Prospect: information for the patient

Farmorubicina 2 mg/ml injectable solution and for perfusion

Epirubicin hydrochloride

Read the entire prospect carefully before starting to use this medication, because it contains important information for you.

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

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

• If you experience adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect.See section 4.

1.What is Farmorubicina 2 mg/ml injectable solution and for perfusion and for what it is used

2.What you need to knowbefore starting to use Farmorubicina 2 mg/ml injectable solution and for perfusion

3.How to use Farmorubicina 2 mg/ml injectable solution and for perfusion

4.Possible adverse effects

1. Storage of Farmorubicina 2 mg/ml injectable solution and for perfusion

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 cancers, 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 cancers:

• 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 2 mg/ml injectable solution and for infusion:

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

Do not use Farmorubicina if administration is intravenous:

• If you have fewer blood cells than normal, decrease the activity of the bone marrow, 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 epirubicina or other anticancer agents of the same group (anthracyclines). These medications have similar adverse effects.
• If you have a severe acute generalized infection.

Do not use Farmorubicina if 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 2 mg/ml injectable solution and for infusion.

• If you have or have had heart problems or if you receive 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 contraction.
• 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 have or have had kidney problems.
• If you have or have had gout, as epirubicina 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 in the injection site or its surroundings during perfusion (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 section Pregnancy, breastfeeding and fertility).
• If you are breastfeeding your child (see section Pregnancy, breastfeeding and fertility).
• If you are male or female, you should use effective contraceptive methods during treatment with epirubicina, given the potential toxicity of the medication (see section 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 may affect the heart, do not use Farmorubicina until 7 months after stopping trastuzumab. If Farmorubicina is used before this time, then your cardiac function should be closely monitored.
• In pregnant women, some reports have associated epirubicina with heart problems in newborns and fetuses, including fetal death.

Children and adolescents

No data are available on efficacy and safety in children and adolescents under 18 years.

Use of Farmorubicina 2 mg/ml injectable solution and for infusion with other medications

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

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

Determine types of vaccines (live and attenuated) should not be administered during treatment with epirubicina.

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.

You should not use Farmorubicina during pregnancy unless your doctor considers that immediate treatment is vital.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 epirubicina 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.

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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 driveif you experience any adverse event(nausea or vomiting), that modifies the ability to drivevehicles or operate machinery.

Farmorubicina 2 mg/ml solution contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially “sodium-free”.

This medication may be prepared for administration with solutions that contain sodium. Inform your doctor if you follow a low-sodium diet.

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Farmorubicina 2 mg/ml injectable and for infusionshould 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 route of administration for you, according to your condition and response to treatment.

Your doctor will indicate the number of treatment cycles that 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.

- Decrease in the number of red blood cells (anemia) that can make you feel tired or drowsy (lethargy), decrease in the number of different types of white blood cells (leucopenia, neutropenia, granulocytopenia), neutropenic fever, decrease in the number of platelets (thrombocytopenia), which can 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), toxicity in the skin near the area of administration of the medicine.

- Amenorrhea, absence of menstruation.

- Discomfort, fever.

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

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

- Cystitis after administration of the medicine 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), decrease in heart rate (bradycardia), cardiac alterations (congestive heart failure) that can cause difficulty breathing (dyspnea).

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

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

- Polakiuria, frequent urination.

- Erythema, redness of the skin at the site of administration of the medicine, chills.

- Pain or burning 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.

-Various types of leukemia (acute myeloid leukemia and acute lymphocytic leukemia).

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

- Pulmonary embolism.

- Gastrointestinal bleeding.

- Urticaria, red itchy rash on the skin, erythema.

- Asthenia, feeling of fatigue.

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.

- Hyperuricemia, increased uric acid in the blood.

- Cardiac toxicity that can cause abnormalities in the electrocardiogram.

- Azoospermia, decrease in the number of sperm in the semen.

- Dizziness.

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

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

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

- Hypoxia, lack of oxygen in the tissues due to decreased bone marrow function.

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

- Photosensitivity, sensitivity to light.

- Necrosis of soft tissue after accidental injection outside the vein, pain.

- Radiation recall reaction, hypersensitivity of irradiated skin.

When the medicine 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 occur. Cystitis may also occur. 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 medicine.

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

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. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose ofthepackaging and themedicines that you no longerneed.By doing so, you will help protect the environment.

Farmorubicin 2 mg/ml injectable solution and for infusion composition

• The active ingredient is epirubicin hydrochloride.
• The other components (excipients) are: hydrochloric acid (for pH adjustment), sodium chloride, and water for injection preparations.

Product appearance and packaging contents

Transparent polypropylene vials with rubber stopper of 25 ml.

Presented in a format of 1 vial of 25 ml.

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa 20B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Responsible for manufacturing

Pfizer Service Company BV

Hoge Wei, 10

1930 Zaventem

Bélgica

or

Bridgewest Perth Pharma Pty Ltd

15 Brodie Hall Drive

Technology Park

BENTLEY WA 6102

Australia

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

Once the rubber stopper of the vial is pierced, it must be used within 24 hours. The unused portion must be discarded.

Intravenous administration

It is recommended to administer the medication through an intravenous infusion system (using 0.9% saline solution or 5% glucose solution), after checking that the needle is properly inserted into the vein. To minimize the risk of thrombosis or extravasation of the medication, the usual infusion times range from 3 to 20 minutes, depending on the dose and the volume of the solution to be infused. Intravenous bolus injection is not recommended due to the risk of extravasation, which can occur by aspiration of the needle (see section 4.4), even in the presence of adequate blood return.

Intravesical administration

To administer by intravesical route, the planned dose must be diluted in sterile physiological saline solution or water for injection preparations to a volume of 50 ml.

The epirubicin solution must be instilled through a catheter, left to act for one hour, after which the patient is asked to empty the bladder. During instillation, the patient should be rotated to ensure 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 handling techniques.

- Pregnant individuals should avoid handling this medication.

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

- All materials used for 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 with baking soda 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 abundant water for at least 15 minutes. Subsequently, seek medical attention.

- Always wash hands after removing gloves.

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