Irinotecan Accord

Leaflet accompanying the packaging: patient information

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

Irinotecan hydrochloride trihydrate
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.
Read this leaflet carefully before taking the medicine, as it contains important information for you.
Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.

Table of contents of the leaflet

• 1. What is Irinotecan Accord and what is it used for
• 2. Important information before taking Irinotecan Accord
• 3. How to take Irinotecan Accord
• 4. Possible side effects
• 5. How to store Irinotecan Accord
• 6. Contents of the packaging and other information

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

Irinotecan belongs to a group of medicines called cytostatics (anticancer medicines).
Irinotecan is used to treat advanced cancer of the colon and rectum in adults, in combination with other medicines or alone. Irinotecan Accord is an anticancer medicine that contains irinotecan hydrochloride trihydrate as the active substance.
Irinotecan hydrochloride trihydrate disrupts 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) bevacizumabfor the treatment of colorectal cancer (colon and rectal cancer).
Your doctor may prescribe irinotecan in combination with capecitabinewith or without bevacizumabfor the treatment of colon and rectal cancer.
Your doctor may prescribe irinotecan in combination with cetuximabfor the treatment of a certain type of colorectal cancer (with non-mutated KRAS gene),showing expression of a protein called EGFR.

2. Important information before taking Irinotecan Accord

When not to take Irinotecan Accord

If you are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients of this medicine (listed in section 6)
If you have chronic inflammatory bowel disease or bowel obstruction
If you are breastfeeding
If you have severe liver disease (bilirubin levels more than three times higher than the upper limit of normal)
If you have severe bone marrow failure
If you are in poor general condition (assessed according to international standards, WHO performance status greater than 2)
If you are taking a herbal medicine containing St. John's Wort
If you are going to be vaccinated or have recently been vaccinated with live, attenuated vaccines (against yellow fever, chickenpox, measles, mumps, rubella, tuberculosis, rotavirus infection, influenza) and within 6 months after the end of chemotherapy.
If you are taking Irinotecan Accord in combination with other medicines, you should read the patient information leaflets for the other medicines to get information on additional contraindications.

Warnings and precautions

Special caution is required in elderly patients.
Since Irinotecan Accord is an anticancer medicine, it will be administered to you in specialized departments and under the control of a doctor qualified to use anticancer therapy. The medical staff of the department will explain to you what precautions to take during and after treatment. This leaflet can help you remember this.
Before taking Irinotecan Accord, you should inform your doctor if any of the following apply to you:

• If you have liver disease
• If you have kidney function disorders
• If you have asthma
• If you have ever been treated with radiation therapy
• If you have had severe diarrhea and fever after taking Irinotecan Accord
• If you have heart problems
• If you smoke, have high blood pressure, or high cholesterol levels, as this may increase the risk of heart problems during treatment with Irinotecan Accord
• If you have been or are going to be vaccinated
• If you are taking any other medicines. Please see the section "Irinotecan Accord and other medicines"
• If you have Gilbert's syndrome, a hereditary disease that can cause elevated bilirubin levels and jaundice (yellowing of the skin and whites of the eyes)
• 1) The first 24 hours after administration of Irinotecan AccordDuring the administration of Irinotecan Accord (30 - 90 minutes) and immediately after administration, the following symptoms may occur:
• Diarrhea
• Lacrimation
• Excessive sweating
• Visual disturbances
• Abdominal pain
• Excessive salivation

Acute cholinergic syndrome
This medicine may affect the part of the nervous system that controls secretory functions, leading to a so-called cholinergic syndrome. Symptoms may include runny nose, increased salivation, lacrimation, sweating, flushing, abdominal cramps, and diarrhea. You should inform your doctor or nurse if you notice any of these symptoms, as there are medicines that can help control them.

• 2) From the day after treatment with Irinotecan Accord to the next treatment cycleDuring this period, you may experience various symptoms that can be severe and may require immediate treatment and close medical supervision.

