Irinotecan Kabi

Package Leaflet: Information for the User

Irinotecan Kabi, 20 mg/ml, Concentrate for Solution for Infusion

Irinotecanhydrochloridetrihydrate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Irinotecan Kabi and what is it used for
• 2. Important information before using Irinotecan Kabi
• 3. How to use Irinotecan Kabi
• 4. Possible side effects
• 5. How to store Irinotecan Kabi
• 6. Contents of the pack and other information

1. What is Irinotecan Kabi and what is it used for

Irinotecan Kabi belongs to a group of anticancer medicines. The active substance of the medicine is
irinotecan hydrochloride trihydrate.
Irinotecan hydrochloride trihydrate inhibits the growth and spread of cancer cells in the body.
Irinotecan is indicated in combination with other medicines used in the treatment of patients with
advanced colon or rectal cancer or colon or rectal cancer with metastases.
Irinotecan can be used alone in patients with colon or rectal cancer with metastases who have had a
relapse or progression of the disease after initial therapy with fluorouracil.

2. Important information before using Irinotecan Kabi

When not to use Irinotecan Kabi:

• if the patient has chronic inflammatory bowel disease and/or bowel obstruction;
• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6. "Contents of the pack and other information");
• if the patient is breastfeeding (see section 2.);
• if the patient has a bilirubin level three times higher than the upper limit of normal;
• if the patient has severe bone marrow dysfunction;
• if the patient is in poor general condition (WHO performance status greater than 2);
• if the patient is taking or has recently taken St. John's Wort (herbal extract containing Hypericum perforatum);
• if the patient intends to use or has recently used live, attenuated vaccines (against yellow fever, chickenpox, measles, mumps, rubella, tuberculosis, rotavirus, influenza) and within 6 months after the end of chemotherapy.

In case of using Irinotecan Kabi in combination with other medicines, the patient should read the package leaflet for the other medicine to obtain information on additional contraindications.

Warnings and precautions

Before starting treatment with Irinotecan Kabi, the patient should discuss it with their doctor, pharmacist, or nurse.
Particular caution should be exercised when using Irinotecan Kabi. The use of Irinotecan Kabi should be limited to specialized units experienced in the administration of cytotoxic chemotherapy. The medicine should only be administered under the supervision of a doctor qualified in the use of anticancer chemotherapy.
In patients with Gilbert's syndrome, a hereditary disease, elevated bilirubin levels and jaundice (yellowing of the skin and eyes) may occur.
Diarrhea
Irinotecan Kabi may cause diarrhea, which can be severe in some cases. Diarrhea may start a few hours or a few days after infusion. If left untreated, it can lead to dehydration and serious electrolyte disturbances, which can be life-threatening. The doctor will prescribe medicines to help prevent or control these side effects. It is essential to ensure that the medicine is available to take if needed.

• The medicine should be taken as directed by the doctor after the first appearance of loose or frequent stools.
• Lots of water and/or salty fluids (carbonated water, drink, or soup) should be drunk.
• The doctor or pharmacist should be contacted if diarrhea persists, especially if it lasts longer than 24 hours, or if there is a feeling of emptiness in the head, dizziness, or fainting.

