Irinotecan 20 Mg/Ml Concentrate For Solution For Infusion
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Irinotecan 20 mg/ml concentrate for solution for infusion.
The name of your medicine is Irinotecan 20 mg/ml concentrate for solution for infusion, which will be referred to as 'Irinotecan 20 mg/ml concentrate for solution for infusion' or 'Irinotecan 20 mg/ml concentrate for solution for infusion solution' throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
- 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.
In this leaflet:
1. What Irinotecan 20 mg/ml concentrate for solution for infusion is and what it is used for
2. Before you use Irinotecan 20 mg/ml concentrate for solution for infusion
3. How you are given Irinotecan 20 mg/ml concentrate for solution for infusion
4. Possible side effects
5. How to store Irinotecan 20 mg/ml concentrate for solution for infusion
6. Further information
1. WHAT IRINOTECAN 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Irinotecan 20 mg/ml concentrate for solution for infusion belongs to a group of medicines called cytostatics (anticancer-medicines).
Irinotecan 20 mg/ml concentrate for solution for infusion is used for the treatment of advanced cancer of the colon and rectum in adults, either in a combination with other medicines or alone.
2. BEFORE YOU ARE GIVEN IRINOTECAN 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Do not use Irinotecan 20 mg/ml concentrate for solution for infusion if:
You are allergic (hypersensitive) to irinotecan or any of the other ingredients of Irinotecan 20 mg/ml concentrate for solution for infusion
You have any other bowel disease or a history of bowel obstruction
You are pregnant or breast-feeding
You have high levels of bilirubin (a waste blood product)
You have severe bone marrow failure
You are taking the natural remedy St John's wort (Hypericum perforatum - used for depression)
You are in a poor general health (evaluated by an international standard).
Take special care with Irinotecan 20 mg/ml concentrate for solution for infusion
This medicine is intended for adults only. Check with your doctor if this medicine has been prescribed for use in a child.
Special care is also needed in elderly patients.
As Irinotecan is an anti-cancer medicine it will be administered to you in a special unit and under the supervision of a doctor qualified in the use of anti-cancer medicines. The unit's personnel will explain to you what you need to take special care of during and after the treatment. This leaflet may help you to remember that.
1) The first 24 hours after administration of Irinotecan
During administration of Irinotecan (30-90 min.) and shortly after administration you may experience some of the following symptoms
- diarrhoea
- sweating
- abdominal pain
- watering eyes
- visual disturbance
- excessive mouth watering
The medical term for these symptoms is acute cholinergic syndrome which can be treated (with atropine). If you have any of these symptoms immediately tell your doctor who will give you any treatment necessary.
2) From the day after treatment with Irinotecan until next treatment
During this period you may experience various symptoms, which may be serious and require immediate treatment and close supervision.
Diarrhoea
If your diarrhoea starts more than 24 hours after administration of Irinotecan ("delayed diarrhoea") it may be serious. It is often seen about 5 days after administration. The diarrhoea should be treated immediately and kept under close supervision. Immediately after the first liquid stools do the following:
(a) Take any anti-diarrhoeal treatment that the doctor has given you, exactly as he/she has told you. The treatment may not be changed without consulting the doctor.
Recommended anti-diarrhoeal treatment is loperamide (4 mg for the first intake and then 2 mg every 2 hours, also during the night). This should be continued for at least 12 hours after the last liquid stools. The recommended dosage of loperamide may not be taken for more than 48 hours.
(b) Drink large amounts of water and rehydration fluids, immediately (i.e. water, soda water, fizzy drinks, soup or oral rehydration therapy)
(c) Immediately inform your doctor who is supervising the treatment, and tell him/her about the diarrhoea. If you are not able to reach the doctor, contact the unit at the hospital supervising the Irinotecan treatment. It is very important that they are aware of the diarrhoea.
You must immediately tell the doctor, or the unit supervising the treatment, if
- you have nausea and vomiting as well as diarrhoea
- you have any fever as well as the diarrhoea
- you still have diarrhoea 48 hours after starting the diarrhoea treatment
Note! Do not take any treatment for diarrhoea other than that given to you by your doctor and the fluids described above. Follow the doctor's instructions. The anti-diarrhoeal treatment should not be used to prevent a further episode of diarrhoea, even though you have experienced delayed diarrhoea at previous cycles.
