Doxorubicinum Accord

Leaflet attached to the packaging: information for the user

Doxorubicinum Accord, 2 mg/mL, concentrate for solution for infusion

Doxorubicin hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

Doxorubicin belongs to a group of medicines called anthracyclines. These medicines are also known as anticancer or chemotherapeutic medicines, or "chemo". They are used to treat various types of cancer, to delay or stop the growth of cancer cells. To achieve better results and reduce side effects, a combination of different anticancer medicines is often used.

Doxorubicinum Accord is used to treat the following types of cancer:

• breast cancer
• cancer of connective tissue, tendons, bones, and muscles (sarcoma)
• stomach or intestinal cancer
• lung cancer
• lymphomas - tumors of the immune system
• leukemia, a tumor that causes blood cell production disorders
• thyroid gland cancer
• advanced ovarian and uterine cancer (endometrial cancer or cancer of the uterus itself)
• bladder cancer
• advanced immature nerve cell tumor (neuroblastoma) (nerve cell cancer, usually occurring in children)
• malignant kidney tumor in children (Wilms tumor)
• myeloma (bone marrow cancer)

2. Important information before using Doxorubicinum Accord

When not to use Doxorubicinum Accord

• if you are allergic to doxorubicin hydrochloride or any of the other ingredients of this medicine (listed in section 6) or to another anthracycline,
• if you have a permanent decrease in the bone marrow's ability to produce blood cells (myelosuppression),
• if you have been previously treated with doxorubicin or similar chemotherapeutic agents, such as idarubicin, epirubicin, or daunorubicin, as previous treatment with these medicines may increase the risk of side effects associated with Doxorubicinum Accord,
• if you have any infection,
• if you have liver function disorders,
• if you have had a heart attack,
• if you have heart function disorders,
• if you have severe heart rhythm disorders (arrhythmia),
• if you are breastfeeding (see also the section "Pregnancy, breastfeeding, and fertility").

The medicine should not be administered through a catheter into the bladder (a thin, flexible tube) in the following cases:

• if you are allergic to doxorubicin hydrochloride or any of the other ingredients of this medicine (listed in section 6), anthracenediones, or other anthracyclines,
• if you have a tumor that infiltrates the bladder wall,
• if you have a urinary tract infection,
• if you have cystitis,
• if you have blood in your urine (hematuria),
• if you have difficulty inserting the catheter,
• if you are breastfeeding (see also the section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

If you have or have had any of the following conditions or diseases, you should inform your doctor:

• decreased blood cell production in the bone marrow,
• heart disease,
• liver disorders,
• kidney disorders.

You should also inform your doctor if:

• you have been previously treated with doxorubicin or any other similar anticancer medicine (anthracycline) used to treat cancer,
• you have been previously treated with radiation therapy to the upper part of your body.
• you are currently taking or have recently taken trastuzumab (a medicine used to treat certain tumors). Trastuzumab may remain in your body for up to 7 months. Because trastuzumab may affect the heart, doxorubicin should not be used for up to 7 months after stopping trastuzumab. If doxorubicin is used earlier, heart function should be closely monitored.

Before starting treatment with Doxorubicinum Accord and during treatment, your doctor will perform the following tests:

• blood morphology test,
• heart, liver, and kidney function tests.

During treatment with doxorubicin, the bone marrow may not produce enough blood cells and platelets, and their count may change; therefore, blood tests should be performed before and during each treatment. Due to a lack of blood cells and/or platelets, the following symptoms may occur: fever, infections, sepsis, bleeding, and tissue damage. If you experience fever, you should contact your doctor immediately. A rash along the vein into which the medicine is administered occurs frequently and may be followed by vein inflammation. Scarring or thickening of the vein wall may also occur, especially with repeated administration of the medicine into a small vein. If the medicine leaks out of the blood vessel into the surrounding tissues (extravasation), local pain, severe inflammation of the connective tissue, and tissue damage may occur. If you experience a burning sensation during injection, you should inform the nurse. The infusion should be stopped immediately and the needle reinserted into another vein. Your doctor will closely monitor your heart function during treatment, as doxorubicin may damage the heart muscle and lead to heart failure after administration of a certain cumulative dose (gradual administration of single doses).

