Irinotecan 20 mg/ml concentrate for solution for infusion
Irinotecan hydrochloride trihydrate
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.
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.
In this leaflet:
- 1. What Irinotecan is and what it is used for
- 2. Before you use Irinotecan
- 3. How to use Irinotecan
- 4. Possible side effects
- 5. How to store Irinotecan
- 6. Further information
What Irinotecan is and what it is used for
Irinotecan belongs to a group of medicines called cytostatics (anti-cancer medicines).
Irinotecan is used for the treatment of advanced cancer of the colon and rectum in adults, either in a combination with other medicines or alone.
Before you use Irinotecan
Do not use Irinotecan if you
- are allergic (hypersensitive) to irinotecan hydrochloride trihydrate or any of the other ingredients of Irinotecan
- have any other bowel disease or a history of bowel obstruction
- are pregnant or breast feeding
- have increased levels of bilirubin in the blood (more than 3 times the upper limit of normal)
- have severe bone marrow failure
- are in a poor general health (evaluated by an international standard)
- are using the natural remedy St Johns’ Wort (Hypericum perforatum)
Take special care with Irinotecan
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:
- 1. 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.
- 2. Drink large amounts of water and rehydration fluids, immediately (i.e. water, soda water, fizzy drinks, soup or oral rehydration therapy)
- 3. 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, vomiting or any fever as well as 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 immediately 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.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is also valid for herbal medicines, strong vitamins and minerals.
Some medicines may alter the effects of Irinotecan e.g. ketoconazole (for the treatment of fungal infections), rifampicin (for the treatment of tuberculosis) and some medicines for the treatment of epilepsy (carbamazepine, phenobarbital and phenytoin).
The herbal medicine St John’s Wort (Hypericum perforatum) may not be used concurrent with Irinotecan and not between treatments, as it may decrease the effect of irinotecan.
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.
Pregnancy and breast-feeding
Irinotecan must not be used during pregnancy.
Women of child-bearing age should avoid becoming pregnant.
Contraceptive measures must be taken by both male and female patients during and for at least three months after cessation of therapy. Still, if you become pregnant during this period you must immediately inform your doctor.
Breast-feeding must be discontinued for the duration of irinotecan therapy.
Driving and using machines
In some cases Irinotecan may cause side effects which affect the ability to drive and use tools and machines. Contact your doctor or pharmacist if you are unsure.
During the first 24 hours after administration of Irinotecan you may feel dizzy or have visual disturbances. If this happens to you do not drive or use any tools or machines.
Important information about some of the ingredients of Irinotecan
Irinotecan contains sorbitol. If you suffer from an intolerance to some sugars, tell your doctor before you are given this medicinal product.
How to use Irinotecan
Irinotecan will be given as an infusion into your veins over a period of 30•90 minutes. The amount of infusion 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 meters (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.
Possible side effects
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, see also information in section “Take special care with Irinotecan ”.
Very common side effects (more than 1 in 10 patients):
- Blood disorders: Neutropenia (decreased number of some white blood cells), thrombocytopenia (decreased number of blood platelets), anaemia.
- Delayed diarrhoea.
- Nausea, vomiting.
- Hair loss (the hair grows again after end of treatment).
- In combination therapy transient serum levels of some enzymes (ALT, AST, alkaline phosphatase) or bilirubin
Common side effects (less than 1 in 10 patients):
- 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 .
- Fever, infections.
- Fever associated with a severe decrease in the number of some white blood cells
- Dehydration, commonly associated with diarrhoea and /or vomiting.
- Constipation.
- Fatigue.
- Increased levels of liver enzymes and creatinine in the blood
Uncommon side effects (Less than 1 in 100 patients):
- Allergic reactions.
- Mild skin reactions; mild reactions at the infusion site.
- Early effects such as breathing difficulties.
- Lung disease (interstitial pulmonary disease).
- Intestinal blockage.
- Abdominal pain and inflammation, causing diarrhoea (a condition known as pseudomembraneous colitis)
- Infrequent cases of 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):
- Severe allergic reactions (anaphylactic/anaphylactoid reactions). If this happens you should tell your doctor immediately
- Early effects such as muscular contraction or cramps and numbness (paraesthesia).
- Gastrointestinal bleeding and inflammation of the colon including the appendix.
- Intestinal perforation; Anorexia; abdominal pain; inflammation of the mucous membranes.
- Inflammation of the pancreas.
- 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)
- 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
Keep out of the reach and sight of children.
Do not freeze.
For single use only.
Keep the vial in the outer carton in order to protect from light.
Do not use this medicinal product after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
The product should be diluted and used immediately after opening.
If prepared aseptically, the diluted solution can be stored for 24 hours at temperatures up to 30°C and for 48 hours at 2-8°C (e.g. in a fridge).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment
Further information
What Irinotecan contains
- The active substance is irinotecan hydrochloride trihydrate
- 1 ml of concentrate contains 20 mg irinotecan hydrochloride trihydrate equivalent to 17.33 mg of irinotecan.
- One 2ml vial contains 40 mg irinotecan hydrochloride trihydrate.
- One 5ml vial contains 100 mg irinotecan hydrochloride trihydrate.
- One 25ml vial contains 500 mg irinotecan hydrochloride trihydrate.
- The other ingredients are sorbitol E420, lactic acid, sodium hydroxide, hydrochloric acid and water for injections
What Irinotecan looks like and contents of the pack
Irinotecan 20 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellow solution.
Pack size:
1 x 2 ml vial
1 x 5 ml vial
1 x 25 ml vial
Marketing Authorisation Holder
Manufacturer
Or
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Irinotecan Actavis 20mg/ml, Konzentrat zur Herstellung einer Infusionslösung
Belgium: IRINOTECAN ACTAVIS GROUP 20mg/ml, solution à diluer pour perfusion
Germany: Irinotecan-Actavis 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
France: IRINOTECAN ACTAVIS 20mg/ml, solution à diluer pour perfusion
Ireland: Irinotecan hydrochloride 20mg/ml Concentrate for solution for infusion;
Malta: Irinotecan Actavis 20mg/ml Concentrate for solution for infusion
Portugal: Irinotecano Actavis
Spain: Irinotecan Actavis 20mg/ml concentrado para solución para perfusión
Czech, Slovakia: Irinotecan HCL Actavis 20 mg/ml
Denmark, Estonia, Finland, Iceland, Italy, Lithuania, Latvia, Netherlands, Norway, Sweden: Irinotecan Actavis
Hungary, Poland, Slovenia: Irinotesin
This leaflet was last approved in March 2010.
SINPL025
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