Irinotecan accord

Package leaflet: Information for the patient

Irinotecan Accord, 20 mg/ml, concentrate for solution for infusion
Irinotecani hydrochloridum trihydricum
The medicine is called "Irinotecan Accord, 20 mg/ml, concentrate for solution for infusion"
and will be referred to as "Irinotecan Accord" throughout this leaflet.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Irinotecan Accord is and what it is used for
2. Important information 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 cytostatic agents (anticancer drugs).
Irinotecan is used in the treatment of advanced colorectal cancer in adults, either in combination with other medicines or as monotherapy. Irinotecan Accord is an anticancer medicine containing irinotecan hydrochloride trihydrate as the active substance.
Irinotecan hydrochloride trihydrate interferes with the growth and spread of cancer cells in the body.

Your doctor may prescribe irinotecan in combination with 5-fluorouracil/folinic acid (5-FU/FA) and bevacizumab for the treatment of colorectal cancer (colon and rectal cancer).
Your doctor may prescribe irinotecan in combination with capecitabine, with or without bevacizumab, for the treatment of colorectal cancer.
Your doctor may prescribe irinotecan in combination with cetuximab for the treatment of a certain type of colorectal cancer (with non-mutated KRAS gene) that expresses a protein called EGFR.

2. Important information before using Irinotecan Accord

When not to use Irinotecan Accord

if the patient is allergic to irinotecan hydrochloride trihydrate or any of the
other ingredients of this medicine (listed in section 6)
if the patient has or has had chronic inflammatory bowel disease or intestinal obstruction
if the patient is breastfeeding
if the patient has severe liver disease (bilirubin concentration more than 3 times above
the upper limit of normal)
if the patient has severe bone marrow failure
if the patient is in poor general condition (assessed according to international standards,
WHO performance status higher than 2)
if the patient is taking a natural medicine containing St. John’s wort (Hypericum perforatum)
if the patient intends to receive or has recently received live attenuated vaccines
(yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis,
rotavirus infections, influenza) and for 6 months after completion of chemotherapy.
If Irinotecan Accord is being used in combination with other medicines, please refer to the
patient leaflets included with the other medicines for information on additional
contraindications.

Warnings and precautions

Particular caution should be exercised in elderly patients.

Since Irinotecan Accord is an anticancer medicine, it will be administered to the patient in
specialized departments and under the supervision of a physician qualified in anticancer
treatment. The medical staff will explain to the patient what precautions should be taken during
and after treatment.
This leaflet may help the patient remember them.

Before using Irinotecan Accord, inform the doctor if any of the following apply to the patient:

• if the patient has liver disease
• if the patient has kidney function disorders
• if the patient has asthma
• if the patient has ever been treated with radiotherapy
• if the patient previously experienced severe diarrhoea and fever after receiving Irinotecan Accord
• if the patient has heart problems
• if the patient smokes, has high blood pressure or high cholesterol levels, as this may increase the risk of heart disorders during treatment with Irinotecan Accord
• if the patient has been or will be vaccinated
• if the patient is taking any other medicines. Please refer to the section “Irinotecan Accord and other medicines” below
• if the patient has Gilbert’s syndrome, a hereditary condition that may cause elevated bilirubin levels and jaundice (yellowing of the skin and whites of the eyes)

1) First 24 hours after administration of Irinotecan Accord

During administration of Irinotecan Accord (30–90 min) and immediately after, the following symptoms may occur:

• diarrhoea
• tearing
• excessive sweating
• visual disturbances
• abdominal pain
• excessive salivation

Acute cholinergic syndrome
This medicine may affect the part of the nervous system controlling secretory functions, leading to a condition known as cholinergic syndrome. Symptoms may include runny nose, increased salivation, excessive tearing, sweating, flushing, abdominal cramps, and diarrhoea. Inform the doctor or nurse immediately if any of these symptoms occur, as there are medicines available that can help control them.

2) From the day after administration of Irinotecan Accord until the next treatment cycle

During this period, the patient may experience various symptoms, which may be severe and may require immediate treatment and close medical supervision.