• Doxorubicin may damage the heart muscle
• Treatment with doxorubicin may lead to heart failure after administration of a certain cumulative dose (gradual administration of single doses).
• In patients who have previously received medicines that may damage the heart muscle or have undergone radiation therapy to the upper part of the body, the risk of heart muscle damage is higher.

Generally, it is not recommended to use this medicine in combination with live, attenuated vaccines. You should avoid contact with people who have been recently vaccinated against polio. During treatment with doxorubicin, inflammation of the mucous membranes (mainly in the mouth, rarely in the esophagus) may occur, including symptoms such as pain or burning, rash, superficial ulceration of the mucous membrane (often on the entire surface of the tongue or under the tongue), bleeding, and infection. Any inflammation in the mouth usually appears soon after administration of the medicine, and in severe cases, it may develop into mucous membrane ulcers within a few days. In most cases, side effects resolve within 3 weeks of treatment. Nausea, vomiting, and sometimes diarrhea may occur. They can be prevented or alleviated with appropriate treatment prescribed by your doctor. Red discoloration of urine (which is normal and related to the color of the medicine). You should inform your doctor if this discoloration does not resolve within a few days or if you think your urine contains blood. You should inform your doctor if you experience any of these symptoms. Doxorubicin may cause fertility disorders and may damage reproductive cells. Both men and women must use effective contraception during treatment and for a period after completion of doxorubicin treatment (see the section "Pregnancy, breastfeeding, and fertility"). If a patient plans to become pregnant after treatment with doxorubicin, they should discuss genetic counseling and the possibility of preserving fertility with their doctor before starting treatment.

Skin reactions and hypersensitivity reactions:

• hair loss and inhibition of beard growth may occur. This side effect is usually temporary, and complete hair regrowth occurs within 2-3 months after completion of treatment.
• sudden redness, especially of the face, skin discoloration, and nail discoloration, as well as increased sensitivity to sunlight, may occur.
• in rare cases, allergic reactions (hypersensitivity) may occur; symptoms and signs of these reactions may include rash and itching (pruritus, urticaria), as well as fever, chills, and anaphylactic shock.

Doxorubicinum Accord and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Doxorubicinum Accord may interact with the following medicines:

• other cytostatic medicines (anticancer medicines), such as trastuzumab, anthracyclines (daunorubicin, epirubicin, idarubicin), cisplatin, cyclophosphamide, cyclosporine, cytarabine, dacarbazine, dactinomycin, fluorouracil, mitomycin C, taxanes (e.g., paclitaxel), mercaptopurine, methotrexate, and streptozocin
• cyclosporine may enhance the effect of doxorubicin and may cause prolonged reduction of bone marrow function and blood cell count (reports have also included coma and seizures during concomitant administration of cyclosporine and doxorubicin)
• cardioactive medicines (medicines used to treat heart diseases), such as calcium channel blockers, verapamil, and digoxin
• cytochrome P-450 inhibitors (medicines that inhibit the action of an important substance for detoxification of the body, cytochrome P-450: e.g., cimetidine), cytochrome P-450 inducers (e.g., rifampicin, barbiturates, including phenobarbital)
• antiepileptic medicines (e.g., carbamazepine, phenytoin, valproate)
• antipsychotic medicines: clozapine (a medicine used to treat schizophrenia)
• warfarin (an anticoagulant medicine)
• antiretroviral medicines (medicines used to treat certain viral infections)
• chloramphenicol and sulfonamides (medicines used to treat bacterial infections)
• amphotericin B (a medicine used to treat fungal diseases)
• vaccines containing live microorganisms (e.g., polio [spinal cord inflammation], malaria)
• certain medicines may affect the concentration and clinical effect of doxorubicin (e.g., St. John's wort)
• paclitaxel: may enhance the effect of doxorubicin.

Remember that this may also apply to medicines that have been used recently.

