Irinotecan Kabi

Irinotecan Hydrochloride Concentrated Injection

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Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Irinotecan hydrochloride concentrated injection.

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 Irinotecan hydrochloride concentrated injection against the benefits they expect it will have for you.

Ask your doctor if you have any concerns about being treated with this medicine.

Keep this leaflet with the medicine. You may need to read it again.

What Irinotecan hydrochloride concentrated injection is used for

Irinotecan hydrochloride concentrated injection 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 and one of the options in this situation is treatment with an anticancer medicine, known as chemotherapy.

Alternatively, Irinotecan hydrochloride concentrated injection is used alone when the cancer has not responded or has returned after initial treatment.

Irinotecan hydrochloride concentrated injection is specially developed to target cancer cells rather than normal, healthy cells.

Ask your doctor if you have any questions about why Irinotecan hydrochloride concentrated injection has been prescribed for you. Your doctor may have prescribed Irinotecan hydrochloride concentrated injection for another purpose. Irinotecan hydrochloride concentrated injection is not addictive.

This medicine is available only with a doctor’s prescription.

Use in children
It is not known if Irinotecan hydrochloride concentrated injection is safe and effective in the treatment of children.

Before being treated with Irinotecan hydrochloride concentrated injection

When Irinotecan hydrochloride concentrated injection must not be given it

Irinotecan hydrochloride concentrated injection must not be given if you:

• are allergic to irinotecan hydrochloride or any of the ingredients listed at the end of this leaflet
• are or may become pregnant
• are breastfeeding or intend to breastfeed

Before treatment with Irinotecan hydrochloride concentrated injection

You should only be treated with Irinotecan hydrochloride concentrated injection 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.

You will probably feel nauseous and have diarrhoea, vomiting, stomach cramping and possibly infections during or after treatment with Irinotecan hydrochloride concentrated injection.

• It is likely that your doctor will give you one or more medicines before administering Irinotecan hydrochloride concentrated injection, which will help stop you vomiting or feeling sick after treatment. You will probably also have a blood test before each treatment.

You should tell your doctor if:

• you are 65 years of age or older
• you have or have had liver disease, kidney disease or heart disease
• you have previously been treated with radiation therapy
• you have diabetes or asthma
• you have constipation or difficulty urinating
• you have hereditary fructose intolerance

If you have not told your doctor about any of the above, tell your doctor before you are given Irinotecan hydrochloride concentrated injection.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Irinotecan hydrochloride concentrated injection may interfere with each other. In particular, tell your doctor if you are taking:

• laxatives, medicines used to treat constipation
• diuretics (medicines which make you pass urine more frequently e.g. for heart disease)
• any medicine for nausea or diarrhoea
• dexamethasone, which may be used to treat skin diseases, asthma or other allergic disorders
• anticonvulsants used to treat seizures
• St John’s Wort a herbal medicines used to treat depression
• ketoconazole used to treat fungal infections

Ask your doctor or other health care professional if you are not sure about this list of medicines. You may need to take different medicines. Your doctor will advise you.

How Irinotecan hydrochloride concentrated injection is given

Irinotecan hydrochloride concentrated injection will be given to you by your doctor. It is diluted and given by a slow infusion into a vein over a period of 90 minutes.

It is recommended that Irinotecan hydrochloride concentrated injection be given in different treatment courses depending on whether Irinotecan hydrochloride concentrated injection is given alone or in combination with other anticancer medicines.

When Irinotecan hydrochloride concentrated injection 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.

When Irinotecan hydrochloride concentrated injection is given alone, treatment courses include Irinotecan hydrochloride concentrated injection being given weekly for 4 weeks followed by a 2 week rest period and Irinotecan hydrochloride concentrated injection being given once every 3 weeks.

Depending on your response, treatment with Irinotecan hydrochloride concentrated injection should be interrupted if you get severe diarrhoea or other intolerable side effects.

Dose
The recommended dose for Irinotecan hydrochloride concentrated injection varies between 125 mg/m² and 350 mg/m² (based on body surface are, depending on the dosing schedule.

Your doctor will decide what dose of Irinotecan hydrochloride concentrated injection to be given.

Ask your doctor if you want more information about the dose of Irinotecan hydrochloride concentrated injection you will be receiving. After your first treatment course, the dose of Irinotecan hydrochloride concentrated injection 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.

In case of 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 Irinotecan hydrochloride concentrated injection.

While you are being treated with Irinotecan hydrochloride concentrated injection

Things you must do

Keep all appointments with your doctor and always discuss with your doctor any problems during or after treatment with Irinotecan hydrochloride concentrated injection.

Tell your doctor as soon as possible if diarrhoea occurs. Diarrhoea is a common side effect of Irinotecan hydrochloride concentrated injection. If untreated, severe diarrhoea can be life-threatening.

Your doctor will prescribe lopermide (an antidiarrhoeal) 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 bowel movements more frequent 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 diaarhoea or fever persists you may become dehydrated and need to go to 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 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 Irinotecan hydrochloride concentrated injection. If pregnancy occurs, consult your doctor.

Things you must not do

Because of the risk of diarrhoea, do not take laxatives during treatment courses with Irinotecan hydrochloride concentrated injection. 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.

Side effects

Irinotecan hydrochloride concentrated injection, like all other medicines, may have unwanted side effects. Side-effects are very common with anti-cancer medicines such as Irinotecan hydrochloride concentrated injection and they may be severe. Deaths have occurred which, in some cases, may have been related to treatment.

Tell your doctor immediately if you get any of the following side effects:

• diarrhoea
• 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
• anemia, which may make you weak and light-headed or may cause you to faint
• increased risk of infections including severe infections
• weakness
• hair loss

Common side effects (occurring in 10-50% or 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
• skin rash
• coughing, 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)
• kidney problems

In addition to the above side effects the following have also been reported:

• allergic reaction; some of the symptoms of an allergic reaction may include: rash, itching or hives on the skin. In more severe cases symptoms may also also include shortness or breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body.
• pins and needles
• abdominal bloating and/or pain
• chest pains

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 Irinotecan hydrochloride concentrated injection have also been reported. These include effects on the heart and blood vessels such as:

• slowed heart beat
• fainting
• blackouts
• swelling ane redness along a vein, which is extremely tender when touched
• chest pains
• heart attack
• stroke

Your doctor has information on monitoring for such side effects and their treatment. A very small number of patients have died suddenly while on Irinotecan hydrochloride concentrated injection.

Tell your doctor as soon as possible if you experience any side effects, including any effects not listed above.

After treatment with Irinotecan hydrochloride concentrated injection

Storage

Irinotecan hydrochloride concentrated injection will normally be stored in a hospital. It should be kept below 25°C and should be protected from light (kept in the packaging before use)

Irinotecan hydrochloride concentrated injection must never be frozen.

Product description

What it looks like

Irinotecan hydrochloride concentrated injection is a light yellow coloured solution free from visible particles.

Ingredients

Active ingredients:

• irinotecan hydrochloride

Other ingredients

• sorbitol
• lactic acid
• sodium hydroxide
• water for injections

Irinotecan hydrochloride concentrated injection does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Fresenius Kabi Australia Pty Limited
964 Pacific Highway
Pymble NSW 2073
Australia.
Telephone: (02) 9391 5555

Irinotecan hydrochloride concentrated injection is available in the following sizes:

• 40mg/ 2mL – AUST R 171228
• 100mg/ 5mL – AUST R 171227
• 300 mg/15 mL – AUST R 206415
• 500 mg/25 mL – AUST R 206416

Date of preparation of this leaflet:
23 Aug 2012

Published by MIMS May 2014