NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
Irinotecan hydrochloride trihydrate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about CAMPTOSAR. 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 risks of you taking CAMPTOSAR against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What CAMPTOSAR is used for
CAMPTOSAR is used to treat bowel cancer which has spread to other parts of the body. Cancer which has spread cannot be treated by surgery alone.One of the options in this situation is treatment with an anticancer medicine, known as chemotherapy.
CAMPTOSAR may be used once spread of cancer beyond the bowel is first diagnosed.At this time CAMPTOSAR will be given in combination with other anticancer medicines. Alternatively, CAMPTOSAR is used alone when the cancer has not responded or has returned after initial treatment.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another purpose.
Use in children
It is not known if CAMPTOSAR is safe and effective in the treatment of children.
Before you are given CAMPTOSAR
When you must not be given it
You must not be given CAMPTOSAR if you have an allergy to:
any medicine containing irinotecan hydrochloride trihydrate
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, alli weight loss message boards tongue or other parts of the body
rash, itching or hives on the skin
add any other specific reactions listed in the PI.
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Pregnancy should be avoided if you or your partner is receiving CAMPTOSAR.
Females: Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.
Avoid becoming pregnant by using effective contraception during treatment and up to 6 months after therapy.
Males: Tell your doctor or pharmacist if your partner intends to become pregnant while you are being given CAMPTOSAR, or shortly after you have stopped treatment with irinotecan.
It is recommended that you use effective contraception while you are using CAMPTOSAR and for at least 3 months after you stop treatment.
Do not breast-feed if you are taking this medicine.
The active ingredient in CAMPTOSAR passes into breast milk and there is a possibility that your baby may be affected.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Before you are given it
You should be treated with CAMPTOSAR by a doctor who is experienced in treating patients with cancer.Treatment will normally take place in a hospital because of the need for hospital facilities and skilled personnel.
It is likely that your doctor will give you one or more medicines before administering CAMPTOSAR, to help stop you vomiting or feeling sick after the treatment.You will probably also have a blood test before each treatment.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if:
you have or have had liver problems, including liver disease or raised liver enzymes
you have kidney disease or have difficulty urinating
problems with your heart or blood vessels
you have previously been treated with radiation therapy
you have diabetes
you have asthma
you have constipation or obstruction of the bowel
you have had diarrhoea or have taken anti-diarrhoea medication with the last 24 hours
you have hereditary fructose intolerance
you have Crigler-Najjar syndrome or Gilbert’s syndrome
you are going to be vaccinated (have an injection to prevent a certain disease).
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you are given CAMPTOSAR.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and CAMPTOSAR may interfere with each other. These include:
laxatives (e.g. for constipation)
diuretics (medicines which make you pass urine more frequently e.g. for heart disease)
any medicine for nausea or diarrhoea
dexamethasone (may be used to treat skin diseases, asthma or other allergic disorders)
anticonvulsants, used to treat seizures
St John’s Wort, a herbal medicine used to treat depression
ketoconazole, used to treat fungal infections
atazanavir, used to treat HIV-1 infection
prochlorperazine, used to treat nausea, vomiting and dizziness
suxamethonium or other medicines used as an anaesthetic
other medicines used to treat cancer.
These medicines may be affected by CAMPTOSAR or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How CAMPTOSAR is given
How much is given
Your doctor will decide the most appropriate dose of CAMPTOSAR to be given.
Ask your doctor if you want more information about the dose of CAMPTOSAR and the other medicines you will be receiving and how they are given while you are being treated with CAMPTOSAR.
After your first treatment course, the dose of CAMPTOSAR may be increased by your doctor if you have not had too many side effects.
Your doctor will lower the dose or stop treatment if you have serious side effects, particularly diarrhoea or changes appearing in your blood tests.
How it is given
CAMPTOSAR will be given to you by your doctor.It is diluted and given by slow infusion into a vein over a period of 90 minutes.
It is recommended that CAMPTOSAR be given in different treatment courses depending on whether CAMPTOSAR is given alone or in combination with other anticancer medicines.