Fever
If the body temperature increases over 38°C it may be a sign of infection, especially if you also have diarrhoea. If you have any fever (over 38°C) contact your doctor or the unit immediately so that they can give you any treatment necessary.
Nausea and vomiting
If you have nausea and/or vomiting contact your doctor or the unit immediately
Neutropenia
Irinotecan may cause a decrease in the number of some of your white blood cells, which play an important role in fighting infections. This is called neutropenia. Neutropenia is often seen during treatment with Irinotecan and is reversible. Your doctor should arrange for you to have regular blood tests to monitor these white blood cells. Neutropenia is serious and should be treated immediateley and carefully monitored.
Breathing difficulties
If you have any breathing difficulties contact your doctor immediately.
Impaired liver function
Before treatment with Irinotecan is started and before every following treatment cycle the liver function should be monitored (by blood tests).
If you have one or more of the symptoms mentioned, after you have returned home from the hospital, you should immediately contact the doctor or the unit supervising the Irinotecan treatment.
Impaired kidney function
As this medicine has not been tested in patients with kidney problems, please check with your doctor if you have any kidney problems.
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, as they may interact with Irinotecan 20 mg/ml concentrate for solution for infusion . This is especially important of:
- muscle relaxants, e.g suxamethonium
- medicines for the treatment of epilepsy (e.g. carbamazepine, phenobarbital or phenytoin)
- ketoconazole (used to treat fungal infections)
- rifampicin (an antibiotic)
- the natural remedy St. John's Wort (a treatment for depression)
This is also valid for herbal medicines, strong vitamins and minerals.
If you require an operation, please tell your doctor or anaesthetist that you are using this medicine, as it may alter the affect of some medicines used during surgery.
It may still be all right for you to be given Irinotecan 20 mg/ml concentrate for solution for infusion and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
You must not receive Irinotecan 20 mg/ml concentrate for solution for infusion if you are pregnant. Tell your doctor if you are pregnant, think you could be pregnant, or could become pregnant.
Contraceptive measures must be taken by both male and female patients of reproductive age during and for at least three months after cessation of therapy. If you become pregnant during this period you must immediately inform your doctor.
You should not breast-feed while you are treated with Irinotecan 20 mg/ml concentrate for solution for infusion. Ask your doctor or pharmacist for advice before taking any medicine
Driving and using machines
Irinotecan 20 mg/ml concentrate for solution for infusion may make you feel dizzy or cause visual disturbances within 24 hours after administration of the product. If this happens to you do not drive or use any tools or machines.
Important information about some of the ingredients of Irinotecan 20 mg/ml concentrate for solution for infusion
Irinotecan 20 mg/ml concentrate for solution for infusion solution contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW YOU ARE GIVEN IRINOTECAN 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Dosage
Irinotecan 20 mg/ml concentrate for solution for infusion is for adults only and will be given to you by a doctor or
nurse. Irinotecan 20 mg/ml concentrate for solution for infusion solution is infused into a vein.
The usual dose when used alone in patients who have been treated before is 350 mg/m2 (square meter of
body area) given as an infusion over a 30 to 90 minute period every three weeks.
The usual dose for patients who have not been treated before is 180 mg/m2 (square meter of body area) given once every 2 weeks as an infusion over a 30 to 90 minute period, followed by infusion with folinic acid and 5-fluorouracil (other cancer treatments).
Altered dosages
- The dose of Irinotecan 20 mg/ml concentrate for solution for infusion may be reduced if you suffer side effects
- The dose of Irinotecan 20 mg/ml concentrate for solution for infusion may be reduced if you have a liver disorder
- The dose of Irinotecan 20 mg/ml concentrate for solution for infusion may be altered if it is used with other chemotherapy.
- The dose should be chosen carefully in elderly; more intense surveillance is required.
- Irinotecan 20 mg/ml concentrate for solution for infusion is not recommended for patients with kidney disorders.
- Treatment is continued until the cancer gets worse or the side effects are unacceptable.
If you receive more Irinotecan 20 mg/ml concentrate for solution for infusion than you should
Irinotecan 20 mg/ml concentrate for solution for infusion will be given to you by a doctor or nurse who is familiar with this type of treatment so the chance is very small to be given an overdose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Irinotecan 20 mg/ml concentrate for solution for infusion 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, see also information in section "Take special care with Irinotecan".
