Irinotecan 20 Mg/Ml Concentrate For Solution For Infusion
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER IRINOTECAN 20 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION (IRINOTECAN HYDROCHLORIDE TRIHYDRATE)
Read all of this leaflet carefully before you are given Irinotecan
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What Irinotecan is and what it is used for
2. Before you are given Irinotecan
3. How Irinotecan is given
4. Possible side effects
5. How to store Irinotecan
6. Further information
1. WHAT IRINOTECAN IS AND WHAT IT IS USED FOR
Irinotecan belongs to a group of medicines called cytostatics (anti-cancer medicines).
Irinotecan is normally used for the treatment of advanced cancer of the large intestine (colon or rectum) in adults, either alone or in a combination with other medicines.
Your doctor may use a combination of Irinotecan with capecitabine with or without bevacizumab to treat your cancer of the colon and rectum.
Your doctor may use a combination of Irinotecan with 5-fluorouracil/folinic acid (5FU/FA) and bevacizumab to treat your cancer of the colon and rectum.
Your doctor may use a combination of Irinotecan with cetuximab to treat certain types of cancer of the large intestine expressing a factor known as EGFR.
If you need any further information on your condition, please ask your doctor.
2. BEFORE YOU ARE GIVEN IRINOTECAN
If you receive Irinotecan in combination with other products, please make sure that you also read the package insert for them.
You should not be given Irinotecan:
• If you have any other bowel disease or a history of bowel obstruction.
• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Irinotecan in the past.
• If you are pregnant, planning to become pregnant, or breast-feeding.
• Ifyou have any liver problems.
• If you have severe bone marrow failure.
• If you are in bed or sitting in a chair for more than half the day or all the time; and you need some help or a lot of help in looking after yourself.
• If you are treated with St John's Wort.
Take special care with Irinotecan:
• You should tell your doctor if you had prior radiotherapy, especially to your abdomen or pelvis, as this can increase your risk of having diarrhoea with irinotecan treatment. You should also tell your doctor if you have had radiotherapy to the lungs, or have taken drugs which have had toxic effects on your lungs as this can increase the likelihood of experiencing respiratory symptoms during treatment with irinotecan. Your doctor should monitor you closely if you have had any of these treatments.
• You should inform your doctor if you have symptoms like inability to pass stools or flatus (suggestive of bowel obstruction). Irinotecan should not be given in patients with these symptoms.
• If you are elderly the dose of irinotecan should be carefully chosen and you should be closely monitored by your doctor.
• You should take contraceptive measures during and for at least three months after treatment has stopped.
• If you suffer from an inherited condition called fructose intolerance, tell your doctor or hospital pharmacist before you are given Irinotecan. Irinotecan contains sorbitol, which is unsuitable for people who cannot tolerate fructose.
• Your doctor should perform blood tests to check your liver and bone marrow function before you start treatment.
Taking other medicines:
• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or:
• Antiepileptic drugs (e.g. carbamazepine, phenobarbital or phenytoin).
• Antifungal drugs (e.g. ketoconazole).
• Neuromuscular blocking agents (e.g. suxamethonium)
• Medicines like rifampicin or other prescription medicines.
• Any non-prescription medicines that you may have bought yourself, in particular St Johns' Wort.
If you receive Irinotecan in combination with either capecitabine, cetuximab or bevacizumab, please make sure that you also read the patient information leaflet for each medicine.
Pregnancy and Breast Feeding:
If you are pregnant or planning to become pregnant, tell your doctor or hospital pharmacist immediately, as you should not receive Irinotecan during pregnancy.
You should not breast feed while you are being treated with Irinotecan. Do not restart breast feeding until your doctor tells you it is safe to do so.
Do not drive or operate machinery as Irinotecan may make you feel dizzy or cause visual disturbances.
Irinotecan will be given as an infusion into your veins over a period of 30 to 90 minutes. The amount of Irinotecan you are given will depend on your age, size and general medical condition. It will also depend on any other treatment you may have received for your cancer. Your doctor will calculate your body surface area in square metres (m2).
• If you have previously been treated with 5-fluorouracil you will normally be treated with Irinotecan alone starting with a dose of 350 mg/m2 every 3 weeks
• If you have not had previous chemotherapy you will normally receive 180 mg/m2 Irinotecan every two weeks. This will be followed by folinic acid and 5-fluorouracil.
• These dosages may be adjusted by your doctor depending on your condition and any side-effects you may have.
• Your doctor will perform regular blood tests after giving you irinotecan. Irinotecan may cause a decrease in the number of your white blood cells, which play an important role in fighting infections. Irinotecan may also affect your liver function, so your doctor will also arrange for you to have liver function tests at regular intervals while receiving treatment with irinotecan.
If you receive Irinotecan in combination with cetuximab, Irinotecan must not be administered earlier than 1 hour after the end of the cetuximab infusion. Please follow the advice of your doctor regarding your current treatment.
Like all medicines, Irinotecan can cause side effects, although not everybody gets them.
Your doctor will discuss these side-effects with you and explain the risks and benefits of your treatment.
Some of these side-effects must be treated immediately. Please read the following instructions carefully and follow them if you have any of the side-effects listed.
Tell your doctor immediately if you notice any of the following:
• If your diarrhoea starts less than 24 hours after the infusion ("early diarrhoea").
• If your diarrhoea starts more than 24 hours after the infusion ("delayed diarrhoea").
• Any fever, and particularly if you also have diarrhoea.
• Nausea and vomiting.
• Breathing difficulties.
Very common side effects (in more than 1 in 10 patients) are:
• Diarrhoea, which starts more than 24 hours after the infusion (“delayed diarrhoea”). You should immediately
take any anti-diarrhoeal treatment that the doctor has given you exactly as he has told you. If you are unsure of
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what this is, ask your doctor or nurse. Drink large amounts of rehydration fluids, immediately (i.e. water, soda water, fizzy drinks, soup or oral rehydration therapy).
