Leaflet: information for the user

IrinotecanSUN 1,5mg/ml infusion solution

Irinotecan trihydrochloride

Read this 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 side effects, consult your doctor or pharmacist, Even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Irinotecan SUN

3. How to use Irinotecan SUN

4. Possible side effects

5. Storage of Irinotecan SUN

6. Contents of the pack and additional information

IIrinotecán SUN is a cancer medication that contains irinotecan hydrochloride trihydrate as its active ingredient.

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

Irinotecan is indicated in combination with other medications 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 treatment with fluorouracil.

Do not use Irinotecán SUN in any of the following cases

• if you have a chronic inflammatory intestinal disease and/or intestinal obstruction
• if you are allergic to irinotecanhydrochloridetrihydrate or to any of the other components of this medication (listed in section 6)
• if you are breastfeeding (see section 2)
• if you have an increase in blood bilirubin levels (more than 3 times the upper normal limit)
• if you have severe myelosuppression
• if your general health status does not allow you to perform daily activities normally (WHO performance status greater than 2)
• if you are taking or have recently taken St. John's Wort (a plant extract containing Hypericum)
• if you are to receive or have recently received live attenuated vaccines (vaccines against yellow fever, varicella, herpes zoster, measles, mumps, rubella, tuberculosis, rotavirus, and influenza) and for 6 months after chemotherapy

If you are taking irinotecan in combination with other medications, make sure to also read the prospectus of the other medications regarding additional contraindications.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use irinotecan.

• if you have Gilbert's syndrome, a hereditary disease that can cause high bilirubin levels and jaundice (yellow skin and eyes)

Since irinotecan is a cancer medication, it will be administered in a special unit and under the supervision of a doctor trained in the use of this type of medication. The unit staff will explain what special care you need to take during and after treatment. This prospectus may help you remember.

Children

This medication is only intended for adults. Consult your doctor if they have prescribed this medication for a child.

Older patients

Special caution is required in older patients.

Dyspepsia

Irinotecan may cause diarrhea, which in some cases can be severe. This may start a few hours or a couple of days after the medication infusion. If not treated, it can lead to dehydration and severe chemical imbalances, which can be fatal. Your doctor will prescribe a medication to help prevent or control this side effect. Make sure to acquire the medication immediately to have it at home when you need it.

• take the medication as prescribed by your doctor with the first sign of loose stools or frequent bowel movements
• drink plenty of water and/or electrolyte-rich beverages (water with gas, soda, or soup)
• call your doctor or nurse if you still have diarrhea, especially if it lasts more than 24 hours, or if you feel dizzy, nauseous, or faint.

Neutropenia (decrease in some white blood cells)

This medication may decrease the white blood cell count, mainly in the weeks following medication administration. This may increase the risk of infection. Make sure to inform your doctor or nurse immediately if you have any signs of infection, such as fever (38°C or higher), chills, painful urination, new cough, or sputum. Avoid being near people who are sick or have infections. Inform your doctor immediately if you have signs of infection.

Blood control

Your doctor will likely perform blood tests before and during treatment to monitor the medication's effects on blood cell count or blood chemistry. According to the test results, you may need medications to help treat the effects. Your doctor may also reduce or delay your next dose of this medication, or even stop it completely. Keep all your doctor's appointments and laboratory tests.

This medication may decrease the platelet count in the weeks following administration, which may increase the risk of bleeding. Talk to your doctor before taking any medication or supplement that may affect your body's ability to stop bleeding, such as aspirin or medications containing aspirin, warfarin, or vitamin E. Inform your doctor immediately if you have 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 medication or in the first few days after. Your doctor may give you medications before your treatment to help prevent nausea and vomiting. Your doctor may prescribe anti-nausea medications for you to take at home. Make sure to have these medications on hand when you need them. Call your doctor if you cannot take liquids orally due to nausea and vomiting.

Acute cholinergic syndrome

This medication may affect the part of your nervous system that controls bodily secretions, leading to the so-called acute cholinergic syndrome. Symptoms may include nasal secretion, increased saliva, excessive tear production in the eyes, sweating, flushing, abdominal cramps, and diarrhea. Inform your doctor or nurse immediately if you notice any of these symptoms, as there are medications that can help control them.

Pulmonary disorders

In rare cases, people taking this medication have severe lung problems. Inform your doctor immediately if you develop a cough or if it worsens, difficulty breathing, and fever. Your doctor may need to suspend your treatment to treat this problem. This medication may increase the risk of large blood clots in the veins of the legs or lungs, which can move 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 heat in an arm or leg.