Very common side effects (more than 1 in 10 patients):
- Blood disorders:
- Decreased number of a certain type of white blood cells (neutropenia) which increases the risk of infections
- Decreased number of red blood cells (anaemia) which can make the skin pale and cause weakness and breathlessness.
- In combination therapy, decreased number of blood platelets (thrombocytopenia) which increases the risk of bruising and bleeding.
- In monotherapy, fever and infections.
- Delayed severe diarrhoea.
- In monotherapy, nausea and vomiting.
- Hair loss (the hair grows again after end of treatment).
In combination therapy transient serum levels of some liver enzymes (AST, ALT, alkaline phosphatase) or bilirubin.
Common side effects (less than 1 in 10 patients but more than 1 in 100):
Severe transient acute cholinergic syndrome: the main symptoms are defined as early diarrhoea and various other symptoms such as abdominal pain; red, sore, itching or weeping eyes (conjunctivitis); running nose (rhinitis); low blood pressure; widening of the blood vessels; sweating, chills; a feeling of general discomfort and illness; dizziness; visual disturbances; pupil contraction; watering eyes and increased salivation, occurring during or within the first 24 hours after the infusion of Irinotecan.
- In monotherapy, decreased number of blood platelets (thrombocytopenia) which increases the risk of bruising and bleeding
- In combination therapy, fever and infections.
- Infections associated with a severe decrease in the number of a certain type of white blood cells (neutropenia) resulting in death in 3 cases.
- Fever associated with a severe decrease in the number of a cetain type of white blood cells.
- In combination therapy, severe nausea (feeling sick) and vomiting (being sick).
- Loss of water (dehydration), commonly associated with diarrhoea and/or vomiting.
- Constipation.
- Fatigue (severe weakness).
- In monotherapy, increased levels of some liver enzymes (transaminases, alkaline phosphatase) or bilirubin.
- Increase of creatinine in the blood.
- In combination therapy, transient severe (grade 3) increase in serum levels of bilirubin.
Uncommon side effects (less than 1 in 100 patients but more than 1 in 1000):
- Mild allergic reactions causing skin rash including red itchy skin, urticaria, conjunctivitis, rhinitis.
- Mild skin reactions; mild reactions at the infusion site.
- Early effects such as breathing difficulties.
- Lung disease (interstitial pulmonary disease) presenting as shortness of breath, dry cough and inspiratory crackles.
- Intestinal blockage.
- Gastrointestinal bleeding.
- Abdominal pain and inflammation, causing diarrhoea (a condition known as pseudomembraneous colitis)
- Kidney problems (renal insufficiency), low blood pressure or cardio-circulatory failure have been observed in patients who experienced episodes of dehydration associated with diarrhoea and/or vomiting or sepsis.
Rare side effects (less than 1 in 1000 patients but more than 1 in 10,000):
- Severe allergic reactions (anaphylactic/anaphylactoid reactions) causing swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing). If this happens you should tell your doctor immediately.
- Early effects such as muscular contraction or cramps and numbness (paraesthesia).
- Inflammation of the large bowel (colitis including typhlitis, ischemic and ulcerative colitis) causing abdominal pain.
- Intestinal perforation, loss of appetite (anorexia), abdominal pain, inflammation of the mucous membranes.
- Inflammation of the pancreas (pancreatitis) which may cause upper abdominal pain.
- Increased blood pressure during and following administration.
- Decreased levels of potassium and sodium in the blood, mostly related to diarrhoea and vomiting.
Very rare side effects (less than 1 in 10,000 patients):
- Bruising or bleeding easily due to your body destroying its own blood platelets (peripheral thrombocytopenia with antiplatelet antibodies [one case]).
- Transient speech disorders.
- Increase in levels of some digestive enzymes which break down sugars and fats.
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.
HOW TO STORE IRINOTECAN 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
5.
This medicinal product does not require any special storage conditions.
The irinotecan solution should be used immediately after dilution as it contains no antibacterial preservative. If dilution is performed under strict aseptic conditions (e.g. laminar air flow bench) irinotecan solution should be used (infusion completed) within 12 hours at room temperature or 24 hours if stored 2-8°C after the first breakage.
