IDARUBICIN ACCORD 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Idarubicina Accord 1 mg/ml concentrate for solution for infusion EFG

Idarubicina hydrochloride

Read all of this leaflet carefully before you start using this medicine because 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

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

Idarubicina Accord belongs to a group of medicines known as cytotoxic and antimitotic agents, which intercalate with DNA and interact with topoisomerase II, resulting in inhibition of nucleic acid synthesis.

Idarubicina Accord is a medicine used for the treatment:

Adults

• Acute non-lymphocytic leukemia (ANLL) for induction of remission in previously untreated patients or for induction of remission in relapsed or refractory patients.
• Acute lymphocytic leukemia (ALL) as a second-line treatment.

Children

• Acute non-lymphocytic leukemia, in combination with cytarabine, for induction of remission in previously untreated patients.
• Acute lymphocytic leukemia as a second-line treatment.

Idarubicina Accord may also be used in combination with other anticancer agents.

2. What you need to know before you use Idarubicina Accord

Do not use Idarubicina Accord:

• if you are allergic to idarubicin or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other anthracyclines or anthracenediones,
• if you have an uncontrolled infection,
• if your liver or kidneys are not working properly
• if you have or have had bone marrow depression caused by previous treatments,
• if you have or have had heart disease,
• if you have or have had abnormal heart rhythms,
• if you have been previously treated with idarubicin hydrochloride and/or other anthracyclines or anthracenediones,
• if you are breast-feeding

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Idarubicina Accord

• if you have heart problems. Heart function should be evaluated before starting treatment with idarubicin and should be monitored during treatment to minimize the risk of incurring severe heart failure,
• if you have bone marrow depression due to previous treatments,
• if you have a marked and persistent increase in abnormal white blood cells in the blood. You may be developing leukemia,
• if you have had or have stomach problems (e.g. ulcer) or any intestinal problems,
• if you have liver problems,
• if you have kidney problems,
• this medicine may cause vomiting, you may develop inflammation of the oral mucosa or inflammation of the mucosa of the digestive tract,
• you may develop a reaction at the injection site,
• if there is extravasation during injection, you may feel pain and the extravasation may cause serious tissue damage. If there is extravasation, administration of the medicine should be discontinued immediately,
• as with other cytotoxics, inflammation of the walls of the veins may occur, with the formation of blood clots,
• if you have recently had or think you have been vaccinated,
• if you are a man, idarubicin may cause irreversible infertility.
• if you are taking or have recently taken trastuzumab (a medicine used to treat certain types of cancer). Trastuzumab may remain in the body for up to 7 months. Since trastuzumab may affect the heart, you should not use until 7 months after you have stopped taking it. If you use before this time, your heart function should be closely monitored.

Idarubicin should only be administered under the supervision of a doctor with experience in cytotoxic chemotherapy.

This medicine may cause a red coloration of the urine for one to two days after administration.

Before and during treatment with Idarubicina Accord, you should have regular blood, liver, kidney, and heart tests. Babies and children seem to have a greater sensitivity to anthracycline-induced cardiac toxicity. Therefore, in these patients, regular heart tests should be performed over a long period of time.

Other medicines and Idarubicina Accord

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Idarubicin is mainly used in combination with other cytotoxic agents and additive toxicity may occur, especially in relation to bone marrow, blood, and gastrointestinal systems. The risk of cardiac toxicity may increase in patients who have received other cardiotoxic medicines at the same time.

Since idarubicin is extensively metabolized by the liver, liver function impairments caused by other medicines may affect the metabolism of idarubicin, its pharmacokinetics, and its therapeutic efficacy and/or toxicity.

Anthracyclines, including idarubicin, should not be administered in combination with other cardiotoxic agents unless cardiac function is closely monitored.

In the case of combination with oral anticoagulants and anticancer chemotherapy, it is recommended to increase the frequency of monitoring of the International Normalized Ratio (INR).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Men undergoing treatment with idarubicin should use effective contraceptive methods for at least 3 months after treatment.

There are no controlled studies in pregnant women. Idarubicin should only be used during pregnancy if the benefits outweigh the potential risks to the fetus.

Breast-feeding

It is not known whether idarubicin is excreted in breast milk. As this occurs with many medicines, mothers should stop breast-feeding before starting treatment.

Driving and using machines

No studies have been performed on the effects of idarubicin on the ability to drive and use machines.

Idarubicina Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which is essentially "sodium-free".

3. How to use Idarubicina Accord

Follow exactly the instructions of administration indicated by your doctor. Ask your doctor or pharmacist if you have any doubts.

The dosage is normally calculated based on body surface area (mg/m2). Administration is normally intravenous.

Acute non-lymphocytic leukemia

Adults: In acute non-lymphocytic leukemia, the recommended dose is 12 mg/m2 daily by intravenous infusion for 3 days in combination with cytarabine. It may also be administered as a single agent and in combination at a dose of 8 mg/m2 daily by intravenous infusion for 5 days.

