Irinotecan Accord 20 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Irinotecan hydrochloride trihydrate

The name of the medicine is “Irinotecan Accord 20 mg/ml concentrate for solution for infusion”, but in the rest of the leaflet it will be referred to as “Irinotecan Accord”.

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, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Irinotecan belongs to a group of medicines called cytostatics (anti-cancer medicines). Irinotecan Accord is used for the treatment of advanced colorectal cancer in adults, either alone or in combination with other medicines. Irinotecan Accord is an anticancer medicine that contains the active substance irinotecan hydrochloride trihydrate. Irinotecan hydrochloride trihydrate interferes with the growth and spread of cancer cells in the body.

Your doctor may use a combination of irinotecan with 5-fluorouracil/leucovorin (5-FU/LV) and bevacizumab to treat your colorectal cancer (colon or rectum). Your doctor may use a combination of irinotecan with capecitabine, with or without bevacizumab, to treat colon and rectal cancer. Your doctor may use a combination of irinotecan with cetuximab to treat a particular type of colorectal cancer (wild-type RAS) that expresses a protein called EGFR.

2. What you need to know before using Irinotecan Accord

Do not use Irinotecan Accord if

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

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

Warnings and precautions

Special caution is needed in elderly patients.

Since irinotecan is an anticancer medicine, it must be administered in a specialized unit and under the supervision of a physician experienced in the use of anticancer drugs. The staff at the unit will explain the precautions you should take during and after treatment. This leaflet helps you remember them.

Before starting treatment with Irinotecan Accord, talk to your doctor if any of the following apply to you: • You have liver problems
• You have kidney problems
• You have asthma
• You have previously received radiotherapy
• You have previously experienced severe diarrhea or fever after treatment with irinotecan
• You have heart problems
• You smoke, have high blood pressure, or high cholesterol, as these may increase the risk of heart problems during treatment with irinotecan
• You have received or are due to receive any vaccine
• You are taking other medicines. Please refer to the section "Other medicines and irinotecan"
• You have Gilbert’s syndrome, a hereditary condition that may cause elevated bilirubin levels and jaundice (yellowing of the skin and eyes)

1. The first 24 hours after administration of Irinotecan Accord

During and immediately after the administration of Irinotecan Accord (30–90 min), you may experience one or more of the following symptoms:

• Diarrhea
• Watery eyes
• Sweating
• Blurred vision
• Abdominal pain
• Excessive salivation

Acute cholinergic syndrome

This medicine may affect the part of your nervous system that controls body secretions, leading to what is known as cholinergic syndrome. Symptoms may include runny nose, increased saliva, excessive tearing, sweating, flushing, abdominal cramps, and diarrhea. Inform your doctor or nurse immediately if you notice any of these symptoms, as there are medicines available that can help control them.

1. From the day after Irinotecan Accord treatment until the next treatment

During this period, you may experience several symptoms that could be serious and require immediate treatment and strict monitoring.

Diarrhea

If you develop diarrhea more than 24 hours after receiving irinotecan ("delayed diarrhea"), it may be severe. It often appears about 5 days after administration. Diarrhea must be treated immediately and closely monitored. If left untreated, it may lead to dehydration and serious electrolyte imbalances, which can be life-threatening. Your doctor will prescribe a medicine to help prevent or manage this side effect. Make sure you have the medication available immediately, so you have it at home when needed. Immediately after the first loose stool, you should do the following:

1. Take the anti-diarrheal treatment prescribed by your doctor and follow your doctor’s instructions exactly. Do not change the treatment without consulting your doctor. The recommended anti-diarrheal treatment is loperamide (4 mg for the first dose, then 2 mg every 2 hours, including during the night). This treatment should continue for at least 12 hours after the last loose stool. The recommended dose of loperamide should not be taken for more than 48 hours.
2. Drink plenty of water and rehydration fluids immediately (e.g., water, soda water, carbonated drinks, soup, or oral rehydration therapy).
3. Inform your doctor immediately that you are experiencing diarrhea and who is supervising your treatment. If you cannot reach your doctor, contact the hospital unit supervising your irinotecan treatment. It is very important that they know you have developed diarrhea from the treatment.

You must contact your doctor or treatment-supervising unit immediately if:

• You experience nausea, vomiting, or fever along with diarrhea
• Diarrhea continues for more than 48 hours after starting anti-diarrheal treatment

Note: Only take the anti-diarrheal medicine prescribed by your doctor and the fluids described above. Follow your doctor’s instructions. The anti-diarrheal treatment should not be used to prevent future episodes of diarrhea, even if you experienced delayed diarrhea in previous cycles.