Diarrhoea

Diarrhoea starting more than 24 hours after administration of Irinotecan Accord (“delayed diarrhoea”) may be severe. It commonly begins about 5 days after administration of the drug. Treatment of diarrhoea must be started immediately and closely monitored. If left untreated, it may lead to dehydration and serious disturbances in body chemistry, which may be life-threatening. The doctor will prescribe medicines to help prevent or control these adverse effects. Ensure that the medicine is readily available so the patient can take it at home if needed. Immediately after the first loose stool, the following actions should be taken:

1. Take the anti-diarrhoeal medicine prescribed by the doctor, strictly according to the doctor’s instructions. Do not change the medicine or its dose without prior consultation with the doctor. Loperamide is the recommended anti-diarrhoeal (initial dose 4 mg, then 2 mg every 2 hours, including at night). Treatment should continue for at least 12 hours after the last loose stool. Do not continue the recommended dose of loperamide for longer than 48 hours.
2. Immediately start drinking large amounts of water or other rehydration fluids (e.g. water, soda water, carbonated drinks, soup or other oral rehydration solutions).
3. The patient should immediately inform the supervising doctor and report the diarrhoea. If contact with the doctor is not possible, contact the hospital department where the patient receives Irinotecan Accord. It is important that the department staff are aware of the occurrence of diarrhoea.

Inform the doctor or supervising department immediately:

• if the patient has nausea, vomiting, fever or diarrhoea,
• if diarrhoea persists after 48 hours of starting anti-diarrhoeal treatment.

Note: Do not use any other anti-diarrhoeal treatment apart from that prescribed by the attending doctor, and do not drink any other fluids than those listed above. Strictly follow the doctor’s instructions. Do not use anti-diarrhoeal treatment to prevent further episodes of diarrhoea, even if delayed diarrhoea occurred in previous treatment cycles.

Fever

Body temperature above 38°C may be a sign of infection, especially if it occurs simultaneously with diarrhoea. If the patient develops a fever above 38°C, contact the doctor or hospital department immediately for appropriate treatment.

Nausea and vomiting

If nausea and/or vomiting occur, contact the doctor or hospital department immediately. Before starting treatment, the doctor may administer a medicine to prevent nausea and vomiting. The doctor will likely prescribe anti-nausea medicines for use at home. These medicines should be easily accessible in case of need. Contact the doctor if the patient is unable to take fluids orally due to nausea and vomiting.

Neutropenia

Irinotecan Accord may also reduce the number of white blood cells, which are important in fighting infections. This is known as neutropenia. Neutropenia is commonly observed during Irinotecan Accord therapy and is reversible. The doctor should order regular blood tests to monitor white blood cell counts. Neutropenia is a serious adverse effect and should be treated immediately and carefully monitored. Inform the doctor or nurse immediately if any signs of infection occur, such as fever (38°C or higher), chills, pain during urination, cough or expectoration of sputum. Avoid close contact with sick people or those with infections. Inform the doctor immediately if signs of infection occur.

Blood monitoring

The doctor will likely perform blood tests before and during treatment to assess the medicine’s effect on blood cell counts or blood composition. Test results may indicate the need for medicines to help manage these reactions. The doctor may also reduce or delay the next dose of this medicine, or even discontinue treatment. Attend all scheduled medical appointments and laboratory tests.

This medicine may reduce the number of platelets within the first few weeks after administration, which may increase the risk of bleeding. Consult the doctor before taking any medicines or supplements that may affect blood clotting, such as acetylsalicylic acid or medicines containing acetylsalicylic acid, warfarin, or vitamin E. Inform the doctor if unusual bruising or bleeding occurs, such as nosebleeds, bleeding gums during tooth brushing, or black, tarry stools.

Lung function disorders

Serious lung problems have been rarely observed in patients receiving this medicine. Inform the doctor immediately if cough, difficulty breathing or fever develops or worsens. The doctor may need to discontinue treatment to manage these problems.

This medicine may increase the risk of developing large 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 the doctor immediately if the patient experiences chest pain, shortness of breath, or swelling, pain, redness or warmth in the arm or leg.

Chronic inflammatory bowel disease and/or intestinal obstruction

Inform the doctor if the patient experiences abdominal pain and is unable to defecate, especially if bloating and loss of appetite also occur.

