Irocan 40 mg/2 ml Solution

• IROCAN is an anticancer medicine containing the active substance irinotecan hydrochloride, trihydrate. Irinotecan hydrochloride trihydrate interferes with the growth and spread of cancer cells in the body.

• IROCAN is indicated in combination with other medicines or as a single medicine for the treatment of patients with advanced or metastatic cancer of the colon or rectum.

Do not take IROCAN:

• If you are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of IROCAN (listed in section 6 “What IROCAN contains”)
• If you have chronic inflammatory bowel disease and/or bowel obstruction
• If you are breast-feeding or pregnant or you are of childbearing age (able to give birth to children).
• If your bilirubin level is higher than 1,5 times the upper limit of the normal range
• If you have severe bone marrow failure (a condition that results in energy loss, pale skin, small red dots under skin, easy bruising, recurring/unexplained infections, difficulty in stopping to bleed)
• if you are in poor general condition (WHO performance status higher than 2)
• If you are taking or have recently taken St John’s Wort (a herbal extract containing Hypericum)
• 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
• If you are a child
• If you are using medicines called azole antifungals (a group of medicines that inhibit the growth of a wide range of fungi e.g. fluconazole, itraconazole, terbinafine)

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection if you suffer from: Impaired kidney function

As this medicine has not been tested in patients with kidney problems, please check with your doctor if you have any kidney problems.

Take Special Care with IROCAN:

• In the first 24 hours after administration of IROCAN During administration of IROCAN (30 – 90 minutes) and within 24 hours after administration you may experience some of the following symptoms: - diarrhoea - sweating - abdominal pain - watering eyes - visual disturbance - excessive mouth watering The medical term for these symptoms is “acute cholinergic syndrome”. If you have any of these symptoms, immediately tell your doctor who will give you the treatment necessary.
• From the day after treatment with IROCAN until next treatment During this period, you may experience various symptoms, which may be serious and require immediate treatment and close supervision.

Do not share medicines prescribed for you with any other person. Always take IROCAN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with IROCAN will last. Do not stop treatment early because it will not have a positive effect on the disease.

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

IROCAN will be given to you by a healthcare professional. The solution is infused into the vein (as a drip). IROCAN is for adults only.

Usual dose:

The amount of infusion you are given will depend on your age, size, weight 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).

Treatment is continued as long as possible. If the cancer gets worse or the side effects are unacceptable, the treatment may be stopped.

If you receive more IROCAN than you should Since a healthcare professional will administer IROCAN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive IROCAN Do not receive a double dose to make up for forgotten individual doses. Since a healthcare provider will administer IROCAN, it is unlikely that the dose will be missed.

If you stop taking IROCAN Do not stop treatment early. Treatment is continued as long as possible. If the cancer gets worse or the side effects are unacceptable, the treatment may be stopped. The healthcare professional will take the necessary decisions when treatment is stopped.

IROCAN can have side effects. Not all side-effects reported for IROCAN are included in this leaflet. Should your general health worsen while taking IROCAN, 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:

• Shortness of breath, dry cough, and inspiratory crackles (crackles when taking a breath); early effects such as breathing difficulties.
• Allergic reaction (skin rash including red itchy skin, urticaria, conjunctivitis, rhinitis).
• Severe allergic reactions causing swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing (anaphylactic/ anaphylactoid reaction).
• Skin reactions.
• Reactions at the infusion site.
• Fever and infections.
• Delayed severe diarrhoea.
• Severe nausea and vomiting.
• Hair loss (the hair grows again after end of treatment).
• Severe transient acute cholinergic syndrome: the main symptoms are defined as early diarrhoea and various other symptoms such as abdominal pain; red, sore, itching or weeping eyes (conjunctivitis); running nose (rhinitis); low blood pressure; widening of the blood vessels (vasodilation); sweating; chills; a feeling of general discomfort and illness; dizziness; visual disturbances; pupil contraction; watering eyes and increased salivation, occurring during or within the first 24 hours after the infusion of IROCAN.
• Fever associated with a severe decrease in the number of a certain type of white blood cells (febrile neutropenia).
• Severe nausea and vomiting.
• Loss of water (dehydration), commonly associated with diarrhoea and /or vomiting.
• Constipation.
• Severe weakness (asthenia).

These are all very serious side effects. If you have them, you may have had a serious reaction to IROCAN. 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:

• Constipation.
• Bleeding from the stomach.
• Abdominal pain and/or diarrhoea (a condition known as pseudomembranous colitis).
• Difficulty in passing urine (renal insufficiency), low blood pressure, dehydration associated with diarrhoea and/or vomiting.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent: Bruising or bleeding easily due to your body destroying its own blood platelets (peripheral thrombocytopaenia with antiplatelet antibodies).
• Less frequent: Muscular contraction or cramps and numbness (paraesthesia).
• Inflammation of the large bowel causing abdominal pain (colitis, ischemic and ulcerative colitis).
• Intestinal perforation, loss of appetite (anorexia), abdominal pain, inflammation of the mucous membranes.
• Inflammation of the pancreas (pancreatitis) which may cause abdominal pain.
• Increased blood pressure during and following administration.
• Decreased levels of potassium and sodium in the blood, mostly related to diarrhoea and vomiting.
• Temporary speech disorders.
• Increase in levels of some digestive enzymes which break down sugars and fats.

Other side effects:

• Decreased number of a certain type of white blood cells (neutropenia) which increases the risk of infections.
• Decrease number of red blood cells (anaemia) which can make the skin pale and cause weakness and breathlessness.
• Decreased number of blood platelets (thrombocytopenia) which increases the risk of bruising and bleeding.

Laboratory tests:

• Transient and mild to moderate increase in serum levels of some liver enzymes (AST, ALT, alkaline phosphate) or bilirubin.
• Transient and mild to moderate increase in serum levels of some liver enzymes (transaminases, alkaline phosphatase) or bilirubin.
• Transient and mild to moderate increase of creatinine in the blood.
• Transient severe (grade 3) increase in serum levels of bilirubin.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of IROCAN.

Single-dose vials of IROCAN solution for infusion should be stored at or below 25 °C and protected from light.

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 or 4 days under refrigeration (2 – 8ºC). Discard any unused portion thereafter. Do not freeze.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN

Any unused medicine or waste material should be returned to the pharmacy for destruction. Do not dispose of unused medicine in drains or sewerage systems (e.g toilets).