Diarrhea

Diarrhea that starts more than 24 hours after administration of Irinotecan Accord ("delayed diarrhea") can be severe. It usually occurs around 5 days after administration. You should start treating diarrhea and closely monitor its course immediately. If left untreated, it can lead to dehydration and serious electrolyte imbalances that can be life-threatening. Your doctor will prescribe medicines to help prevent or control these side effects. Make sure you have the medicine available at home to take if needed. As soon as you experience the first loose stool, you should:

• 1. Take the anti-diarrheal medicine prescribed by your doctor, strictly according to their instructions. Do not change the medicine or its dose without consulting your doctor first. The recommended anti-diarrheal medicine is loperamide (initial dose 4 mg, then 2 mg every 2 hours, also at night). Treatment should be continued for at least 12 hours after the last loose stool. Do not take the recommended dose of loperamide for more than 48 hours.
• 2. Start drinking large amounts of water or other hydrating fluids (e.g., water, soda water, carbonated drinks, soup, or other oral hydration fluids) immediately.
• 3. You should immediately inform your doctor supervising the treatment and tell them about the diarrhea. If it is not possible to contact your doctor, you should contact the hospital department where you are receiving Irinotecan Accord. It is essential that the department staff knows about the diarrhea.

You should immediately inform your doctor or the department supervising the treatment:

• If you have nausea, vomiting, fever, or diarrhea,
• If, after 48 hours of starting anti-diarrheal treatment, you still have diarrhea.

Warning:Do not take any other anti-diarrheal treatment except the one prescribed by your doctor, and do not drink any other fluids except those listed above. You should strictly follow your doctor's instructions. Do not use anti-diarrheal treatment to prevent further episodes of diarrhea, even if delayed diarrhea occurred in previous treatment cycles.

Fever

A body temperature above 38°C may be a sign of infection, especially if it occurs at the same time as diarrhea. If you have a fever above 38°C, you should immediately contact your doctor or the hospital department for proper treatment.

Nausea and vomiting

If you experience nausea and/or vomiting, you should immediately contact your doctor or the hospital department. Before starting treatment, your doctor may give you a medicine to prevent nausea and vomiting. Your doctor will likely prescribe anti-nausea medicines that you can take at home. You should have these medicines readily available in case you need them. You should contact your doctor if you are unable to take fluids orally due to nausea and vomiting.

Neutropenia

Irinotecan Accord may also cause a decrease in the number of white blood cells that are important for fighting infections. This is neutropenia. Neutropenia is often observed during treatment with Irinotecan Accord and is reversible. Your doctor should order regular blood tests to check your white blood cell count. Neutropenia is a serious side effect and should be treated and closely monitored immediately. You should immediately inform your doctor or nurse if you experience any signs of infection, such as fever (38°C or higher), chills, pain when urinating, coughing, or expectorating sputum. You should avoid being near people who are sick or have an infection. You should immediately inform your doctor if you experience signs of infection.

Blood monitoring

Your doctor will likely perform blood tests before and during treatment to check the effect of the medicine on your blood cell count or blood composition. The test results may show the need to use medicines that can help treat these reactions. Your doctor may also reduce or delay the next dose of this medicine or even stop treatment. You should attend all scheduled doctor's appointments and laboratory tests.
This medicine may decrease the number of platelets in your blood within the first few weeks after administration, which can increase the risk of bleeding. You should consult your doctor before taking any medicines or supplements that may affect your ability to stop bleeding, such as acetylsalicylic acid or medicines containing acetylsalicylic acid, warfarin, or vitamin E. You should inform your doctor if you experience unusual bruising or bleeding, such as nosebleeds, bleeding gums when brushing your teeth, or black, tarry stools.