Fever

If your temperature rises above 38°C, it may be a sign of infection, especially if you have also had diarrhea. If you develop a fever (above 38°C), contact your doctor or treatment center immediately so they can provide necessary treatment.

Nausea and vomiting

If you experience nausea and/or vomiting, contact your doctor or hospital unit immediately. Your doctor may give you medicines before treatment to help prevent nausea and vomiting. You may also be prescribed anti-nausea medicines to take at home. Keep these medicines available for when you need them. Inform your doctor if you are unable to take fluids orally due to nausea and vomiting.

Neutropenia

Irinotecan may reduce the number of your white blood cells (neutropenia), which are important in fighting infections. Neutropenia is often observed during treatment with irinotecan and is reversible. Your doctor should perform regular blood tests to monitor these white blood cells. Neutropenia is serious and must be treated immediately and closely monitored. Inform your doctor or nurse immediately if you have signs of infection, such as fever (38°C or higher), chills, pain when urinating, new cough, or sputum. Avoid contact with people who are ill or have an infection. Inform your doctor if you develop symptoms of infection.

Blood tests

Your doctor will likely perform blood tests before and during your treatment to check for medicine-related effects on blood counts or blood chemistry results. Based on test results, you may need medicines to help manage side effects. Your doctor may also need to reduce or delay your next dose of this medicine, or even stop treatment completely. Keep all your medical appointments and laboratory test visits.

This medicine may reduce the number of platelets in the weeks following its use, 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 aspirin or aspirin-containing products, warfarin, or vitamin E. Inform your doctor immediately if you experience unusual bruising or bleeding, such as nosebleeds, bleeding gums when brushing teeth, or black, tarry stools.

Pulmonary disorders

Rarely, people receiving this medicine may develop serious lung problems. Inform your doctor immediately if you develop a new or worsening cough, difficulty breathing, or fever. Your doctor may need to stop 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 experience chest pain, difficulty breathing, or swelling, pain, redness, or warmth in one arm or leg.

Chronic intestinal inflammation and/or intestinal obstruction

Inform your doctor if you have abdominal pain and cannot pass stools, especially if you also have bloating and loss of appetite.

Radiotherapy

If you recently received pelvic or abdominal radiotherapy, you may be at increased risk of developing bone marrow suppression. Please talk to your doctor before starting irinotecan treatment.

Renal function

Cases of worsening kidney function have been reported.

Cardiac disorders

Inform your doctor if you have or have had heart disease or if you previously received anticancer medicines. Your doctor will monitor you closely and discuss ways to reduce risk factors (e.g., smoking, high blood pressure, high fat levels).

Vascular disorders

Irinotecan is rarely associated with blood flow disturbances (blood clots in the vessels of the legs and lungs) and may rarely occur in patients with multiple risk factors.

Hepatic impairment

Before starting treatment with Irinotecan and before each cycle, liver function should be monitored (via blood tests).

Other

This medicine may cause mouth or lip sores, often within the first few weeks of 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 brush your teeth. If needed, your doctor may prescribe medicines to help relieve pain.

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 medicine if you are planning surgery or any other procedure.

If this medicine is used in combination with other anticancer medicines for your condition, ensure you also read the package leaflets of the other medicines.

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

Other medicines and irinotecan Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. This includes herbal, vitamin, and mineral supplements.

• Medicines used to treat epilepsy (carbamazepine, phenobarbital, phenytoin, or fosphenytoin)
• Medicines used to treat fungal infections (ketoconazole, itraconazole, voriconazole, and posaconazole)
• Medicines used to treat bacterial infections (clarithromycin, erythromycin, and telithromycin)
• Medicine used to treat tuberculosis (rifampicin and rifabutin)
• St. John’s Wort (Hypericum perforatum) (an herbal dietary supplement)
• Live attenuated vaccines
• Medicine for HIV treatment (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir, and others)
• Medicines used to suppress the immune system to prevent transplant rejection (cyclosporine and tacrolimus)
• Medicines used to treat cancer (regorafenib, crizotinib, idelalisib, and apalutamide)
• Vitamin K antagonists (anticoagulants used to thin the blood, such as warfarin)
• Medicines used to relax muscles during anesthesia and surgery (suxamethonium)
• 5-fluorouracil/folinic acid
• Bevacizumab (a blood vessel growth inhibitor)
• Cetuximab (an EGFR inhibitor)

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

If you need surgery, inform your doctor or anesthesiologist that you are being treated with irinotecan, as it may alter the effect of some medicines used during surgery.

Do not start or stop taking any medicines while being treated with irinotecan without first talking to your doctor.