Combination Treatment Courses
When CAMPTOSAR is given in combination, treatment courses are of 6 weeks’ duration given either weekly or fortnightly.Rest periods of 1 or 2 weeks are incorporated into the 6-week courses.
Single Treatment Courses
CAMPTOSAR may be given either weekly for 4 weeks followed by a 2 week rest period or it may be given once every 3 weeks.
Depending on your response, treatment courses may be repeated more than once.
It is recommended that treatment with CAMPTOSAR should be interrupted if you get severe diarrhoea or other intolerable side effects.
If you receive too much (overdose)
Overdose is unlikely as treatment will be given in hospital under the supervision of a doctor.The possible effects of overdose are the same as those listed below under Side effects.
Tell your doctor immediately if you do not feel well while being given CAMPTOSAR.
You may need urgent medical attention.
While you are being given CAMPTOSAR
Things you must do
Keep all appointments with your doctor and always discuss with your doctor any problems during or after treatment with CAMPTOSAR.
Tell your doctor as soon as possible if diarrhoea occurs.
Diarrhoea is a common side effect of CAMPTOSAR.If untreated, severe diarrhoea can be life-threatening.
Your doctor will prescribe loperamide (a medicine to treat diarrhoea) for you to take in case you get diarrhoea after treatment.You should start taking loperamide, when you first have poorly formed or loose stools or have more frequent bowel movements than you would normally expect.
You must tell your doctor if you cannot get diarrhoea under control within 24 hours after taking loperamide.
You should not take loperamide for more than 48 hours.
Also tell your doctor if you develop a fever in addition to the diarrhoea.
In these cases, your doctor may give you antibiotics.If the diarrhoea or fever persists you may become dehydrated and need to go to Accident and Emergency at your nearest hospital for treatment.
You may need to take antibiotics if there are changes in your blood tests indicating a lack of white blood cells.Symptoms of this may include frequent infections such as fever, severe chills, sore throat or mouth ulcers.If this persists, you may need to go to Accident and Emergency at your nearest hospital for treatment.
If you have severe stomach cramps you may need to be treated with antibiotics.
You must use a reliable method of contraception (birth control) while being treated with CAMPTOSAR.However, if you become pregnant while being treated with this medicine, tell your doctor immediately.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given CAMPTOSAR.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
Keep all of your doctor’s appointments so that:
your progress can be checked
you have your follow up doses of CAMPTOSAR.
Your doctor may want to check your blood pressure and do some blood and other tests from time to time to make sure the medicine is working and to prevent unwanted side effects. It is also important to have your follow-up doses of CAMPTOSAR at the appropriate times to get the best effects from your treatments.
Things you must not do
Because of the risk of diarrhoea, do not take laxatives during treatment courses with CAMPTOSAR.
Talk to your doctor if you need more information about this.
Do not start taking any other medicines, prescription or not, without first telling your doctor or pharmacist.
Things to be careful of
This medicine can lower the number of white blood cells and platelets in your blood. This means that you have an increased chance of getting an infection or bleeding. The following precautions should be taken to reduce your risk of infection or bleeding.
Avoid people who have infections.
Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain or find it painful or difficult to urinate.
Be careful when using a toothbrush, toothpick or dental floss.
Your doctor, dentist, nurse or pharmacist may recommend other ways to clean your teeth and gums.Check with your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor or nail cutters.
Avoid contact sports or other situations where you may bruise or get injured.
Take precautions to protect other people while you are receiving chemotherapy and for one week after the treatment period.
Your body breaks down irinotecan (the active ingredient of CAMPTOSAR) and uses it to fight cancer. The breakdown products may be excreted in body fluids and waste, including blood, urine, faeces, vomit and semen.
Take the following precautions:
flushing the toilet twice to dispose of any body fluids and waste
wearing gloves to clean any spill of body fluid or waste.Use paper towels or old rags, a strong solution of non-bleaching detergent and large amounts of water to mop up the spill.Discard the towels or rags into a separate waste bag and dispose of fluids in the toilet
washing linen or clothing that is heavily contaminated by body fluids or waste separately from other items.Use a strong solution of non-bleaching detergent and large amounts of water
placing soiled disposable nappies and other pads in a plastic bag, seal and dispose into the garbage
using a barrier method such as a condom, for sexual intercourse.
