Leaflet: information for the user

Doxorubicina Tedec 2 mg/ml concentrate for infusion solution

Doxorubicina, 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 your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Doxorubicina Tedec and what it is used for

2.What you need to know before starting to use Doxorubicina Tedec

3.How to use Doxorubicina Tedec

4.Possible side effects

5.Storage of Doxorubicina Tedec

6.Contents of the pack and additional information

Doxorubicina is an anticancer antibiotic that belongs to the anthracyclines group and is used for the treatment of different types of cancers, administered either intravenously or in some cases intravesically (direct injection into the organ). Doxorubicina acts by inhibiting the cell cycle, preventing the proliferation of cancer cells.

Doxorubicina may be used alone or in combination with other medications, in the treatment of children and adults, for the following types of cancers:

• Breast cancer
• Bone sarcomas: malignant tumors in the bones.
• Soft tissue sarcomas: malignant tumors that can affect cartilages, muscles, fat, blood vessels, or other tissues.
• Lung cancer
• Stomach cancer
• Lymphomas, such as Non-Hodgkin lymphomas (diseases that affect white blood cells or lymphocytes) and Hodgkin lymphoma (disease of the lymphatic system)
• Thyroid gland cancer
• Gynecological and genitourinary tumors: tumors in ovaries, endometrium, testicles, prostate, or bladder.
• Solid tumors in pediatrics, such as rhabdomyosarcoma (cancer that forms in soft tissue of the muscle), neuroblastoma (cancer of immature cells that mainly affects infants and children), Wilms tumor (disease in which malignant cells are found in the kidney) and liver tumors
• Leukemias (bone marrow cancer) such as acute lymphoblastic leukemia, acute myeloid leukemia, and chronic leukemias
• Induction of multiple myeloma: cancer that begins in white blood cells that produce antibodies responsible for the body's defense.

Doxorubicina will only be prescribed by an experienced doctor in cancer medications.

If you have any doubts about how doxorubicina works or why this medication has been prescribed to you, consult your doctor.

No useDoxorubicina Tedec

If you are allergic to hydrochloride doxorubicin, or to other anticancer agents in the same group or to any of the other components of this medication (listed in section 6).

Do not use Doxorubicina Tedec if the administration is intravenous:

-If you have a persistent alteration of your immune system (altered ability to fight infections or diseases)

-If you have or have had severe liver problems

-If you have severe heart problems (arrhythmias, heart attacks, or insufficiency)

Do not use Doxorubicina Tedec if the administration is intravesical:

-If you have urinary tract infections, bladder inflammation, or blood in the urine.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Doxorubicina Tedec

-If you have or have had heart problems or if you receive or have received radiation therapy in areas close to the heart.

-If you have received treatment with other anthracyclines.

-If you are being treated with other medications capable of suppressing heart contraction.

-If you are being treated with other medications to treat cancer.

-If your immune system is altered, that is, you have lost the ability to fight infections or diseases.

-If you have or have had liver problems.

-If you are receiving treatment for a heart or liver disease

-If you have or have had gout, as doxorubicin can cause an increase in uric acid.

-If you are pregnant or think you may be pregnant (see details below).

-If you are breastfeeding your child (see details below).

-If you are a male, you must use effective contraceptive methods during treatment with doxorubicin, given the toxic potential of the medication. If you want to have children after treatment with Doxorubicina Tedec, you must consult your doctor about genetic counseling and options for preserving fertility before starting treatment.

-If you need to be vaccinated while on treatment with this medication, as

no live or attenuated virus vaccines should be administered and the response to inactivated or killed vaccines may be reduced.

-

-If you are diabetic, as doxorubicin contains sugar and may require an adjustment of your diabetes treatment.

-If you have Kaposi's sarcoma and have had your spleen removed.

-If you observe ulcers, discoloration, or any discomfort in your mouth.

Interstitial lung disease cases have been reported in patients receiving pegylated liposomal doxorubicin, including fatal cases. The symptoms of interstitial lung disease are cough and difficulty breathing, sometimes with fever, not caused by physical activity. Seek immediate medical attention if you experience symptoms indicative of interstitial lung disease.

