Irinotecan Hikma 20 mg/ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irinotecan Hikma 20 mg/ml concentrate for solution for infusion EFG

Irinotecan, trihydrate hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Irinotecan Hikma is and what it is used for
2. What you need to know before using Irinotecan Hikma
3. How to use Irinotecan Hikma
4. Possible adverse effects
5. How to store Irinotecan Hikma
6. Contents of the pack and other information

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

Irinotecan Hikma is an anticancer medication containing the active substance irinotecan hydrochloride trihydrate.

Irinotecan hydrochloride trihydrate interferes with the growth and spread of cancer cells in the body.

Irinotecan is indicated in combination with other anticancer drugs for the treatment of patients with advanced or metastatic colorectal cancer.

Irinotecan may be used as monotherapy in patients with metastatic colorectal cancer whose disease has recurred or worsened after initial therapy with fluorouracil.

2. What you need to know before using Irinotecan Hikma

Do not use Irinotecan Hikma:

• If you are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6).
• If you have chronic inflammatory bowel disease and/or intestinal obstruction.
• If you are breastfeeding (see section 2).
• If your bilirubin level is more than 3 times the upper limit of the normal range. If you have severe bone marrow insufficiency. If your general health condition is poor (WHO performance status greater than 2).
• If you are taking or have recently taken a herbal remedy called St. John’s wort (Hypericum perforatum extract).
• If you are due to receive or have recently received live attenuated vaccines (vaccines against yellow fever, chickenpox, herpes zoster, measles, mumps, rubella, tuberculosis, rotavirus, influenza) and during the 6 months following discontinuation of chemotherapy.

If you receive irinotecan in combination with other medicines, make sure to also read the package leaflet of the other medicines regarding additional contraindications.

Warnings and precautions

Talk to your doctor or pharmacist before starting Irinotecan Hikma:

• If you have Gilbert’s syndrome, a hereditary condition that may cause elevated bilirubin levels and jaundice (yellowing of the skin and eyes).

Take special care with irinotecan. The use of irinotecan should be restricted to specialized units experienced in the administration of cytotoxic chemotherapy and must be administered only under the supervision of a qualified physician experienced in anticancer chemotherapy.

Diarrhea

Irinotecan may cause diarrhea, which in some cases can be severe. This may begin a few hours or a couple of days after infusion of the medicine. If left untreated, it may lead to dehydration and serious chemical imbalances, which may be fatal. Your doctor will prescribe a medicine to help prevent or control this side effect. Make sure to obtain the medicine promptly so you have it at home when needed.

• Take the medicine exactly as instructed by your doctor at the first sign of loose or frequent bowel movements.
• Drink plenty of water and/or electrolyte-containing fluids (sparkling water, soda, or soup).
• Contact your doctor or nurse if you still have diarrhea, especially if it lasts longer than 24 hours, or if you feel confused, dizzy, or faint.

Neutropenia (reduction in certain white blood cells)

This medicine may reduce your white blood cell count, particularly in the weeks following administration. This may increase your risk of developing an infection. Inform your doctor or nurse immediately if you experience any signs of infection, such as fever (38°C or higher), chills, painful urination, new cough, or sputum production. Avoid close contact with people who are ill or have infections. Inform your doctor immediately if you develop signs of infection.

Blood monitoring

Your doctor will likely perform blood tests before and during treatment to monitor the medicine’s effects on blood counts or blood chemistry. Depending on the test results, you may require additional medicines to help manage side effects. Your doctor may also need to reduce or delay your next dose, or even discontinue treatment completely. Keep all scheduled appointments and laboratory tests.

This medicine may reduce platelet counts in the weeks following administration, increasing the risk of bleeding. Talk to your doctor before taking any medicine or supplement that may affect your body’s ability to stop bleeding, such as acetylsalicylic acid or medicines containing acetylsalicylic acid, warfarin, or vitamin E. Inform your doctor immediately if you develop unusual bruising or bleeding, such as nosebleeds, bleeding gums when brushing your teeth, or black, tarry stools.

Nausea and vomiting

You may experience nausea and vomiting on the day you receive this medicine or in the first few days afterward. Your doctor may give you medicines before treatment to help prevent nausea and vomiting. Your doctor will likely prescribe anti-nausea medicines for you to take at home. Keep these medicines available for when you need them. Contact your doctor if you are unable to take fluids orally due to nausea and vomiting.

Acute cholinergic syndrome

This medicine may affect the part of your nervous system that controls bodily secretions, leading to a condition called cholinergic syndrome. Symptoms may include runny nose, increased salivation, excessive tearing, sweating, flushing, abdominal cramps, and diarrhea. Inform your doctor or nurse immediately if you experience any of these symptoms, as medicines are available to help control them.