Respiratory disorders

In patients taking this medicine, serious lung problems have been observed in rare cases. You should immediately inform your doctor about the onset or worsening of cough, difficulty breathing, and fever. To address these problems, your doctor may need to interrupt treatment.
This medicine may increase the risk of large blood clots in the veins of the legs or lungs, which can travel to other parts of the body, such as the lungs or brain. You should immediately inform your doctor if you experience chest pain, shortness of breath, or swelling, pain, redness, or a feeling of warmth in your arm or leg.

Chronic intestinal inflammation and/or bowel obstruction

You should inform your doctor if you experience abdominal pain and are unable to have a bowel movement, especially if you also experience bloating and loss of appetite.

Radiation therapy

If you have recently undergone radiation therapy to the pelvis or abdomen, there may be an increased risk of bone marrow suppression. You should consult your doctor before starting treatment with Irinotecan Accord.

Kidney function

Disorders of kidney function have been reported.

Heart disorders

You should inform your doctor if you have or have had heart disease or have previously taken anticancer medicines. Your doctor will closely monitor you and discuss with you how to reduce risk factors (e.g., smoking, high blood pressure, and high fat content in the diet).

Vascular disorders

Irinotecan Accord is rarely associated with vascular disorders (blood clots in the veins of the legs and lungs); these can occur rarely in patients with multiple risk factors.

Liver function disorders

Before starting treatment with Irinotecan Accord and before each subsequent treatment cycle, you should have your liver function checked (blood tests).

Other

This medicine may cause mouth sores or sores on the lips, often within the first few weeks after starting treatment. This can cause pain in the mouth, bleeding, and even problems with eating. Your doctor or nurse may suggest ways to reduce these problems, such as changing your diet or brushing your teeth. If necessary, your doctor may prescribe a medicine to reduce pain.
Information on contraception, pregnancy, breastfeeding, and fertility can be found below in the section "Contraception, pregnancy, breastfeeding, and fertility".
If you are planning surgery or another procedure, you should tell your doctor or dentist that you are taking this medicine, as it may affect the action of some medicines used during the procedure.
If this medicine is used in combination with other anticancer medicines, you should make sure you have read the patient information leaflet for the other anticancer medicine.
If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Irinotecan Accord and other medicines

You should tell your doctor or hospital pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription. This includes herbal medicines, strong vitamin preparations, and mineral supplements.
Medicines used to treat epilepsy (carbamazepine, phenobarbital, phenytoin, and fosphenytoin);

• Medicines used to treat fungal infections (ketoconazole, itraconazole, voriconazole, and posaconazole);
• Medicines used to treat bacterial infections (clarithromycin, erythromycin, and telithromycin);
• Medicines used to treat tuberculosis (rifampicin and rifabutin);
• St. John's Wort (a herbal dietary supplement);
• Live, attenuated vaccines;
• Medicines used to treat HIV 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 anesthesia and surgery (suxamethonium);
• 5-fluorouracil/folinic acid;
• Bevacizumab (a vascular endothelial growth factor inhibitor);
• Cetuximab (an epidermal growth factor receptor inhibitor).

Before administering Irinotecan Accord, you should tell your doctor, pharmacist, or nurse if you are currently or have recently undergone chemotherapy (and radiation therapy).
If you are going to have surgery, you should inform your doctor or anesthesiologist that you are taking this medicine, as it may affect the action of some medicines used during the procedure.
You should not start or stop taking any medicines during treatment with Irinotecan Accord without consulting your doctor first.
This medicine can cause severe diarrhea. While taking this medicine, you should avoid laxatives and stool softeners.
It is possible that other medicines may also interact with Irinotecan Accord. You should consult your doctor, pharmacist, or nurse to check if other medicines, herbal preparations, and supplements, as well as alcohol, may interact with this medicine.

Contraception, pregnancy, breastfeeding, and fertility

Contraception
Women of childbearing age must use effective contraception during and up to 6 months after the end of treatment.
Men must use effective contraception during and up to 3 months after the end of treatment. It is essential to consult your doctor about what 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, your doctor will ensure that you are not pregnant.
If you are pregnant, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Breastfeeding
Irinotecan and its metabolite pass into breast milk.
You should not breastfeed while taking Irinotecan Accord.
Before taking any medicine, you should consult your doctor or pharmacist.
Fertility
No studies have been conducted on the effects on fertility, but this medicine may affect fertility. Before taking this medicine, you should consult your doctor about the possible risks associated with taking this medicine and the possibilities that can protect you so that you can have children in the future.