Make sure you know what to do if you experience nausea, vomiting or diarrhoea.
You may feel nauseous, and have vomiting, diarrhoea, and/or stomach cramping, during or after treatment with irinotecan. This can lead to dehydration. It is likely that your doctor will give you one or more medicines to help manage these side effects.
Be careful driving or operating machinery until you know how CAMPTOSAR affects you.
This medicine may cause dizziness or visual disturbances which may occur within 24 hours following the administration of irinotecan in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are being given this medicine.
If you drink alcohol, dizziness light-headedness and diarrhoea may be worse.
Tell your doctor or pharmacist as soon as possible if you do not feel well or if you experience severe side effects while you are being treated with CAMPTOSAR.
CAMPTOSAR, like all other medicines, may cause unwanted side effects.Side effects are very common with anti-cancer medicines such as CAMPTOSAR and they may be severe. Deaths have occurred which, in some cases, may have been related to treatment.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
If any of the following happen, tell your doctor immediately:
start to vomit
develop a fever or any type of infection
fainting, light-headedness or dizziness
bloody or black stools
cannot eat or drink due to nausea or vomiting.
The above side effects may be serious.You may need urgent medical attention.
Very common side effects (occurring in over 50% of patients) are:
diarrhoea or stomach cramps; may occur early (during or shortly after a treatment) or late (usually more than 24 hours after treatment)
nausea, vomiting, loss of appetite
anaemia, which may make you weak and light-headed or may cause you to faint
increased risk of infections including severe infections
Common side effects (occurring in 10-50% of patients) are:
constipation, flatulence (passing wind), sore mouth, heartburn
fever (increased body temperature), chills, headache, back pain or other types of pain, infection, fluid retention which results in swelling
weight loss, dehydration
runny nose or eyes, increased saliva, sweating or flushing
coughing, difficulty breathing
difficulty sleeping or dizziness.
Less common side effects (occurring in less than 10% of patients) are:
increased risk of bleeding
severe fever associated with a reduction in white blood cell numbers
bleeding from the bowel
jaundice (yellowing of skin and eyes)
severe breathing difficulties
generally feeling unwell
abnormal manner of walking
fungal infections (e.g. thrush)
In addition to the above side effects the following have also been reported:
allergic reactions; some of the symptoms of an allergic reaction may include: rash, itching or hives on the skin. In more severe cases symptoms may also include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body
pins and needles
bloating or pain in upper stomach
Other side effects not listed above may happen in some people.Some of these side effects can only be found when your doctor does tests to check your progress.
Rare side effects of CAMPTOSAR have also been reported. These include effects on the heart and blood vessels such as:
slowed heart beat
swelling and redness along a vein, which is extremely tender when touched
Your doctor has information on monitoring for such side effects and their treatment. A very small number of patients have died suddenly while on CAMPTOSAR.
Tell your doctor as soon as possible if you experience any side effects, including any effects not listed above.
Other side effects not listed above may also occur in some people.
After treatment with CAMPTOSAR
CAMPTOSAR will normally be stored in a hospital.It should be stored below 30°C and should be protected from light (kept in the packaging before use). CAMPTOSAR must never be frozen.
What it looks like
CAMPTOSAR is a sterile, clear, light yellow, solution in a vial.Each vial is for single use only and is contained in an outer carton.
The active ingredient in CAMPTOSAR is irinotecan hydrochloride.There is 20 mg of irinotecan hydrochloride in each 1 mL of CAMPTOSAR injection.
water for injections.
It might also contain sodium hydroxide or hydrochloric acid.
CAMPTOSAR is supplied in Australia by:
Pfizer Australia Pty Ltd
Sydney NSW 2000
Toll Free Number: 1800 675 229
Australian Registration Numbers
40 mg/2 mL:AUST R 58807
(not currently supplied)
100 mg/5 mL:AUST R 58806
(not currently supplied)
300 mg/15 mL:AUST R 146909.
Date of preparation
This leaflet was revised in April 2020.
© Pfizer Australia Pty Ltd 2014.
® = Registered trademark
Source: Read Full Article