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Campto 40mg/2ml Concentrate For Solution For Infusion

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/jTgk Campto® 20mg/ml

Concentrate for solution for infusion

irinotecan hydrochloride


PACKAGE LEAFLET: INFORMATION FOR THE USER


rff&i Campto® 20mg/ml

Concentrate for solution for infusion

irinotecan hydrochloride


HEALTHCARE PROFESSIONAL INFORMATION:


The following information is intended for medical or healthcare professionals only:

Instructions for use/handling, preparation and disposal guide for use with Campto Concentrate for Solution for Infusion.

Use/handling

As with other neoplastic agents, Campto must be prepared and handled with caution.

The use of glasses, masks and gloves is required. If Campto solution or infusion solution should come in contact with the skin, wash IMMEDIATELY and thoroughly with soap and water. If Campto solution or infusion solution should come into contact with the mucous membranes, wash IMMEDIATELY with water.

Preparation for the intravenous solution

As with any other injectable drugs, the Campto solution must be prepared aseptically.

If any precipitate is observed in the vials or after dilution, the product should be discarded according to standard procedures for cytotoxic agents.

Aseptically withdraw the required amount of Campto solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle containing either 0.9% sodium chloride or 5% glucose solution. The infusion should then be thoroughly mixed by manual rotation.


Following dilution: Campto is physically and chemically stable with infusion solutions (0.9% (w/v) sodium chloride and 5% (w/v) glucose solution) for up to 28 days when stored in LDPE or PVC containers at 5°C or at 30°C and protected from light. When exposed to light, physicochemical stability has been demonstrated for up to 3 days.

It is recommended, that in order to reduce microbiological hazard, the infusion solutions should be prepared immediately prior to use and infusion commenced as soon as practicable after preparation. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Campto infusion should be infused into a peripheral or central vein.

Campto should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.

Disposal

All materials used for dilution and administration should be disposed of according to hospital standard procedures applicable.


Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    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 or pharmacist.

In this leaflet:

1.    What Campto is and what it is used for

2.    Before you are given Campto

3.    How you will be given Campto

4.    Possible side effects

5.    How to store Campto

6.    Further information


1. What Campto is and what it is used for

Your medicine is called Campto. Campto belongs to a group of medicines called cytostatics (anti-cancer medicines).

Campto may be used alone or in combination with a number of other medicines used to treat cancer. These combinations may be used to treat cancers of the large intestine (colon or rectum) where the disease is at an advanced stage.

Your doctor may use a combination of Campto with 5-fluorouracil/folinic acid (5FU/FA) and bevacizumab to treat your cancer of the large intestine (colon or rectum).

Your doctor may use a combination of Campto with capecitabine with or without bevacizumab to treat your cancer of the colon and rectum.

Your doctor may use a combination of Campto with cetuximab to treat a particular type of cancer of the large intestine (KRAS wild-type) which expresses a protein called EGFR.


2. Before you are given Campto

You should not be given Campto if any of the following apply to you:

•    If you are allergic to irinotecan hydrochloride or any of the other ingredients of Campto

•    If you have or have had chronic inflammatory bowel disease or bowel obstruction

•    If you are pregnant or breast-feeding or if

you think you might be pregnant

•    If you have severe liver disease

•    If you have severe bone marrow failure

•    If your general health status does not allow you to carry out general activities of daily living

•    If you are taking St Johns’ Wort (a herbal supplement)

Take special care with Campto

Before treatment with Campto tell your doctor if any of the following apply to you:

•    You have liver problems or jaundice

•    You have kidney problems

•    You have asthma

•    You have ever received radiation therapy

•    You experienced severe diarrhoea or fever after being treated with Campto before.

   You have heart problems

   You smoke, have high blood pressure or high cholesterol as these can increase the risk of heart problems during treatment with Campto

   You have had or are due to have any vaccinations.

•    You are taking any other medicines. Please see the section below “Taking other medicines”

As with all anti-cancer medicines the use of Campto is associated with a number of side-effects which may be serious. These side-effects require special management to minimise the risk of complications.

