Irinotecan 40 mg/2 ml

IRINOTECAN FKSA is a cancer medication containing the active substance irinotecan hydrochloride, trihydrate that interferes with the growth of cancer cells and slows their growth and spread in the body. IRINOTECAN FKSA is used to treat cancers of the colon and rectum. It may be given with other cancer medicines in a combination chemotherapy.

IRINOTECAN FKSA should not be administered to you:

• If you are hypersensitive (have a history of allergic reactions) to irinotecan hydrochloride trihydrate or any of the other ingredients (see WHAT IRINOTECAN FKSA CONTAINS)
• If you are pregnant or breastfeeding
• If you have severe bone marrow disease
• If your general health status does not allow you to carry out general activities of daily living (WHO performance status higher than 2)
• If you have a disease involving frequent inflammation of the intestine (chronic inflammatory bowel disease) or blockage of the intestine (ileus).
• if your bilirubin level is higher than 1,5 times the upper limit of the normal range
• If you are a child below 18 years of age
• If you are taking St John’s Wort (a herbal extract containing Hypericum) or ketoconazole.
• if you are to take or have recently taken live attenuated vaccines (vaccines against yellow fever, chicken pox, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza) and during the 6 months after stopping chemotherapy.

Warnings and precautions
IRINOTECAN FKSA will only be administered to you in a specialised unit where chemotherapy (cancer treatment) is administered and will only be administered by a qualified doctor (oncologist). Tell your doctor or health care provider before being given the injection:

• If you have Gilbert’s syndrome, an inherited condition that can cause elevated bilirubin levels and jaundice (yellow skin and eyes)

You will not be expected to give yourself IRINOTECAN FKSA. It will be given to you by a person who is qualified to do so. IRINOTECAN FKSA is for intravenous use only. Your doctor will decide on the suitable dose and duration of the treatment based on your specific condition and needs. The amount of IRINOTECAN FKSA that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule. IRINOTECAN FKSA is injected into a vein through an intravenous route (IV). You will receive this injection in a clinic or hospital setting. IRINOTECAN FKSA must be given slowly, and the IV infusion can take up to 90 minutes to complete. You may be given other medications to prevent nausea, vomiting, diarrhoea, and other side effects while you are receiving IRINOTECAN FKSA. You may need to keep using these medicines for at least a day after your IRINOTECAN FKSA injection. Tell your care givers if you feel any burning, pain, or swelling around the IV needle when IRINOTECAN FKSA is injected. If the medicine escapes from the vein it can cause tissue damage. If you experience pain or notice redness or swelling at the IV site while you are receiving IRINOTECAN FKSA, alert your healthcare professional immediately. There are currently several treatment schedules recommended for IRINOTECAN FKSA. It is usually given either once every 3 weeks (IRINOTECAN FKSA given alone) or once every week (IRINOTECAN FKSA given in combination with 5FU/FA chemotherapy). The dose will depend on a number of factors, including the treatment schedule, your body size, your age and general health, your blood counts, how well your liver is working, whether you have had radiation to your abdomen/pelvis, and whether you have any side effects such as diarrhoea.

IRINOTECAN FKSA can have side effects. Not all side effects reported for IRINOTECAN FKSA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking IRINOTECAN FKSA, please consult your health care provider for advice. If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• Signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
• inflammation at the injection site
• inflammation of the lining of the mouth
• swelling of feet and hands, headache, increased sweating, flushing
• Fever
• Dehydration
• Early diarrhoea, more than 24 hours after you have received IRINOTECAN FKSA, accompanied by symptoms of increased salivation, watery eyes, sweating, flushing, abdominal cramping, 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), myosis (constriction to the pupil of the eyes), conjunctivitis (inflammation of the eye), vasodilation (widening of blood vessels) (This can occur while the medicine is being administered. If so, alert your healthcare professional promptly. Medication can be given to stop and/or lessen this early side effect).
• Late diarrhoea, more than 48 hours after anti-diarrhoeal treatment. Because of concerns of dehydration and electrolyte imbalances with diarrhoea it is important to be in contact with health care professionals for monitoring, and for medication and diet modifications advice.
• Severe diarrhoea
• Nausea and Vomiting
• Decrease in white blood cells

IRINOTECAN FKSA 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. If you have any fever this may be an indication of infection associated with this neutropenia. These are all very serious side effects. If you have them, you may have had a serious reaction to IRINOTECAN FKSA. you may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Sweating
• Abdominal cramping
• Tears
• Narrowing of the pupils

Store all medicine out of reach of children. Store at or below 25 °C. Do not freeze. Protect from light. For intravenous use. Single use only.