Label: information for the patient

Irinotecan Hospira 20mg/mL concentrate for infusion solution EFG

irinotecan hydrochloride, trihydrate

Read this label carefully before starting to use this medication, because it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4

Irinotecán Hospira is an anticancer medication that contains the active ingredient hydrochloride of irinotecan trihydrate.

The hydrochloride of irinotecan trihydrateinterferes with the growth and dispersion of cancerous cells in the body

Irinotecanis 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 progressed after initial treatment with fluorouracil.

No use Irinotecán Hospira:

• if you have a chronic inflammatory intestinal disease or intestinal obstruction
• if you are allergic to irinotecan hydrochloride trihydrate or any of the other components of this medication (listed in section 6)
• if you are breastfeeding (see section 2)
• if your bilirubin level is greater than 3 times the upper limit of the normal range
• if you have severe bone marrow deficiency
• if your general health status is not good (WHO performance status greater than 2)
• if you are taking or have recently taken St. John's Wort (a herbal extract containingHypericum)
• if you are to receive or have recently received live attenuated vaccines (vaccines against yellow fever, chickenpox, herpes zoster, measles, mumps, rubella, tuberculosis, rotavirus, flu) and for the 6 months following the interruption of 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 elevated bilirubin levels and jaundice (yellow skin and eyes)

Be especially careful with irinotecan. The use of irinotecan should be restricted to specialized units for the administration of cytotoxic chemotherapy and should only be administered under the supervision of a qualified doctor in the use of antineoplastic chemotherapy.

Diarrea

Irinotecan can cause diarrhea, which in some cases can be severe. This can start a few hours or a couple of days after the infusion of the medication. 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 adverse effect. Make sure to obtain the medication immediately to have it at home when you need it.

• Takethe medication as your doctor has told you with the first sign of loose stools or frequent defecation.
• Drinklarge amounts 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 can decrease the white blood cell count, mainly in the weeks following the administration of the medication. This can 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, pain while urinating, cough, or sputum production. Avoid being near people who are sick or have infections. Inform your doctor immediately if you present signs of infection.

Hematology

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

This medication can decrease the platelet count in the weeks following administration, which can 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 while brushing your teeth, or black, tarry stools.

Nauseas (sensation of discomfort)and vomiting

You may experience nausea and vomiting on the day you receive this medication or in the first few days following. Your doctor may give you medications before your treatment to help prevent nausea and vomiting. It is likely that your doctor will prescribe anti-nausea medications that you can take at home. Have these medications on hand when you need them. Call your doctor if you cannot take liquids by mouth due to nausea and vomiting.

Síndrome colinérgico agudo

This medication can affect the part of your nervous system that controls bodily secretions, leading to the so-called cholinergic syndrome. Symptoms can include nasal secretion, excessive salivation, excessive tearing, 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.

Respiratory disorders

In rare cases, people taking this medication have severe lung problems. Inform your doctor immediately if you start with a cough or if it worsens, difficulty breathing, and fever. Your doctor may need to suspend your treatment to treat this problem.

This medication can 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.

Inflamación intestinal crónica y/u obstrucción intestinal

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

Radioterapia

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 treatment withirinotecan.

Función renal

There have been reported cases of renal dysfunction.

Cardiac disorders

Inform your doctor if you have or have had a heart disease or if you have previously received anticancer drugs. Your doctor will closely monitor you and discuss how to reduce risk factors (such as smoking, high blood pressure, and high fat content).

Vascular disorders

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

Others

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

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 medication if you plan to undergo surgery or any procedure.

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

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

Other medications and Irinotecán Hospira

Irinotecan can interact with several medications and supplements, which can increase or decrease the level of the medication in your blood. Inform your doctor, pharmacist, or nurse before you are administered Irinotecán Hospira if you are already receiving or have recently received chemotherapy (and radiation therapy).

While you are being treated withirinotecan, do not start or stop taking any medication without consulting your doctor first.

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

You may have more medications that interact withirinotecan. Consult with your doctor, pharmacist, or nurse about your other medications, herbal products, and supplements, and if alcohol can cause problems with this medication.

Contraception, pregnancy, breastfeeding, and fertility

Contraception

If you are a woman of childbearing age, you should use effective contraceptive methods during and for 6 months after completing treatment.

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

Pregnancy

This medication can cause problems for the fetus if used during conception or during pregnancy.Before starting treatment, your doctor will ensure that you are not pregnant.

If you are pregnant, think you might 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 suspended during treatment with this medication.

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

Fertility

No studies have been conducted, however, this medication may affect fertility.Before using this medication,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 the first 24 hours or so after administration of this medication, you may feel dizzy or have vision disturbances. If you have these symptoms, do not drive or operate machinery.

This medication contains sorbitol

This medication contains 45 mg of sorbitol in each mL. 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 adverse 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, stomach cramps, or diarrhea.

This medication contains 45 mg of sorbitol in each mL equivalent to 90 mg/2 mL, 225 mg/5 mL, and 1125 mg/25 mL.

This medication contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Irinotecán will be administered by healthcare professionals.

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

Some people are genetically more prone to having some side effects of the medication.

The amount of irinotecán you will receive depends on many factors, including your height and weight, your overall health status or other health problems, and the type of cancer or disease you have. Your doctor will determine your dose and treatment schedule.

Irinotecán is injected into a vein by intravenous (IV) route and will be administered in a clinic or hospital. Irinotecán 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 receiving irinotecán. You may need to continue taking these medications for at least one day after the administration of irinotecán.

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

Currently, several treatment regimens are recommended for irinotecán. It is usually administered once every 3 weeks (irinotecán administered alone) or once every 2 weeks (irinotecán administered in combination with chemotherapy with 5FU/AF). The dose will depend on several factors, including the treatment regimen, your body size, age, and overall health status, your blood counts, liver function, if you have received radiation in the abdomen or pelvis, and if you have any side effects, such as diarrhea.