Pregnancy, breastfeeding, and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
In animal studies, it has been shown that doxorubicin crosses the placenta and damages the fetus.
If you are pregnant, your doctor will only prescribe doxorubicin if the benefits of treatment outweigh the potential harm to the unborn child. You should tell your doctor immediately if you are pregnant or think you may be pregnant.
Women should not become pregnant during treatment with doxorubicin or for 7 months after completion of treatment. Men should take appropriate precautions to ensure that their partner does not become pregnant during treatment with doxorubicin or for 4 months after completion of treatment.
Breastfeeding
You should not breastfeed while using Doxorubicinum Accord and for at least 14 days after the last dose. The medicine may pass into the baby's body with breast milk and may harm the baby.
Fertility
Before starting treatment, men should seek advice on cryopreservation of semen due to the possibility of irreversible infertility resulting from doxorubicin treatment.
If patients are considering having children after treatment, they should discuss this with their doctor.
Before using any medicine, you should consult your doctor or pharmacist.

Driving and using machines

Because nausea and vomiting often occur after administration of the medicine, driving and using machines are not recommended.

Doxorubicinum Accord contains sodium

This medicine contains 0.15 mmol (3.5 mg) of sodium per milliliter. This should be taken into account for patients controlling their sodium intake. Different sizes of this medicinal product contain the following amounts of sodium:
This medicine contains less than 1 mmol of sodium (23 mg) per 5 mL vial, which means that the medicine is considered "sodium-free".
This medicine contains 35.42 mg of sodium (the main component of table salt) per 10 mL vial. This corresponds to 1.77% of the WHO-recommended maximum daily sodium intake for an adult.
This medicine contains 88.55 mg of sodium (the main component of table salt) per 25 mL vial. This corresponds to 4.43% of the WHO-recommended maximum daily sodium intake for an adult.
This medicine contains 177.10 mg of sodium (the main component of table salt) per 50 mL vial. This corresponds to 8.85% of the WHO-recommended maximum daily sodium intake for an adult.
This medicine contains 354.20 mg of sodium (the main component of table salt) per 100 mL vial. This corresponds to 17.71% of the WHO-recommended maximum daily sodium intake for an adult.

3. How to use Doxorubicinum Accord

Method and route of administration

Doxorubicinum Accord should only be administered under the supervision of a doctor experienced in the use of anticancer therapy.
The dose of the medicine will be determined by your doctor.
You should not take the medicine without discussing it with your doctor. The medicine will be administered as an intravenous infusion into a blood vessel under the supervision of specialist doctors. You will be subject to regular monitoring during treatment and after its completion. In patients with superficial bladder cancer, it may be necessary to administer the medicine into the bladder.

Dosage

The dose of the medicine is usually calculated based on the patient's body surface area. A dose of 60-75 mg per square meter of body surface area may be repeated every 3 weeks if the medicine is used as monotherapy. When doxorubicin is used in combination with other anticancer medicines, it may be necessary to reduce the dose to 30-60 mg per square meter of body surface area and increase the interval between treatments. Your doctor will recommend the dose of the medicine you should take. If the medicine is used once a week, a dose of 15-20 mg per square meter of body surface area is recommended. Your doctor will recommend the dose of the medicine you should take.

Patients with liver and kidney function disorders

In patients with kidney or liver function disorders, the dose of the medicine should be reduced.
Your doctor will recommend the dose of the medicine you should take.

Children, elderly patients, and (or) after radiation therapy

Dose reduction may also be necessary in children, elderly patients, or patients who have undergone radiation therapy. Your doctor will recommend the dose of the medicine you should take.

Patients with bone marrow function suppression

Dose reduction may be necessary in patients with bone marrow function suppression.
Your doctor will recommend the dose of the medicine you should take.

Obese patients

In obese patients, it may be necessary to reduce the initial dose or prolong the intervals between doses. Your doctor will recommend the dose of the medicine you should take and how often.

Use of a higher dose of Doxorubicinum Accord than recommended

Your doctor or nurse will closely monitor you during treatment and after its completion. Symptoms of overdose are usually an extension of possible side effects of doxorubicin. In particular, this concerns changes in blood parameters, stomach and intestine disorders, and heart diseases. Heart muscle disorders may occur even 6 months after overdose. In case of overdose, your doctor will take appropriate measures. It may be necessary to perform a blood transfusion and/or antibiotic treatment. You should tell your doctor if you experience any side effects.

Missing a dose of Doxorubicinum Accord

Your doctor will decide on the duration of treatment with Doxorubicinum Accord. If treatment is discontinued before the recommended completion date, the effectiveness of doxorubicin may be reduced. Before stopping treatment, you should consult your doctor.