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

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

Contraception, pregnancy, breastfeeding, and fertility
Contraception

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

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

Pregnancy

This medicine may harm the fetus if taken 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 human milk.

Breastfeeding must be discontinued during treatment with irinotecan. Ask your doctor before taking any medicine.

Fertility

No studies have 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 use of machines

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

During the first 24 hours after irinotecan administration, you may feel dizzy or experience visual disturbances. If this happens, do not drive or operate tools or machinery.

Important information about some of the ingredients of Irinotecan Accord This medicine contains 45 mg of sorbitol per 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 given. Patients with HFI cannot break down fructose, which may cause serious adverse effects.

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

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

3. How to use Irinotecan Accord

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor.

Irinotecan will be administered to you by healthcare professionals.

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

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

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

Inform your caregivers if you feel burning, pain, or swelling around the intravenous needle during administration of irinotecan. If the medicine leaks out of the vein, it may cause damage at the injection site. If you experience pain or notice redness or swelling at the IV site while irinotecan is being administered, alert your healthcare professional immediately.

This medicine will be given to you as an intravenous infusion over a period of 30 to 90 minutes. The amount of infusion to be administered will depend on your age, body weight, and general health condition, as well as on any other cancer treatments you may have received. Your doctor will calculate your body surface area in square meters (m²).

• If you have previously been treated with 5-fluorouracil, you will usually be treated with irinotecan alone, starting at a dose of 350 mg/m² every 3 weeks.

• If you have not previously received chemotherapy, you will usually receive 180 mg/m² of irinotecan every two weeks, followed by folinic acid and 5-fluorouracil.

• If you are being treated with irinotecan in combination with cetuximab, you will usually receive the same dose of irinotecan as that administered in the last cycles of the previous regimen containing irinotecan. Irinotecan must not be administered less than 1 hour after the end of the cetuximab infusion.

Your doctor will adjust these doses depending on your condition and any adverse effects you may experience.

If you receive more Irinotecan Accord than you should

It is unlikely that you will be given too much Irinotecan Accord. However, if this were to happen, you might experience severe blood disorders and diarrhea. Supportive care must be provided to prevent dehydration due to diarrhea and to treat infectious complications. You should speak with the doctor administering the medicine.

If you miss a dose of Irinotecan Accord

It is very important to receive all scheduled doses. If you miss a dose, contact your doctor promptly.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Your doctor will inform you about the possible adverse effects and explain the risks and benefits of your treatment. Some of these adverse effects must be treated immediately.

See also information in section “Warnings and precautions”

If you experience any of the following adverse effects after receiving the medicine, inform your doctor immediately. If you are not in the hospital, YOU MUST GO IMMEDIATELY.

• Allergic reactions. If you have wheezing, difficulty breathing, swelling, rash or itching (especially affecting the whole body), contact your doctor or nurse immediately.
• Severe allergic reactions (anaphylactic/anaphylactoid reactions) may occur more frequently within minutes after administration of the product: skin rashes including itching of red skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), and you may also feel faint.
• Diarrhea (see section 2).
• Early diarrhea: occurs within the first 24 hours after receiving this medicine, accompanied by symptoms such as runny nose, increased salivation, watery eyes, sweating, flushing, and abdominal cramps. (This may occur while the medicine is being administered. If so, notify your healthcare professional immediately. Medication may be given to stop and/or reduce this early adverse effect.)
• Late diarrhea: occurs more than 24 hours after receiving this medicine. Because of the risk of dehydration and electrolyte imbalances associated with diarrhea, it is important to stay in contact with healthcare professionals for monitoring and advice on medication and dietary modifications.

Very common (may affect more than 1 in 10 people)

• Blood disorders: neutropenia (decrease in the number of certain white blood cells), thrombocytopenia (decrease in the number of platelets in the blood), anemia (decrease in the number of red blood cells).
• Late diarrhea
• Nausea and vomiting
• Hair loss (hair will grow back after treatment ends)
• In combination therapy, transient increase in levels of certain liver enzymes or bilirubin.

Common (may affect up to 1 in 10 people)

• Acute cholinergic syndrome: main symptoms include early diarrhea and other symptoms such as abdominal pain; redness, burning, itching or tearing of the eyes (conjunctivitis); runny nose (rhinitis); low blood pressure; blood vessel dilation; sweating, chills; general malaise, dizziness; vision disturbances, pupil constriction; eye tearing and increased salivation, occurring within the first 24 hours after irinotecan infusion.
• Fever, infections (including sepsis)
• Fever associated with a severe decrease in the number of certain white blood cells
• Dehydration, usually associated with diarrhea and/or vomiting
• Constipation
• Fatigue
• Increased levels of liver enzymes and creatinine in the blood.