Only your doctor can assess the duration of treatment.

If you use more Irinotecán Hospira than you should:
Seek emergency medical attention. Symptoms of overdose may include some of the severe side effects listed in this prospectus.

If you forgot to use Irinotecán Hospira

Consult with your doctor for instructions if you miss a scheduled appointment for irinotecán administration.

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

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

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 the following symptoms 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, 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: begins 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.

Frequency not known (cannot be estimated from available data)

• Severe, persistent, or bloody diarrhea (which may be associated with stomach pain or fever), produced by a bacteria called Clostridium difficile
• Blood infection
• Dehydration (due to diarrhea and vomiting)
• Dizziness, rapid heartbeat, and paleness (a condition called hypovolemia)
• Allergic reactions
• Transient speech disorders during or shortly after treatment
• Tickling
• High blood pressure (during or after infusion)
• Cardiac problems*
• Lung disease that produces wheezing and difficulty breathing (see section 2)
• Hypophagia
• Intestinal obstruction
• Colon enlargement
• Intestinal bleeding
• Colitis
• Abnormal results in laboratory tests
• Intestinal perforation
• Fatty liver
• Skin reactions
• Reactions at the site of administration
• Low potassium levels in the blood
• Low electrolyte levels in the blood, mainly related to diarrhea and vomiting
• Muscle cramps
• Renal problems*
• Low blood pressure
• Fungal 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.

Reporting of adverse reactions

If you experienceany type of adverse reaction, consult your doctor or pharmacist, even if it is apossibleadverse reaction that does not appear in this prospectus.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

• Maintain this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month that is indicated.
• Shelf life:theshelf life in the closed vial is 3 years. Once opened, vials must be used immediately since they do not contain antimicrobial preservatives.
• Concentrate: store the vials in the outer packaging to protect them from light. Do not freeze.
• Diluted concentrate: for single use only. Unused solution must be discarded.
• After dilution: chemical and physical stability has been demonstrated in use in glucose 50 mg/mL (5%) and sodium chloride 9 mg/mL (0.9%) for 72 hours at 2-8 °C.From a microbiological point of view, the product must be used immediately.If not used immediately, the times and conditions prior to use of conservation are the responsibility of the user and should normally not exceed 24 hours between 2 and 8 °C, unless the dilution has taken place in controlled and validated conditions of asepsis.

Do not use this medication if you observe visible particles in the concentrate or in the infusion solution.

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

Composition ofIrinotecan Hospira:

• The active ingredient is irinotecan hydrochloride trihydrate. Each milliliter (mL) of solution contains 20 milligrams (mg) of irinotecan hydrochloride trihydrate, equivalent to 17.33 mg of irinotecan
• The other components are sorbitol (E420), lactic acid, water for injectable preparations, sodium hydroxide, and hydrochloric acid (used to adjust the pH) (see section 2).

Aspect of the product and content of the package

Irinotecan Hospira is aconcentrateforinfusion(a concentrated solution that is dilutedto make a solutionthat is administered by slowinfusion throughintravenous drip).

Themedicine comesin glass containerscalledampoules, which contain 2mL, 5mLand25mLofirinotecan hydrochloridetrihydrate.

The ampoulesare wrapped ina plastic protectivecover to reducethe risk ofspills ifthe ampoulesare broken-these are calledONCO-TAIN® ampoules.

It is presented in individual ampoules.You may notfind allpresentationsavailable for sale.

Marketing authorization holder andresponsible manufacturer

Marketing authorization holder:

Pfizer, S.L.

Avenida de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible manufacturer

Pfizer Service Company BV

Hoge Wei 10

1930 Zaventem

Belgium

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last review of this leaflet: September 2023

The detailed information on this medicine is available on the website of the European Medicines Agency and Healthcare Products (AEMPS)(http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

Instructions for personnel on safe handling of Irinotecan Hospira

Like other anticancer agents, irinotecan infusion should be prepared and handled with caution. Goggles, mask, and protective gloves should be used.

Pregnant women should not handle cytotoxics.

If the concentrate or infusion solution of irinotecan comes into contact with the skin, wash immediately with plenty of water and soap. If the concentrate or infusion solution of irinotecan comes into contact with mucous membranes, wash immediately with water.

Preparation for infusion solution

Like other infusions, the irinotecan infusion should be prepared using aseptic techniques.

Using a graduated syringe, withdraw the required amount of Irinotecan Hospira concentrate for solution, in aseptic conditions, and inject it into a 250 mL infusion bag or bottle of 9 mg/mL (0.9%) sodium chloride or 50 mg/mL (5%) glucose, only. The infusion solution to be administered should be mixed carefully by manual rotation. Do not mix with other medications.

Period of validity

Once opened, the ampoulesfor injectionof irinotecan should be used immediately since they do not contain antimicrobial preservatives.

Stability after dilution:

The chemical and physical stability during use has been demonstrated in glucose50 mg/mL(5%) and sodium chloride9 mg/mL (0.9%)for 72 hours at 2 to 8°C. From a microbiological point of view, the product should be used immediately. If not, the storage times and previous use conditions will be the responsibility of the user and should not normally exceed 24 hours at 2 to 8°C, unless the dilution has been performed in validated and controlled aseptic conditions.

Warning about visual signs of deterioration

If you observe visible particles in the concentrate or infusion solution, the product should be eliminated following the procedures for elimination ofcytotoxic agents.

Administration

For information on administration, please refer to the Technical Data Sheet of Irinotecan Hospira.

Elimination:

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations,applicable to the elimination of cytotoxic agents.