Neutropenia (reduced number of a certain type of white blood cell)
This medicine may lower the number of white blood cells, especially in the first few weeks after administration. This can increase the risk of infection. The patient should immediately inform the doctor or nurse if they experience any signs of infection, such as fever (38°C or higher), chills, pain when urinating, coughing, or expectoration. The patient should avoid being near people who are sick or have an infection. The doctor should be informed immediately if symptoms of infection occur.
Blood monitoring
The doctor will likely perform blood tests before and during treatment to check the effect of the medicine on blood cell count or blood composition. The test results may show the need to use medicines to treat these reactions. The doctor may also reduce or delay the next dose of this medicine or even stop treatment. All doctor's appointments and laboratory test results should be kept.
This medicine may lower the number of platelets in the blood within a few weeks after administration, which can increase the risk of bleeding. The patient should consult their doctor before taking any medicines or supplements that may affect bleeding, such as aspirin or medicines containing aspirin, warfarin, or vitamin E. The doctor should be informed if there are any unusual bruises or bleeding, such as nosebleeds, bleeding gums when brushing teeth, or black, tarry stools.
Nausea and vomiting
On the day of administration or within a few days after, nausea and vomiting may occur. Before starting treatment, the doctor may give a medicine to prevent nausea and vomiting. The doctor will likely prescribe anti-nausea medicines that can be taken at home. These medicines should be kept on hand in case of need. The doctor should be contacted if the patient cannot take fluids orally due to nausea and vomiting.
Acute cholinergic syndrome
This medicine may affect the part of the nervous system that controls secretory functions, leading to a so-called cholinergic syndrome. Symptoms may include runny nose, increased salivation, excessive tear production, sweating, flushing, abdominal cramps, and diarrhea. The doctor or nurse should be informed if any of these symptoms are noticed, as there are medicines that can help control them.
Respiratory disorders
Patients taking this medicine have rarely experienced serious lung problems. The doctor should be informed immediately if a new or worsening cough, difficulty breathing, and fever occur. The doctor may stop treatment to deal with this problem.
This medicine may increase the risk of developing large blood clots in the veins of the legs or lungs, which can travel to other parts of the body, such as the lungs or brain. The doctor should be informed immediately if the patient experiences chest pain, shortness of breath, or swelling, pain, redness, or warmth in the arm or leg.
Chronic intestinal inflammation and/or bowel obstruction
The doctor should be informed if the patient experiences abdominal pain and cannot have a bowel movement, especially if there is also bloating and loss of appetite.
Radiation therapy
If the patient has recently undergone radiation therapy to the pelvis or abdomen, they may have an increased risk of bone marrow suppression. The doctor should be consulted before starting treatment with Irinotecan Kabi.
Kidney function
There have been reports of kidney function disorders.
Heart disorders
The doctor should be informed if the patient has or has had heart disease or has previously received anticancer medicines. The doctor will closely monitor the patient and discuss how to reduce risk factors (such as smoking, high blood pressure, and high fat content in the diet).
Vascular disorders
Irinotecan Kabi is rarely associated with vascular disorders (blood clots in the legs and lungs) and may occur rarely in patients with multiple risk factors.
Other
This medicine may cause mouth ulcers or sores on the lips, often within the first few weeks of starting treatment. This can cause pain in the mouth, bleeding, or even problems with eating. The doctor or nurse may suggest ways to reduce these discomforts, such as changing the way of eating or brushing teeth. If necessary, the doctor may prescribe a medicine to reduce pain.

Information on contraception, pregnancy, breastfeeding, and fertility can be found below, in section

Contraception, pregnancy, breastfeeding, and fertility.

In case of planned surgery or other procedures, the doctor or dentist should be informed about the use of this medicine.
If the medicine is used in combination with other anticancer medicines, the patient should ensure that they have read the package leaflet for the other anticancer medicine.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before using this medicine.

Irinotecan Kabi and other medicines

Irinotecan Kabi may interact with other medicines and supplements, which may increase or decrease the level of the medicine in the blood. The doctor or pharmacist should be informed if the patient is taking, has recently taken, or may take any of the following medicines or supplements:

• medicines used to treat epilepsy (carbamazepine, phenobarbital, phenytoin, and fosphenytoin);
• medicines used to treat fungal infections (ketoconazole, itraconazole, voriconazole, and posaconazole);
• medicines used to treat bacterial infections (clarithromycin, erythromycin, and telithromycin);
• medicines used to treat tuberculosis (rifampicin and rifabutin);
• St. John's Wort (herbal dietary supplement);
• live, attenuated vaccines;
• medicines used to treat HIV infection (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir, and others);
• medicines that suppress the immune system, used to prevent transplant rejection (cyclosporine and tacrolimus);
• medicines used to treat cancer (regorafenib, crizotinib, idelalisib, and apalutamide);
• vitamin K antagonists (blood thinners, such as warfarin);
• medicines used to relax muscles during general anesthesia and surgery (suxamethonium);
• 5-fluorouracil/folinic acid;
• bevacizumab (inhibitor of angiogenesis);
• cetuximab (inhibitor of EGF receptor).

