Prospect: information for the patient

Farmorubicina 50 mg powder for injectable solution and for infusion

Epirubicin hydrochloride

Read this prospect carefully before starting to usethismedication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourmedic or pharmacist.

-This medication has been prescribedonlyto you,and you should not give it to other people even if they have the same symptomsas you, as it may harm them.

• Ifyou experienceadverse effects, consult your doctor or pharmacist,evenifthey do not appearin this prospect. See section 4.

1.What is Farmorubicina 50 mg powder and for what it is used

2.What you need to knowbeforestarting touse Farmorubicina 50 mg powder

3.How to use Farmorubicina 50 mg powder

4.Possible adverse effects

1. Storage of Farmorubicina 50 mg powder

6.Contents of the package and additional information

Farmorubicina is an anticancer antibiotic medication belonging to the anthracyclines group, used for the treatment of various types of cancer, administered via intravenous (into a vein) or intravesical (direct injection into the urinary bladder) routes. Farmorubicina acts cytotoxically: inhibiting the cell cycle and preventing the proliferation of cancerous cells.

Farmorubicina maybe used alone or in combination with other medications, in the treatment of the following types of cancer:

• Breast cancer.
• Soft tissue sarcoma:malignant tumors that can affect cartilage, muscles, fat, blood vessels, or other tissues.
• Stomach cancer.
• Small cell lung cancer (a special type of lung cancer).
• Advanced ovarian cancer.
• Early (superficial) bladder tumors and as a prevention of possible recurrences after surgery.

Do not use Farmorubicina 50 mg powder:

-If you are allergic to the active ingredient (hydrochloride of epirubicin), to other cancer agents in the same group (anthracyclines), or to any of the other components of this medication (listed in section 6).

Do not use Farmorubicina if the administration is intravenous:

• If you have fewer blood cells than normal, decreased bone marrow activity, altering the ability to fight infections or diseases.
• If you have or have had severe liver problems.
• If you have severe heart problems (severe heart failure, recent myocardial infarction, severe arrhythmias, unstable angina, and cardiomyopathy).
• If you have previously been treated with high doses of hydrochloride of epirubicin or other cancer agents in the same group (anthracyclines). These medications have similar adverse effects.
• If you have a severe acute generalized infection.

Do not use Farmorubicina if the administration is intravesical:

• If you have urinary tract infections, bladder inflammation, or blood in the urine.
• If you have a tumor that has penetrated the bladder wall.
• If you have problems with catheterization (tube in the bladder).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Farmorubicina 50 mg powder.

• If you have or have had heart problems or if you are receiving or have received or are receiving radiation therapy in areas close to the heart.
• If you have received treatment with other anthracyclines.
• If you are being treated with other medications to treat cancer.
• If you are being treated with other medications capable of suppressing heart contractions.
• If your immune system is altered, i.e., you have lost the ability to fight infections or diseases.
• If you have or have had liver problems.
• If you have or have had kidney problems.
• If you have or have had gout, as epirubicin can cause elevated uric acid levels.
• If you need to be vaccinated while on treatment with this medication, as live or attenuated virus vaccines should not be administered and the response to inactivated or killed vaccines may be decreased.
• If you experience discomfort or pain at the injection site or surrounding areas during infusion (possible loss of fluid to the surrounding tissue).
• If you have stomatitis or mucositis (painful lips or ulcers in the mouth).
• If you are pregnant or believe you may be pregnant (see Pregnancy, breastfeeding, and fertility).
• If you are breastfeeding your child (see Pregnancy, breastfeeding, and fertility).
• If you are male or female, you should use effective contraceptive methods during treatment with epirubicin, given the potential toxicity of the medication (see Pregnancy, breastfeeding, and fertility).
• If you are taking or have taken recently trastuzumab (a medication used to treat certain types of cancer). Trastuzumab may remain in the body for up to 7 months. As trastuzumab can affect the heart, do not use Farmorubicina until 7 months after stopping trastuzumab. If Farmorubicina is used before this time, your cardiac function should be closely monitored.
• In pregnant women, some reports have associated epirubicin with cardiac problems in newborns and fetuses, including fetal death.