Radiotherapy

If the patient has recently undergone pelvic or abdominal radiotherapy, there may be an increased risk of bone marrow suppression. This should be discussed with the doctor before starting Irinotecan Accord.

Kidney function

Kidney function disorders have been reported.

Heart disorders

Inform the doctor if the patient has or has had heart disease or previously received anticancer medicines. The doctor will closely monitor the patient and discuss ways to reduce risk factors (e.g. smoking, high blood pressure, excessive dietary fat).

Vascular disorders

Irinotecan Accord has rarely been associated with blood flow disorders (blood clots in the vessels of the legs and lungs); these may rarely occur in patients with multiple risk factors.

Liver function disorders

Liver function (blood tests) should be checked before starting Irinotecan Accord therapy and before each subsequent treatment cycle.

Other

This medicine may cause mouth or lip ulcers, often within the first few weeks of treatment. This may cause mouth pain, bleeding, and even eating difficulties. The doctor or nurse may suggest ways to reduce these discomforts, such as changing eating or tooth brushing habits. If needed, the doctor may prescribe a medicine to reduce pain.

Information on contraception, pregnancy, breastfeeding and fertility is provided below in the section “Contraception, pregnancy, breastfeeding and effects on fertility”.

If surgery or another procedure is planned, inform the doctor or dentist about the use of this medicine.

If this medicine is used in combination with other anticancer medicines, ensure that the patient has read the leaflet accompanying the other anticancer medicine.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before using this medicine.

Irinotecan Accord and other medicines

Tell the doctor or hospital pharmacist about all medicines currently taken or taken recently, including those available without a prescription. This also includes herbal medicines, strong vitamin and mineral supplements.

• medicines used to treat seizures (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 (herbal dietary supplement);
• live attenuated vaccines;
• medicines used to treat HIV infection (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir and others);
• medicines that suppress the immune system, used to prevent transplant rejection (cyclosporine and tacrolimus);
• medicines used to treat cancer (regorafenib, crizotinib, idelalisib and apalutamide);
• vitamin K antagonists (blood-thinning medicines such as warfarin);
• medicines used to relax muscles during general anaesthesia and surgery (succinylcholine);
• 5-fluorouracil/folinic acid;
• bevacizumab (an inhibitor of blood vessel formation);
• cetuximab (an EGFR inhibitor).

Before administering Irinotecan Accord, inform the doctor, pharmacist or nurse if the patient is currently or has recently undergone chemotherapy (and radiotherapy).

If the patient is to undergo surgery, inform the doctor or anaesthesiologist about the use of this medicine, as it may alter the effect of certain medicines used during the procedure.

Do not start or stop taking any medicines during treatment with Irinotecan Accord without prior consultation with the doctor.

This medicine may cause severe diarrhoea. During treatment with this medicine, avoid using laxatives or stool softeners.

Other medicines may also interact with Irinotecan Accord. Consult the doctor, pharmacist or nurse to check whether other medicines, herbal products and supplements, as well as alcohol, may interact with this medicine.

Contraception, pregnancy, breastfeeding and effects on fertility

Contraception

Women of childbearing potential must use effective contraception during and for 6 months after completion of treatment.

Men must use effective contraception during and for 3 months after completion of treatment. It is important to consult the doctor about which types of contraception can be used with this medicine.

Pregnancy

This medicine may have a negative effect on fetal development if taken during conception or pregnancy. Before starting treatment, the doctor will confirm that the patient is not pregnant.

If the patient is pregnant, suspects she may be pregnant, or plans to have a child, consult the doctor or pharmacist before using this medicine.

Breastfeeding

Irinotecan and its metabolite pass into breast milk.

Breastfeeding must be discontinued during treatment with Irinotecan Accord.

Before using any medicine, consult the doctor or pharmacist.

Effects on fertility

No studies have been conducted on effects on fertility; however, this medicine may affect fertility. Before using this medicine, consult the doctor about the possible risks associated with its use and options available to preserve the patient’s ability to have children in the future.

Driving and operating machinery

In some cases, Irinotecan Accord may cause adverse effects that may affect the ability to drive and operate devices or machinery.