Stopping treatment with Doxorubicinum Accord

If you have any further questions about using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In some people, this medicine may cause a potentially life-threatening severe allergic reaction (anaphylaxis). If you notice sudden difficulty breathing, you should contact your doctor immediately, swelling of the face and throat, and general malaise (shock). Doxorubicin significantly reduces the ability of the immune system to respond, so there is a high risk of infections, which can lead to sepsis. If you have a high fever, you should immediately contact your doctor, as sepsis can be life-threatening. Other side effects that may occur include:

Very common:may occur in more than 1 in 10 people

• Infection
• Lack of appetite (anorexia)
• Mouth ulcers/mucositis
• Diarrhea
• Nausea or vomiting
• Reduced blood cell count: red blood cells (anemia), all or some white blood cells (leukopenia, neutropenia), and platelets (thrombocytopenia)
• Redness, swelling, numbness, pain, and tingling of the hands and feet (palmar-plantar erythrodysesthesia or hand-foot syndrome)
• Hair loss on the head and body (alopecia and inhibition of beard growth)
• Fever, feeling weak (asthenia), chills
• Abnormal ECG (electrocardiogram, a test of heart function)
• Asymptomatic reduction of left ventricular ejection fraction
• Changes in liver enzyme activity (transaminases)
• Weight gain in patients with early breast cancer
• Heart muscle damage (cardiotoxicity)

Common: may occur in up to 1 in 10 people

• Conjunctivitis, i.e., inflammation of the membrane covering the front of the eye and the inner side of the eyelids
• Changes in heart function, especially heart rhythm (sinus tachycardia), reduced amount of blood pumped by the heart to the body (congestive heart failure)
• Esophagitis
• Abdominal pain
• Itching rash, rash, skin and nail discoloration
• Sepsis
• At the injection site, redness and swelling may occur
• Local side effects after administration into the bladder, such as cystitis (chemical cystitis)

Uncommon:may occur in up to 1 in 100 people

• Thrombosis (blood clot in a blood vessel)

Rare:may occur in up to 1 in 1,000 people

• Secondary leukemia (a blood tumor that develops as a result of treatment of another tumor), when doxorubicin is used in combination with other anticancer medicines that damage DNA
• Tumor lysis syndrome (a complication of chemotherapy caused by the breakdown products of dying cancer cells, which can affect the blood and kidneys)

Frequency not known:frequency cannot be estimated from available data

• Dehydration
• Increased uric acid levels in the blood (hyperuricemia)
• Blood tumor (acute lymphatic leukemia, acute myeloid leukemia)
• Shock
• Inflammation of the corneal surface, increased tear production
• Increased heart rate (tachyarrhythmia), disorders of electrical conduction in the heart (atrioventricular block and bundle branch block)
• Inflammation of the veins, complete blockage of the veins (thrombophlebitis), heat strokes, bleeding (hemorrhage)
• Irritation or bleeding in the intestines, painful or ulcerative mouth sores, which may appear only after 3-10 days after the procedure, discoloration inside the mouth
• Increased sensitivity of the skin to sunlight
• Inflammation of the colon (large intestine) and inflammation of the stomach lining
• Itching of the skin and other skin diseases
• Hypersensitivity of irradiated skin (recurrence of radiation symptoms)
• Red discoloration of urine
• In women, menstrual cessation may also occur, but after stopping treatment, menstruation should return to normal. In some cases, early menopause may occur.
• In men, doxorubicin may cause a lack or reduction of sperm count (oligospermia, azoospermia), but this condition may return to normal after stopping treatment.
• Nausea or malaise
• Toxic effect on the liver
• Transient increase in liver enzyme activity
• A condition in which the kidneys stop working (acute kidney failure)
• Shortness of breath caused by bronchospasm (bronchospasm).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
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 Doxorubicinum Accord

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or carton after 'Expiry Date (EXP)'. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store the vial in the outer packaging to protect from light.
Do not use this medicine if you notice that the solution is not clear, red, and free from particles.
For single use only.
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.
Instructions for preparing and using cytotoxic medicines should be followed.
Unopened vials: 18 months
Opened vials: The medicine should be used immediately after opening the vial.
Chemical and physical stability of the prepared solution has been demonstrated in light-protected glass containers for up to 28 days at a temperature of 2°C to 8°C and for up to 7 days at a temperature of 25°C, after dilution in 0.9% sodium chloride injection and 5% glucose injection.
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions of the prepared solution. The solution should not be stored for more than 24 hours at a temperature of 2°C to 8°C, unless dilution is performed under controlled and validated aseptic conditions.

