IRINOTECAN 20 mg /Ml Concentrate

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Irinotecan Eugia, 20 mg/mL, Concentrate for Solution for Infusion
   1. Read All of This Leaflet Carefully Before You Start Using This Medicine.
   2. Contents of the Pack
3. What is Irinotecan Eugia and What is it Used For
4. Before You Use Irinotecan Eugia
   1. When You Should Not Use Irinotecan Eugia
   2. Warnings and Precautions
   3. Other
   4. Information on Contraception, Pregnancy, and Breastfeeding
   5. Irinotecan Eugia and Other Medicines
   6. Contraception, Pregnancy, and Breastfeeding
   7. Driving and Using Machines
   8. Irinotecan Eugia Contains Sorbitol
   9. Irinotecan Eugia Contains Sodium
5. How to Use Irinotecan Eugia
   1. Overdose
   2. Missed Dose
6. Possible Side Effects
   1. Frequency Not Known: Cannot be Estimated from the Available Data
   2. Reporting Side Effects
7. How to Store Irinotecan Eugia
8. Contents of the Pack and Other Information
   1. What Irinotecan Eugia Contains
   2. What Irinotecan Eugia Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder:
   5. Importer:
   6. This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:
   7. Date of Last Revision of the Leaflet: 01/2023
   8. Irinotecan Eugia, 20 mg/mL, Concentrate for Solution for Infusion
   9. Information Intended for Healthcare Professionals Only:
   10. Instructions for Healthcare Professionals on the Safe Handling of the Medicinal Product
   11. Irinotecan Eugia, 20 mg/mL, Concentrate for Solution for Infusion
   12. Preparation of the Infusion Solution
   13. Shelf-Life
   14. Warning Signs of Deterioration
   15. Administration
   16. Disposal

Package Leaflet: Information for the Patient

Irinotecan Eugia, 20 mg/mL, Concentrate for Solution for Infusion

Irinotecan Hydrochloride Trihydrate

Read All of This Leaflet Carefully Before You Start Using This Medicine.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What is Irinotecan Eugia and What is it Used For
• 2. Before You Use Irinotecan Eugia
• 3. How to Use Irinotecan Eugia
• 4. Possible Side Effects
• 5. How to Store Irinotecan Eugia
• 6. Contents of the Pack and Other Information

1. What is Irinotecan Eugia and What is it Used For

Irinotecan Eugia is an anti-cancer medicine that contains the active substance irinotecan hydrochloride trihydrate.
Irinotecan hydrochloride trihydrate works by stopping the growth and spread of cancer cells in the body.
Irinotecan Eugia is used to treat patients with advanced cancer of the colon or rectum (large bowel) or with colon cancer that has spread to other parts of the body.
Irinotecan Eugia may be used alone (as monotherapy) in patients with colon or rectal cancer that has spread to other parts of the body and whose disease has recurred or progressed after initial treatment with 5-fluorouracil.

2. Before You Use Irinotecan Eugia

When You Should Not Use Irinotecan Eugia

2);

If you are taking Irinotecan Eugia with other medicines, you should also read the package leaflets that come with those medicines.

Warnings and Precautions

Before using Irinotecan Eugia, discuss it with your doctor, pharmacist, or nurse.
During treatment, you should be carefully monitored. Irinotecan Eugia should be administered in a hospital setting specialized in the use of cytotoxic chemotherapy and under the supervision of a doctor experienced in the use of anticancer medicines.
Diarrhea
Irinotecan Eugia may cause diarrhea, which can be severe. It can occur a few hours or a few days after infusion. Untreated diarrhea can lead to dehydration and severe electrolyte disturbances, which can be life-threatening. Your doctor will prescribe a medicine to prevent or control this side effect. You should make sure you receive this medicine and take it home with you to use if needed. You should:

• take the anti-diarrheal medicine prescribed by your doctor after the first loose stools or frequent bowel movements;
• drink plenty of water and/or salty drinks (soda water, fizzy drinks, or soups);
• tell your doctor or nurse if the diarrhea does not improve (especially if it lasts more than 24 hours) or if you are dizzy, have fainting spells, or experience palpitations.

Neutropenia (Low White Blood Cell Count)
This medicine may cause a decrease in the number of white blood cells (mainly within a week after administration), which can increase the risk of infection. You should immediately tell your doctor or nurse if you experience any signs of infection, such as fever (38°C or higher), chills, pain when urinating, coughing, or bringing up phlegm. You should avoid being near people who are sick or have infections. You should immediately tell your doctor if you experience any signs of infection.
Blood Tests
Your doctor will order blood tests before starting treatment and during treatment to monitor the effect of the medicine on your blood cell count or blood chemistry. Based on the results, your doctor may decide to use medicines that help treat any changes found. It may also be necessary to reduce or delay the next dose of the medicine or even stop treatment. You should follow the scheduled visits to your doctor and laboratory tests.