Chronic inflammatory intestinal disease and/or intestinal obstruction

Contact your doctor if you have abdominal pain and constipation, especially if you also have swelling and loss of appetite.

Radiation therapy

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

Renal function

There have been reported cases of renal dysfunction.

Cardiovascular disorders

Inform your doctor if you have or have had a heart disease or if you have previously taken cancer medications. Your doctor will closely monitor you and discuss how to reduce risk factors (e.g., smoking, high blood pressure, and high fat content).

Vascular disorders

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

Others

This medication may cause mouth ulcers or lip ulcers, often in the first weeks after starting treatment. This may cause mouth pain, bleeding, or even eating difficulties. Your doctor or nurse may suggest ways to reduce this, such as changing the way you eat or brush your teeth. If necessary, your doctor may prescribe pain medications.

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

Inform your doctor or dentist that you are being treated with this medication if you plan to undergo surgery or any type of procedure.

If you are taking this medication in combination with other cancer medications for your disease, make sure to also read the prospectus of the other medications.

Use of Irinotecán SUN with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those obtained without a prescription.

Irinotecán SUN may interact with various medications and supplements, which may increase or decrease the level of the medication in your blood.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any of the following:

-medications used to treat epilepsy (carbamazepine, phenobarbital, phenytoin, and fosphenytoin)

-medications used to treat fungal infections (ketoconazole, itraconazole, voriconazole, and posaconazole)

-medications used to treat bacterial infections (clarithromycin, erythromycin, and telithromycin)

-medications used to treat tuberculosis (rifampicin and rifabutin)

-St. John's Wort (a dietary supplement based on plants)

-live attenuated vaccines

-medications used to treat HIV (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir, and others)

-medications to suppress your immune system to prevent rejection in transplants (ciclosporin and tacrolimus)

-medications used to treat cancer (regorafenib, crizotinib, idelalisib, and apalutamide)

-anticoagulants (a medication used to thin the blood, such as warfarin)

-muscle relaxants used during general anesthesia and surgery (suxamethonium)

-5-Fluorouracil/acid folinate

-bevacizumab (a vascular growth inhibitor)

-cetuximab (an epidermal growth factor receptor inhibitor)

Inform your doctor, pharmacist, or nurse before administering Irinotecán SUN if you are already receiving or have recently received chemotherapy (and radiation therapy).

While undergoing treatment with irinotecan, do not start or stop taking any medication without consulting your doctor first.

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

You may have more medications that interact with irinotecan.

Consult your doctor, pharmacist, or nurse about the use of other medications, plant-based products, and supplements, and if alcohol can cause problems with this medication.

Contraceptionpregnancy, breastfeeding, and fertility

Contraception

If you are a fertile woman, you must use an effective contraceptive method during and for 6 months after stopping treatment.

If you are a man, you must use an effective contraceptive method during and for 3 months after stopping treatment. It is essential to consult your doctor about the types of contraceptives that can be used with this medication.

Pregnancy

This medication may cause problems for the fetus if used during conception or pregnancy. Before starting treatment, your doctor will ensure that you are not pregnant. Men and women using this medication must use reliable contraceptive methods during treatment. It is essential to consult your doctor about the types of contraceptives that can be used with this medication. In pregnant women, treatment with this medication should only be used if the potential benefit to the mother outweighs the risk to the fetus.

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

Breastfeeding

Irinotecan and its metabolite were measured in breast milk.. Breastfeeding should be discontinued during treatment with this medication.

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

Fertility

No studies have been conducted, but this medication may affect fertility. Talk to your doctor about the possible risk with this medication and the options that may preserve your ability to have children.

Driving and operating machinery

In some cases, irinotecan may cause side effects that affect your ability to drive and operate tools and machinery. Contact your doctor or pharmacist if you are unsure.

In the first 24 hours after irinotecan administration, you may experience dizziness or vision disturbances. If this happens, do not drive or operate machinery until it resolves.

Irinotecán SUN contains sorbitol

This medication contains sugar (sorbitol).

This medication contains 607.50 mg of sorbitol in each 180 ml infusion bag, equivalent to 3.375 mg/ml.

This medication contains 675.00 mg of sorbitol in each 200 ml infusion bag, equivalent to 3.375 mg/ml.

This medication contains 742.50 mg of sorbitol in each 220 ml infusion bag, equivalent to 3.375 mg/ml.