6. Contents of the packaging and other information

What Doxorubicinum Accord contains

The active substance of the medicine is doxorubicin hydrochloride.
Each milliliter contains 2 mg of doxorubicin hydrochloride.
Each 5 mL vial contains 10 mg of doxorubicin hydrochloride.
Each 10 mL vial contains 20 mg of doxorubicin hydrochloride.
Each 25 mL vial contains 50 mg of doxorubicin hydrochloride.
Each 50 mL vial contains 100 mg of doxorubicin hydrochloride.
Each 100 mL vial contains 200 mg of doxorubicin hydrochloride.
The other ingredients are sodium chloride, hydrochloric acid (to adjust pH), and water for injections.

What Doxorubicinum Accord looks like and contents of the pack

Doxorubicinum Accord is a clear red solution, essentially free from particulate matter.
Pack sizes:
1 vial of 5 mL
1 vial of 10 mL
1 vial of 25 mL
1 vial of 50 mL
1 vial of 100 mL
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 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 B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare single member S.A.
64th Km National Road Athens Lamia
32009 Schimatari
Greece

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Country Marketing authorization holder

United Kingdom (Northern Ireland)
Doxorubicin 2 mg/mL Concentrate for Solution for Infusion
Austria
Doxorubicin Accord 2 mg/mL Konzentrat zur Herstellung einer Infusionslösung
Doxorubicin Accord Healthcare 2 mg/mL, solution à diluer pour perfusion / concentraat voor oplossing voor infusie / Konzentrat zur Herstellung einer Infusionslösung
Bulgaria
Доксорубицин Акорд 2 mg/mL концентрат за инфузионен разтвор
Belgium
Germany
Doxorubicin Accord 2 mg/mL Konzentrat zur Herstellung einer Infusionslösung
Denmark
Doxorubicin Accord
Estonia
Doxorubicin Accord 2 mg/mL
Spain
Doxorubicin Accord 2 mg/mL concentrado para solución para perfusión
Finland
Doxorubicin Accord 2 mg/mL infuusiokonsentraatti, liuosta varten / koncentrat till infusionsvätska, lösning
Hungary
Doxorubicin Accord 2 mg/mL koncentrátum oldatos infúzióhoz

Date of last revision of the leaflet: February 2025

Information intended for healthcare professionals only

Dosage and administration

Doxorubicin in the form of a solution for infusion should only be administered under the supervision of a qualified doctor with extensive experience in the use of cytotoxic medicines. Patients must also be regularly and closely monitored during treatment. Due to the risk of often life-threatening cardiomyopathy, the risk and benefits for the individual patient should be assessed before each administration. Doxorubicin is administered intravenously and into the bladder. It should not be administered orally, subcutaneously, intramuscularly, or intraperitoneally. Doxorubicin can be administered as a bolus lasting several minutes, as a short infusion lasting up to 1 hour, or as a continuous infusion not exceeding 96 hours. The solution is administered through a freely flowing intravenous infusion of 0.9% sodium chloride injection (9 mg/mL) or 5% glucose injection (50 mg/mL) over 3 to 10 minutes. This technique minimizes the risk of thrombophlebitis or extravasation, which can lead to severe local inflammation of the connective tissue, blistering, and tissue necrosis. Direct intravenous injection is not recommended due to the possibility of extravasation, which can occur even with proper insertion of the needle into the vein lumen confirmed by blood aspiration.

Intravenous administration

The dose of doxorubicin depends on the dosing regimen, the patient's overall condition, and previous treatment. The dose of doxorubicin hydrochloride may vary depending on the indication (solid tumors or acute leukemia) and the specific treatment regimen used (the medicine may be administered as monotherapy, in combination with other cytotoxic agents, or as part of a multidisciplinary procedure that includes a combination of chemotherapy, surgery, and radiation therapy, as well as hormonal therapy).