If you are in any of the cases listed above, consult your doctor before using this medication.

Your doctor will regularly monitor your condition to check if doxorubicin is having the expected effect.

While on treatment with doxorubicin, you will have periodic blood tests and heart function tests.

Other medications and Doxorubicina Tedec

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is possible that they may increase the adverse effects or modify the action of other medications, such as those used for heart alterations, cancer treatment, antibiotics, female hormones, medications that alter the immune system, and medications used in epilepsy treatment, as well as medications based on plants containing St. John's Wort (Hypericum perforatum). Your doctor should also be informed of vaccine administration.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use doxorubicina during pregnancy unless it is strictly necessary. Your doctor will inform you of the potential risks of taking doxorubicin during pregnancy.

Contraception in fertile women

You must always use an effective contraceptive method (contraception) while receiving Doxorubicina Tedec and for at least 6.5 months after the last dose. Consult your doctor about the contraceptive methods that are suitable for you and your partner.

Contraception in men

Males must always use effective contraceptive methods while receiving Doxorubicina Tedec and for at least 3.5 months after the last dose.

If you are breastfeeding your child, inform your doctor. Do not breastfeed during treatment with Doxorubicina Tedec or for at least 10 days after the last dose, as it is excreted in breast milk. Doxorubicina Tedec may cause amenorrhea and infertility during treatment.

Both men and women should seek advice on fertility preservation before treatment.

Driving and operating machinery

The effects of this medication on the ability to drive vehicles or operate machinery are unknown. However, if you experience any effect that modifies your ability to drive (weakness, nausea, or vomiting), you should not drive vehicles or operate machinery.

Doxorubicina Tedec contains sodium

This medication contains less than 23 mg of sodium (1 mmol) in eachvial of 5 ml; this is essentially "sodium-free".

This medication contains 88.61 mg of sodium (main component of table salt/for cooking) in eachvial of 25 ml, equivalent to 4.4% of the maximum daily sodium intake recommended for an adult.

Your doctor will determine the dosage and duration of treatment, as well as the most suitable administration route for you, based on your condition and response to treatment.

Your doctor will inform you of the number of treatment cycles you need.

If you use moreDoxorubicina Tedecthan you should

Although unlikely, if you receive more doxorubicina than you should, you may experience some of the known side effects of the medication. Consult your doctor immediately as hospitalization may be required.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

include:

? Alterations in the electrocardiogram.

? Reduction in the number of white blood cells, especially neutrophils, red blood cells, and/or platelets in the blood.

? Inflammation of the mucous membrane of the mouth and/or gums, diarrhea, nausea, and vomiting.

? Redness, sensitivity, and/or peeling of the palms of the hands and soles of the feet (erythrodysthesia plantar palmar), hair loss (alopecia).

? Infection.

? Fever, weakness, chills.

? Asymptomatic decrease in the amount of blood pumped by the left ventricle of the heart, alteration of liver enzyme levels (transaminases), weight gain.

? Loss of appetite.

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

include:

? Heart failure, increase in heart rate originating from the sinoatrial node of the heart.

? Inflammation of the esophagus (esophagitis), abdominal pain.

? Eruption, skin spots and nails (hyperpigmentation), urticaria.

? Conjunctivitis (inflammation of the conjunctiva of the eye).

? Generalized infection.

? Reaction at the injection site.

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

? Obstruction of a blood vessel with material transported by the blood.

? Abnormal heart rhythm, the heartbeat feels fast or irregular (palpitations), heart failure, which may cause difficulty breathing and may cause swelling of the legs, cardiac arrest.

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

? Blue discoloration of the skin and mucous membranes caused by low oxygen in the blood.

? Thickened skin areas.

Side effects of unknown frequency (cannot be estimated from available data) include:

? Alterations in heart rate (tachyarrhythmias), deterioration of the conduction of cardiac impulses from the atria to the ventricles (atrioventricular and branch block).

? Keratitis (inflammation of the cornea), excessive tear production (lacrimation).