This medicine may cause a decrease in the number of platelets in your blood (within a week after administration), which can increase the risk of bleeding. You should consult your doctor before taking any medicine or supplement that may affect blood clotting (such as aspirin or medicines containing aspirin, warfarin, or vitamin E). You should immediately tell your doctor if you notice any unusual bruising or bleeding, such as nosebleeds, bleeding gums when brushing your teeth, or black, tarry stools.
Nausea and Vomiting
Nausea and vomiting may occur on the day of administration or within a few days after administration. Before administration of Irinotecan Eugia, you may receive a medicine to prevent nausea and vomiting. Your doctor may prescribe an anti-emetic medicine for you to take at home. You should take it as needed. You should tell your doctor if nausea and vomiting prevent you from taking fluids by mouth.
Acute Cholinergic Syndrome
This medicine may affect the part of the nervous system that regulates certain secretory functions of the body, causing a condition called cholinergic syndrome. Symptoms of this syndrome include runny nose, increased salivation, excessive tear production, sweating, flushing, abdominal cramps, and diarrhea. You should immediately tell your doctor or nurse if you experience any of these symptoms, as there are medicines that can help control them.
Respiratory Disorders
In some people taking this medicine, severe respiratory disorders may rarely occur.
If you experience coughing, difficulty breathing, or fever, you should immediately tell your doctor. Your doctor may decide to stop treatment until these disorders are under control.
This medicine may increase the risk of blood clots in the veins, which can travel to other parts of the body, such as the lungs or brain. You should immediately tell your doctor if you experience chest pain, shortness of breath, or swelling, pain, redness, or warmth in your arm or leg.
Chronic Intestinal Inflammation and/or Intestinal Obstruction
You should tell your doctor if you experience abdominal pain and constipation, especially if accompanied by bloating and loss of appetite.
Radiation Therapy
In patients who have recently undergone radiation therapy in the pelvic or abdominal area, there may be an increased risk of bone marrow suppression. You should discuss this with your doctor before starting treatment with Irinotecan Eugia.
Kidney Function
There have been reports of kidney function disorders.
Heart Disorders
You should tell your doctor if you have or have had heart disease or have previously taken anticancer medicines. Your doctor will closely monitor your condition and discuss with you how to reduce the risk factors (such as smoking, high blood pressure, and high levels of fats in the blood).
Vascular Disorders
Taking Irinotecan Eugia is rarely associated with vascular disorders (blood clots in the veins and lungs), which can occur in patients with multiple risk factors.
If you have Gilbert's syndrome, a hereditary disease that can cause elevated bilirubin levels and jaundice (yellowing of the skin and eyes).

Other

The medicine may cause mouth sores or ulcers, often within the first few weeks of treatment. This can cause pain in the mouth, bleeding, and difficulty eating. Your doctor or nurse may suggest ways to alleviate these symptoms, such as changing your diet or toothbrushing habits. If necessary, your doctor may prescribe a pain-relieving medicine.

Information on Contraception, Pregnancy, and Breastfeeding

is given below in the section "Contraception, Pregnancy, and Breastfeeding".

If you are going to have surgery or any other treatment, you should tell your doctor or dentist that you are taking Irinotecan Eugia.
If you are taking Irinotecan Eugia with other medicines, you should also read the package leaflets that come with those medicines.
If you have been told that you have an intolerance to some sugars, you should tell your doctor before taking this medicine.

Irinotecan Eugia and Other Medicines

Irinotecan Eugia may interact with other medicines and supplements, which can increase or decrease its levels in the blood. You should tell your doctor if you are taking, have recently taken, or plan to take any of the following medicines:

• anti-epileptic medicines (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 (a 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 to prevent rejection of a transplanted organ (cyclosporine and tacrolimus)
• anticancer medicines (regorafenib, crizotinib, idelalisib, and apalutamide)
• vitamin K antagonists (commonly used anticoagulant medicines, such as warfarin)
• muscle relaxants used during general anesthesia and surgery (suxamethonium)
• 5-fluorouracil/folinic acid
• bevacizumab (a medicine that inhibits tumor angiogenesis)
• cetuximab (an epidermal growth factor receptor inhibitor, EGF).

Before taking Irinotecan Eugia, you should tell your doctor, pharmacist, or nurse if you are currently or have recently undergone chemotherapy (and radiation therapy).
During treatment with Irinotecan Eugia, you should not start or stop taking any other medicine without first discussing it with your doctor.
This medicine may cause severe diarrhea. During treatment, you should avoid taking laxatives and stool softeners.
More medicines may interact with Irinotecan Eugia. You should ask your doctor, pharmacist, or nurse about other medicines, herbal medicines, and supplements, as well as any problems related to drinking alcohol during treatment with this medicine.

