Irinotecan Hydrochloride 20 Mg/Ml Concentrate For Solution For Infusion
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Irinotecan Hydrochloride 20 mg/ml concentrate for solution for infusion
The name of the product is Irinotecan Hydrochloride 20 mg/ml concentrate for solution for infusion and will be referred to as Irinotecan Solution throughout this document.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Irinotecan Solution is and what it is used for
2. What you need to know before you are given Irinotecan Solution
3. How Irinotecan Solution will be given to you
4. Possible side effects
5. How to store Irinotecan Solution
6. Contents of the pack and other information
1. What Irinotecan Solution is and what it is used for
Irinotecan Solution belongs to a group of medicines called cytostatics (anti-cancer medicines). It is used for the treatment of advanced cancer of the colon and rectum in adults, either alone or in combination with other medicines.
2. What you need to know before you are given Irinotecan Solution You should not be given Irinotecan Solution if you:
• are allergic (hypersensitive) to irinotecan hydrochloride trihydrate or to any of the other ingredients of this medicine (listed in section 6)
• 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 poor general health (evaluated by an international standard)
• are using the natural remedy St John’s Wort (Hypericum perforatum).
Take special care with Irinotecan Solution
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 for elderly patients.
As Irinotecan Solution 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 Solution
During administration of Irinotecan Solution (30 - 90 min) and within 24 hours after administration you may experience some of the following symptoms: diarrhoea, 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 disturbance, pupil contraction, watering eyes and excessive mouthwatering. 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 Solution until the 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 Solution (“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 (such as 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 Solution 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 if 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 Solution 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 Solution 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 Solution 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.
Other medicines and Irinotecan Solution
Please tell your doctor or pharmacist 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 Solution, for example, 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 at the same time as Irinotecan Solution 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 effects of some medicines used during surgery.
Pregnancy, breast-feeding and fertility
Irinotecan Solution 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. If you become pregnant during this period you must immediately inform your doctor.
Driving and using machines
In some cases Irinotecan Solution 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 Solution you may feel dizzy or have visual disturbances. If this happens to you do not drive or use any tools or machines.
Irinotecan Solution contains sorbitol and sodium
Irinotecan Solution contains sorbitol. If you suffer from an intolerance to some sugars, tell your doctor before you are given Irinotecan Solution.
This medicinal product contains less than 1 mmol sodium per dose, therefore it can be considered to be essentially “sodium-free”.
3. How Irinotecan Solution will be given to you
Irinotecan Solution will be given as an infusion into your vein over a period of 30 to 90 minutes.
The amount of Irinotecan Solution you will be given depends on your age, height, weight and general medical condition. It will also depend on any other treatment you may have received for your cancer. Your doctor will decide what is the right amount to use (the dose).
• If you have previously been treated with 5-fluorouracil, you will normally be treated with Irinotecan Solution 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 Solution every 2 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.
If you receive more Irinotecan Solution than you should
Tell your doctor or care provider if you think that you have been given too much Irinotecan Solution. Acute overdosing worsens side effects like diarrhoea or neutropenia (a decrease in the number of white blood cells in the blood). Should this happen you will receive treatment to prevent dehydration. Your blood cell count will be monitored and any infections treated accordingly.
4. Possible side effects
Like all medicines, this medicine 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 medicine.
Serious side effects: if you notice any of the following, tell your doctor immediately as you
may need urgent medical attention. See also the information in section 2, “Take special care
with Irinotecan Solution”.
• 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 blood vessels, sweating, chills, a feeling of general discomfort and illness, dizziness, visual disturbances, pupil contraction, watering eyes and excessive mouth-watering occurring during or within the first 24 hours after the infusion of Irinotecan Solution.
• “Delayed diarrhoea” which may occur more than 24 hours after administration of Irinotecan Solution and often occurs about 5 days after administration. Please read and follow the instructions in section 2.
• Fever above 38°C.
• Breathing difficulties.
If any of the above symptoms occur, you should inform your doctor who will give you any
necessary treatment.