Lung disorders

Rarely, people taking this medicine may develop serious lung problems. Inform your doctor immediately if you develop cough or worsening cough, difficulty breathing, or fever. Your doctor may need to stop your treatment to manage this condition.

This medicine may increase the risk of serious blood clots in the veins of the legs or lungs, which may travel to other parts of the body, such as the lungs or brain. Inform your doctor immediately if you notice chest pain, difficulty breathing, or swelling, pain, redness, or warmth in one arm or leg.

Chronic intestinal inflammation and/or intestinal obstruction

Contact your doctor if you have abdominal pain and constipation, especially if accompanied by bloating and loss of appetite.

Radiation therapy

If you have recently received pelvic or abdominal radiation therapy, you may have an increased risk of developing bone marrow suppression. Talk to your doctor before starting irinotecan treatment.

Kidney function

Cases of renal dysfunction have been reported.

Heart disorders

Inform your doctor if you have or have had heart disease or if you previously received cancer medicines. Your doctor will monitor you closely and discuss how risk factors (e.g., smoking, high blood pressure, high fat levels) can be reduced.

Vascular disorders

Irinotecan is rarely associated with circulatory disorders (blood clots in the vessels of the legs and lungs), which may rarely occur in patients with multiple risk factors.

Other

This medicine may cause mouth or lip sores, often in the first few weeks after starting treatment. This may lead to mouth pain, bleeding, or difficulty eating. Your doctor or nurse may suggest ways to reduce this, such as changing how you eat or how you brush your teeth. If needed, your doctor may prescribe pain medicines.

For information on contraception and breastfeeding, see the information provided later in the section Contraception, pregnancy, breastfeeding, and fertility.

Inform your doctor or dentist that you are being treated with this medicine if you are planning surgery or any medical procedure.

If used in combination with other anticancer medicines for your condition, make sure to also read the package leaflet of the other medicines.

If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before using this medicine.

Other medicines and irinotecan:

Irinotecan Hikma may interact with several medicines and supplements, which may increase or decrease the level of the medicine in your blood. Inform your doctor or pharmacist if you are using, have recently used, or might use any of the following:

• 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 (a herbal dietary supplement)
• Live attenuated vaccines
• Medicines used to treat HIV (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir, and others)
• Medicines used to suppress your immune system to prevent transplant rejection (cyclosporine and tacrolimus)
• Medicines used to treat cancer (regorafenib, crizotinib, idelalisib, and apalutamide)
• Vitamin K antagonists (common anticoagulants such as warfarin)
• Medicines used to relax muscles during general anesthesia and surgery (suxamethonium)
• 5-Fluorouracil/folinic acid
• Bevacizumab (a blood vessel growth inhibitor)
• Cetuximab (an epidermal growth factor receptor inhibitor)

Inform your doctor, pharmacist, or nurse before receiving irinotecan if you are currently receiving or have recently received chemotherapy (and radiotherapy).

While being treated with irinotecan, do not start or stop taking any medicine without first consulting your doctor.

This medicine may cause severe diarrhea. Try to avoid using laxatives and stool softeners while using this medicine.

There may be other medicines that interact with irinotecan. Consult your doctor, pharmacist, or nurse about your other medicines, herbal products, and supplements, and whether alcohol could cause problems with this medicine.

Contraception, pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Contraception

If you are a woman of childbearing age, you must use an effective method of contraception during treatment and for 6 months after treatment ends.

If you are a man, you must use an effective method of contraception during treatment and for 3 months after treatment ends. It is important to consult your doctor about which types of contraception can be used with this medicine.

Pregnancy

This medicine may harm the unborn baby if used at the time of conception or during pregnancy. Before starting treatment, your doctor will ensure you are not pregnant.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

Irinotecan and its metabolite have been detected in breast milk. Breastfeeding must be discontinued during treatment with this medicine.

If you are breastfeeding, consult your doctor or pharmacist before using this medicine.

Fertility

Studies have not been conducted; however, this medicine may affect fertility. Before using this medicine, talk to your doctor about the potential risk with this medicine and options that may preserve your ability to have children.

Driving and using machines

During the first 24 hours after receiving irinotecan, you may experience dizziness or visual disturbances. If these symptoms occur, do not drive or operate tools or machinery.

This medicine contains sorbitol

This medicine contains 45 mg of sorbitol per ml, equivalent to 90 mg/2 ml, 225 mg/5 ml, 675 mg/15 ml, and 1125 mg/25 ml.

Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, this medicine must not be administered. Patients with HFI cannot break down fructose, which may lead to serious adverse effects.

Consult your doctor before receiving this medicine if you (or your child) have HFI or if your child cannot consume sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects such as bloating, stomach cramps, or diarrhea.