Before administering Irinotecan Kabi, the doctor, pharmacist, or nurse should be informed if the patient is currently or has recently undergone chemotherapy (and radiation therapy).
Do not start or stop taking any medicines during treatment with Irinotecan Kabi without consulting the doctor.
This medicine may cause severe diarrhea. During treatment with this medicine, laxatives and stool softeners should be avoided.
It is possible that other medicines may also interact with Irinotecan Kabi. The doctor, pharmacist, or nurse should be consulted if the patient is taking other medicines, herbs, and supplements, as well as the possibility of alcohol interacting with this medicine.

Contraception, pregnancy, breastfeeding, and fertility

Contraception
Women of childbearing age must use effective contraception during treatment and for 6 months after its completion.
Men must use effective contraception during treatment and for 3 months after its completion. It is essential to consult with the doctor about which contraceptive measures can be used with this medicine.
Pregnancy
This medicine may cause problems in the fetus if used during conception or pregnancy. Before starting treatment, the doctor will ensure that the patient is not pregnant.
If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Breastfeeding
Irinotecan and its metabolite have been detected in human milk. Breastfeeding should be stopped during treatment with this medicine.
If the patient is breastfeeding, they should consult their doctor or pharmacist before using this medicine.
Fertility
No studies have been conducted on the effects on fertility; however, this medicine may affect fertility. Before using this medicine, the patient should consult their doctor about the possible risks associated with using this medicine and the possibilities that can ensure the patient can have children in the future.

Driving and using machines

Within 24 hours after administration of this medicine, dizziness and/or vision problems may occur. If these side effects occur, the patient should not drive or operate machinery.

Irinotecan Kabi contains sorbitol and sodium

This medicine contains 45 mg of sorbitol in each ml of concentrate. Sorbitol is a source of fructose. This medicine should not be taken if the patient (or their child) has a rare genetic disorder, hereditary fructose intolerance. Patients with hereditary fructose intolerance cannot metabolize fructose, which may cause serious side effects.
The doctor should be informed before using this medicine if the patient (or their child) has hereditary fructose intolerance or if the child cannot take sweet foods or drinks due to nausea, vomiting, or unpleasant reactions, such as bloating, stomach cramps, or diarrhea.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Irinotecan Kabi

This medicine should always be used as directed by the doctor. In case of doubt, the doctor should be consulted.
Irinotecan Kabi is administered by medical professionals.
The doctor may recommend a DNA test before the first dose of Irinotecan Kabi.
Some people are genetically more prone to experiencing certain side effects.
The amount of Irinotecan Kabi administered depends on several factors, including body surface area, overall health, or other health problems, as well as the type of cancer or other disease being treated. The doctor will determine the dose and treatment schedule.
Irinotecan Kabi is injected into a vein (intravenous, i.v.). The patient will receive an injection in a hospital or clinic. Irinotecan Kabi should be administered slowly, and the infusion may last up to 90 minutes.
During treatment with Irinotecan Kabi, the patient may receive other medicines to prevent nausea, vomiting, diarrhea, and other side effects. It may be necessary to use these medicines for at least a day after administration of Irinotecan Kabi.
If the patient experiences burning, pain, or swelling at the injection site after administration of Irinotecan Kabi, they should inform the medical staff. If the medicine leaks out of the vein, it can cause tissue damage. If pain or redness occurs at the injection site during treatment with Irinotecan Kabi, the doctor should be informed immediately.
Currently, several treatment schedules are recommended for Irinotecan Kabi. It is usually administered once every 3 weeks (Irinotecan Kabi alone) or once every 2 weeks (Irinotecan Kabi in combination with 5FU/FA chemotherapy). The administered dose depends on several factors, including the treatment schedule, body surface area, age, and overall health, blood cell count, liver function, whether the patient has undergone radiation therapy to the abdomen/pelvis, and whether any side effects occur, such as diarrhea.
Only the doctor can assess the duration of treatment.

Overdose of Irinotecan Kabi

Medical help should be sought immediately. Symptoms of overdose may include some of the serious side effects listed in this package leaflet.

