Irinotecan hydrochloride Injection (Concentrated)
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Irinotecan Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits it is expected to have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may want to read it again.
WHAT IRINOTECAN IS USED FOR
The name of your medicine is Irinotecan Sandoz. It contains the active ingredient irinotecan hydrochloride.
This medicine is used to treat bowel cancer which has either spread to other parts of the body or has recurred or progressed following initial therapy.
Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why it was prescribed for you.
How Irinotecan Sandoz works
This medicine belongs to a group of medicines called antineoplastic drugs or cytotoxic drugs.
It works by stopping or slowing the growth and spread cancer cells. There is no evidence that it is addictive.
BEFORE YOU ARE GIVEN IRINOTECAN SANDOZ
You should only be treated with this medicine by a doctor who is experienced in treating cancer patients. Treatment would normally take place in a hospital.
You will probably feel sick and have diarrhoea, vomiting, stomach pain and possibly infections while you are being treated or following treatment with this medicine. It is likely that your doctor will give you one or more medicines before administering this medicine, which will help you stop vomiting and feeling sick after the treatment. You will probably also have a blood test before each treatment.
When you must not be given Irinotecan Sandoz
You must not be given Irinotecan Sandoz if:
- you are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product description
- it is past its expiry date or the packaging appears to have been tampered with
- you are pregnant. It may affect your developing baby if you take it while you are pregnant
- you are breastfeeding. Irinotecan passes into breast milk and it can possibly affect your baby.
There is not enough information regarding the safety and effective use of irinotecan in children.
Before you are given Irinotecan Sandoz
Tell your doctor if you have an infection or high temperature. Your doctor may decide to postpone your treatment until your infection has gone.
Tell your doctor if you have allergies to any other substances, including foods, preservatives or dyes.
Tell your doctor if you plan on becoming pregnant or will be breastfeeding while you are using this medicine.
Tell your doctor about any of the following:
- if you have been treated with radiotherapy
- if you are 65 years of age or older
- if you are going to be vaccinated.
Tell your doctor if you have or have had any medical conditions, especially the following:
- liver problems or liver disease
- heart disease or problems with your blood vessels
- constipation or difficulty urinating
- hereditary fructose intolerance
- Crigler-Najjar syndrome or Gilbert’s syndrome
Your doctor may possibly give you one or more medicines before giving you Irinotecan Sandoz, which will stop you feeling sick after the treatment. You will probably also have a blood test before each treatment with this medicine.
Taking other medicines
Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
In particular, tell your doctor if you take any of the following:
- any other medicine used to treat cancer or any other treatment which lowers your immune system
- diuretics (medicines which cause you to pass more urine more frequently)
- any medication used to treat nausea, vomiting or diarrhoea
- dexamethasone, a medicine which may be used to prevent nausea and vomiting, treat skin diseases, asthma or other allergic reactions
- St Johns Wort, a herbal medicine used for the treatment of depression
- anti-convulsants used for the treatment of seizures
- ketoconazole, an antifungal medicine.
These medicines may be affected by Irinotecan Sandoz, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
HOW IRINOTECAN SANDOZ IS USED
This medicine will be given to you by your doctor or by a nurse under the supervision of your doctor. It will be diluted and given to you as a slow injection into a vein over a period of 90 minutes.
Your doctor will decide how much you will be given. Ask your doctor if you want to know more about the dose you will be receiving.
Irinotecan Sandoz may be given alone or with other medicines used to treat cancer.
Treatment with this medicine may be repeated more than once, depending on how your body responds to the treatment.
Treatment may not be repeated until your blood cell numbers return to an acceptable level. Treatment should be interrupted if you get severe diarrhoea or any other intolerable side effects.
If you receive too much (overdose)
An overdose is unlikely because Irinotecan Sandoz will be given to you under the supervision of your doctor. The possible effects of having too much irinotecan are the same as those listed in the ‘Side effects’ section of this leaflet.
WHILE YOU ARE BEING GIVEN IRINOTECAN SANDOZ
Things you must do
Keep all of your doctor’s appointments, so that your progress can be assessed and any problems can be discussed with your doctor.
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are being treated with Irinotecan Sandoz.
If you are going to have surgery, tell your surgeon or the anaesthetist that you are being given this medicine.
If you are going to get vaccinated, tell your doctor, nurse or pharmacist that you are being treated with Irinotecan Sandoz.
You must use a reliable method of contraception (birth control) while you are being treated with this medicine. However, if you become pregnant while you are being treated with this medicine, tell your doctor immediately.