Use ofFarmorubicina 50 mg powderwith other medications

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

They may increase the adverse effects or modify the action of other medications, such as those used to treat heart problems, cancer, ulcers, and medications that alter the immune system.

Do not administer certain types of vaccines (live and attenuated) during treatment with epirubicin.

Pregnancy,breastfeeding,and fertility

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

Do not use Farmorubicina during pregnancy unless your doctor considers immediate treatment essential. Your doctor will inform you of the potential risks of receiving this medication during pregnancy.

Both men and women should seek advice on preserving fertility before treatment. Women of childbearing age should use effective contraceptive methods during treatment with epirubicin and for at least 6.5 months after the last dose. Men should use effective contraceptive methods during treatment and for at least 3.5 months after the last dose.

Do not breastfeed while on treatment with Farmorubicina or for at least 7 days after the last dose.

Farmorubicina may cause amenorrhea and infertility during treatment.

Driving and operating machinery

No studies have been conducted on the effects of Farmorubicina on the ability to drive and operate machinery.

The effects of Farmorubicina on the ability to drive vehicles or operate machinery are unknown. However, do not drive if you experience any adverse event (nausea or vomiting) that may affect your ability to drive vehicles or operate machinery.

Farmorubicina 50 mg powder contains methyl parahydroxybenzoate

Farmorubicina 50 mg powder may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) due to the presence of methyl parahydroxybenzoate.

This medication does not contain sodium. However, it may be prepared with a solution containing sodium. Inform your doctor if you follow a low-sodium diet.

Farmorubicina 50 mg powdermust be administered only under the supervision of a doctor with experience in the use of this type of treatment. Consult with your doctor or pharmacist if you have any doubts.

Your doctor will establish the dose and duration of treatment as well as the most suitable administration route for you, according to your condition and response to treatment.

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

If you use more Farmorubicina than you should

This medication will be administered in the hospital, so it is unlikely that you will receivemore Farmorubicina than you should; howeversome of the known serious side effects of the medication may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Frequent side effects(may affect more than 1 in 10 people) include:

- Infections,

- Conjunctivitis, an inflammation of the conjunctiva of the eye.

- Decreased red blood cell count (anemia) that may cause fatigue or lethargy, decreased white blood cell count (leucopenia, neutropenia, granulocytopenia), febrile neutropenia, decreased platelet count (thrombocytopenia), which may cause bruising or bleeding more easily when injured.

- Keratitis, an inflammation of the cornea.

- Fever.

- Inflammation of a vein (phlebitis).

- Nausea, vomiting, inflammation of the mucous membranes of the mouth (stomatitis), inflammation of the mucous membranes of the gastrointestinal tract, diarrhea.

- Hair loss (alopecia), skin toxicity near the site of medication administration.

- Amenorrhea, absence of menstruation.

- Uncomfortable feeling, fever.

- Changes in liver enzyme levels (transaminases) that indicate possible liver problems.

- Red urine for 1 or 2 days after medication administration, this is normal and should not be a concern.

- Cystitis after medication administration directly into the bladder, in some cases, blood may appear in the urine.

Frequent side effects(may affect up to 1 in 10 people) include:

- Loss of appetite, dehydration.

- Increased heart rate (ventricular tachycardia), heart conduction disorders (atrioventricular block and bilateral branch block), decreased heart rate (bradycardia), cardiac alterations (congestive heart failure) that may cause difficulty breathing (dyspnea).

- Bleeding, appearance of redness on the skin and mucous membranes (rubefaction).

- Esophagitis, gastrointestinal pain, gastrointestinal erosion, gastrointestinal ulcer. - Skin rash, itching, abnormal skin and nail coloration, skin lesions.

- Frequent urination (pollakiuria).

- Redness of the skin (erythema) at the site of medication administration, chills.

- Pain or burning sensation at the injection site.

- Alteration in heart function tests (decreased ejection fraction).

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

-Sepsis, pneumonia.

- Different types of leukemia: acute myeloid leukemia and acute lymphocytic leukemia.

- Thrombophlebitis, obstruction of a blood vessel (embolism).