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions. If you have wheezing, difficulty breathing, sweating, swelling, rash or itching (especially affecting the whole body), contact your doctor or nurse immediately.
• Mild skin reactions; mild reactions at the infusion site.
• Breathing difficulties
• Lung disease (interstitial lung disease)
• Intestinal obstruction
• Abdominal pain and inflammation, leading to diarrhea (a condition known as pseudomembranous colitis)
• Uncommon cases of kidney failure, low blood pressure, or heart or vascular failure have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting or sepsis.

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (anaphylactic/anaphylactoid reactions) that may occur more frequently within minutes after administration of the product: skin rashes including itching of red skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), and you may also feel faint.
• Early effects such as muscle contraction or cramps and numbness (paresthesia).
• Gastrointestinal bleeding and inflammation of the colon, including the appendix.
• Intestinal perforation; anorexia (loss of appetite); abdominal pain; mucosal inflammation
• Inflammation of the pancreas.
• Increase in blood pressure during and after administration.
• Decreased levels of potassium and sodium in the blood, mainly related to diarrhea and vomiting.

Very rare (may affect up to 1 in 10,000 people)

• Transient speech disorders.
• Increased levels of certain digestive enzymes that digest sugars and fats.

Unknown (frequency cannot be estimated from available data)

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

• Blood infection

• Dehydration (due to diarrhea and vomiting)

• Dizziness, rapid heartbeat and pale skin (a condition called hypovolemia)

• Allergic reaction

• Temporary speech disorders during or shortly after treatment

• Tingling

• High blood pressure (during or after infusion)

• Heart problems*

• Lung disease causing wheezing and shortness of breath (see section 2)

• Hiccups

• Intestinal blockage

• Enlarged colon

• Bleeding from the intestines

• Inflammation of the large intestine

• Abnormal laboratory test results

• Hole in the intestine

• Fatty liver disease

• Skin reactions

• Reactions at the site where the medicine was administered

• Low potassium level in the blood

• Low sodium level in the blood, mainly related to diarrhea and vomiting

• Muscle cramps

• Kidney problems*

• Low blood pressure*

• Fungal infections

• Viral infections

• Uncommon cases of these adverse effects have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting, or blood infections.

If you receive irinotecan in combination with cetuximab, some of the side effects you may experience could also be related to this combination. These side effects may include an acne-like skin rash. Therefore, make sure to also read the cetuximab package leaflet.

If you receive irinotecan in combination with capecitabine, some of the side effects you may experience could also be related to this combination. These side effects may include: very commonly, blood clots; commonly, allergic reactions, heart attacks, and fever in patients with low white blood cell count. Therefore, make sure to also read the capecitabine package leaflet.

If you receive irinotecan in combination with capecitabine and bevacizumab, some of the side effects you may experience could also be related to this combination. Such side effects include: low white blood cell count, blood clots, high blood pressure, and heart attack. Therefore, make sure to also read the package leaflets of capecitabine and bevacizumab.

If any of the adverse effects you experience is severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Irinotecan Accord

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

Do not freeze.

For single use only.

This medicine does not require special storage temperature conditions. Store this medicine in the original container to protect it from light.

Do not use this medicine after the expiry date stated on the container 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 any unused medicine and its container. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irinotecan Accord

• The active substance is irinotecan hydrochloride trihydrate.
• 1 ml of concentrate contains 20 mg of irinotecan hydrochloride trihydrate, equivalent to 17.33 mg of irinotecan.
• 1 vial of 2 ml contains 40 mg of irinotecan hydrochloride trihydrate.
• 1 vial of 5 ml contains 100 mg of irinotecan hydrochloride trihydrate.
• 1 vial of 15 ml contains 300 mg of irinotecan hydrochloride trihydrate.
• 1 vial of 25 ml contains 500 mg of irinotecan hydrochloride trihydrate.
• 1 vial of 50 ml contains 1000 mg of irinotecan hydrochloride trihydrate.
• The other components are sorbitol (E420), lactic acid, sodium hydroxide, hydrochloric acid and water for injections.

Nature of the product and pack sizes

Irinotecan Accord 20 mg/ml concentrate for solution for infusion is a clear, pale yellow solution.

Pack sizes: 2 ml, 5 ml, 15 ml, 25 ml, 50 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona, Spain

Manufacturer

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50,

95-200 Pabianice, Poland

or

Accord Healthcare single member S.A.

