Inotrix 40 mg/2 ml/100 mg/5 ml/300 mg/15 ml

INOTRIX belongs to a group of medicines called cytostatics (anti-cancer medicines). INOTRIX is used to treat cancer of the lower bowel, alone or in combination with two other medicines (5-fluorouracil and folinic acid).

INOTRIX should not be administered to you :

• If you are hypersensitive (allergic) to irinotecan hydrochloride trihydrate or any of the ingredients of INOTRIX (listed in section 6).
• If you are pregnant or breastfeeding or if you think you may be pregnant.
• If you have severe bone marrow failure.
• If your WHO performance status > 2 (i.e. if your general health status does not allow you to carry out general activities of daily living).
• If you have a disease involving frequent inflammation of the intestine (chronic inflammatory bowel disease) or blockage of the intestine (ileus).
• If your bilirubin (breakdown product of red blood cells) level is high.
• If you are a child or adolescent.
• If you are taking azole antifungal medication (used to treat fungal infections).
• If you are taking St John’s Wort (a herbal supplement).
• If you are having any live attenuated vaccinations. Speak to your healthcare provider before any vaccination.

Warnings and precautions

Tell your doctor or healthcare professional before being given the INOTRIX concentrate for solution for infusion if:

• you have impaired liver function you are at greater risk of developing severe decrease in white blood cells or fever.
• you experience nausea and vomiting. If you experience vomiting together with delayed diarrhoea, you should be hospitalised for treatment.
• you experience early diarrhoea together with a group of symptoms such as sweating, abdominal cramping, watery eyes and salivation. If this occurs, inform your doctor as a specific medication is required in order for these symptoms to disappear.
• you are an elderly patient, the dose may have to be adjusted accordingly.
• If you have recently had or are due to have vaccinations
• If you have previously received pelvic/abdominal radiotherapy you may be at increased risk of developing bone marrow suppression
• if you suffer/suffered from heart disease Your doctor will monitor you closely and discuss with you how risk factors (for example smoking, high blood pressure and to high fat content) can be reduced.
• If you have a type of lung disease that causes scarring of lungs

INOTRIX should only be administered under the supervision of a qualified medical doctor in units specialised in the administration of chemotherapy. It is recommended that INOTRIX be administered only in healthcare institutions with adequately equipped facilities, including an intensive care unit.

You will not be expected to give yourself INOTRIX. It will be given to you by a person who is qualified to do so.

Your doctor will calculate the exact dosage for you based on your weight and height. When INOTRIX is administered on it’s own, the usual dose is 350 mg/m2 given as an intravenous infusion over 30 to 90 minutes every three weeks. When INOTRIX is to be used together with 5-fluorouracil and folinic acid, the usual dose is 80 mg/m2 given as an intravenous infusion over 30 to 90 minutes, followed by an infusion of folinic acid and the 5-fluorouracil over six weeks. After this period there will be one weeks rest. The usual dose will be adjusted or delayed if you have neutropenia (very low blood count of a type of white blood cells), severe diarrhoea, vomiting or if you are elderly. Your doctor will tell you how long your treatment with INOTRIX will last. Do not stop any treatment unless your doctor tells you to do so. If you have the impression that the effect of INOTRIX is too strong or too weak, tell your doctor.

INOTRIX can have side effects. Not all side effects reported for INOTRIX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking INOTRIX, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling around the eyes or face or tongue, (which may rarely be a serious allergic reaction)
• Swelling in the ankles, wrists, arms and legs
• Difficulty breathing
• Severe nausea, vomiting
• Fever
• Severe diarrhoea

These are all very serious side effects. If you have them, you may have had a serious reaction to INOTRIX. You may need urgent medical attention or hospitalisation.

A frequent side-effect with INOTRIX is diarrhoea. Please take note of the following important information:

Diarrhoea

INOTRIX 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 tell your doctor or healthcare professional immediately. Patients with an increased risk of diarrhoea are those who had a previous abdominal/pelvic radiotherapy and initial raised white blood cells.

Early diarrhoea

(Frequent)

if diarrhoea starts less than 24 hours after the infusion (“early diarrhoea”) you should contact your doctor IMMEDIATELY. This “early diarrhoea” may be accompanied by a group of other symptoms listed below. This is known as acute cholinergic syndrome occurring during or within the first 24 hours after the infusion of INOTRIX. The symptoms may be:

• Frequent: abdominal pain/cramping
• Less frequent: chills, lacrimation (watery eyes), rhinitis (irritation and inflammation inside the nose which may result in stuffy nose, runny nose and/or post-nasal drip), dizziness, hypotension (low blood pressure), malaise (lack of well being), increased salivation (mouth watering), myosis (constriction to the pupil of the eyes)

Delayed diarrhoea

(Frequent)

if your diarrhoea starts more than 24 hours after the infusion (“delayed diarrhoea”) you should IMMEDIATELY contact your doctor. 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.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. INOTRIX will be stored in the pharmacy Store at or below 25 °C. After dilution in either 0,9 % sodium chloride or 5 % dextrose, the diluted solution is stable for 24 hours at a temperature at or below 25 ºC for 4 days under refrigeration (between 2 and 8 ºC). Discard any unused portion thereafter. Do not freeze. Keep the container in the outer carton in order to protect from light. Do not use after the expiry date stated on the vial and the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).