This medication contains 810.00 mg of sorbitol in each 240 ml infusion bag, equivalent to 3.375 mg/ml.El sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medication. Patients with HFI cannot break down fructose, which can cause severe side effects. Consult your doctor before receiving this medication if you (or your child) have HFI or cannot take sweet foods or drinks because they cause dizziness, vomiting, or symptoms like bloating, abdominal cramps, or diarrhea.

Irinotecán SUN contains sodium

This medication contains less than 1 mmolof sodium (23 mg) per dose, which is essentially "sodium-free".

Irinotecan SUN contains glucose

This medication contains glucose. Patients with diabetes mellitus should note that this medication contains8.325 g of glucose per 180 ml infusion bag; 9.250 g of glucose per 200 ml infusion bag; 10.175 g of glucose per 220 ml infusion bag, and 11.100 g of glucose per 240 ml infusion bag.

If your doctor has indicated that you have intolerance to certain sugars, consult them before taking this medication.

If you are prescribed irinotecan, only experienced medical professionals or nurses in chemotherapy administration will administer it to you.

Administration form

Irinotecan is administered as a perfusion solution (infusion) through a vein over a period of 30 to 90 minutes.

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

Inform your caregivers if you feel burning, pain, or swelling around the needle when irinotecan is administered. If the medication leaks from the vein, it may cause tissue damage. If you experience pain or notice redness or swelling at the infusion site while receiving irinotecan, immediately inform your healthcare professional.

Irinotecan dosage

The dose will depend on various factors, including the treatment regimen, your body size, age, overall health, blood counts, liver function, whether you have received radiation in the abdomen or pelvis, and any side effects, such as diarrhea. Your doctor will calculate your body surface area in square meters (m2).

-If you have previously been treated with 5-fluorouracil, you will typically receive irinotecan alone, starting with a dose of 350mg/m2every three weeks

• If you have not been previously treated with chemotherapy, you will typically receive 180mg/m2of irinotecan every two weeks, followed by folinic acid and 5-fluorouracil.

If you receive irinotecan in combination with cetuximab, do not receive irinotecan until at least one hour has passed since the end of the cetuximab infusion.

Only your doctor can determine the duration of treatment.

The number of infusions you will receive depends on your response to treatment. Your doctor will explain this to you.

If you receive more Irinotecan SUN than you should

Seek emergency medical attention if you believe you have received too much irinotecan.Overdose worsens adverse effects such as diarrhea or neutropenia (a decrease in the number of white blood cells in the blood). If this occurs, you will receive treatment to prevent dehydration. Your white blood cell count will be monitored, and any infection will be treated accordingly.

If you forgot to use Irinotecan SUN

Consult with your doctor for instructions if you miss a scheduled irinotecan infusion appointment.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.Your doctor will discuss these side effectsandexplain the risks and benefits of your treatment.

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

Seek emergency medical attention if you have any of these symptoms 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, and is accompanied by symptoms such as: runny nose, increased salivation, tearing of the eyes, sweating, flushing, abdominal cramps (this may occur while the medicine is being administered. In this case, inform your healthcare professional immediately. Medications may be administered to stop and/or reduce this early side effect).
• late diarrhea: starts more than 24 hours after receiving this medicine. Due to dehydration and electrolyte imbalance with diarrhea, it is essential to be in contact with healthcare professionals for control and to obtain recommendations on medications and dietary modifications.

Inform your doctor or nurse if you experience any of the following symptoms.

* Very common: may affect more than 1 in 10 people.

† Common: may affect up to 1 in 10 people.

Unknown frequency (cannot be estimated from available data)

-severe, persistent, and bloody diarrhea (which may be associated with stomach pain or fever), produced by a bacteria calledClostridium difficile

-blood infection

-dehydration (due to diarrhea and vomiting)

-lightheadedness, rapid heartbeat, and paleness (a condition called hypovolemia)

-allergic reaction

-transient speech disorders during or shortly after treatment

-tingling

-high blood pressure (during or after infusion)

-heart problems*

-lung disease that causes wheezing and difficulty breathing (see section 2)

-hypo

-intestinal obstruction

-colon enlargement

-intestinal bleeding

-inflammatory bowel disease

-abnormal laboratory test results

-intestinal perforation

-fatty liver

-skin reactions

-reactions at the injection site

-low potassium levels in the blood

-low sodium levels in the blood, mainly related to diarrhea and vomiting

-muscle cramps

-kidney problems*

-low blood pressure*

-fungus infections

-viral infections.

* Cases of these events have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting, or blood infections.