Contraception, Pregnancy, and Breastfeeding

Contraception
Women of childbearing age must use effective contraception during and up to 6 months after the end of treatment.
Men must use effective contraception during and up to 3 months after the end of treatment. It is essential to consult with your doctor about what types of contraception can be used with this medicine.
Pregnancy
This medicine may cause harm to the unborn baby if taken during conception or pregnancy. Before starting treatment, your doctor will ensure that you are not pregnant.
If you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Breastfeeding
Irinotecan and its metabolite have been detected in human milk. Breastfeeding should be discontinued during treatment with this medicine.
If you are breastfeeding, you should consult your doctor or pharmacist before taking this medicine.
Fertility
No studies have been conducted, but this medicine may affect fertility. Before taking this medicine, you should discuss with your doctor the possible risks associated with this medicine and the options that may affect your ability to have children.

Driving and Using Machines

Within the first 24 hours after administration of Irinotecan Eugia, you may experience dizziness and/or vision disturbances. If this occurs, you should not drive or operate machinery.

Irinotecan Eugia Contains Sorbitol

This medicine contains a sugar (sorbitol). Sorbitol is a source of fructose. If you have been previously diagnosed with hereditary fructose intolerance, a rare genetic disorder, you should not take this medicine. In patients with hereditary fructose intolerance, the body does not break down the fructose contained in this medicine, which can cause severe side effects. You should inform your doctor before taking this medicine if you have hereditary fructose intolerance or if your child should not consume sweets or drinks containing fructose due to nausea, vomiting, or unpleasant side effects, such as bloating, stomach cramps, or diarrhea.

Irinotecan Eugia Contains Sodium

Irinotecan Eugia contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to Use Irinotecan Eugia

You should always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Irinotecan Eugia is administered by medical professionals.
Before the first administration of Irinotecan Eugia, your doctor may order a DNA test to determine your genetic characteristics.
Some people may be more likely to experience certain side effects due to genetic reasons.
The amount of medicine administered depends on several factors, including your height and weight, overall health, or other health problems, the type of cancer or disease being treated. Your doctor will determine the dose and administration schedule.
Irinotecan Eugia is injected into a vein (intravenously). You will receive this injection in a clinic or hospital. Irinotecan should be administered slowly, and the intravenous infusion may last up to 90 minutes.
You may receive other medicines to prevent nausea, vomiting, diarrhea, and other side effects during treatment with Irinotecan Eugia. You may need to continue taking these medicines for at least one day after injection of Irinotecan Eugia.
You should inform your caregivers if you experience burning, pain, or swelling around the intravenous needle. If the medicine leaks out of the vein, it can cause tissue damage. If you experience pain or notice redness or swelling at the infusion site during treatment, you should immediately tell your doctor.
There are several recommended treatment schedules for irinotecan. It is usually administered once every 3 weeks (irinotecan alone) or once every 2 weeks (irinotecan in combination with 5FU/FA chemotherapy). The dose will depend on several factors, including the treatment schedule, body surface area, age, and overall health, blood cell count, liver function, use or non-use of abdominal and/or pelvic radiation therapy, and presence or absence of side effects such as diarrhea.
Only your doctor can determine the duration of treatment.

Overdose

You should immediately seek medical attention. Symptoms of overdose may include some of the severe side effects listed in this leaflet.

Missed Dose

If you miss a visit during which you were supposed to receive a dose of Irinotecan Eugia, you should contact your doctor for instructions on what to do next.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Irinotecan Eugia can cause side effects, although not everybody gets them.
Some side effects can be serious. If you experience any of the serious side effects listed in section 2, you should immediately contact your doctor.
You should seek immediate medical attention if you experience any signs of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, tongue, or throat.

• Diarrhea (see section 2).
• Early diarrhea: starts within 24 hours after receiving this medicine, may be accompanied by symptoms such as runny nose, increased salivation, tear production, sweating, flushing, abdominal cramps. (Early diarrhea may occur during administration. If this happens, you should immediately inform the medical staff. You may receive a medicine to prevent or alleviate this early side effect).
• Delayed diarrhea: starts more than 24 hours after administration. Due to the associated risk of dehydration and electrolyte disturbances, it is essential to contact the medical staff for observation and advice on treatment and dietary changes.

