Idarubicin Accord

Leaflet attached to the packaging: patient information

Idarubicin Accord, 5 mg/5 ml, solution for injection

Idarubicin Accord, 10 mg/10 ml, solution for injection

Idarubicin Accord, 20 mg/20 ml, solution for injection

Idarubicin hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Idarubicin Accord belongs to a group of medicines called cytotoxic and antimitotic agents, which bind to DNA and interact with topoisomerase II, exerting an inhibitory effect on nucleic acid synthesis.

Idarubicin Accord is used to treat:

Adults:

• Acute myeloid leukemia, to induce remission in untreated patients or patients with relapse or resistance to treatment.
• Acute lymphoblastic leukemia - as a second-line treatment.

Children:

• As first-line treatment for acute myeloid leukemia, in combination with cytarabine, to induce remission.
• Acute lymphoblastic leukemia, as a second-line treatment.

Idarubicin Accord may also be used in combination with other anticancer medicines.

2. Important information before using Idarubicin Accord

When not to use Idarubicin Accord:

Warnings and precautions

Before starting treatment with Idarubicin Accord, consult your doctor, pharmacist, or nurse:

• this medicine may cause vomiting, oral mucositis, and gastrointestinal mucositis;
• reactions at the injection site may occur;
• as with other cytotoxic agents, phlebitis with thrombosis may occur;
• in men, idarubicin may cause irreversible infertility;

Idarubicin should only be used under the supervision of a doctor experienced in the use of cytotoxic chemotherapy.

The medicine may cause a red discoloration of the urine for 1 to 2 days after administration.

Before and during treatment with Idarubicin Accord, regular blood tests, liver, kidney, and heart function tests should be performed. It appears that infants and children are more sensitive to the toxic effects of anthracyclines on the heart, so these patients should undergo long-term, periodic monitoring of heart function.

Idarubicin Accord and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Idarubicin is mainly used in combination with other cytotoxic agents, so cumulative toxicity may occur, especially with regard to bone marrow, blood, and the gastrointestinal tract. The risk of cardiotoxicity may be increased in patients who have received other cardiotoxic agents at the same time.

Since idarubicin is extensively metabolized in the liver, liver function disorders caused by other medicines may affect the metabolism, pharmacokinetic properties, therapeutic efficacy, and/or toxicity of idarubicin.

Anthracyclines, including idarubicin, should not be used in combination with other cardiotoxic agents unless heart function is carefully monitored.

In the case of concurrent use of oral anticoagulants and anticancer chemotherapy, it is recommended to increase the frequency of monitoring the international normalized ratio (INR).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Men treated with idarubicin must use effective contraception for up to 3 months after the end of treatment.

There are no adequate, controlled studies in pregnant women. Idarubicin may be used during pregnancy only when the potential benefits justify the possible risk to the fetus.

Breastfeeding

It is not known whether idarubicin passes into breast milk. Since many medicines pass into breast milk, mothers should stop breastfeeding before starting treatment.

Driving and using machines

No systematic evaluation of the effect of idarubicin on the ability to drive and use machines has been performed.

Idarubicin Accord contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per vial, which means the medicine is considered "sodium-free".

3. How to use Idarubicin Accord

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The dose is usually calculated based on body surface area (mg/m2). The medicine is usually administered intravenously.

Acute myeloid leukemia

Adults: The recommended dose for the treatment of acute myeloid leukemia is 12 mg/m2 per day, administered intravenously for 3 days, in combination with cytarabine.

Children: The recommended dose is 10-12 mg/m2 per day, administered intravenously for 3 days, in combination with cytarabine.

Acute lymphoblastic leukemia

Adults: The recommended dose for the treatment of acute lymphoblastic leukemia is 12 mg/m2 per day, administered intravenously for 3 days.

Children: The recommended dose is 10 mg/m2 per day, administered intravenously for 3 days.

If the patient receives a higher dose of Idarubicin Accord than recommended

Very high doses of idarubicin may cause acute toxic effects on the heart muscle within the first 24 hours and severe bone marrow suppression within one to two weeks.