? Mucous membrane spots in the mouth, erosions in the stomach, gastrointestinal bleeding, inflammation of the colon (colitis).

? Red discoloration of the urine for 1 or 2 days after administration.

? Itching, skin changes, skin sensitivity to light (photosensitivity), increased sensitivity of the irradiated skin area. Dehydration, increased uric acid in the blood (hyperuricemia).

? Acute leukemia affecting blood cells (acute myeloid leukemia), bone marrow disease affecting blood cells (myelodysplastic syndrome), acute lymphocytic leukemia, cancer of the mouth or lips.

? Bleeding, obstruction, and inflammation of a blood vessel (thrombophlebitis), inflammation of blood vessels (phlebitis), hot flashes, shock.

? General discomfort.

? Severe allergic reaction throughout the body (anaphylaxis).

? Absence of menstruation (amenorrhea), reduction in the number of sperm (oligospermia), absence of sperm (azoospermia).

• Cough and difficulty breathing, possibly accompanied by fever, not caused by physical activity (interstitial lung disease)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more informationon the safety of this medicine.

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

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

Store vials in the outer packaging to protect them from light.

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

Do not use this medication if you observe that the packaging is damaged or open.

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

Any spill or leak must be treated with diluted sodium hypochlorite solution (1% available chlorine), preferably by soaking, and then with water.

All cleaning materials must be disposed of as indicated above.

Composition ofDoxorubicina Tedec

-The active ingredient is doxorubicin hydrochloride.

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

Each ml of concentrated solution contains 2 mg of doxorubicin hydrochloride.

Each vial of 25 ml contains 50 mg of doxorubicin hydrochloride.

Each vial of 5 ml contains 10 mg of doxorubicin hydrochloride.

Appearance ofDoxorubicina Tedecand contents of the package

Clear red solution. The solution is packaged in a transparent glass vial, containing 5 ml or 25 ml of concentrate for infusion solution.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Responsible for manufacturing:

GP-PHARM, S.A. Polígono Industrial Els Vinyets-Els Fogars, 2.Carretera C-244, km 22

08777-Sant Quintí de Mediona-Barcelona

Last review date of this leaflet:November 2023

The detailed and updated 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 solely for healthcare professionals:

Doxorubicina is a potent cytotoxic agent that should only be prescribed, prepared, and administered by professionals who have received training in the safe use of the preparation. For consultation of dosage recommendations and administration, see section 4.2 of the Technical Dossier. For manipulation, preparation, and disposal of doxorubicina, the following guidelines should be observed:

DoxorubicinaTedecdoes not contain any preservative or bacteriostatic agent. The vials are for single use only, and any unused portion should be discarded.

The vials ofDoxorubicinaTedecshould be stored in the refrigerator (between 2°C and 8°C). It should be noted that during refrigeration of the medicine, the solution may gelify and return to its original state within 2 hours and up to a maximum of 4 hours at controlled temperature (15°C-25°C).

DoxorubicinaTedecshould not be diluted with bacteriostatic solutions. It is recommended to inject doxorubicina into an intravenous infusion system with sodium chloride 0.9% or glucose 5% solution, after ensuring that the needle is properly placed in the vein. This technique reduces the risk of extravasation of the drug and ensures the flushing of the vein at the end of administration.

To reduce the microbiological risk, the dilution should be made immediately before use. It is recommended to perform a visual inspection of the solution prior to administration to check that the solution is free of particles.

Protection measures

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

-Staff should be trained in handling techniques.

-Pregnant women should avoid handling this medication.

-Staff handling doxorubicina should wear protective clothing: protective glasses, aprons, gloves, and disposable masks.

-Manipulation should be performed in a designated area (preferably under a laminar flow system). The work surface should be protected with absorbent, plasticized, and disposable paper.

-All materials used for handling, 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.

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

-In case of skin contact, wash the affected area with water and soap or bicarbonate solution. In any case, do not scrub the skin with a brush.

-In case of eye contact, remove the eyelid(s) and wash the affected eye(s) with plenty of water for at least 15 minutes. Subsequently, seek medical attention.

-Always wash hands after removing gloves.