If you experience any of the following symptoms, you should tell your doctor or nurse:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people

Frequency Not Known: Cannot be Estimated from the Available Data

• severe, persistent, or bloody diarrhea (which may be caused by the bacteria Clostridium difficile)
• blood infection
• dehydration (due to diarrhea and vomiting)
• dizziness, rapid heartbeat, and pale skin (hypovolemia)
• allergic reaction
• temporary speech disorders during or shortly after administration
• tingling
• high blood pressure (during or after infusion)
• heart disorders
• lung disease causing wheezing and shortness of breath (see section 2)
• hiccups
• intestinal obstruction
• colon enlargement
• gastrointestinal bleeding
• colitis
• abnormal laboratory test results
• perforation (hole) in the intestine
• fatty liver
• skin reactions
• reactions at the injection site
• low potassium levels in the blood
• low salt levels in the blood, mainly due to diarrhea and vomiting
• muscle cramps
• kidney function disorders
• low blood pressure
• fungal infections
• viral infections

Rare cases of these side effects have been observed in patients with episodes of dehydration associated with diarrhea and/or vomiting or blood infections.

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system (see below). By reporting side effects, you can help provide more information on the safety of this medicine.
In Poland, you can report side effects to the Department of Drug Post-Marketing Surveillance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.

5. How to Store Irinotecan Eugia

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine. Store the vials in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and vial after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Irinotecan Eugia Contains

• The active substance is irinotecan hydrochloride trihydrate.
• 1 mL of concentrate contains 20 mg of irinotecan hydrochloride trihydrate, which corresponds to 17.33 mg of irinotecan.
• Each 2 mL vial contains 40 mg of irinotecan hydrochloride trihydrate.
• Each 5 mL vial contains 100 mg of irinotecan hydrochloride trihydrate.
• Each 15 mL vial contains 300 mg of irinotecan hydrochloride trihydrate.
• Each 25 mL vial contains 500 mg of irinotecan hydrochloride trihydrate.
• The other ingredients are sorbitol (E 420), lactic acid, sodium hydroxide, hydrochloric acid, and water for injections.

What Irinotecan Eugia Looks Like and Contents of the Pack

Concentrate for Solution for Infusion.
Clear, colorless to slightly yellow solution without visible particles.
The medicine is available in single vials containing: 40 mg/2 mL, 100 mg/5 mL, 300 mg/15 mL, or 500 mg/25 mL.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valetta Waterfront
Floriana, FRN1914
Malta
e-mail: [email protected]

Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Czech Republic:
Irinotecan Aurovitas
Poland
Irinotecan Eugia
Portugal:
Irinotecano Generis
Romania:
Irinotecan Aurobindo 20 mg/ml concentrate for solution for infusion

Date of Last Revision of the Leaflet: 01/2023

Irinotecan Eugia, 20 mg/mL, Concentrate for Solution for Infusion

Information Intended for Healthcare Professionals Only:

Instructions for Healthcare Professionals on the Safe Handling of the Medicinal Product

Irinotecan Eugia, 20 mg/mL, Concentrate for Solution for Infusion

As with all anticancer medicines, irinotecan should be handled with care. Protective clothing, including gloves and eye protection, is required.
In case of skin contact with irinotecan, the area should be washed immediately with soap and water.
In case of eye contact, the eyes should be flushed with water.
As with all injectable medicines, irinotecan should be prepared in aseptic conditions.
If the vial or diluted solution contains particulate matter, the product should not be used and should be disposed of according to standard procedures for cytotoxic waste.

Preparation of the Infusion Solution

As with other injectable medicines, the irinotecan infusion solution should be prepared in aseptic conditions.
In case of particulate matter in the vial or infusion solution, the product should be disposed of according to standard procedures for cytotoxic waste.
Aseptically withdraw the calculated dose of irinotecan from the vial and transfer it to a 250 mL infusion bag or bottle containing 0.9% (w/v) sodium chloride solution or 5% (w/v) glucose solution. Mix the infusion solution thoroughly by manually rotating the bag or bottle.
Do not mix with other medicines.

Shelf-Life

The diluted irinotecan solution is physically and chemically stable for 28 days as an infusion solution (0.9% (w/v) sodium chloride solution and 5% (w/v) glucose solution) when stored in an LDPE container at 5°C or 30°C and protected from light.
When the diluted solution is not stored and protected from light, it retains physical and chemical stability for 3 days.
From a microbiological point of view, the product should be used immediately. If not used immediately after dilution, the storage time and conditions are the responsibility of the user and are normally not more than 24 hours at 2°C to 8°C, unless dilution has been made in controlled aseptic conditions.

Warning Signs of Deterioration

Do not use irinotecan if you notice particulate matter in the vials or diluted solution. In such cases, the product should be disposed of according to standard procedures for cytotoxic waste. Do not dispose of any medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Administration

Information on administration can be found in the Summary of Product Characteristics for irinotecan.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.