Very common side effects (more than 1 in 10 patients):
• Blood disorders: Neutropenia (decreased number of some white blood cells which may make you more susceptible to infections)
• Feeling tired and weak and looking pale (caused by anaemia, a reduction in your red blood cells)
• In combination therapy (when Irinotecan Solution is used with other medicines to treat your cancer), bruising or bleeding easily (caused by thrombocytopenia, a reduction in your blood platelets)
• In monotherapy (when Irinotecan Solution is used alone to treat your cancer), fever and infections
• In monotherapy, fever when there is no infection and no severe reduction in some of your white blood cells
• Delayed severe diarrhoea
• In monotherapy, severe nausea, and vomiting
• Temporary hair loss
• In combination therapy short-term increase in levels of liver enzymes (SGPT,SGOT,
alkaline phosphatase) or bilirubin
Common side effects (less than 1 in 10 patients):
• Severe transient acute cholinergic syndrome: the main symptoms are defined in this section under ‘serious side effects’
• In monotherapy, bruising or bleeding easily (caused by thrombocytopenia, a reduction in your blood platelets)
• Infections associated with a severe decrease in the number of some white blood cells (resulting in death in 3 cases)
■ Fever associated with a severe decrease in the number of some white blood cells (febrile neutropenia)
■ In combination therapy, fever when there is no infection and no severe reduction in some of your white blood cells
• Loss of water (dehydration), commonly associated with diarrhoea and/or vomiting
• Constipation
• In combination therapy, severe nausea and vomiting
• Severe weakness (asthenia)
• Short-term increase in levels of liver enzymes (transaminases, alkaline phosphatase) or bilirubin (which may be severe in combination therapy), short-term increase in levels of creatinine
Uncommon side effects (less than 1 in 100 patients):
• Mild skin reactions and allergic reactions (skin rash, sore and itchy eyes, runny nose)
• Pain or redness close to or at the injection site during the infusion
• Early effects such as breathing difficulties
• Scarring of the lungs, which causes shortness of breath, dry cough and crackly breathing (interstitial pulmonary disease)
• Partial or complete bowel obstruction
• Bowel inflammation which causes abdominal pain and/or diarrhoea (a condition known as pseudomembraneous colitis)
• Bleeding in the stomach or bowel, which may cause you to vomit blood or pass dark tarry stools
• Dehydration, often associated with diarrhoea and vomiting, which can lead to kidney problems, low blood pressure or collapse
• Sepsis (a severe, whole-body response to infection), which can lead to kidney problems, low blood pressure or collapse
Rare side effects (less than 1 in 1,000 patients):
• Severe allergic reactions (anaphylactic/anaphylactoid reactions), causing skin rash including red itchy skin, 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) causing abdominal pain
• Intestinal perforation causing severe abdominal pain, nausea and vomiting
• Loss of appetite (anorexia), abdominal pain, inflammation of the mucous membranes
• Inflammation of the pancreas causing 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 (one case)
• Short- term speech disorders
• Increase in levels of some digestive enzymes which break down sugars and fats (lipase, amylase)
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Irinotecan Solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and outer carton after EXP.
Keep the vial in the outer carton in order to protect from light.
For single use only.
Do not store above 25°C. Do not freeze.
After reconstitution and dilution under strict aseptic conditions, Irinotecan Solution must be used (infusion completed) immediately or within 24 hours if stored in a refrigerator (2°C-8°C).
If any cloudiness (precipitate) is observed in the vials or after reconstitution, the product should be disposed of.
Your doctor must use the Irinotecan Solution as soon as it has been made.
Vials that have already been used must be disposed of by your healthcare professional according to hospital standard procedures applicable to cytotoxic medicines.
6. Contents of the pack and other information What Irinotecan Solution contains
• The active substance is irinotecan hydrochloride trihydrate 20 mg/ml.
• The other ingredients are sorbitol E420, lactic acid, sodium hydroxide, hydrochloric acid and water for injections.
What Irinotecan Solution looks like and contents of the pack
Irinotecan Hydrochloride Trihydrate 20 mg/ml concentrate for solution for infusion is a clear, yellow solution. It must be diluted before infusion into the patient.
It comes in two sizes:
• 1 x 40 mg of irinotecan hydrochloride trihydrate in a 2 ml amber glass, rubber stoppered vial
• 1 x 100 mg of irinotecan hydrochloride trihydrate in a 5 ml amber glass, rubber stoppered vial.
Marketing Authorisation Holder
Fair-Med Healthcare GmbH Planckstrasse 13, 22765 Hamburg Germany
Manufacturer
Thymoorgan Pharmazie GmbH Schiffgraben 23 38690 Vienenburg GERMANY
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom Irinotecan Hydrochloride 20 mg/ml concentrate for solution for
infusion
France Irinotecan Fair-Med Healthcare, 20 mg/ml, Solution a diluer pour
perfusion
Spain Irinotecan Fair-Med Healthcare, 20 mg/ml, concetrado para
solution para perfusion, EFG
For leaflet in an alternative format, call 01462458974 (from the UK)
This leaflet was last revised in September 2014.
INFORMATION FOR HEALTHCARE PROFESSIONALS
Irinotecan Hydrochloride Trihydrate 20 mg/ml concentrate for solution for infusion
The following information is intended for medical or healthcare professionals only: Instructions for use - cytotoxic Handling of Irinotecan
As with all other 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 of as HAZARDOUS WASTE.
4. In the event of Irinotecan contact with the skin, the area 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 the infusion solution
Irinotecan 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 dilution, the product should be discarded according to standard procedures for cytotoxic agents.
This medicinal product must not be mixed with other medicinal products except those mentioned above.
Irinotecan solution for infusion should be infused into a peripheral or central vein.
Irinotecan should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.
After dilution: the solution should be used immediately as it contains no antibacterial preservative. If reconstitution and dilution are performed under strict aseptic conditions (e.g. on Laminar Air Flow bench) the solution should be used (infusion completed) immediately or within 24 hours if stored at 2°-8°C after the first opening.
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.
PL 20242/0012