Irinotecan 20 mg/ml concentrate for solution for infusion should be kept out of the reach and sight of children.
Do not use Irinotecan 20 mg/ml concentrate for solution for infusion after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
Do not use Irinotecan 20 mg/ml concentrate for solution for infusion if you notice any particle s in the solution or if there are any other visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Irinotecan 20 mg/ml concentrate for solution for infusion contains:
The active substance is irinotecan (as hydrochloride trihydrate).
Each vial filled with 2 ml Irinotecan hydrochloride Trihydrat 2 mg/ml contains 40mg irinotecan hydrochloride trihydrate equivalent to 34.66mg irinotecan.
Each vial filled with 5 ml Irinotecan hydrochloride Trihydrat 2 mg/ml contains 100mg irinotecan hydrochloride trihydrate equivalent to 86,65mg irinotecan.
The other ingredients are: sorbitol, lactic acid, sodium hydroxide, hydrochloric acid, water for injection
What Irinotecan 20 mg/ml concentrate for solution for infusion looks like and contents of the pack
Irinotecan 20 mg/ml concentrate for solution for infusion is a clear, yellowish coloured solution. Irinotecan 20 mg/ml concentrate for solution for infusion 20 mg/ml is available in boxes containing a single amber type-I tubular glass vial with bromobutyl rubber stopper and flip off seal.
Pack size:
2 ml fill volume 5 ml fill volume
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd Floor, P.C. 1060 Nicosia, Cyprus Manufacturer
SymPhar Sp. z o.o., ul.Wtoska 1, 00-777 Warsaw, Poland
Tecnimede - Sociedade Tecnico-Medicinal, SA, Quinta da Cerca, Caixaria, 2565-187 Dois Portos, Portugal Alkaloida Chemical Co. Zrt., Kabay Janos u. 29, 4440 Tiszavasvari, Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Irinotecan 20 mg/ml concentrate for solution for infusion PL: Symtecan 20 mg/ml
This leaflet was last revised in [11/2011]
Irinotecan 20 mg/ml concentrate for solution for infusion 20 mg/ml concentrate for solution for infusion.
The following information is intended for medical or healthcare professionals only:
Instruction for use - Cytotoxic Handling of Irinotecan
As with all antineoplastic agents, caution should be exercised when handling Irinotecan. Dilution should be carried out under aseptic conditions by trained personnel in a designated area. Precautions should be taken to avoid contact with the skin and mucous membranes.
Protection instructions for preparation of Irinotecan solution for infusion:
1. Protective chamber should be used and protective gloves as well as protective gown should be worn. If there is no protective chamber available mouth cover and goggles should be used.
2. Opened containers, like injection vials and infusion bottles and used cannulae, syringes, catheters, tubes, and residuals of cytostatics should be considered as hazardous waste and undergo disposal according to local guidelines for the handling of HAZARDOUS WASTE.
3. Follow the instructions below in case of spillage:
- protective clothing should be worn
- broken glass should be collected and placed in the container for HAZARDOUS WASTE.
- Contaminated surfaces should be flushed properly with copious amounts of cold water.
- the flushed surfaces should then be wiped thoroughly and the materials used for wiping should be disposed as HAZARDOUS WASTE.
4. In the event of Irinotecan contact with the skin, the areas should be rinsed with plenty of running water and then washed with soap and water. In case of contact with mucous membranes, wash the contacted area thoroughly with water. If you have any discomfort, contact a doctor.
5. In case of contact of Irinotecan with eyes, wash them thoroughly with plenty of water contact an ophthalmologist immediately.
Preparation of infusion solution
Irinotecan concentrate for solution for infusion is intended for intravenous infusion only after diluting prior to administration in the recommended diluents, either 0.9 % Sodium chloride solution for infusion or 5 % glucose solution for infusion. Aseptically withdraw the required amount of Irinotecan concentrate for solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle. The infusion should be thoroughly mixed by manual rotation.
If any precipitate is observed in the vials or after reconstitution the product should be discarded according to standard procedures for cytotoxic agents.
Irinotecan should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.
Disposal
All items used for preparation, administration or otherwise coming into contact with Irinotecan should undergo disposal according to local guidelines for the handling of cytotoxic compounds.