Children: The recommended dose range is 10-12 mg/m2 daily by intravenous infusion for 3 days in combination with cytarabine.

Acute lymphocytic leukemia

Adults: As a single agent, the recommended dose is 12 mg/m2 daily by intravenous infusion for 3 days.

Children: As a single agent, the recommended dose is 10 mg/m2 daily by intravenous infusion for 3 days.

All dosing regimens should take into account the patient's hematological status and the dosages of other cytotoxic medicines when used in combination.

If you receive more Idarubicina than you should

High doses of idarubicin may cause acute cardiac muscle toxicity within the first 24 hours and severe suppression of blood cell production by the bone marrow within one to two weeks.

Delayed anthracycline-induced heart failure has been observed several months after an overdose.

If you forget to use Idarubicina Accord

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Idarubicina Accord can cause side effects, although not everybody gets them.

The following side effects may occur very frequently:

• infections, decrease in the number of red blood cells, white blood cells, and platelets in the blood, marked reduction or loss of appetite, nausea, vomiting, diarrhea, abdominal pain, sensation of burning, inflammation of the mouth mucosa, hair loss, red coloration of the urine during 1-2 days after taking the medicine: fever, headache, and chills.

The following side effects may occur frequently:

• increased or decreased heart rate, increased or irregular heart rhythm, alteration of heart function, vein inflammation, vein inflammation associated with thrombosis, bleeding, gastrointestinal tract hemorrhage, stomach pain, increase in liver enzymes and bilirubin, skin rash, itching, skin hypersensitivity to radiation.

The following side effects may occur infrequently:

• generalized infection, secondary leukemia, increase in uric acid concentration in the blood, irregularities in the electrocardiogram, shock, esophagus inflammation, colon inflammation, skin and nail hyperpigmentation, cellulitis, tissue necrosis.

The following side effects may occur rarely:

• cerebral hemorrhage

The following side effects may occur very rarely:

• severe general allergic reaction, heart infection and other disorders, blood vessel occlusion, gastric ulcer, skin redness particularly on the extremities.

There have also been reports of pancytopenia, tumor lysis syndrome, and local reaction.

Reporting of side effects:

If you experience any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Idarubicina Accord

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

Keep the container in the outer carton to protect from light.

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and other information

Composition of Idarubicina Accord

• The active substance is idarubicin hydrochloride.
• 1 ml of solution contains 1 mg of idarubicin hydrochloride.
• Each 5 ml vial contains 5 mg of idarubicin hydrochloride.
• Each 10 ml vial contains 10 mg of idarubicin hydrochloride.
• Each 20 ml vial contains 20 mg of idarubicin hydrochloride.
• The other ingredients are: glycerol, concentrated hydrochloric acid, sodium hydroxide (for pH adjustment) and water for injections.

Appearance of the product and pack contents

Concentrate for solution for infusion.

Clear, orange-red solution, free from particles in suspension.

Each glass vial of type I contains concentrate for solution for infusion with 5 mg, 10 mg or 20 mg of idarubicin hydrochloride.

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, 6ª planta

08039 Barcelona

Spain

Manufacturer:

ACCORD HEALTHCARE POLSKA SP.Z.O.O.

ul. Lutomierska 50

95-200 Pabianice

Poland

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: November 2021

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

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This information is intended only for healthcare professionals:

This medicine is intended for intravenous administration.

Incompatibilities

Contact with any alkaline pH solution should be avoided, as it may lead to degradation of the drug. Idarubicin should not be mixed with heparin as it gives rise to the formation of a precipitate.

Idarubicina Accord is a single-use medicine and any remaining medicine should be discarded.

Administration of Idarubicina Accord should be only by intravenous route, diluted through an intravenous infusion system over which is passing during 5 to 10 minutes a solution of sodium chloride 0.9% or dextrose 5%. This technique minimizes the risk of thrombosis and perivascular extravasation that may lead to severe cellulitis and necrosis. Phlebosclerosis may result from injection into small veins or repeated injections into the same vein.

Due to the toxic nature of the compound, the following protection recommendations should be followed:

• Staff should be instructed in the correct handling techniques.
• Pregnant women should be excluded from handling this medicine.
• Staff handling idarubicin should wear protective clothing: protective glasses, gowns, gloves, and disposable masks.
• The work surface should be protected by a absorbent, plasticized, and disposable paper.
• All material used for administration or cleaning, including gloves, should be disposed of in high-risk residual material bags for destruction by high-temperature incineration.

Any spill or leak should be treated with diluted sodium hypochlorite solution (1% available chlorine) and then with water. All cleaning materials should be disposed of as indicated above.

In case of accidental contact with the skin or eyes, it should be treated immediately by washing with plenty of water or soap and water or with a sodium bicarbonate solution; medical attention may be required. Discard unused solution.