Farmorubicin 2 mg/ml solution for injection and for infusion

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Farmorubicin 2 mg/ml concentrate for solution for infusion

Epirubicin hydrochloride

Read the entire 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents

1. What Farmorubicin 2 mg/ml concentrate for solution for infusion is and what it is used for

2. What you need to know before using Farmorubicin 2 mg/ml concentrate for solution for infusion

3. How to use Farmorubicin 2 mg/ml concentrate for solution for infusion

4. Possible side effects

   1. How to store Farmorubicin 2 mg/ml concentrate for solution for infusion

5. Contents of the pack and other information

1. What Farmorubicin 2 mg/ml injection and infusion solution is and what it is used for

Farmorubicin is an anticancer antibiotic-type medicine belonging to the anthracycline group, used for the treatment of various types of cancers. It is administered intravenously (into a vein) or intravesically (direct injection into the urinary bladder). Farmorubicin acts as a cytotoxic agent: it inhibits the cell cycle and prevents the proliferation of cancer cells.

Farmorubicin may be used alone or in combination with other medicines to treat the following types of cancers:

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

2. What you need to know before using Farmorubicina 2 mg/ml injection solution and infusion

Do not use Farmorubicina 2 mg/ml injection solution and infusion:

• If you are allergic to the active substance (epirubicin hydrochloride), to other anticancer agents of the same group (anthracyclines), or to any of the other ingredients of this medicine (listed in section 6).

Do not use Farmorubicina if administered intravenously:

• If you have lower than normal blood cell counts, reduced bone marrow activity, impairing your 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, or cardiomyopathy).
• If you have previously been treated with high doses of epirubicin hydrochloride or other anticancer agents of the same group (anthracyclines). These medicines have similar adverse effects.
• If you have a severe, generalized acute infection.

Do not use Farmorubicina if administered intravesically:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Farmorubicina 2 mg/ml injection solution and infusion.

• If you have or have had heart problems, or if you are receiving, have received, or previously received radiotherapy in areas near the heart.
• If you have been treated with other anthracyclines.
• If you are being treated with other medicines for cancer.
• If you are being treated with other medicines capable of suppressing heart contraction.
• If your immune system is impaired, 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 may increase uric acid levels.
• If you need to be vaccinated while undergoing treatment with this medicine, since live or attenuated virus vaccines must not be administered, and the response to inactivated or killed vaccines may be reduced.
• If you experience discomfort at or near the injection site during infusion (possible leakage of fluid into surrounding tissue).
• If you suffer from stomatitis or mucositis (painful lips or mouth ulcers).
• If you are pregnant or think you might be pregnant (see section Pregnancy, breastfeeding, and fertility).
• If you are breastfeeding (see section Pregnancy, breastfeeding, and fertility).
• If you are male or female, you must use effective contraception during treatment with epirubicin due to the potential toxicity of the medicine (see section Pregnancy, breastfeeding, and fertility).
• If you are taking or have recently taken trastuzumab (a medicine used to treat certain types of cancer). Trastuzumab can remain in the body for up to 7 months. Since trastuzumab can affect the heart, you must not use Farmorubicina until 7 months after stopping trastuzumab. If Farmorubicina is used earlier, your cardiac function must be carefully monitored.
• In pregnant women, some reports have linked epirubicin to heart problems in newborns and fetuses, including fetal death.

Children and adolescents

There are no data on efficacy and safety in children and adolescents under 18 years of age.

Using Farmorubicina 2 mg/ml injection solution and infusion with other medicines

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

The adverse effects may be increased or the action of other medicines may be altered, such as those used to treat heart conditions, cancer, ulcers, or medicines that affect the immune system.

Certain types of vaccines (live and attenuated) must not be administered during treatment with epirubicin.

Pregnancy, breastfeeding, and fertility

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

You must not use Farmorubicina during pregnancy unless your doctor considers immediate treatment to be essential. Your doctor will inform you of the potential risks of receiving this medicine during pregnancy.

