Iritero 40 mg/2 ml/100 mg/5 ml/300 mg/15 ml Injection

IRITERO belongs to a group of medicines called cytostatics (anti-cancer medicines). IRITERO 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 and rectum.

IRITERO should not be administered to you:

• If you are hypersensitive (allergic) to irinotecan hydrochloride trihydrate (active ingredient) or any of the other ingredients of IRITERO.
• If you are pregnant or breastfeeding.
• 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.
• If you are taking azole antifungal medication (used to treat fungal infections) or St John’s Wort (a herbal supplement).

Warnings and precautions

Tell your doctor or health care provider before being given the injection: Special care should be taken with IRITERO:

• If you have impaired liver function you are at greater risk of developing severe decrease in white blood cells or fever.
• If you experience nausea and vomiting. If you experience vomiting together with delayed diarrhoea, you should be hospitalised for treatment.
• If 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.
• If you are an elderly patient, the dose may have to be adjusted accordingly.

Contraceptive measures must be taken during and for at least 3 months after stopping therapy. Avoid vaccination with live vaccines.

IRITERO is an injection. You will not be expected to give yourself IRITERO. It will be given to you by a person who is qualified to do so. IRITERO will be given as an infusion into your veins over a period of 30 to 90 minutes. The amount of IRITERO 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 meters (m2). Your doctor will tell you how long your treatment with IRITERO will last.

If you have the impression that IRITERO is too strong or too weak, tell your doctor or pharmacist.

IRITERO can have side effects. Not all side effects reported for IRITERO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving IRITERO, please consult your health care provider for advice.

If any of the following happens, stop treatment with IRITERO and tell your doctor immediately:

• allergic skin reactions
• inflammation at the injection site
• inflammation of the lining of the mouth
• swelling of feet and hands, headache, increased sweating, flushing

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

Tell your doctor immediately if you notice any of the following:

• Diarrhoea. IRITERO 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 health care professional immediately.

Store at or below 25 °C and store in original package, protect from light and moisture as well as do not freeze. KEEP OUT OF REACH OF CHILDREN.

In-use storage conditions IRITERO are subjected to 0,9 % Nacl (0,12 mg/ml Concentration), 0,9 % Nacl (2,8 mg/ml Concentration), 5 % Glucose (0,12mg/ml concentration), 5 % Glucose (2,8 mg/ml Concentration) for 24 Hrs at 2 - 8 °C, 3 days at 25 °C and 28 days at 5 °C.