If in doubt, discuss with the doctor or pharmacist.

During the first 24 hours after administration of Irinotecan Accord, dizziness and visual disturbances may occur. If such symptoms occur, do not drive or operate any devices or machinery.

Important information about some ingredients of Irinotecan Accord

Irinotecan Accord contains 45 ml of sorbitol per ml. Sorbitol is a source of fructose. This medicine must not be taken if the patient (or their child) has the rare hereditary fructose intolerance. Patients with hereditary fructose intolerance cannot metabolize fructose, which may lead to serious adverse effects.

Inform the doctor before using this medicine if the patient (or their child) has hereditary fructose intolerance or if the child cannot consume sweet foods or drinks due to nausea, vomiting or unpleasant reactions such as bloating, stomach cramps or diarrhoea.

This medicine contains less than 1 mmol sodium (23 mg) per vial, meaning the medicine is considered “sodium-free”.

3. How to use Irinotecan Accord

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor.
Irinotecan Accord is administered by trained medical personnel.
Your doctor may recommend a DNA test before the first dose of Irinotecan Accord is given.
Some individuals are genetically more susceptible to certain adverse effects.
While receiving Irinotecan Accord, the patient may also be given other medicines to prevent
nausea, vomiting, diarrhoea, and other side effects. These medicines may need to be continued
for at least one day after administration of Irinotecan Accord.
If the patient experiences burning, pain, or swelling around the injection site after receiving
Irinotecan Accord, medical staff should be informed immediately. If the medicine leaks out of the
vein, it may cause tissue damage. If pain, redness, or swelling occurs at the infusion site during
administration of Irinotecan Accord, the doctor must be notified immediately.
Irinotecan Accord is administered to the patient as an intravenous infusion lasting between 30 and 90
minutes. The dose depends on the patient's age, body surface area, and general condition. The dose
also depends on other anticancer medicines used in treatment. The doctor will calculate the
patient's body surface area in square meters (m²).

• If the patient has previously been treated with 5-fluorouracil, standard treatment with Irinotecan Accord alone will be administered at an initial dose of 350 mg/m², given every three weeks.
• If the patient has not previously undergone chemotherapy, a dose of 180 mg/m² of Irinotecan Accord will be given every two weeks, followed by administration of folinic acid and 5-fluorouracil.
• If the patient is receiving Irinotecan Accord in combination with cetuximab, the same dose of irinotecan as used in the last cycles of previous irinotecan treatment will be administered. Irinotecan Accord must not be administered earlier than one hour after the end of the cetuximab infusion.

The dosing schedule may be adjusted by the doctor depending on the patient's condition and
observed adverse effects.
Overdose of Irinotecan Accord
It is unlikely that a patient would receive too high a dose of Irinotecan Accord. However, if this
occurs, severe blood disorders and diarrhoea may develop. The patient will require appropriate
supportive treatment to prevent dehydration due to diarrhoea and treatment of infection-related
complications. Consult the doctor administering the medicine.
Missed dose of Irinotecan Accord
It is very important to receive all scheduled doses. If a dose is missed, contact the doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss with you the possible side effects and explain the risks and benefits
of treatment. Some of these side effects require immediate treatment.
See also the information in section "Warnings and precautions".
If any of the following side effects occur after administration of the medicine,
you must inform your doctor immediately. If you are not in hospital, you must
GO TO HOSPITAL IMMEDIATELY.

• Allergic reactions. If you experience wheezing, difficulty breathing, swelling, rash or itching (especially affecting the whole body), contact your doctor or nurse immediately.
• Severe allergic reactions (anaphylactic and/or anaphylactoid reactions) may occur most frequently within a few minutes after administration of the medicine: skin rash, including redness and itching of the skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and a feeling of impending fainting.
• Diarrhoea (see section 2.).
• Early-onset diarrhoea: occurs within 24 hours after administration of the medicine, with symptoms such as runny nose, increased salivation, tearing, sweating, flushing and abdominal cramps. This reaction may occur during administration of the medicine. In such a case, inform medical personnel immediately. Medicines may then be given to stop and/or reduce these symptoms.
• Late-onset diarrhoea: occurring more than 24 hours after administration of the medicine. Because of the risk of dehydration and electrolyte imbalance caused by diarrhoea, it is important that the patient contacts a healthcare professional to monitor their health status and receive advice on medications and dietary modifications.