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

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

Farmorubicina may cause loss of menstruation and infertility during treatment.

Driving and using machines

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

It is unknown whether Farmorubicina has any effect on the ability to drive vehicles or operate machinery. However, you should not drive if you experience any adverse events (such as nausea or vomiting) that could impair your ability to drive or operate machinery.

Farmorubicina 2 mg/ml solution contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; hence, it is essentially "sodium-free".

This medicine may be prepared for administration with solutions containing sodium. Inform your doctor if you are on a low-salt (sodium) diet.

3. How to use Farmorubicin 2 mg/ml concentrate for solution for infusion

Farmorubicin 2 mg/ml concentrate for solution for infusion must be administered only under the supervision of a physician experienced in the use of this type of treatment. Consult your doctor or pharmacist if you have any questions.

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

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

If you use more Farmorubicin than you should

This medicine will be administered to you in the hospital, so it is unlikely that you will receive more Farmorubicin than intended; however, some of the known serious adverse effects of the medicine could occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Farmorubicin may cause adverse effects, although not everyone experiences them.

If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet.

Very common adverse effects (may affect more than 1 in 10 people) include:

• Infections,
• Inflammation of the eye's conjunctiva (conjunctivitis),
• Decreased number of red blood cells (anaemia), which may make you feel tired or drowsy (lethargy); decreased number of different types of white blood cells (leucopenia, neutropenia, granulocytopenia); febrile neutropenia; decreased number of platelets (thrombocytopenia), which may cause you to bruise or bleed more easily when injured,
• Inflammation of the cornea (keratitis),
• Hot flushes,
• Inflammation of a vein (phlebitis),
• Nausea, vomiting, inflammation of the mucosa of the mouth (stomatitis), inflammation of the mucous membranes in the gastrointestinal tract, diarrhoea,
• Hair loss (alopecia), skin toxicity near the site of drug administration,
• Absence of menstruation (amenorrhoea),
• Malaise, fever,
• Changes in liver enzyme levels (transaminases), indicating possible liver problems,
• Reddish discoloration of urine for 1 or 2 days after administration of the medicine; this is normal and should not be a cause for concern,
• Cystitis following administration of the medicine directly into the bladder; in some cases, blood may appear in the urine.

Common adverse effects (may affect up to 1 in 10 people) include:

• Loss of appetite, dehydration,
• Increased heart rate (ventricular tachycardia), disturbances in the conduction of heart impulses (atrioventricular block and bilateral bundle branch block), decreased heart rate (bradycardia), cardiac disorders (congestive heart failure) which may cause difficulty breathing (dyspnoea),
• Bleeding, appearance of redness on the skin and mucous membranes (rubefaction),
• Inflammation of the oesophagus (oesophagitis), gastrointestinal pain, gastrointestinal erosion, gastrointestinal ulcer,
• Skin rash, itching, abnormal pigmentation of nails and skin, skin lesions,
• Need to urinate frequently (polyuria),
• Redness of the skin (erythema) at the site of administration, chills,
• Pain or burning sensation at the injection site,
• Abnormalities in tests assessing heart function (reduced ejection fraction).

Uncommon adverse effects (may affect up to 1 in 100 people) include:

• Systemic infection (sepsis), pneumonia,
• Malignant tumour of blood-forming tissue (various types of leukaemia: acute myeloid leukaemia and acute lymphocytic leukaemia),
• Inflammation of a vein due to the presence of a blood clot (thrombophlebitis), blockage of a blood vessel (embolism),
• Blockage of an artery in the lungs (pulmonary embolism),
• Bleeding in the gastrointestinal tract,
• Red, itchy skin rash (urticaria), redness of the skin (erythema),
• Feeling of tiredness (asthenia).