64th Km National Road Athens, Lamia, 32009,

Greece

This medicinal product is authorised in the following EEA Member States:

Country	Medicinal Product Name
Austria	Irinotecan Accord 20 mg/ml Concentrate for Solution for Infusion
Belgium	Irinotecan Accord 20 mg/ml concentrate for solution for infusion
Bulgaria	Irinotecan Accord 20 mg/ml Concentrate for Solution for Infusion
Cyprus	Irinotecan Accord 20 mg/ml Concentrate for Solution for Infusion
Czech Republic	Irinotecan Accordpharma 20 mg/ml concentrate for infusion solution
Germany	Irinotecan Accord 20 mg/ml Concentrate for Solution for Infusion
Denmark	Irinotecan Accord
Estonia	Irinotecan Accord
Greece	Irinotecan Accord 20 mg/ml Concentrate for Solution for Infusion
Finland	Irinotecan Accord 20 mg/ml Infusion Concentrate, solution
Croatia	Irinotecan Accord 20 mg/ml concentrate for infusion solution
Hungary	Irinotecan Accord 20 mg/ml concentrate for infusion solution
Ireland	Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion
Iceland	Irinotecan Accord 20 mg/ml, concentrate for solution for infusion
Italy	Irinotecan Accord
Latvia	Irinotecan Accord 20 mg/ml concentrate for infusion solution
Lithuania	Irinotecan Accord 20 mg/ml concentrate for infusion solution
Malta	Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion
Poland	Irinotecan Accord
Netherlands	Irinotecan Accord 20 mg/ml concentrate for solution for infusion
Norway	Irinotecan Accord
Portugal	Irinotecan Accord
Romania	Irinotecan Accord 20 mg/ml concentrate for infusion solution
Slovakia	Irinotecan Accord 20 mg/ml infusion concentrate
Slovenia	Irinotecan Accord 20 mg/ml concentrate for solution for infusion
Sweden	Irinotecan Accord 20 mg/ml, concentrate for infusion solution
United Kingdom	Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion
Spain	Irinotecan Accord 20 mg/ml concentrate for solution for infusion EFG
France	IRINOTECAN ACCORD 20 mg/ml, solution to be diluted for infusion

Date of the most recent review of this summary: October 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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

This information is intended for healthcare professionals only:

Instructions for use – Cytotoxic

Handling of Irinotecan Accord

As with other antineoplastic agents, Irinotecan Accord must be handled with caution. Dilution must be performed under aseptic conditions by trained personnel in a designated area. Precautions must be taken to avoid contact with skin and mucous membranes.

Protective instructions for the preparation of irinotecan infusion solution:

1. A safety cabinet, as well as protective gloves and gowns, must be used. If a safety cabinet is not available, protective goggles and a mask must be worn.

2. Opened containers such as injection vials, infusion bottles, used cannulae, syringes, catheters, tubes, and waste from cytotoxic agents must be considered hazardous waste and must be disposed of in accordance with local regulations for handling HAZARDOUS WASTE.

3. In case of spillage, follow these instructions:

• protective clothing must be worn
• broken glass must be collected and discarded into a HAZARDOUS WASTE container
• contaminated surfaces must be thoroughly washed with large amounts of cold water
• surfaces washed with water must be completely cleaned, and all materials used must be disposed of as HAZARDOUS WASTE

1. If irinotecan comes into contact with the skin, rinse the affected area with copious amounts of running water and then wash with water and soap. In case of contact with mucous membranes, thoroughly rinse the contact area with water. If any discomfort occurs, contact a physician.

2. In case of eye contact with irinotecan, thoroughly rinse eyes with large amounts of water. Immediately contact an ophthalmologist.

Preparation of the infusion solution

Irinotecan Accord concentrate for solution for infusion is for intravenous infusion only after prior dilution in the recommended diluents: 0.9% sodium chloride infusion solution or 5% glucose infusion solution. Aseptically withdraw the required amount of irinotecan concentrate for infusion from the vial using a calibrated syringe and inject into a 250 ml infusion bag or bottle. The infusion solution must be thoroughly mixed by manual rotation.

After opening, the product must be diluted and used immediately.

The irinotecan solution is physically and chemically stable in 0.9% (w/v) sodium chloride infusion solutions and 5% (w/v) glucose solutions for up to 28 days when stored in low-density polyethylene or PVC containers at 5°C or 25°C and protected from light. When exposed to light, the physicochemical stability is 3 days. From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C, unless reconstitution/dilution (etc.) has been carried out under controlled, validated aseptic conditions.

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

Irinotecan Accord must not be administered as an intravenous bolus or by intravenous infusion lasting less than 30 minutes or more than 90 minutes.

Disposal

All materials used in the preparation, administration, or that come into contact with irinotecan must be disposed of in accordance with local regulations for handling cytotoxic compounds.