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

• Blood disorders: neutropenia (reduced number of white blood cells), thrombocytopenia (reduced number of platelets), anaemia
• Delayed diarrhoea
• Nausea and vomiting
• Hair loss (hair will regrow after treatment ends)
• In combination therapy: transient increase in liver enzyme activity and bilirubin levels

Common (may affect up to 1 in 10 people)

• Acute cholinergic syndrome: main symptoms include early-onset diarrhoea and other symptoms such as abdominal pain, flushing, abdominal pain, redness, itching and tearing of the eyes (conjunctivitis), runny nose, low blood pressure, vasodilation, excessive sweating, chills, general discomfort and malaise, dizziness, visual disturbances, miosis (constriction of the pupils), tearing and increased salivation, during or within the first 24 hours after infusion of Irinotecan Accord.
• Fever, infections (including sepsis)
• Fever associated with a significant decrease in the number of certain types of white blood cells
• Dehydration, mainly related to diarrhoea and/or vomiting
• Constipation
• Fatigue
• Increased liver enzyme activity and increased blood creatinine levels

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions. If you experience wheezing, difficulty breathing, 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 inflammatory condition causing diarrhoea (pseudomembranous colitis)
• Rare cases of renal failure, hypotension or cardiovascular failure have been observed in patients who experienced episodes of dehydration related to diarrhoea and/or vomiting or sepsis.

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

• Severe allergic reactions (anaphylactic and/or anaphylactoid reactions) may occur most frequently within a few minutes after administration of the product: skin rash, including redness and itching of the skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and a feeling of impending fainting. If these symptoms occur, contact your doctor immediately.
• Early-onset symptoms such as muscle spasms or cramps and numbness (paresthesia)
• Gastrointestinal bleeding and inflammation of the colon, including appendicitis
• Intestinal perforation, anorexia, abdominal pain, mucositis
• Pancreatitis
• Increased blood pressure during and after administration
• Decreased levels of potassium and sodium in the blood, mainly related to diarrhoea and vomiting

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

• Transient speech disorders
• Increased activity of certain digestive enzymes that break down sugars and fats

Frequency not known (cannot be estimated from available data)

• Severe, persistent or bloody diarrhoea (which may be associated with abdominal pain or fever) caused by bacteria (Clostridium difficile)
• Blood infection
• Dehydration (due to diarrhoea and vomiting)
• Dizziness, rapid heartbeat and pale skin (a condition called hypovolemia)
• Allergic reaction
• Transient speech disorders during or shortly after treatment
• Sensation of pricking or tingling
• High blood pressure (during or after infusion)
• Heart problems*
• Lung disease causing wheezing and shortness of breath (see section 2)
• Hiccups
• Intestinal obstruction
• Enlargement of the large intestine
• Bleeding from the intestine
• Inflammation of the large intestine
• Abnormal laboratory test results
• Intestinal perforation
• Fatty liver
• Skin reactions
• Reactions at the site of administration
• Low potassium levels in the blood
• Low salt levels in the blood, mainly related to diarrhoea and vomiting
• Muscle cramps
• Kidney problems*
• Low blood pressure*
• Fungal infections
• Viral infections.

* Rare cases of these adverse reactions have been observed in patients who experienced
episodes of dehydration related to diarrhoea and/or vomiting or blood infections.
If Irinotecan Accord is used in combination with cetuximab, some adverse reactions
experienced by the patient may be related to this combination therapy. These adverse
reactions may include acne-like rash. Please refer to the patient leaflet for cetuximab.
If Irinotecan Accord is used in combination with capecitabine, some adverse reactions
experienced by the patient may be related to this combination therapy. These adverse
reactions may include: very common - blood clots; common - allergic reactions, heart attack,
and fever in patients with reduced white blood cell count. Therefore, please refer to the
patient leaflet for capecitabine.
If Irinotecan Accord is used in combination with capecitabine and bevacizumab,
some adverse reactions experienced by the patient may be related to this combination
therapy. These adverse reactions may include: reduced white blood cell count, blood clots,
decreased blood pressure, and heart attack. Therefore, please refer to the patient leaflets for
capecitabine and bevacizumab.
If any of the side effects worsen or if you experience any side effects not listed in this leaflet,
inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including any possible side effects not listed in this leaflet,
talk to your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices
and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported directly to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Irinotecan Accord