Rare adverse effects (may affect up to 1 in 1,000 people) include:

• Severe allergic reaction (anaphylactic reaction), local reactions such as a burning sensation in the bladder, and increased frequency of urination following intravesical administration,
• Increased uric acid levels in the blood (hyperuricaemia),
• Cardiac toxicity that may cause abnormalities in the electrocardiogram,
• Decreased number of sperm in semen (azoospermia),
• Dizziness.

Adverse effects with unknown frequency (cannot be estimated from available data) include:

• Shock due to systemic infection (septic shock), pain at the injection site, severe inflammation of soft tissues beneath the skin (cellulitis),
• Shock, hardening of the vein used for injection (phlebosclerosis),
• Tissue hypoxia due to reduced bone marrow function (hypoxia),
• Abdominal discomfort, appearance of pigmentation (brown spots) in the oral mucosa,
• Sensitivity to light (photosensitivity),
• Death of affected tissue (soft tissue necrosis) following accidental injection outside the vein, pain,
• Hypersensitivity of irradiated skin (radiation recall reaction).

When the medicine is administered directly into the bladder for the treatment of superficial tumours of the bladder, severe allergic reactions are rare, but local reactions such as a burning sensation in the bladder and increased frequency of urination may occur. Cystitis may also appear. These adverse reactions are usually reversible.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Farmorubicin 2 mg/ml solution for injection and infusion

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

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Farmorubicin 2 mg/ml solution for injection and infusion

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

Appearance of the product and contents of the pack

Colorless glass vials with rubber stoppers sealed with an aluminum cap protected by an overlaid plastic disc.

The vials are wrapped in a transparent plastic known as "Oncotain" to prevent spillage in case of breakage.

Presented in a pack containing 1 vial of 25 ml.

Marketing Authorization Holder

Pfizer, S.L.

Avda. de Europa 20B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer

Pfizer Service Company BV

Hoge Wei, 10

1930 Zaventem

Belgium

Date of the most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS

Once the vial’s rubber stopper has been punctured, the product should be used within 24 hours. Any unused portion must be discarded.

Intravenous administration

It is recommended that the medicinal product be administered via an intravenous infusion system (using 0.9% sodium chloride solution or 5% glucose solution), after confirming that the needle is properly inserted into the vein. To minimize the risk of thrombosis or drug extravasation, typical infusion times range between 3 and 20 minutes, depending on the dose and volume of the solution to be infused. Bolus injection is not recommended due to the risk of extravasation, which may occur despite adequate blood return upon needle aspiration (see section 4.4).

Intravesical administration

For intravesical administration, the intended dose should be diluted in sterile physiological saline or water for injections to a final volume of 50 ml.

The epirubicin solution should be instilled via a catheter, left in place for one hour, after which the patient should be instructed to empty the bladder. During instillation, the patient should be repositioned periodically to ensure maximum contact of the solution with the pelvic bladder mucosa. To avoid unwanted dilution with urine, the patient should refrain from drinking any fluids during the 12 hours prior to instillation.

Protective measures

Due to the toxic nature of the compound, the following protective recommendations should be observed:

• Personnel must be trained in proper handling techniques.
• Pregnant individuals should avoid handling this medicinal product.
• Personnel handling epirubicin must wear protective clothing: protective goggles, gowns, disposable gloves, and masks.
• All materials used for administration or cleaning, including gloves, must be placed in high-risk waste material bags for destruction by high-temperature incineration.
• Any spillage or leakage should be treated with diluted sodium hypochlorite solution (1% available chlorine), preferably by soaking, followed by rinsing with water.
• All cleaning materials must be disposed of as described above.
• In case of skin contact, wash the affected area thoroughly with water and soap or with a sodium bicarbonate solution. In any case, do not scrub the skin with a brush.
• In case of eye contact, retract the eyelid(s) and rinse the affected eye(s) with copious amounts of water for at least 15 minutes. Seek medical attention afterwards.
• Always wash hands after removing gloves.

Disposal of unused medicinal product and of all materials that have come into contact with it must be carried out in accordance with local regulations.