You will be treated by a specialist team experienced in using these kinds of treatments and managing their side effects, which are


usually temporary. However, it is essential that you read the section “POSSIBLE SIDE EFFECTS” and follow the instructions carefully if you get any of the symptoms described.

Taking other medicines:

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you receive Campto in combination with either capecitabine, cetuximab or bevacizumab, please make sure that you also read the patient information leaflet for each medicine.

Some medicines, when taken at the same time as Campto, may affect the way Campto works or Campto may affect the way they work. Tell your doctor if you are taking any of the following medicines:

•    St John’s Wort (a herbal supplement)

•    Ketoconazole (an antibiotic)

•    Rifampicin (an antibiotic)

•    Carbamazepine (used to treat seizures)

•    Phenobarbital (used to treat seizures)

•    Phenytoin (used to treat epilepsy)

•    Warfarin (an anticoagulant used to thin the blood)

•    Atazanavir (used to treat HIV)

•    Ciclosporin or Tacromilus (used to dampen down your body’s immune system)

If you go into hospital to have an operation, tell the anaesthetist and the medical staff that you are being treated with Campto and any other medicines you are taking.

Pregnancy and breast-feeding You must not use Campto if you are pregnant as it may harm your unborn baby.

You should also avoid becoming pregnant while you are being treated with Campto.

Men and Women should use adequate contraception while being treated with Campto and for:

•    up to 1 month after you receive your last dose of Campto if you are female

•    up to 3 months after your last dose of Campto if you are male.

If you do become pregnant while being treated with Campto you must inform your doctor IMMEDIATELY.

Because Campto may be harmful to nursing infants, women must not breast-feed while being treated with Campto.


Driving and Using Machines

Campto may make you feel dizzy or cause visual disturbances. If this happens to you do not drive or operate machinery until this resolves.

Important Information about some of the ingredients of Campto Warning:

This medicine contains sorbitol, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars tell your doctor or nurse before you are given Campto.

3. How you will be given Campto

If you are prescribed Campto it will only be given to you by doctors or nurses experienced in giving chemotherapy.

Method of administration: Campto will be given as an infusion into your veins over a period of 30 to 90 minutes.

If you receive Campto in combination with cetuximab, Campto must not be administered earlier than 1 hour after the end of the cetuximab infusion.

Dosage and frequency of administration:

The amount of Campto 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 metres (m2).

•    If you have previously been treated with 5-fluorouracil you will normally be treated with Campto alone starting with a dose of 350 mg/m2 every three weeks.

•    If you have not had previous chemotherapy you will normally receive 180 mg/m2 Campto 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.

Duration of treatment:

The number of infusions that you receive will depend on how you are responding to treatment. Your doctor will discuss this with you.



Blood Monitoring

Whilst you are taking Campto and/or other similar medicines you will have regular blood tests to monitor your treatment and to ensure that there are no untoward adverse effects.

4. Possible side effects

Medicines like Campto will cause unwanted side-effects.

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.

Please read the following instructions carefully and follow them if you have any of the side-effects listed.

Diarrhoea

Campto may cause you to have diarrhoea. There are two types of diarrhoea, which can be distinguished by when they start. “Early” diarrhoea starts less than 24 hours after the infusion and “delayed” diarrhoea starts more than 24 hours after the infusion. If you have ANY DIARRHOEA it is IMPORTANT that you follow these instructions carefully.

Early diarrhoea

•    if your diarrhoea starts less than 24 hours after the infusion (“early diarrhoea”)

you should contact your doctor or nurse IMMEDIATELY and they will give you a suitable treatment.

This “early diarrhoea” may be accompanied by other symptoms such as

•    sweating

•    chills

•    abdominal cramps

•    watering eyes

•    stuffy nose

•    visual disturbance

•    dizziness

•    low blood pressure

•    feeling unwell

•    feeling weak

•    excessive mouth watering

•    pupils of the eye get smaller

Tell your doctor or nurse about all your symptoms.