Driving and using machines

In some cases, Irinotecan Accord may cause side effects that can affect your ability to drive and use machines or equipment.
In case of doubt, you should consult your doctor or pharmacist.
During the first 24 hours after administration of Irinotecan Accord, dizziness and visual disturbances may occur. If you experience these symptoms, you should not drive or operate any machines or equipment.

Important information about some of the ingredients of Irinotecan Accord

Irinotecan Accord contains 45 mg of sorbitol per ml. Sorbitol is a source of fructose. You should not take this medicine if you have a rare genetic disorder, hereditary fructose intolerance. Patients with hereditary fructose intolerance cannot metabolize fructose, which can cause serious side effects.
You should inform your doctor before taking this medicine if you or your child have hereditary fructose intolerance or if your child cannot tolerate sweet foods or drinks due to nausea, vomiting, or unpleasant reactions, such as bloating, stomach cramps, or diarrhea.
This medicine contains less than 1 mmol of sodium (23 mg) per vial, which means the medicine is "sodium-free".

3. How to take Irinotecan Accord

You should always take this medicine exactly as your doctor has told you. If you are unsure, you should ask your doctor.
Irinotecan Accord is administered by medical professionals.
Your doctor may recommend a DNA test before taking the first dose of Irinotecan Accord.
Some people are genetically more prone to experiencing certain side effects.
While taking Irinotecan Accord, you may receive other medicines to prevent nausea, vomiting, diarrhea, and other side effects. You may need to take these medicines for at least one day after administration of Irinotecan Accord.
If you experience burning, pain, or swelling at the injection site after administration of Irinotecan Accord, you should inform the medical staff. If the medicine leaks out of the vein, it can cause tissue damage. If you experience pain, redness, or swelling at the injection site during administration of Irinotecan Accord, you should immediately inform your doctor.
Irinotecan Accord is administered as an intravenous infusion lasting from 30 to 90 minutes. The infusion rate depends on your age, body surface area, and general condition. The dose also depends on other anticancer medicines used in treatment. Your doctor will calculate your body surface area in square meters (m²).

• If you have been previously treated with 5-fluorouracil, you will receive standard treatment with Irinotecan Accord alone at an initial dose of 350 mg/m², administered every three weeks.
• If you have not been previously treated with chemotherapy, you will receive a dose of 180 mg/m² of Irinotecan Accord every two weeks. Then, you will receive folinic acid and 5-fluorouracil.
• If you are taking Irinotecan Accord in combination with cetuximab, you will receive the same dose of irinotecan as you had in the previous cycles of irinotecan treatment. Irinotecan Accord should not be administered until at least one hour after the end of the cetuximab infusion.

The dosage may be modified by your doctor depending on your condition and observed side effects.

Taking a higher dose of Irinotecan Accord than recommended

It is unlikely that you will receive too high a dose of Irinotecan Accord. However, if this happens, you may experience severe blood disorders and diarrhea. You will receive appropriate supportive treatment to prevent dehydration due to diarrhea and treatment of complications related to infections. You should consult your doctor.

Missing a dose of Irinotecan Accord

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

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 the section "Warnings and precautions".
If you experience any of the following side effects after taking the medicine, you should immediately inform your doctor. If you are not in the hospital, you should go there immediately.