Diarrhoea is a common side effect of irinotecan. Tell your doctor as soon as possible if you have diarrhoea. Your doctor may need to prescribe a medicine to treat the diarrhoea. If left untreated, severe diarrhoea can be life threatening. You must tell your doctor if you cannot get diarrhoea under control within 24 hours after taking an antidiarrhoeal. Also tell your doctor if you develop a fever in addition to the diarrhoea.
This medicine can increase the chance of you getting an infection and can increase the chance of bleeding. So the following precautions need to be taken:
- Avoid people who have infections and tell your doctor if you think you may be getting an infection. Signs of an infection include fever, chills, coughing, a hoarse throat, mouth ulcers, lower back pain, side pain or painful urination.
- Be careful when using a toothbrush, toothpick or dental floss. Tell your doctor before having any dental work.
- Be careful not to cut yourself when using sharp objects (such as a razor, or nail clippers) and avoid situations where you may bruise yourself or get injured.
- Tell your doctor if you have severe stomach cramps. You may need to be treated with medication.
Things to be careful of
Your body breaks down irinotecan and the breakdown products may be excreted in body fluids and waste, including blood, urine, faeces vomitus and semen. Other people need to be protected from these body fluids and waste while you are being treated with irinotecan.
The following precautions should be taken while you are receiving chemotherapy and for 1 week after the treatment period:
- Use gloves and disposable towels when cleaning or disposing of any body fluids and waste.
- Wash any clothing or linen that is heavily contaminated by body fluids separately in a strong solution of detergent.
- Use a condom for sexual intercourse.
Be careful driving or operating machinery until you know how this medicine affects you. It may cause dizziness or light-headedness in some people.
Be careful when drinking alcohol while you are being treated with this medicine. Light-headedness, dizziness and diarrhoea may become worse.
Because of the risk of diarrhoea, do not take laxatives during treatment course with irinotecan. Talk to your doctor if you need more information regarding this.
All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. You may not experience any of them. Fatal outcomes have occurred, which in some cases, may have been related to treatment.
Tell your doctor if you notice any of the following and they worry you:
- loss of appetite
- weight loss
- hair loss
- constipation (do not take laxatives)
- excessive wind
- sore mouth or mouth ulcers
- having trouble sleeping.
These side effects are usually mild and short-lived.
Tell your doctor or nurse as soon as possible if you notice diarrhoea. Severe diarrhoea can be life threatening if left untreated. Your doctor may prescribe a medicine such as loperamide, which is used to treat diarrhoea. You should start taking loperamide when you first have loose stools, poorly formed stools or more frequent bowel movements.
Tell your doctor immediately if you notice any of the following:
- abdominal pain
- unusual tiredness, weakness, headaches, shortness of breath when exercising, dizziness and looking pale
- runny nose or watery eyes, increase in saliva, sweating or flushing
- swelling and redness along a vein
- fluid retention that causes swelling.
These may be serious side effects that may need urgent medical attention.
If any of the following happen, stop treatment and tell your doctor or nurse immediately, or go to Accident and Emergency at your nearest hospital:
- The inability to control diarrhoea within 24 hours after taking loperamide.
- Symptoms of dehydration which include faintness or dizziness, light-headedness, increase in thirst and wrinkling skin.
- An inability to drink due to nausea or vomiting.
- Signs of an infection such as chills, fever, sore throat, cough, lower back pain, pain or difficulty in urinating.
- Signs of an allergic reaction eg swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
- Unusual bleeding (such as bloody or black stools and bloody urine) or bruising.
- Yellowing of the skin or eyes.
- Chest pains.
- Any of the following rare side effects: slowed heart beat, fainting, blackouts, blood clots, swelling and redness along a vein which is extremely tender when touched.
Other rare side effects reported include: heart attack, stroke.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
AFTER TREATMENT WITH IRINOTECAN SANDOZ
This medicine will normally be stored in a hospital. It should be stored below 30°C, in a dry place, protected from light. It should be kept in the packaging before use and it must never be frozen.
What it looks like
This medicine is a clear, pale yellow solution. It is supplied in an amber glass vial and is supplied in single pack sizes of 40mg/2mL and 100mg/5mL.
- Each Irinotecan Sandoz 2mL vial contains 40mg of irinotecan hydrochloride trihydrate.
- Each Irinotecan Sandoz 5mL vial contains 100mg of irinotecan hydrochloride trihydrate.
Irinotecan Sandoz also contains
- lactic acid,
- sodium hydroxide,
- hydrochloric acid and
- water for injection.
Irinotecan Sandoz is supplied in Australia by:
Sandoz Pty Ltd
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
ABN 60 075 449 553
This leaflet was revised in October 2010.
Australian Register Numbers
Irinotecan Sandoz 40mg/2mL vial AUST R 125140
Irinotecan Sandoz 100mg/5mL vial AUST R 125141
Published by MIMS September 2015