Campto (Irinotecan Hydrochloride Trihydrate)

Campto 20 mg/ml. Irinotecan Hydrochloride Trihydrate

What is in Campto?

The active ingredient in Campto is irinotecan hydrochloride trihydrate. It is available as a concentrate, which should be diluted before infusion and comes in three sizes:

• 40 mg of irinotecan hydrochloride trihydrate in 2 ml
• 100 mg of irinotecan hydrochloride trihydrate in 5 ml
• 300 mg of irinotecan hydrochloride trihydrate in 15 ml

Other ingredients include sorbitol, lactic acid, sodium hydroxide, hydrochloric acid and water for injections.

Campto 40 mg/2 ml, 100 mg/5 ml and 300mg/15 ml are available in boxes containing a single vial.

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

Why have you been prescribed Campto?

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 colon, rectum and where the disease is at an advanced stage in the large intestine.

Your doctor may use a combination of Campto with 5-fluorouracil/folinic acid (5FU/FA) and bevacizumab to treat your cancer of the colon and 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 cancer of the large intestine (KRAS wild-type) that is of a certain type known to display cell markers referred to as epidermal growth factor receptors (EGFR) which are blocked by the monoclonal antibody.

If you need any further information on your condition, please ask your doctor.

Before starting your course of treatment

Tell your doctor or hospital pharmacist if any of the following apply to you:

• If you have any other bowel disease or a history of bowel obstruction
• If you have had a severe allergic reaction to Campto in the past
• If you are pregnant or breast feeding or if you think you might be pregnant
• If you have any liver problems
• If you are taking any prescription medicines
• If you are taking any non-prescription medicines that you may have bought yourself, in particular
• St Johns’ Wort
• If you receive Campto in combination with cetuximab, please make sure that you also read the package insert for cetuximab
• If you receive Campto in combination with bevacizumab, please make sure that you also read the package insert for bevacizumab
• If you receive Campto in combination with capecitabine, please make sure that you also read the package insert for capecitabine

Special warnings

If you suffer from an inherited condition called fructose intolerance, tell your doctor or hospital pharmacist before you are given Campto. Campto contains sorbitol, which is unsuitable for people who cannot tolerate fructose.

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 “Does Campto have any side-effects?” and follow the instructions carefully if you get any of the symptoms described.

Can you drive or operate machinery?

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

How will you be given Campto?

Campto will be given as an infusion into your veins over a period of 30 to 90 minutes. 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 3 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.
• If you receive Campto in combination with cetuximab, Campto must not be administered earlier than 1 hour after the end of the cetuximab infusion. Please follow the advice of your doctor regarding your current treatment.

These dosages may be adjusted by your doctor depending on your condition and any side-effects you may have.

Does Campto have any 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 onset” 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.

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.

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

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

• sweating
• abdominal cramps
• watering eyes
• visual disturbance
• dizziness
• low blood pressure
• feeling unwell
• excessive mouth watering

Tell your doctor or nurse about all your symptoms.

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
• if you have any fever as well as the diarrhoea
• if 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 the fluids described above.

Neutropenia

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 any treatment necessary.

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

Very few patients who become dehydrated as a result of diarrhoea, vomiting or infection may have kidney problems, low blood pressure or circulatory failure.

Other side-effects may occur, but you do not need to contact your doctor unless they become troublesome:

• hair loss
• fatigue
• allergic skin reactions
• stomach ache
• muscular cramps
• constipation
• inflammation at the injection site
• abdominal pain
• transient speech disorders
• inflammation of the lining of the mouth

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 a 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.

Tell your doctor or nurse immediately if you have any side-effects that are not mentioned in this leaflet.

Expiry date

Campto must not be used after the expiry date. This date can be found on the vial and on the box. In both places it is given as “EXP” followed by the month and year.

Storing your medicine

• Store in the pack in which it is supplied and protect from light.
• Once the concentrate has been diluted for infusion the solution can be kept for 12 hours at room temperature (below 25°C) or for 24 hours in a refrigerator (at 2 to 8°C).
• Always keep Campto in a safe place and out of the reach and sight of children.

Campto is a trademark.

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 reconstitution, 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% (w/v) sodium chloride or 5% (w/v) glucose solution. The infusion should then be thoroughly mixed by manual rotation.

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 would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution (etc) 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 to cytotoxic agents.