If you receive Irinotecán SUN in combination with cetuximab, some of the possible side effects may be related to that association. These side effects may include acne-like eruptions. Therefore, make sure to read the prospectus of cetuximab as well.

If you receive Irinotecán SUN in combination with capecitabine, some of the possible side effects may be related to that association. These side effects may be: frequent blood clots, frequent allergic reactions, heart attack, and fever in patients with low white blood cell count. Therefore, make sure to read the prospectus of capecitabine as well.

If you receive Irinotecán SUN in combination with capecitabine and bevacizumab, some of the possible side effects may be related to that association. These side effects may be: low white blood cell count, blood clots, high blood pressure, and heart attack. Therefore, make sure to read the prospectuses of capecitabine and bevacizumab as well.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the infusion bag and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C. Store in the original packaging to protect it from light.

Once opened, the infusion bag must be used immediately.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Irinotecan SUN

• The active ingredient is irinotecan (as hydrochloride, trihydrate).
• The other components are: glucose (E620), sorbitol (E420), lactic acid (E270), sodium hydroxide (for pH adjustment) (E524), hydrochloric acid, concentrated (for pH adjustment) (E507), and water.

A 180 ml infusion bag contains 270 mg of irinotecan hydrochloride trihydrate (which corresponds to 234 mg of irinotecan).

A 200 ml infusion bag contains 300 mg of irinotecan hydrochloride trihydrate (which corresponds to 260 mg of irinotecan).

A 220 ml infusion bag contains 330 mg of irinotecan hydrochloride trihydrate (which corresponds to 286 mg of irinotecan).

A 240 ml infusion bag contains 360 mg of irinotecan hydrochloride trihydrate (which corresponds to 312 mg of irinotecan).

One ml of the infusion solution contains 1.5 mg of irinotecan hydrochloride trihydrate (which corresponds to 1.3 mg/ml of irinotecan).

Appearance of the product and contents of the packaging

Irinotecan SUN infusion solution is a transparent, pale yellow to yellow solution, sterile, and free of visible particles.

Irinotecan SUN infusion solution is presented in packaging, each of which contains 1, 5, or 10 single-dose infusion bags of 180 ml, 200 ml, 220 ml, or 240 ml.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for Manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia S.A.

124 Fabricii Street

400632, Cluj-Napoca

Romania

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Phone: +34 93 342 78 90

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

Germany: Irinotecan SUN

Denmark: Irinotecan SUN

Spain: Irinotecán SUN

Finland: Irinotecan SUN

France: Irinotecan SUN

Italy: Irinotecan SUN

Romania: Irinotecan SUN

Sweden: Irinotecan SUN

United Kingdom (Northern Ireland): Irinotecan

Last revision date of this leaflet: May 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended solely for healthcare professionals:

Handling

- Calculate the dose and decide which size of Irinotecan SUN infusion bag is needed

- Inspect the packaging of the product for any damage. Do not use it if there are signs of tampering

- Put the patient-specific label on the packaging

Extraction of the infusion bag from the packaging and inspection of the infusion bag

- Tear the packaging along the perforation. Do not use the product if the packaging is open or damaged

- Remove the infusion bag from the packaging

- Use it only if the infusion bag and the seal are intact. Before administration, check for small leaks by pressing the bag firmly. If leaks are detected, discard the bag and the solution, as it may not be sterile

- It is necessary to visually inspect parenteral medications for any particles or discoloration before administration. If you notice the presence of particles or discoloration, do not administer it

Administration

- Break the seal of the stopper by applying pressure on one side with your hand

- Connect, using aseptic technique, the sterile administration equipment

- Consult the usage instructions that come with the administration equipment

Precautions

- Do not use in a series connection

- Do not introduce additives into the infusion bag

- The infusion solution is ready for use and should not be mixed with other medications

- Irinotecan SUN infusion solution is exclusively for single use.

Provide the necessary handling material to the staff, such as long-sleeved gowns, protective masks, caps, safety glasses, sterile single-use gloves, work surface covers, and waste disposal bags.

Pregnant women should not handle cytotoxic preparations.

If the product comes into contact with the eyes, it may cause intense irritation. In this case, rinse your eyes immediately with plenty of water. Consult a doctor if the irritation persists. If the solution comes into contact with the skin, rinse the affected area with plenty of water. Excretions and vomit should be handled with caution.

Disposal

The disposal of unused medication and materials that have come into contact with it will be carried out in accordance with local regulations on cytotoxic medications.