• Allergic reactions. If you experience wheezing, difficulty breathing, swelling, rash, or itching (especially affecting the whole body), you should immediately contact your doctor or nurse.
• Severe allergic reactions (anaphylactic and/or pseudoanaphylactic reactions) may occur most frequently within a few minutes after administration: skin rash, including redness and itching of the skin, swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and a feeling of impending fainting.
• Diarrhea (see section 2).
• Early diarrhea: occurs within 24 hours after taking the medicine, with symptoms such as runny nose, increased salivation, lacrimation, sweating, flushing, abdominal cramps, and diarrhea. This reaction may occur during administration of the medicine. In this case, you should immediately inform the medical staff. Medicines can be administered to stop and/or reduce these symptoms.
• Delayed diarrhea: occurs later than 24 hours after administration of the medicine. Due to the possibility of dehydration and electrolyte imbalances caused by diarrhea, it is essential to be in contact with healthcare professionals to monitor your condition and receive recommendations for medicines and dietary changes.

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

• Blood disorders: neutropenia (decrease in white blood cell count), thrombocytopenia (decrease in platelet count), anemia
• Delayed diarrhea
• Nausea and vomiting
• Hair loss (hair grows back 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 diarrhea and other symptoms such as abdominal pain, flushing, pain, itching and lacrimation of the eyes (conjunctivitis), runny nose, low blood pressure, vasodilation, excessive sweating, chills, feeling of general discomfort and illness, dizziness, visual disturbances, miosis, lacrimation, 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 a certain type of white blood cell
• Dehydration, mainly associated with diarrhea and/or vomiting
• Constipation
• Fatigue
• Increased liver enzyme activity and creatinine levels in the blood

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), you should immediately contact your doctor or nurse.
• Mild skin reactions, mild reactions at the infusion site
• Breathing difficulties
• Lung disease (interstitial lung disease)
• Bowel obstruction
• Abdominal pain and inflammation causing diarrhea (pseudomembranous colitis)
• Rare cases of kidney failure, low blood pressure, or cardiovascular 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 and/or pseudoanaphylactic reactions) may occur most frequently within a few minutes after administration: skin rash, including redness and itching of the skin, swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and a feeling of impending fainting. If you experience these symptoms, you should immediately inform your doctor.
• Early effects, such as muscle spasms or cramps and numbness (paresthesia)
• Gastrointestinal bleeding and colitis, including appendicitis
• Perforation of the intestine, loss of appetite, abdominal pain, inflammation of the mucous membranes
• Pancreatitis
• Increased blood pressure during and after infusion
• Decreased potassium and sodium levels in the blood, mainly associated with diarrhea and vomiting

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

• Transient speech disturbances
• Increased activity of certain enzymes in the digestive system that break down sugars and fats

Frequency not known (cannot be estimated from the available data)

• Severe, persistent, or bloody diarrhea (which may be associated with abdominal pain or fever) caused by bacteria (Clostridium difficile)
• Blood infection
• Dehydration (due to diarrhea and vomiting)
• Dizziness, rapid heartbeat, and paleness (a condition called hypovolemia)
• Allergic reaction
• Transient speech disturbances during or shortly after treatment
• Feeling of tingling or numbness
• High blood pressure (during or after infusion)
• Heart problems*
• Lung disease causing wheezing and shortness of breath (see section 2)
• Hiccup
• Bowel obstruction
• Intestinal enlargement
• Gastrointestinal bleeding
• Colitis
• Abnormal laboratory test results
• Perforation of the intestine
• Fatty liver
• Skin reactions
• Reactions at the infusion site
• Low potassium levels in the blood
• Low sodium levels in the blood, mainly associated with diarrhea and vomiting
• Muscle cramps
• Kidney problems*
• Low blood pressure*
• Fungal infections
• Viral infections.

