium chloride 9 mg/ml (0.9%) solution for injection, the solution may be stored for up to 6 hours below 25°C and protected from light.
Further Information
What TORISEL contains
The active substance is temsirolimus.
Each vial of 1.2 ml of TORISEL 25 mg/ml concentrate contains 30 mg of temsirolimus.
The other ingredients in TORISEL are anhydrous ethanol, all-rac-alpha-tocopherol (E 307), propylene glycol and anhydrous citric acid (E 330). The diluent contains polysorbate 80 (E 433), macrogol 400 and anhydrous ethanol.
What TORISEL looks like and contents of the pack
TORISEL is a concentrate for infusion supplied with a diluent.
The concentrate is a clear, colourless to light-yellow solution. The diluent is a clear to slightly turbid, light-yellow to yellow solution. The solutions are essentially free from visable particulates.
Each pack of TORISEL contains one vial of 1.2 ml concentrate and one vial of 2.2 ml diluent.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
This leaflet was last approved in 07/2010
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu There are also links to other websites about rare diseases and treatments.
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