Keep this medicine out of the sight and reach of children.
Do not freeze.
For single use only.
No special storage temperature requirements.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and vial after EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Irinotecan Accord contains

• 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.
• 2 ml vial contains 40 mg of irinotecan hydrochloride trihydrate
• 5 ml vial contains 100 mg of irinotecan hydrochloride trihydrate
• 15 ml vial contains 300 mg of irinotecan hydrochloride trihydrate
• 25 ml vial contains 500 mg of irinotecan hydrochloride trihydrate
• 50 ml vial contains 1000 mg of irinotecan hydrochloride trihydrate
• Other ingredients are: sorbitol (E420), lactic acid, sodium hydroxide, hydrochloric acid and water for injections.

What Irinotecan Accord looks like and contents of the pack
Irinotecan Accord is a clear, light yellow solution.
Pack sizes:
2 ml vial
5 ml vial
15 ml vial
25 ml vial
50 ml vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens Lamia
32009 Schimatari
Greece
This medicinal product is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

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

The following information is intended solely for medical or healthcare personnel

Instructions for Use – Cytotoxic Medicinal Product
Handling of Irinotecan Accord
As with other antineoplastic agents, caution must be exercised when preparing and administering Irinotecan Accord. Dilution must be performed under aseptic conditions by trained personnel in a designated area. Precautions should be taken to avoid contact with skin and mucous membranes.

Guidelines for protection during preparation of Irinotecan Accord, concentrate for solution for infusion

1. A biological safety cabinet should be used, and gloves and protective clothing must be worn. If a biological safety cabinet is not available, a face mask and protective goggles should be used.
2. Open containers such as vials and infusion bottles, as well as used cannulas, syringes, catheters, tubing, and any cytostatic waste, must be treated as hazardous waste and disposed of in accordance with local guidelines for handling HAZARDOUS WASTE.
3. In case of spillage, follow the instructions below:
   • Wear protective clothing.
   • Broken glass should be collected and placed in a container designated for HAZARDOUS WASTE.
   • Contaminated surfaces should be thoroughly rinsed with a large amount of cold water.
   • After rinsing, wipe surfaces thoroughly; materials used for cleaning must be discarded as HAZARDOUS WASTE.
4. In case of contact of Irinotecan Accord with the skin, the affected area should be flushed with copious amounts of running water and then washed with soap and water. In case of contact with mucous membranes, the area should be carefully rinsed with water. If any symptoms occur, medical advice should be sought.
5. In case of contact of Irinotecan Accord with the eyes, rinse thoroughly with water. Seek immediate advice from an ophthalmologist.

Preparation of the infusion solution
Irinotecan Accord, concentrate for solution for infusion, is intended for intravenous infusion after dilution prior to administration in the recommended diluents, i.e., 0.9% sodium chloride solution for injection or 5% glucose solution for infusion. The required volume of Irinotecan Accord should be aseptically withdrawn from the vial using a calibrated syringe and added to a 250 ml infusion bag or bottle. The resulting infusion solution should be mixed thoroughly by gentle manual agitation.

The product should be diluted and used immediately after opening.
Physicochemical stability of the solution has been demonstrated for up to 28 days when stored in LDPE or PVC containers diluted with either 0.9% sodium chloride (0.9% w/v) or 5% glucose solution, at temperatures up to 5°C or 25°C, protected from light.
The diluted solution may be stored for up to 3 days when exposed to light.
From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration. Under normal circumstances, storage should not exceed 24 hours at 2°C to 8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

If a precipitate is visible in the vials before or after reconstitution, the product should be discarded according to standard procedures for cytotoxic drugs.

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 and administration of Irinotecan Accord, and any materials coming into contact with the product, must be disposed of in accordance with local guidelines for handling cytotoxic substances.