This medicine contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose and is therefore considered essentially "sodium-free."

3. How to use Irinotecan Hikma

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor again.

Irinotecan will be administered to you by healthcare professionals.

Your doctor may recommend a DNA test before the first dose of irinotecan.

Some people are genetically more likely to experience certain side effects from the medicine.

The amount of irinotecan you will receive depends on many factors, including your height and weight, your general health status or other health problems, and the type of cancer or illness you have.

Your doctor will determine your dose and treatment schedule. Irinotecan is injected into a vein intravenously (IV). You will receive this injection at a clinic or hospital. Irinotecan must be administered slowly, and the intravenous infusion may take up to 90 minutes to complete.

You may be given other medications to prevent nausea, vomiting, diarrhea, and other side effects while you receive irinotecan. You may need to continue taking these medications for at least one day after your irinotecan injection.

Inform your caregivers if you feel burning, pain, or swelling around the intravenous needle when irinotecan is injected. If the medicine leaks out of the vein, it may cause tissue damage. If you feel pain or notice redness or swelling at the administration site while receiving irinotecan, inform the healthcare professional immediately.

Several treatment schedules are currently recommended for irinotecan. It is usually administered once every 3 weeks (irinotecan given alone) or once every 2 weeks (irinotecan given in combination with 5FU/FA chemotherapy). The dose will depend on several factors, including the treatment schedule, your body size, age and general health status, blood counts, liver function, whether you have received radiation to the abdomen or pelvis, and whether you have any side effects, such as diarrhea.

Only your doctor can assess the duration of treatment.

If you receive more Irinotecan Hikma than you should

Seek urgent medical attention. Symptoms of overdose may include some of the serious side effects listed in this leaflet.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered.

If you miss a dose of Irinotecan Hikma

Consult your doctor for instructions if you miss an appointment for your irinotecan injection.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects could be serious. Contact your doctor immediately if you experience any of the following serious adverse effects (see section 2).

Seek urgent medical attention if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

• Diarrhea (see section 2).
• Early diarrhea: begins within 24 hours after receiving this medicine, and is accompanied by symptoms such as runny nose, increased salivation, tearing of the eyes, sweating, flushing, and abdominal cramps (this may occur while the medicine is being administered. In this case, inform the healthcare professional immediately. Medicines can be given to stop and/or reduce this early adverse effect).
• Late diarrhea: begins more than 24 hours after receiving this medicine. Because of dehydration and electrolyte imbalance associated with diarrhea, it is important to stay in contact with healthcare professionals for monitoring and to receive recommendations regarding medications and dietary changes.

Tell your doctor or nurse if you experience any of the following symptoms:

Symptoms	Frequency*† of occurrence in monotherapy	Frequency*† of occurrence in combination therapy
Abnormally low white blood cell count, which may increase the risk of infection	Very common	Very common
Low red blood cell count, causing fatigue and difficulty breathing	Very common	Very common
Decreased 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
Loss of hair (reversible)	Very common	Very common
Inflammation of mucous membranes	Very common	Very common
Fever	Very common	Common
Feeling of weakness and lack of energy	Very common	Very common
Low platelet count (blood cells that help clotting), which may cause bruising or bleeding	Common	Very common
Abnormal liver function test results	Common	Very common
Infection	Common	Common
Low white blood cell count with fever	Common	Common
Constipation	Common	Common
Abnormal renal 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 (cannot be estimated from the available data)

• Severe, persistent, and bloody diarrhoea (which may be associated with stomach pain or fever), caused by a bacterium called Clostridium difficile.

• Blood infection.

• Dehydration (due to diarrhoea and vomiting).

• Dizziness, rapid heartbeat, and paleness (a condition called hypovolemia).

• Allergic reactions.

• Transient speech disorders during or shortly after treatment.

• Tingling.

• High blood pressure (during or after infusion).

• Heart problems*.

• Lung disease causing wheezing and difficulty breathing (see section 2).

• Hiccups.

• Intestinal obstruction.

• Enlargement of the colon.

• Intestinal bleeding.

• Inflammation of the large intestine.

• Abnormal results in laboratory tests.

• Intestinal perforation.

• Fatty liver.

• Skin reactions.

• Reactions at the site where the medicine is administered.

• Low blood potassium levels.

• Low levels of salts in the blood, mainly related to diarrhoea and vomiting.

• Muscle cramps.

• Kidney problems*.

• Low blood pressure*.

• Fungal infections.

• Viral infections.

• Infrequent cases of these events have been observed in patients who experienced episodes of dehydration associated with diarrhoea and/or vomiting, or blood infections.

Reporting of adverse reactions

If you experience any type of adverse reaction, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Irinotecan Hikma

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not refrigerate or freeze.