Delayed heart failure has been observed after anthracycline overdose, which occurred up to several months after the overdose.

Missing a dose of Idarubicin Accord

Do not take a double dose to make up for a missed dose.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that may occur very frequently: infections; reduction in the number of circulating red blood cells, white blood cells, and platelets; significant reduction or loss of appetite; nausea, vomiting, diarrhea, abdominal pain, burning sensation, oral mucositis; hair loss; red discoloration of urine 1-2 days after administration; fever, headache, and chills.

Side effects that may occur frequently: increased or decreased heart rate, increased and irregular heart rhythm, heart function disorders, phlebitis, phlebitis with thrombosis, bleeding, gastrointestinal bleeding, abdominal pain, increased liver enzyme activity and bilirubin levels, skin rash, itching, hypersensitivity of irradiated skin.

Side effects that may occur infrequently: generalized infection, secondary leukemia, increased uric acid levels in the blood, ECG abnormalities, shock, esophagitis, colitis, skin and nail discoloration, connective tissue inflammation, tissue necrosis.

Side effects that may occur rarely: cerebral hemorrhage.

Side effects that may occur very rarely: severe allergic reaction, heart infection and other disorders, vascular occlusion, redness, ulcerative disease, skin redness, especially of the limbs.

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 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 Idarubicin Accord

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

Do not use this medicine after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of the month stated.

Store in a refrigerator (2°C - 8°C). Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. 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 Idarubicin Accord contains:

The active substance is idarubicin hydrochloride.

One ml of the solution contains 1 mg of idarubicin hydrochloride.

Each vial containing 5 ml of the solution contains 5 mg of idarubicin hydrochloride.

Each vial containing 10 ml of the solution contains 10 mg of idarubicin hydrochloride.

Each vial containing 20 ml of the solution contains 20 mg of idarubicin hydrochloride.

The other ingredients are: glycerol, hydrochloric acid, sodium hydroxide (to adjust pH), water for injections.

What Idarubicin Accord looks like and what the pack contains:

A clear, orange-red solution, without visible solid particles.

A vial made of colorless glass type I contains a ready-to-use solution for injection containing 5 mg, 10 mg, or 20 mg of idarubicin hydrochloride.

The packaging contains 1 vial of 5 ml, 10 ml, or 20 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warsaw

Tel: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

95-200 Pabianice

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: November 2023

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS:

MEDICAL:

This medicine is intended for intravenous administration.

Incompatibilities:

Prolonged contact with any solution with a basic pH should be avoided, as it may lead to degradation of the medicine. Idarubicin hydrochloride should not be mixed with heparin, as a precipitate may form. Mixing with other medicines is not recommended. Idarubicin Accord is intended for single use, and any remaining medicine should be discarded.

The ready-to-use solution of Idarubicin Accord should be administered intravenously only through an infusion line, in a freely flowing intravenous infusion of 0.9% sodium chloride solution, over 5 to 10 minutes. This method minimizes the risk of thrombophlebitis or perivenous extravasation, which may lead to severe connective tissue inflammation and tissue necrosis.

Injection into small veins or multiple injections into the same vessel may cause vein hardening.

Due to the toxic properties of this substance, the following precautions should be taken:

• Personnel must be trained in the proper handling of the product.
• Pregnant women should be excluded from working with this medicine.
• Personnel preparing the medicine must wear protective clothing: single-use protective glasses, gowns, gloves, and masks.
• The work surface should be established in a room with a vertical laminar flow hood. The surface should be protected with a absorbent pad covered with foil.
• All items used for administration or cleaning, including gloves, should be placed in containers for high-risk products, intended for incineration at high temperatures.

Spilled solution should be diluted with a diluted sodium hypochlorite solution (1% chlorine), then water.

All materials used for cleaning should be disposed of as described above.

In case of accidental contact of the medicine with the skin or eyes, they should be rinsed immediately with water or soap and water or a solution of sodium bicarbonate; medical attention may be necessary. Unused solution should be discarded.