Leaflet: information for the user

Idarubicina Sandoz 1 mg/ml concentrate for infusion solution

Idarubicina, hydrochloride

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult yourdoctor, pharmacist or nurse.
• If you experience any side effects,consult your doctor, pharmacist or nurse, evenif they do not appear in this leaflet. See section 4.

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

2. What you need to know before you start using Idarubicina Sandoz

3. How to use Idarubicina Sandoz

4. Possible side effects

5. Storage of Idarubicina Sandoz

6. Contents of the pack and additional information

Idarubicina Sandoz contains an active ingredient called idarubicina, which belongs to a group of medicines called anthracyclines. Idarubicina interferes with the way body cells grow and increase in number and is used in the treatment of some cancers (chemotherapy).

Idarubicina is used in the treatment of different types of leukemia (white blood cell cancer).

Idarubicina, in combination with cytarabine, is used in the induction of remission as first-line therapy in children with acute myeloid leukemia (AML) not previously treated.

Do not use Idarubicina Sandoz if:

-You have had any allergic reaction (hypersensitivity) to idarubicina or to any of the other components of this medication (listed in section 6), or to other anthracyclines or anthracenediones,

-Your liver or kidneys do not function properly,

-You have uncontrolled infections,

-You have severe muscle heart problems (cardiomyopathy),

-You have an acute inflammatory heart disease,

-You have a severe heart disease,

-You have severe abnormal heart rhythms,

-You have recently had a heart attack,

-Your bone marrow is not producing enough blood cells (although in this case your doctor will decide to start treatment if the benefit for you outweighs the risk),

-You have received previous treatment with maximum doses of idarubicina and/or other similar anticancer medications such as daunorubicina or doxorubicina,

-You are prone to bleeding,

-You have mouth inflammation,

-You are breastfeeding your child (see “Pregnancy, breastfeeding and fertility”),

-You have recently been vaccinated against yellow fever.

Warnings and precautions

Consult your doctor, pharmacist or nurse before using idarubicina if:

• Suffer frombone marrow depressioncaused by previous treatment. Idarubicina may affect your bone marrow and not produce enough blood cells. Your doctor may want to delay the next cycle of your treatment until your blood has recovered. Regular blood tests will be performed to check this.

• Have hadheart problemsin the past or are currently receiving treatment for them; please ensure your doctor is aware of them. Idarubicina may cause heart damage. Your heart function will be checked through various tests before and during treatment (ECG, MUGA scan [special imaging technique that shows the veins] or ECHO [ultrasound of the heart]). Heart damage with idarubicina may occur especially with high doses, and may not be detected for several weeks, so regular tests are required during this period.

• Havekidney or liver problems. Your kidney and liver function may be damaged by idarubicina. To control these changes, your blood will be analyzed before and periodically during treatment. It is essential that you do not lose these blood tests.

Regular blood tests, liver, kidney and heart checks will be performed before and during idarubicina treatment. Infants and children appear to be more sensitive to anthracycline cardiotoxicity; therefore, regular and long-term checks are necessary in these patients.

Your doctor will perform regular checks such as:

-Blood tests to ensure there are enough blood cells for blood function,

-Blood tests to check uric acid levels,

-Blood tests to check if your kidneys and liver are functioning correctly,

-Heart tests as idarubicina may affect your heart.

Based on the results of these tests, your doctor should decide whether idarubicina is not suitable for your treatment or if a reduced dose is needed.

High doses of idarubicina may worsen adverse effects such as mouth sores or decrease the number of blood cells and platelets (these help blood to clot). If this occurs, you may need antibiotics or blood transfusions. Mouth sores can be treated and made less uncomfortable.

You should not receive live vaccines (e.g., yellow fever) as they may cause severe or even life-threatening infections. Please consult your doctor if you wish to be vaccinated.

If you have an infection, it should be controlled before starting treatment.

Idarubicina may harm the fetus. Both women and men should use suitable contraceptive methods during idarubicina treatment (see “Pregnancy, breastfeeding and fertility”).