Keep in the original container to protect from light.

After opening:

Chemical and physical in-use stability of the concentrate has been demonstrated for 28 days after the first puncture at room temperature, whether exposed to or protected from light, and for 28 days at 2–8°C when protected from light.

From a microbiological standpoint, unless the opening method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user.

After dilution:

After dilution with 5% glucose, chemical and physical in-use stability has been demonstrated for 24 hours when stored between 2°C and 8°C, and for 12 hours when stored below 25±2°C, protected from light.

After dilution with 0.9% sodium chloride, chemical and physical in-use stability has been demonstrated for 24 hours when stored between 2°C and 8°C, and for 12 hours when stored below 25±2°C, protected from light.

For intravenous use after dilution.

From a microbiological standpoint, the medicine should be used immediately after first opening. If not, the time and conditions of storage of the medicine during use prior to administration are the responsibility of the user.

Do not use this medicine after the expiry date stated on the container and label after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

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

6. Pack contents and other information

Composition of Irinotecan Hikma

The active substance is irinotecan hydrochloride trihydrate.

One millilitre of concentrate contains 20 mg of irinotecan hydrochloride trihydrate (equivalent 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 components are sorbitol (E420), sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injections.

Appearance of the medicinal product and contents of the pack

Amber glass vials with a rubber stopper and an aluminium flip-off cap.

Irinotecan Hikma is a yellow, clear solution.

Pack sizes:

Pack containing 1 vial of 2 ml.

Pack containing 1 vial of 5 ml.

Pack containing 1 vial of 15 ml.

Pack containing 1 vial of 25 ml.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, nº 8, 8A – 8B

Fervença

2705 – 906 Terrugem SNT

Portugal

Tel: +351 21 980 84 10

e-mail: [email protected]

Manufacturer

Thymoorgan Pharmazie GmbH

Schiffgraben 23

D-38690 Goslar

Germany

Tel. +49 (0) 5324 7701-0

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

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

Germany: Irinotecan Hikma 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Austria: Irinotecan Hikma 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Belgium: Irinotecan Hikma 20 mg/ml

Spain: Irinotecán Hikma 20 mg/ml concentrado para solución para perfusión EFG

France: Irinotecan Hikma 20 mg/ml, solution à diluer pour perfusion

Italy: Irinto 20mg/ml Concentrato per Soluzione per Infusione

Netherlands: Irinotecan HCl trihydraat Hikma 20 mg/ml concentraat voor oplossing voor infusie

Portugal: Irinotecano Hikma

United Kingdom (Northern Ireland): Irinotecan 20mg/ml Concentrate for solution for infusion

Date of the most recent revision of this leaflet: February 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Irinotecan Hikma 20 mg/ml concentrate for solution for infusion

Irinotecan hydrochloride trihydrate

Handling

As with other antineoplastic/cytotoxic agents, irinotecan should be prepared and handled with caution. The use of safety goggles, mask and gloves is mandatory.

In case of skin contact, rinse the affected area thoroughly with large amounts of water and soap. In case of mucous membrane contact, wash the contact area thoroughly with water.

Instructions for dilution:

As with other injectable medicines, the solution of irinotecan must be prepared under aseptic conditions.

If any precipitate is observed either in the vial or after reconstitution, the product must be discarded according to standard procedures for disposal of cytotoxic agents.

Using a graduated syringe, aseptically withdraw the required amount of Irinotecan Hikma concentrate for solution and inject it into a 250 ml infusion bag or bottle. The infusion should be mixed carefully by manual rotation.

Protection instructions for dilution preparation:

Preparation must be carried out in a safety cabinet using gloves and protective clothing (preferably under a vertical airflow system). The work area should be protected with disposable absorbent paper and plastic. Protective clothing, safety goggles, cap, gown, disposable gloves and masks must be used.

Containers that have been opened, such as vials, infusion bottles and cannulae, syringes, catheters, tubing and cytostatic waste, must be considered hazardous waste and must be disposed of according to local regulations for handling HAZARDOUS WASTE.

In case of spills, wear personal protective equipment. Broken glass should be collected and placed in containers for INFECTIOUS WASTE. Contaminated surfaces should be rinsed with abundant water. After rinsing, surfaces should be carefully wiped with a cloth, which must then be disposed of as HAZARDOUS WASTE.

If irinotecan comes into contact with the skin, place the affected area under running water for some time, then wash with water and soap. If contact occurs with mucous membranes, wash the affected area thoroughly with water. If any discomfort is experienced, consult a physician.

If irinotecan comes into contact with the eyes, wash them thoroughly with large amounts of water. Contact an ophthalmologist immediately.

Disposal: All materials used for dilution and administration must be discarded according to established hospital procedures for cytotoxic agents.