30 mg\u00a0concentrate and liquid for\u00a0infusion, solution
temsirolimus<\/p>\n\n\n\n
Torisel contains the active substance temsirolimus.<\/p>\n\n\n\n
Temsirolimus is a selective inhibitor of the enzyme mTOR (mammalian target of rapamycin) and works by blocking the growth and division of tumor cells.<\/p>\n\n\n\n
Torisel is used to treat the following types of cancer in adults:<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\n Talk to your doctor, pharmacist, or nurse before you are given Torisel<\/p>\n\n\n\n Talk to your doctor, pharmacist, or nurse if you have any questions. This medicine is not intended for children and adolescents under 18 years of age.\u00a0Advanced kidney cancer and mantle cell lymphoma are not relevant for these patients and do not affect other cancer types. Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.<\/p>\n\n\n\n Some medicines can interfere with the breakdown (\u00a0metabolism\u00a0) of Torisel and therefore dose adjustment of Torisel may be required.\u00a0You must inform your doctor or pharmacist if you are using any of the following:<\/p>\n\n\n\n Grapefruit and grapefruit juice may increase blood concentrations of Torisel and should be avoided.<\/a><\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being given this medicine.<\/p>\n\n\n\n Torisel has not been studied in pregnant women and must not be used during pregnancy unless necessary.<\/p>\n\n\n\n Women of childbearing potential must avoid becoming pregnant by using an effective method of contraception during ongoing treatment with Torisel. Men with partners of childbearing potential should use medically acceptable contraception while being treated with Torisel.<\/p>\n\n\n\n Women should not breastfeed during treatment with Torisel, as the agent may affect the growth and development of the child.<\/p>\n\n\n\n Torisel contains alcohol (\u00a0ethanol\u00a0).\u00a0If you are pregnant or breastfeeding your child, you should consult a doctor or pharmacist before using this medicine.<\/p>\n\n\n\n Torisel contains propylene glycol. If you are pregnant, do not use the medicine except on the doctor’s recommendation (see “Torisel contains propylene glycol”). Propylene glycol can pass into breast milk. If you are breastfeeding, do not use the medicine except on the doctor’s recommendation (see “Torisel contains propylene glycol”). Torisel probably does not affect the ability to drive and use machines.\u00a0However, nausea and vomiting, and difficulty falling asleep or staying asleep are among the very common\u00a0side effects\u00a0of this medicine.\u00a0Be especially careful if you drive or use machines if you feel nauseous and are vomiting or if you have difficulty falling asleep or staying asleep.<\/p>\n\n\n\n For patients receiving the higher\u00a0dose\u00a0of Torisel for the treatment of mantle cell lymphoma, the amount of alcohol in this medicine may impair their ability to drive or use machines (see the section below \u201cTorisel contains\u00a0ethanol\u00a0[alcohol]\u201d). This medicine contains alcohol (\u00a0ethanol\u00a0), in an amount equivalent to 18 ml of beer or 7 ml of wine per 25 mg\u00a0dose.\u00a0Patients who receive the higher\u00a0dose of\u00a0175 mg Torisel for the\u00a0initial\u00a0treatment of mantle cell lymphoma may achieve an ethanol amount equivalent to 122 ml of beer or 49 ml of wine per\u00a0dose.\u00a0This is harmful if you are dependent on alcohol and should be taken into account by pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or\u00a0epilepsy.<\/p>\n\n\n\n The amount of alcohol in this medicine probably has no effects on adults and adolescents, and its effect on children is probably not noticeable.\u00a0It may have some effect in infants and younger children, e.g.\u00a0somnolence.\u00a0If you are dependent on alcohol, consult a doctor or pharmacist before using this medicine.<\/p>\n\n\n\n The amount of alcohol in this medicine can affect the effectiveness of other medicines.\u00a0Tell your doctor or pharmacist if you are using other medicines.<\/p>\n\n\n\n The amount of alcohol in this medicine can impair your ability to drive and use machines or affect the effectiveness of other medicines (see sections “Warnings and precautions” and “Ability to drive and use machines”).<\/p>\n\n\n\n Torisel contains propylene glycol<\/strong><\/p>\n\n\n\n Torisel contains 503.3 mg of propylene glycol per 25 mg\u00a0dose, corresponding to 201.33 mg\/ml in the pre-diluted product. If your child is younger than 5 years, contact a doctor or pharmacist before the child uses the medicine, especially if the child is receiving other medicines that contain propylene glycol or alcohol.\u00a0If you are pregnant or breastfeeding, or if you have impaired liver function or impaired kidney function, do not use the medicine except on the recommendation of a doctor.