Your urine may be red for 1 or 2 days after idarubicina treatment. Please consult your doctor if you have any doubts or are concerned about the color of your urine.

Please also consult your doctor if you are receiving radiation therapy at the same time or have received it 2 or 3 weeks before starting treatment.

Other medications and Idarubicina Sandoz

Inform your doctor or pharmacist if you are using or have used recently or may need to use other medications, even those purchased without a prescription.

Particularly inform your doctor or pharmacist if you are using or have used recently any of the following medications:

-Medications against cancer that affect bone marrow function,

-Medications that affect kidney and/or liver function,

-Medications that may damage the heart (e.g., cyclophosphamide),

-Medications for a pre-existing heart disease (calcium channel blockers),

-Any vaccine received in the last few months,

-Immunosuppressive medications (e.g., cyclosporine or tacrolimus),

-Medications to prevent blood clotting (e.g., phenprocoumon or acenocoumarol).

Pregnancy, breastfeeding and fertility

Do notbe treated with idarubicina unless clearly indicated by your doctor. Inform your doctor if you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant. Your doctor will need to consider the possible risks for you or your child.

Avoid becoming pregnant while you or your partner are being treated with idarubicina. If you are sexually active, you should use effective contraceptive methods to avoid pregnancy. Idarubicina may harm the fetus, so it is essential to inform your doctor if you think you may be pregnant.

Contraception in fertile women

You should always use an effective contraceptive method while receiving idarubicina and for at least 6.5 months after the last dose. Discuss suitable contraceptive methods with your doctor.

Contraception in men

Men should always use effective contraceptive methods while receiving idarubicina and for at least 3.5 months after the last dose.

If you wish to have children after completing treatment, please consult your doctor for advice on available genetic techniques.

Idarubicina treatment may cause irreversible infertility in men. Discuss sperm conservation with your doctor if you wish to father a child in the future.

You should not breastfeed during idarubicina treatment, as some amount of the medication may pass into the milk and potentially harm your baby.

Consult your doctor or pharmacist before starting any medication.

Driving and operating machinery

No studies have been conducted on the effects of idarubicina on driving and operating machinery.

Please consult your doctor before driving or operating machinery.

Idarubicina will be administered to you by intravenous infusion (IV drip):

-Your doctor will prescribe the required amount (dose). The dose will be determined based on your overall health, weight, and height.

-Your doctor will calculate your body surface area based on your weight and height. This is necessary because the dose is normally calculated as “milligrams per square meter” (mg/m2), administered over 3 consecutive days.

-However, your doctor must adjust the dose based on your overall condition and any other treatment you are receiving.

LMA

• If the child is receiving idarubicin hydrochloride, in addition to another leukemia medication (citarabine), the recommended dose is in the range of 10-12 mg/m2, administered slowly into a vein once a day for 3 consecutive days. This is repeated every 3 weeks.

Like all medicines, Idarubicina Sandoz may cause side effects, although not everyone will experience them.

Consult your doctor or nurse immediately:

• if you experience a stinging or burning sensation at the site where the medicine is administered into a vein while you are receiving idarubicina. This may mean that the rest of the dose should be administered in another vein,
• if you have chills (like the flu) or skin rashes, you may be allergic to one of your medications,
• if you have a sore throat or fever after treatment or any bleeding or bruising, it may be due to the medicine reducing the number of blood cells.

Side effects that may appear with the following frequencies:

Very common side effects(may affect more than 1 in 10 patients)

-infections,

-decrease in the number of the following blood cells:

• decrease in red blood cells(anemia) that may make you feel tired and drowsy,
• decrease in white blood cells(leucopenia or neutropenia) increasing the risk of infections, fever, and chills (like the flu).