* Rare cases of these side effects have been observed in patients who experienced episodes of dehydration associated with diarrhea and/or vomiting or blood infections.
If Irinotecan Accord is used in combination with cetuximab, some side effects that you may experience may be related to the use of this combination therapy. These side effects may include acne-like rash. You should read the patient information leaflet for cetuximab.
If Irinotecan Accord is used in combination with capecitabine, some side effects that you may experience may be related to the use of this combination therapy. These side effects may include very common - blood clots, common - allergic reactions, and heart attack and fever in patients with reduced white blood cell count. For this reason, you should read the patient information leaflet for capecitabine.
If Irinotecan Accord is used in combination with capecitabine and bevacizumab, some side effects that you may experience may be related to the use of this combination therapy. These side effects may include reduced white blood cell count, blood clots, decreased blood pressure, and heart attack. For this reason, you should read the patient information leaflets for capecitabine and bevacizumab.
If any of the side effects get worse or if you experience any side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should consult your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irinotecan Accord

Keep the medicine out of the sight and reach of children.
Do not freeze.
For single use only.
No special storage temperature instructions.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Irinotecan Accord contains

• The active substance is irinotecan hydrochloride trihydrate.
• 1 ml of the concentrate contains 20 mg of irinotecan hydrochloride trihydrate, which corresponds 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
• The 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, pale 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 authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens Lamia
32009 Schimatari
Greece

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:

Date of last revision of the leaflet: February 2025

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

The following information is intended for medical professionals or healthcare workers only

Instructions for use - Cytotoxic drug Handling of Irinotecan Accord

Similarly to other anticancer drugs, caution should be exercised when preparing and administering Irinotecan Accord. Dilution should be carried out under aseptic conditions by trained personnel in a designated area. Precautions should be taken to avoid skin and mucous membrane contact. Guidelines for safe handling of Irinotecan Accord, solution for infusion

• 1. A protective cabinet and protective gloves and clothing should be used. If a protective cabinet is not available, a mask and protective goggles should be worn.
• 2. Opened containers, such as vials and infusion bottles, and used cannulas, syringes, catheters, tubes, and cytostatic residues should be treated as hazardous waste and disposed of in accordance with local guidelines for the disposal of HAZARDOUS WASTE.
• 3. In the event of spillage, the following instructions should be followed:
• Protective clothing should be worn.
• Broken glass should be collected and placed in a container intended for HAZARDOUS WASTE.
• Contaminated surfaces should be thoroughly rinsed with a large amount of cold water.
• Rinsed surfaces should be thoroughly wiped, and the materials used for wiping should be removed as HAZARDOUS WASTE.
• 4. If Irinotecan Accord comes into contact with the skin, the area should be rinsed with a large amount of running water and then washed with soap and water. If contact occurs with mucous membranes, the area should be carefully rinsed with water. If any discomfort occurs, a doctor should be consulted.
• 5. If Irinotecan Accord comes into contact with the eyes, they should be rinsed thoroughly with water. An ophthalmologist should be consulted immediately.

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 injection solution or 5% glucose infusion solution. The required amount of Irinotecan Accord should be aseptically withdrawn from the vial using a calibrated syringe and injected into a 250 ml infusion bag or bottle. The prepared infusion solution should be thoroughly mixed by manual rotation.
The product should be diluted and used immediately after opening.
Physical-chemical stability of the solution stored in LDPE or PWC containers diluted in 0.9% sodium chloride solution (0.9% w/v) or 5% glucose solution for 28 days, at a temperature of up to 5°C or 25°C under light protection conditions, has been demonstrated.
The diluted solution may be stored for up to 3 days after exposure to light.
From a microbiological point of view, the diluted solution should be used immediately. If the solution is not used immediately, the user is responsible for the storage time and conditions before administration. The storage period should not exceed 24 hours at a temperature of 2°C to 8°C, unless the solution has been reconstituted/diluted under controlled and verified aseptic conditions.
If a precipitate is visible in the vials or after dissolution, the product should be discarded according to the standard procedure for cytotoxic drugs.
Irinotecan Accord should not be administered as an intravenous bolus or intravenous infusion lasting less than 30 minutes or more than 90 minutes.
Disposal
All materials used for the preparation and administration of the drug and coming into contact with Irinotecan Accord should be disposed of in accordance with local guidelines for the handling of cytotoxic substances.