Missed dose of Irinotecan Kabi

In case of a missed appointment for administration of the medicine, the doctor should be contacted for instructions.
In case of any further doubts about using this medicine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The doctor will discuss these side effects with the patient and explain the risks and benefits of treatment.
Some side effects can be serious. The doctor should be informed immediately if any of the following serious side effects occur (see section 2.).
Medical help should be sought immediately if any symptoms of an allergic reaction occur: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

• Diarrhea (see section 2).
• Early diarrhea: occurs within 24 hours after administration, with symptoms of runny nose, increased salivation, tear production, sweating, flushing, abdominal cramps, and diarrhea. This reaction may occur during administration. In this case, the medical staff should be informed immediately. Medicines can be administered to stop and/or reduce these symptoms.
• Late diarrhea: occurs later than 24 hours after administration. Due to the possibility of dehydration and electrolyte disturbances caused by diarrhea, it is essential to be in contact with a healthcare professional to monitor the patient's condition and provide recommendations for medicines and dietary modifications.

If any of the following symptoms occur, the doctor or nurse should be informed.

Frequency of side effects in monotherapy

Frequency of side effects in combination therapy

Abnormally low number of white blood cells, increasing the risk of infections
Very common
Very common
Low number of red blood cells, causing fatigue and shortness of breath
Very common
Very common
Lack of appetite
Very common
Very common
Cholinergic syndrome (see "Warnings and precautions")
Very common
Very common
Vomiting
Very common
Very common
Nausea
Very common
Very common
Abdominal pain
Very common
Common
Hair loss (reversible)
Very common
Very common
Mucosal inflammation
Very common
Very common
Fever
Very common
Common
Weakness and lack of energy
Very common
Very common
Low number of platelets (blood cells involved in clotting) causing bruising and bleeding
Common
Very common
Abnormal liver function test results
Common
Very common
Infection
Common
Common
Low number of white blood cells with fever
Common
Common
Difficulty passing stools
Common
Common
Abnormal kidney function test results
Common
Not reported
* Very common: may affect more than 1 in 10 people
† Common: may affect up to 1 in 10 people

Frequency not known: frequency cannot be estimated from the available data

• Severe, persistent, or bloody diarrhea caused by bacteria called Clostridium difficile
• Blood infection
• Dehydration (due to diarrhea and vomiting)
• Dizziness, rapid heartbeat, and pale skin (a condition called hypovolemia)
• Allergic reaction
• Temporary speech disorders during or shortly after treatment
• Numbness
• High blood pressure (during or after infusion)
• Heart problems*
• Lung disease causing wheezing and shortness of breath (see section 2.)
• Hiccup
• Bowel obstruction
• Enlargement of the large intestine
• Bleeding from the intestines
• Inflammation of the large intestine
• Abnormal laboratory test results
• Perforation of the intestine
• Fatty liver
• Skin reactions
• Reactions at the injection site
• Low potassium levels in the blood
• Low sodium levels in the blood mainly associated with diarrhea and vomiting
• Muscle cramps
• Kidney problems*
• Low blood pressure*
• Fungal infections
• Viral infections.

* Rare cases of these symptoms have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting or blood infections.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Irinotecan Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the vial and carton after EXP. The expiry date refers to the last day of the month.
Store at a temperature below 25°C. The vial should be stored in the outer packaging to protect from light. Do not freeze.
After dilution
Chemical and physical stability of the solution has been demonstrated for 24 hours at a temperature below 25°C and for 48 hours at a temperature between 2°C and 8°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the responsibility for storage conditions and duration lies with the user; normally, the medicine should not be stored for more than 24 hours at a temperature between 2°C and 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Do not use this medicine if visible particles are observed in the concentrate or infusion solution.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Irinotecan Kabi contains

The active substance of the medicine is irinotecan hydrochloride trihydrate.
Each ml contains 20 mg of irinotecan hydrochloride trihydrate, which corresponds to 17.33 mg of irinotecan.
Each vial of 2 ml contains 40 mg of irinotecan hydrochloride trihydrate.
Each vial of 5 ml contains 100 mg of irinotecan hydrochloride trihydrate.
Each vial of 15 ml contains 300 mg of irinotecan hydrochloride trihydrate.
Each vial of 25 ml contains 500 mg of irinotecan hydrochloride trihydrate.
The other ingredients of the medicine are sorbitol, lactic acid, water for injections, sodium hydroxide, and hydrochloric acid (for pH adjustment).