Severe infections may occur after treatment with idarubicina alone or in combination and may be life-threatening,

• decrease in platelets(thrombocytopenia), which may cause bruising or bleeding more easily or bleeding more than usual if you get a cut,

-reduced number of all types of blood cells (pancytopenia),

-loss of appetite (anorexia),

• nausea, vomiting, or diarrhea,

-mouth pain or ulcers (stomatitis), which may not appear until 3-10 days after treatment,

-inflammation of mucous membranes (mucositis),

-abdominal pain,

-burning sensation,

-hair loss, which may be temporary and regrow after treatment ends,

-burning or stinging sensation at the injection site (local toxicity),

-red or orange urine that may appear for a few days after treatment. This is normal and should not worry you,

-fever and chills,

-headache.

Common side effects(may affect up to 1 in 10 patients)

-heart failure (insufficient heart function),

-heart muscle damage (cardiomyopathies), characterized by shortness of breath, swelling of the lungs, swelling that changes location depending on the body position, heart enlargement, and liver enlargement, decreased urine production, abdominal fluid retention, pleural effusion, abnormal heart rhythm (gallop rhythm),

-cardiac lesions and irregularities (abnormal heart rhythm, slow or fast heart rate, changes in rhythm, ineffective heart function),

-inflammation of the veins where the infusion is administered (phlebitis),

-inflammation of the veins due to a blood clot (thrombophlebitis) or bleeding in different areas (hemorrhage),

-bleeding in the stomach or intestines,

-itching,

-skin that has been damaged by radiation may become very sensitive,

-increased liver enzymes and bilirubin (blood values),

-skin rash,

-abdominal pain.

Rare side effects(may affect up to 1 in 100 patients)

-blood poisoning (sepsis, septicemia),

-blood cancer after treatment ends (secondary leukemia),

-complications that may occur after cancer treatment produced by products of cell breakdown (tumor lysis syndrome),

-high levels of uric acid in the blood (may cause gout),

-dehydration,

-changes in the electrocardiogram (ECG),

-heart attack,

-shock,

-inflammation of the esophagus and intestines (may be severe and cause perforation),

-change in nail and skin color,

-itching,

-severe tissue damage (cellulitis and necrosis).

Very rare side effects(may affect up to 1 in 10,000 patients)

-bleeding in the brain,

Side effects of unknown frequency, the frequency cannot be estimated from available data.

-local reaction at the injection site.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

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

Keep the vial in its original packaging to protect it from light.

The diluted solution is chemically stable when stored for up to 14 days at 2 °C-8 °C and at room temperature (20 °C-25 °C); however, it is recommended that in line with good pharmaceutical practices, the solution should not be stored for more than 24 hours at 2 °C-8 °C.

The medication does not contain any preservative. Therefore, if aseptic preparation cannot be guaranteed, the medication should be prepared before use and any remaining preparation should be discarded.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations for cytotoxic agents.

Composition of Idarubicina Sandoz

-The active ingredient is idarubicin hydrochloride. Each milliliter of concentrate for solution for infusion contains 1 mg of idarubicin hydrochloride.

Each vial of 5 ml contains 5 mg of idarubicin hydrochloride.

Each vial of 10 ml contains 10 mg of idarubicin hydrochloride.

Each vial of 20 ml contains 20 mg of idarubicin hydrochloride.

-The other components are glycerol, diluted hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injection.

Appearance of the product and contents of the pack

This medicine is presented as a concentrate for solution for infusion.

Clear, transparent solution of red to orange color, free of particles.

Colorless type I glass vial with a halobutilo rubber stopper coated with fluoropolymer, with or without a plastic protective coating (Onco-safe or Sleeving). The vials are sealed with an aluminum cap. “Onco-Safe” and Sleeving do not come into contact with the medicine and provide additional protection during transport, increasing the safety of medical and pharmaceutical personnel.

Pack sizes: 1x5mg/5ml, 5x5mg/5ml, 10x5mg/5ml, 1x10mg/10ml, 5x10mg/10ml, 10x10mg/10ml, 1x20mg/20ml, 5x20mg/20ml, 10x20mg/ml.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Ebewe Pharma Ges.m.b.H. Nfg. KG

Mondseestraße 11

4866 Unterach

Austria

or

Fareva Unterach GmbH

Mondseestraße 11

4866 Unterach

Austria

Last review date of this leaflet:02/2024.