- Pulmonary embolism.

- Gastrointestinal bleeding.

- Red, itchy rash on the skin (urticaria), erythema.

- Feeling of fatigue (asthenia).

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

- Severe allergic reaction (anaphylactic reaction), local reactions such as burning sensation in the bladder and may increase the number of times you urinate after intravesical administration.

- Increased uric acid levels in the blood (hyperuricemia).

- Cardiac toxicity that may cause abnormalities in the electrocardiogram.

- Decreased sperm count in semen (azoospermia).

- Dizziness.

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

- Septic shock, pain at the injection site, severe inflammation of soft tissues under the skin (cellulitis).

- Shock, hardening of the vein where the injection was made (flebosclerosis).

- Tissue hypoxia due to decreased bone marrow function.

- Abdominal discomfort, appearance of pigmentation (brown spots) on the oral mucosa.

- Sensitivity to light (photosensitivity).

- Soft tissue necrosis after accidental injection outside the vein, pain.

- Radiation recall reaction (hypersensitivity of irradiated skin).

When the medication is administered directly into the bladder for the treatment of superficial bladder tumors, severe allergic reactions are rare, but local reactions such as burning sensation in the bladder and may increase the number of times you urinate may appear. Cystitis may also appear. These adverse reactions are usually reversible.

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 information on the safety of this medication.

No requires special conditions for conservation.

Keepthis medicationout of sightand out of reachof children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Ask your pharmacisthow to disposeofthe packaging and of themedicines that you no longerneed.This way, you will help protect the environment.

Farmorubicina 50 mg powder composition

• The active ingredient is epirubicin hydrochloride.
• The other components (excipients) are: anhydrous lactose and methyl parahydroxybenzoate (E-218).

Product appearance and packaging contents

Transparent glass vials with rubber stoppers containing reddish-colored lyophilized powder.

Presented in a format of1 vial.

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa 20B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer responsible

Latina Pharma S.p.A

Via Murillo, 7

04013 Sermoneta (LT)

Italy

Last review date of this leaflet: March 2023

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

IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS

Reconstitution of lyophilized powder before administration

Dissolve the Farmorubicina 50 mg powder for injectable solution and infusion in 25 ml of sterile physiological saline solution or water for injectable preparations, to obtain a final concentration of 2 mg/ml.

To reduce the risk of microbiological contamination, it is recommended that the reconstitution be performed immediately before use.

The vial contents are under negative pressure. To minimize the formation of aerosol during reconstitution, particular attention should be paid when inserting the needle. Inhaling the aerosol produced during reconstitution should be avoided.

After reconstituting the powder, the obtained solution should be used immediately.The unused portion should be discarded.

Intravenous administration

It is recommended to administer the medicine through an intravenous infusion system (using 0.9% saline solution), after checking that the needle is properly inserted into the vein. To minimize the risk of thrombosis or extravasation of the medicine, the usual infusion times range from 3 to 20 minutes, depending on the dose and the volume of the solution to be infused. The bolus injection is not recommended due to the risk of extravasation, which may occur by aspiration of the needle (see section 4.4), even in the presence of adequate blood return.

Intravesical administration

For intravesical administration, the planned dose (in the form of reconstituted solution) should be diluted in sterile physiological saline solution or water for injectable preparations to a volume of 50 ml.

The epirubicin solution should be instilled through a catheter, left to act for one hour, after which the patient should empty the bladder. During instillation, the patient should be rotated to ensure a greater contact of the solution with the vesical mucosa of the pelvis. To avoid an unwanted dilution with urine, the patient should not ingest any liquids in the 12 hours prior to instillation.

Protection measures

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

- Personnel should be instructed in reconstitution and handling techniques.

- Pregnant individuals should avoid handling this medicine.

- Personnel handling epirubicina should wear protective clothing: protective glasses, aprons, gloves, and disposable masks.

- Reconstitution should be performed in a designated area (preferably under a laminar flow system). 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 spill or leak 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 sodium bicarbonate solution. In any case, do not scrub the skin with a brush.

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

- Always wash hands after removing gloves.

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