What Irinotecan Kabi looks like and contents of the pack

Irinotecan Kabi, 20 mg/ml, concentrate for solution for infusion is a clear, colorless to light yellow solution, without visible particles, in glass vials.
The medicine is available as a single vial containing 40 mg/2 ml, 100 mg/5 ml, 300 mg/15 ml, or 500 mg/25 ml. The vials are for single use only.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
For more detailed information, please contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +48 22 345 67 89

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Czech Republic
Irinotecan Kabi
Denmark
Irinotecan Fresenius Kabi
Estonia
Irinotecan Kabi 20 mg/ml
Finland
Irinotecan Fresenius Kabi 20 mg/ml infusioneeseos, liuosta varten
Spain
Irinotecán Kabi 20 mg/ml concentrado para solución para perfusión
Ireland
Irinotecan 20 mg/ml concentrate for solution for infusion
Lithuania
Irinotecan Kabi 20 mg/ml koncentratas infuziniam tirpalui
Latvia
Irinotecan Kabi 20 mg/ml koncentrāts infūziju šķīduma pagatavošanai
Poland
Irinotecan Kabi
Slovakia
Irinotecan Kabi 20 mg/ml infúzny koncentrát
Hungary
Irinotecan Kabi 20 mg/ml koncentrátum oldatos infúzióhoz
Italy
Irinotecan Kabi
United Kingdom
(Northern Ireland)
Irinotecan 20 mg/ml concentrate for solution for infusion
Date of last revision of the package leaflet:27.11.2024
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Information intended for healthcare professionals only:

The following information is intended for healthcare professionals or healthcare workers only.

Instructions for use

Cytotoxic medicine

Procedure

As with other anticancer medicines, particular caution should be exercised when preparing solutions of Irinotecan Kabi. Dilution should be performed under aseptic conditions, by trained personnel, and in a designated area.
Precautions should be taken to avoid contact with the skin and mucous membranes.
Precautions during preparation of the infusion solution:

• 1. A safety cabinet and protective gloves, as well as a protective gown, should be used. If a safety cabinet is not available, a protective mask and protective glasses should be used.
• 2. Open containers, such as infusion vials and bottles, and used cannulas, syringes, catheters, tubes, and residues of cytostatic medicines, should be considered hazardous waste and disposed of according to local guidelines for HAZARDOUS WASTE.
• 3. In case of spillage, the following procedure should be followed:
• protective clothing should be worn;
• broken glass should be collected and placed in a container for HAZARDOUS WASTE;
• contaminated surfaces should be rinsed with plenty of cold water;
• then, the rinsed surfaces should be thoroughly wiped, and the materials used for wiping should be disposed of as HAZARDOUS WASTE.
• 4. In case of contact with Irinotecan Kabi on the skin, the affected area should be rinsed with plenty of cold water, and then washed with soap and water. In case of contact with mucous membranes, the affected area should be rinsed thoroughly with water. If discomfort occurs, a doctor should be consulted.
• 5. In case of contact with Irinotecan Kabi in the eyes, the eyes should be rinsed thoroughly with water. A doctor (preferably an ophthalmologist) should be consulted immediately.

Preparation of the infusion solution

Irinotecan Kabi, concentrate for solution for infusion, is intended for intravenous infusion only after dilution using the recommended diluents, either 0.9% sodium chloride solution for infusion or 5% glucose solution for infusion. The required amount of Irinotecan Kabi, concentrate for solution for infusion, should be aseptically withdrawn from the vial using a calibrated syringe and injected into an infusion bag or bottle with a capacity of 250 ml. The infusion fluid should then be thoroughly mixed by shaking the bag or bottle by hand.
The prepared solution is clear, colorless to light yellow, without visible particles.
If sediment is observed in the vials or after dilution, the medicine should be disposed of according to standard procedures for cytotoxic medicines.
For information on the stability of the diluted solution, the package leaflet should be consulted.
Irinotecan Kabi should not be administered in a bolus or intravenous infusion lasting less than 30 minutes and more than 90 minutes.

Disposal of leftover medicine and packaging

All materials used for preparation, administration, or otherwise coming into contact with irinotecan should be disposed of according to standard procedures for disposing of cytotoxic medicines.