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended only for doctors or healthcare professionals:

Special precautions for disposal and other manipulations

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

-Personnel handling this medicine should be instructed in safe handling techniques for these preparations.

-Pregnant women should be excluded from handling this medicine.

-Personnel handling idarubicin should wear protective clothing (e.g., protective glasses, aprons, gloves, and disposable masks).

-All handling should be done in a safety cabinet or isolated area.

-The working surface should be protected with absorbent, plasticized, and disposable paper.

-All materials used for reconstitution, administration, or cleaning, including gloves, should be disposed of in high-risk waste bags for destruction by high-temperature incineration.

-Any spills or leaks should be treated with diluted sodium hypochlorite solution (1% available chlorine), preferably by soaking, and then with water. Decolorization indicates loss of cytostatic potential.

-All cleaning materials should be disposed of as indicated above.

-In the event of accidental contact with the skin or eyes, it should be treated immediately with a thorough washing with water or soap and water or with a sodium bicarbonate solution.

-Discard unused solution.

-Idarubicina Sandoz is for single use only.

-Only transparent solutions should be used.

-Before administration, the solution should be tempered to room temperature.

-Do not prepare idarubicin more than 24 hours before administration.

-Be aware of the risk of bacterial contamination due to handling.

i.Intravenous administration

Idarubicina Sandoz should only be administered intravenously.

The infusion can be prepared by diluting Idarubicina Sandoz with sodium chloride 0.9% or glucose 5%.

Alternatively, the undiluted volume of product required can be administered slowly through an intravenous infusion system or by free intravenous infusion with sodium chloride 0.9% or glucose 5%.

Direct injection is not recommended due to the risk of extravasation, which can occur even with adequate return of blood by aspiration of the needle.

ii. Elimination

The elimination of unused medicine and all materials used for reconstitution, dilution, and administration should be carried out in accordance with the hospital's regulations on cytotoxic agents related to current legislation on the disposal of hazardous waste.

Incompatibilities

This medicine should not be mixed with other medicines except with sodium chloride 0.9% or glucose 5%.

Dosage and administration

Only by intravenous route.

Should not be used by intrathecal route.

The dose is usually calculated based on the body surface area.

Posology

Acute myeloid leukemia (AML)

Adults

• 12 mg/m2per day by intravenous route for 3 days in combination with cytarabine,

or

• 8 mg/m2per day by intravenous route for 5 days with or without combination.

Pediatric population

In children with AML, the recommended dose of idarubicin hydrochloride in combination with cytarabine is 10-12 mg/m2of body surface area per day for 3 days by intravenous injection.

NOTE:These are general guidelines. Consult individual protocols for exact dosing.

Do not exceed the maximum total dose of 120 mg/m2of body surface area.

Acute lymphoblastic leukemia (ALL)

Adults

The recommended dose in adults is 12 mg/m2per day by intravenous route for 3 days in combination regimens.

Pediatric population

10 mg/m2per day by intravenous route for 3 days in combination regimens.

However, these dosing schemes should take into account the patient's hematological status and the doses of other cytotoxic drugs used in combination.

Administration of a second dose should be delayed in patients who develop severe mucositis until recovery from this toxicity and a 25% dose reduction is recommended.

Do not exceed the maximum total dose of 120 mg/m2of body surface area.

Patients with hepatic and/or renal insufficiency

Dose adjustment may be required in patients with renal or hepatic insufficiency.

Shelf life

2 years.

Chemical and physical stability has been demonstrated in use for 14 days at 2 ºC-8 ºC and 25 ºC.

From a microbiological point of view, the medicine should be used immediately.

If not used immediately, the time and storage conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2 ºC-8 ºC, unless dilution takes place in controlled and validated aseptic conditions.

Special precautions for storage

Store in refrigerator (2 ºC-8 ºC).

Keep in the original packaging to protect it from light.