• Nausea and vomiting. If you have nausea and vomiting contact your doctor immediately.
• Fever. If you have any fever this may be an indication of infection associated with a reduction in the number of your white blood cells (neutropenia) and you should contact your doctor immediately for treatment.
• Constipation.
• Reduction in white blood cells, which play an important role in fighting infections. This is called neutropenia.
• Reduction in blood platelets, which increases risk of bleeding or bruising.
• Reduction in red blood cells, which can make the skin pale and cause weakness or breathlessness.
• Hair loss.
• Signs of infection.
• High levels of liver enzymes and bilirubin.
Common side effects (in more than 1 in 100, but in less than 1 in 10 patients) are:
• Diarrhoea, which starts less than 24 hours after the infusion ("early diarrhoea”). You should contact your doctor or nurse immediately and they will give you a suitable treatment.
• If you have "early diarrhoea" do not use any anti-diarrhoeal treatment that your doctor has given you for "delayed diarrhoea". This "early diarrhoea" may be accompanied by other symptoms such as
Sweating
Abdominal cramps Watering eyes Conjunctivitis Runny nose Chills
Visual problems Dizziness
Low blood pressure Feeling unwell Excessive mouth watering Stomach pain.
Inflammation of the lining of the mouth.
Fatigue.
Dehydration.
Loss or lack of appetite.
Uncommon side effects (in more than 1 in 1,000 but in less than 1 in 100 patients) are:
• Scarring of the lungs, which cause difficulty in breathing. If you have any breathing difficulties contact your doctor immediately.
• Bowel obstruction.
• Gastrointestinal bleeding.
• Pain or redness close to or at the injection site during the infusion.
• Kidney problems, low blood pressure or collapse in patients dehydrated due to diarrhoea, vomiting or infection.
• Allergic skin reactions.
Rare side effects (in more than 1 in 10,000 but in less than 1 in 1,000 patients) are:
• Inflammation of intestine.
• Intestinal perforation.
• High blood pressure.
• Severe allergic reactions.
• Muscular cramps
• Altered sensation of skin such as tingling, pricking or numbness.
• Low blood levels of potassium which can cause abnormal heart rhythm.
• Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma.
• Inflammation of pancreas
Very rare side effects (less than 1 in 10,000 patients) are:
• Transient speech disorders
If you receive Irinotecan in combination with cetuximab or bevacizumab, some of the side effects you may experience can also be related to this combination. Such side effects may include an acne-like rash. Therefore, please make sure that you also read the package leaflet for the other products you are taking.
If you receive Irinotecan in combination with capecitabine, some of the side effects you may experience can also be related to this combination. Such side effects may include: very common blood clots, common allergic reactions, heart attack and fever in patients with a low white blood cell count. Therefore, please make sure that you also read the package leaflet for capecitabine.
If you receive Irinotecan in combination with capecitabine and bevacizumab, some of the side effects you may experience can also be related to this combination. Such side effects include: low white blood cell count, blood clots, high blood pressure and heart attack. Therefore, please make sure that you also read the package leaflet for capecitabine and bevacizumab.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Always keep Irinotecan in a safe place and out of the reach and sight of children.
Expiry Date
Irinotecan must not be used after the expiry date, which is stated on the vial and carton. In both places it is given as "Expiry:" followed by the month and year.
Storing your medicine
Store below 25°C. Keep vial in the outer carton in order to protect from light. Do not freeze.
6. FURTHER INFORMATION What Irinotecan contains
The active substance is Irinotecan Hydrochloride Trihydrate. The other ingredients are sorbitol, lactic acid, water for injections and sodium hydroxide (to adjust to pH 3.5).
What Irinotecan looks like and contents of the pack It is available as a concentrate, which should be diluted before infusion and comes in four sizes:
• 40 mg of irinotecan hydrochloride trihydrate in 2 ml
• 100 mg of irinotecan hydrochloride trihydrate in 5 ml
• 300 mg of irinotecan hydrochloride trihydrate in 15 ml
• 500 mg of irinotecan hydrochloride trihydrate in 25 ml Irinotecan 40 mg/2 ml, 100 mg/5 ml, 300 mg/15 ml and 500 mg/25 ml concentrate for solution for infusion are available in cartons containing a single vial.
Marketing Authorisation Holder and Manufacturer Fresenius Kabi Oncology Plc
Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF, United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic
Denmark
Estonia
Finland
Hungary
Ireland
Italy
Latvia
Lithuania
Poland
Slovak Republic Spain
United kingdom
Irinotecan Kabi 20 mg/ml, koncentrat pro
pnpravu infuzmho roztoku
Irinotecan Kabi
Irinotecan Kabi 20 mg/ml,
infusioonilahuse kontsentraat
Irinotecan Fresenius Kabi 20 mg/ml
infuusiokonsentraatti, liuosta varten
Irinotecan Kabi 20 mg/ml koncentratum
oldatos infuziohoz
Irinotecan 20 mg/ml Concentrate for
Solution for Infusion
Irinotecan Kabi 20 mg/ml soluzione per
infusione
Irinotecan Kabi 20 mg/ml koncentrats infuziju skfduma pagatavosanai Irinotecan Kabi 20 mg/ml koncentratas infuziniam tirpalui
Irinotecan Kabi 20 mg/ml koncentrat do sporzqdzania roztworu do infuzji Irinotecan Kabi 20 mg/ml infuzny koncentrat
Irinotecan Kabi 20 mg/ml concentrado para solucion para perfusion EFG Irinotecan 20 mg/ml Concentrate for Solution for Infusion
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