What is it and how is it used?
Your doctor has prescribed TORISEL because you have one of the following types of cancer:
TORISEL is a selective inhibitor of mTOR (mammalian target of rapamycin) that blocks tumour cell growth and division.
What do you have to consider before using it?
Do not use TORISEL
Take special care with TORISEL
TORISEL may also
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:
Using TORISEL with food and drink
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.
Children and adolescents
Insufficient data are available in patients under the age of 18 years. The treatment with this medicine is not recommended in children and adolescents.
How is it used?
TORISEL will always be prepared and given to you by a doctor or another healthcare professional as an intravenous infusion (into your vein).
TORISEL 30 mg concentrate must first be diluted with 1.8 ml of withdrawn diluent to achieve a concentration of 10 mg/ml 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.
What are 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:
Common serious side effects observed in more than 1 in 100 patients treated with TORISEL are:
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).
Unexplained muscle pain, tenderness or weakness which could indicate muscle damage ( rhabdomyolysis)
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 should it be stored?
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 30 mg 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.