Monotherapy

The dose is usually calculated based on body surface area (mg/m²). On this basis, when doxorubicin is used as monotherapy, the recommended dose is 60-75 mg/m² every 3 weeks.

Combination therapy regimen

When doxorubicin hydrochloride is administered concomitantly with other anticancer agents with overlapping toxicity, such as high-dose intravenous cyclophosphamide or anthracycline derivatives, such as daunorubicin, idarubicin, and (or) epirubicin, the doxorubicin dose should be reduced to 30-60 mg/m² every 3-4 weeks. In patients who cannot receive the full dose of the medicinal product (e.g., due to immunosuppression, advanced age), alternative dosing is 15-20 mg/m² per week.

Intravesical administration

Doxorubicin may be used as an intravesical instillation in the treatment of superficial bladder cancer or in the prevention of recurrence of the tumor after transurethral resection in patients with a high risk of recurrence. In local treatment of superficial bladder cancer, it is recommended to administer an intravesical instillation of doxorubicin hydrochloride at a dose of 30-50 mg in 25-50 mL of 0.9% sodium chloride injection (9 mg/mL). The optimal concentration is 1 mg/mL. The solution should be retained in the bladder for 1 to 2 hours. During this time, the patient should be rotated by 90° every 15 minutes. To avoid unnecessary dilution with urine, the patient should not drink any fluids for 12 hours before treatment (which should reduce the volume of urine produced to about 50 mL/h). The instillation may be repeated at intervals of 1 week to 1 month, depending on whether the treatment is therapeutic or preventive.

Patients with liver function disorders

Due to the fact that doxorubicin is metabolized mainly in the liver and excreted with bile, elimination of the medicinal product may be delayed in patients with liver function disorders or bile flow impairment, which may lead to severe side effects. General recommendations for dose modification in patients with liver function disorders are based on serum bilirubin levels: Doxorubicin is contraindicated in patients with severe liver function disorders.

Patients with kidney function disorders

In patients with renal failure (GFR <10 ml min), only 75% of the planned dose should be administered. to avoid cardiomyopathy, it is recommended that cumulative lifetime doxorubicin (including related medicines, such as daunorubicin) not exceed 450-550 mg m². in patients with concomitant heart disease undergoing radiation therapy mediastinum and (or) before treatment alkylating agents, at high risk (with hypertension> 5 years, with a history of coronary artery disease, valvular or myocardial disease, aged over 70), the maximum cumulative dose should not exceed 400 mg/m², and heart function should be monitored.

Dosage in children

Dose reduction may be necessary in children. You should consult treatment protocols and specialized literature.

Obese patients and patients with bone marrow infiltration

In obese patients and patients with bone marrow infiltration, it may be necessary to consider reducing the initial dose or prolonging the intervals between doses.

Incompatibilities

Doxorubicin should not be mixed with heparin, as a precipitate may form, nor should it be mixed with 5-fluorouracil, as degradation of the medicine may occur. You should avoid prolonged contact with any solution with a alkaline pH, as this may cause hydrolysis of the medicine. Until more detailed information on compatibility and mixing is available, doxorubicin should not be mixed with other medicinal products except 0.9% sodium chloride injection and 5% glucose injection.

Prepared infusion solutions

Chemical and physical stability of the medicinal product has been demonstrated in light-protected glass containers for up to 28 days at a temperature of 2°C to 8°C and for up to 7 days at a temperature of 25°C, after dilution in 0.9% sodium chloride injection and 5% glucose injection. From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions of the prepared solution. The solution should not be stored for more than 24 hours at a temperature of 2°C to 8°C, unless dilution is performed under controlled and validated aseptic conditions.

Disposal of the medicinal product

Any unused medicinal product or waste material should be disposed of in accordance with local requirements and current legislation regarding the disposal of hazardous waste. All materials used for dilution and administration should be disposed of according to standard hospital procedures for the handling of cytotoxic agents, taking into account current regulations regarding the disposal of hazardous waste.

Shelf life and storage conditions

Unopened vials: 18 months.
Opened vials: The medicinal product should be used immediately after opening the vial.
Store in a refrigerator (2°C - 8°C).
Store the vial in the outer packaging to protect from light.