Do not use any anti-diarrhoeal treatment that your doctor has given you for “delayed diarrhoea”.


Delayed Diarrhoea

   if your diarrhoea starts more than 24 hours after the infusion (“delayed diarrhoea”) you should IMMEDIATELY take any anti-diarrhoeal treatment that the doctor has given you EXACTLY as he has told you. If you are unsure of what this is, ask your doctor or nurse.

Drink large amounts of rehydration fluids, IMMEDIATELY (i.e. water, soda water, fizzy drinks, soup or oral rehydration therapy).

You must tell your doctor if

•    you have nausea and vomiting as well as diarrhoea

•    you have any fever as well as the diarrhoea

•    you still have diarrhoea 48 hours after starting the diarrhoea treatment

Do not take any treatment for diarrhoea other than that given to you by your doctor or nurse and only drink the fluids described above.

Decrease in white blood cells

Campto 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.

Your doctor will probably arrange for you to have regular blood tests to monitor these white blood cells.

If you have any fever this may be an indication of infection associated with this neutropenia and requires immediate treatment.

If you have any fever, and particularly if you also have diarrhoea, contact your doctor or nurse IMMEDIATELY so that they can give you necessary treatment.

Nausea and vomiting

If you have nausea and/or vomiting contact your doctor or nurse IMMEDIATELY.

Breathing difficulties

If you have breathing difficulties contact your doctor or nurse IMMEDIATELY.

Other side effects

All medicines can cause allergic reactions.

If you experience any of the following conditions please report it to a doctor or nurse IMMEDIATELY:

•    wheeziness

•    difficulty in breathing

•    swelling

•    rash or itching (especially affecting the whole body)


•    dehydration

•    kidney problems

•    low blood pressure

•    heart problems

•    blockage or perforation (a ‘hole') in the bowel

•    bleeding from the bowel

•    inflammation in the bowel

•    inflammation of the pancreas

•    severe stomach pain

•    passing black or blood stained stools

•    vomiting blood

•    changes in laboratory tests

If you receive Campto in combination with cetuximab, some of the side effects you may experience can also be related to this combination. Such side effects may include an acne-like rash. Therefore, please make sure that you also read the package leaflet for cetuximab.

If you receive Campto in combination with capecitabine, some of the side effects you may experience can also be related to this combination. Such side effects may include: very common blood clots, common allergic reactions, heart attack and fever in patients with a low white blood cell count. Therefore, please make sure that you also read the package leaflet for capecitabine.

If you receive Campto in combination with capecitabine and bevacizumab, some of the side effects you may experience can also be related to this combination. Such side effects include: low white blood cell count, blood clots, high blood pressure and heart attack. Therefore, please make sure that you also read the package leaflet for capecitabine and bevacizumab.

Other side effects which may occur when you are treated with Campto are:

•    hair loss

•    fatigue

•    loss of appetite

•    mild allergic skin reactions

•    mild stomach pains

•    muscular cramps and twitches

•    pins and needles

•    constipation

•    inflammation at the injection site

•    mouth ulcers

•    temporary speech disorders

•    high blood pressure

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse immediately.


5.    How to store Campto

Keep out of the reach and sight of children.

Store below 25°C. Do not use Campto after the expiry date which is stated on the vial and on the box after “EXP”. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Once the concentrate has been diluted for infusion the solution can be kept for 24 hours in a refrigerator (at 2 to 8°C).

6.    Further information
What Campto contains

The active substance is irinotecan hydrochloride.

The other ingredients are Sorbitol, lactic acid, sodium hydroxide, hydrochloric acid and water for injections.

What Campto looks like and contents of the pack

Campto is a liquid in a vial with a rubber stopper. Each 2ml vial contains 40mg of Campto, each 5ml vial contains 100mg of Campto and each 15ml vial contains 300mg of Campto.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pfizer Limited Ramsgate Road Sandwich Kent

CT13 9NJ UK

Manufacturer

Pfizer Service Company BVBA Hoge Wei 10 1930, Zaventem Belgium

This leaflet was last revised in 11/2011 CF 13_1


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