\u00a0The doctor may want to do extra checks during the treatment. Torisel must always be prepared and given by a doctor or other healthcare professional in the form of an intravenous infusion (drip into a vein).<\/p>\n\n\n\n You should receive an injection of antihistamine (to prevent an allergic reaction to Torisel) directly into the vein about 30 minutes before you receive your dose of Torisel.<\/p>\n\n\n\n The Torisel concentrate must first be diluted with 1.8 ml of the supplied liquid 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).<\/p>\n\n\n\n For advanced kidney cancer, the recommended dose is 25 mg given as a drip over 30 to 60 minutes once a week.<\/p>\n\n\n\n For mantle cell lymphoma, the recommended dose is 175 mg given as a drip over 30 to 60 minutes once a week for 3 weeks followed by a dose of 75 mg once a week given as a drip over 30 to 60 minutes.<\/p>\n\n\n\n Treatment with Torisel should be continued until you no longer benefit from the treatment or until unacceptable side effects occur.<\/p>\n\n\n\n As this medicine is prepared and administered by healthcare professionals, it is unlikely that you would receive too much\u00a0or\u00a0miss a\u00a0dose.<\/p>\n\n\n\n If you are concerned about this, tell your doctor immediately.<\/p>\n\n\n\n If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse. Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0Side effects\u00a0may be more pronounced with the higher\u00a0dose\u00a0of 175 mg per week during the initial treatment of mantle cell lymphoma.<\/p>\n\n\n\n The most important side effects that you may experience during treatment with Torisel are listed below. Seek immediate medical attention if you experience any of these.<\/p>\n\n\n\n Allergic reactions<\/strong><\/p>\n\n\n\n You should\u00a0immediately contact a doctor or nurse<\/strong>\u00a0if you get symptoms of\u00a0angioedema, such as swelling of the face, tongue, throat, and difficulty breathing.\u00a0If you experience any of these symptoms during treatment with Torisel, the doctor or nurse will stop the\u00a0infusion.<\/p>\n\n\n\n Cerebral hemorrhage<\/strong><\/p>\n\n\n\n You should\u00a0seek medical attention immediately<\/strong>\u00a0if you feel confused, abnormally tired, have difficulty speaking or swallowing, and if your\u00a0pupils\u00a0are of different sizes.\u00a0These symptoms can be caused by brain bleeding.<\/p>\n\n\n\n Puncture, tear, or hole in the intestine<\/strong><\/p>\n\n\n\n You should\u00a0seek medical attention immediately<\/strong>\u00a0if you have acute abdominal pain, high fever, nausea, and vomiting, or blood in the stool.\u00a0These symptoms can be caused by holes in the intestine.<\/p>\n\n\n\n Kidney failure<\/strong><\/p>\n\n\n\n You should\u00a0immediately seek medical attention<\/strong>\u00a0if you have general swelling, shortness of breath, or fatigue.\u00a0These symptoms can be caused by a sudden decrease in kidney function.<\/p>\n\n\n\n Embolism in the lung<\/strong><\/p>\n\n\n\n You should\u00a0seek medical attention immediately<\/strong>\u00a0if you have shortness of breath, chest pain, coughing up blood, rapid\u00a0pulse, nausea, fainting, sweating, wheezing, and sticky or bluish skin.\u00a0These symptoms can be caused by a blood clot in your lungs.<\/p>\n\n\n\n You must also inform your doctor immediately<\/strong><\/p>\n\n\n\n Other\u00a0side effects\u00a0of Torisel may include<\/strong><\/p>\n\n\n\n Very common side effects (may affect more than 1 in 10 patients)<\/strong><\/p>\n\n\n\n General weakness, chills, swelling caused by fluid retention, pain (including abdominal, back, chest, and joint pain<\/a>), stomach discomfort (nausea, vomiting), diarrhea, constipation, headache, fever, mouth ulcers, and\u00a0inflammation\u00a0and\/or digestive tract, cough,\u00a0pneumonia, nosebleeds, rash,\u00a0itching, dry skin, decreased appetite, shortness of breath, low blood potassium (which can cause muscle weakness), low\u00a0red blood cell count, decreased\u00a0white blood cell count\u00a0associated with increased risk of\u00a0infection, high blood sugar, high\u00a0cholesterol, high\u00a0triglycerides, abscesses,\u00a0infection (including\u00a0eye infection\u00a0er,\u00a0flu, viral infections,\u00a0bronchitis\u00a0), abnormal kidney function (including\u00a0kidney failure\u00a0), changes in blood test values \u200b\u200bthat show how the kidneys are working, altered sense of taste, difficulty sleeping, low\u00a0platelet count\u00a0which can cause bleeding and bruising.<\/p>\n\n\n\nWhat you need to know before you are given Torisel<\/h2>\n\n\n\n
Do not use Torisel<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
<\/p>\n\n\n\nOther medicines and Torisel<\/h2>\n\n\n\n
Torisel with food, drink, and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nDriving ability and use of machinery<\/h2>\n\n\n\n
<\/p>\n\n\n\nTorisel contains alcohol (ethanol)<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Torisel<\/h2>\n\n\n\n
<\/p>\n\n\n\nPossible side effects<\/h2>\n\n\n\n