Epirubicin 2 mg/ml solution for injection – patient leaflet, side effects, dosage

1. What Epirubicin is and what it is used for

Epirubicin is an injection that contains epirubicin hydrochloride. It belongs to a group of medicines called cytotoxics used for chemotherapy. Epirubicin causes cells that are actively growing, such as cancer cells, to slow or stop their growth and increases the likelihood that they die. This medicine helps to selectively kill the cancer tissue rather than normal, healthy tissue.

Epirubicin is used to treat a variety of cancers, either alone or in combination with other drugs. The way in which it is used depends upon the type of cancer that is being treated.

It has been found to be particularly useful in the treatment of cancers of the breast, ovaries, stomach, bowel and lung. In addition, this medicine can be given to treat cancers of the blood forming tissues such as malignant lymphomas, leukaemias and multiple myeloma.

Epirubicin can also be put directly into the bladder through a tube. This is sometimes used to treat abnormal cells or cancers of the bladder wall. It can be used after other treatments to try and prevent such cells from growing again.

Epirubicin is also used to help prevent recurrence of bladder cancer after surgery.

You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you use Epirubicin

Do not use Epirubicin:

• if you are allergic to epirubicin hydrochloride, or similar medicines classed as anthracyclines or anthracenedionesor any of the other ingredients of Epirubicin listed in Section 6,
• if you have a permanentlyability to produce blood cells in your bone marrow following previous treatments with other cytotoxic medicines or radiotherapy leading to low blood cell counts as it can lower them further,
• if you have previously been treated with the highest doses of Epirubicin or other anthracyclines (e.g. doxorubicin and daunorubicin) or anthracendiones (similar chemotherapy drugs), as previous treatment with these medicines can increase the risk of side effects,
• if you currently have or have had heartproblems, (e.g. poor functioning of the heart muscle, severe irregular heartbeat pattern, heart attack, cardiomyopathy acute inflammation of the heart muscle, unstable angina or any other severe heart trouble in the past, or are presently receiving treatment for this,
• if you have severe liver disease,
• if you are pregnant or breast-feeding,
• if you have an acute systemic infection (i.e. an infection that affects the entire body).

When administered intravesically (directly into the bladder), epirubicin should not be used if:

• you have invasive tumours penetrating the bladder,
• you have a urinary tract infection,
• you have inflammation of the bladder,
• you have catheterization problems (your doctor has problems inserting a catheter (tube) into your bladder),
• you have presence of blood in urine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Epirubicin

• if your liver or kidneys are not working properly,
• if you experience discomfort, redness, swelling or pain at or near the injection site during the infusion. These may be signs of the medicine leaking into the surrounding tissue. Please inform your doctor immediately.
• if you have had or you are due to have any vaccination, Tell your doctor if you have recently received a so-called “live vaccine” (for example, measles, mumps), or are considering getting one.
• if you have any vascular disorders, such as embolism or pulmonary embolism.
• if you have a low white or red blood cell count or low platelet count. Your doctor will check this regularly.
• This is why the level of uric acid in the blood should also be tested regularly. Your doctor will check this regularly.
• if you have inflammation of the mucous membranes of the mouth or other mucosa (sore lips or mouth ulcers).
• if you are sexually active: Menstruation may stop, and epirubicin can cause premature menopause. In men, the number of spermatozoa in the sperm may decrease significantly. As this medicine can harm human chromosomes, both men and women should seek advice on preserving fertility before treatment. Women of childbearing potential should be instructed to use a reliable form of contraception during treatment with epirubicin and for at least 6.5 months after the last dose. Men should be instructed to use a reliable form of contraception during treatment and for at least 3.5 months after the last dose. (see section "Pregnancy, breast-feeding and fertility").
• if you have previously been treated with radiotherapy in the chest area or have taken medicines that may have side effects on your heart. Your doctor will carry out regular checks to make sure your heart is working normally. Version 2.0
• if you are currently taking or have recently taken trastuzumab (a medicine used in the treatment of certain cancers). Trastuzumab can remain in the body for up to 7 months after you stop taking it. As trastuzumab may affect the heart, you should not use Epirubicin for up to 7 months after you have stopped taking trastuzumab. If Epirubicin is used before this time, then your heart function should be carefully monitored.

In pregnant women, there have been reports that epirubicin has been associated with heart problems in infants and unborn babies, including foetal death.

This will help your doctor decide if this medicine is suitable for you.

Other medicines and Epirubicin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription, particularly the following:

• other medicines that affect the heart, e.g. certain anti-cancer medicines (such as trastuzumab) or calcium channel blockers (used to treat high blood pressure, chest pain or irregular heartbeat), or if you are receiving radiotherapy in the chest area
• other medicines that affect the liver
• cimetidine (a medicine usually used to treat stomach ulcers and heartburn). Cimetidine can make the effect of Epirubicin stronger
• quinine (antimalaria drugs)
• vaccination with a live vaccine should be avoided in patients receiving Epirubicin
• paclitaxel or docetaxel (drugs used to treat cancer). When paclitaxel is given prior to epirubicin, it may increase concentration of epirubicin in blood. However when paclitaxel and docetaxel are given together and given after epirubicin, they did not affect concentration of epirubicin
• other medicines that may damage the bone marrow, e.g. other anti-cancer medicines, certain antibiotics (sulfonamides or chloramphenicol), diphenylhydantoin (for the treatment of epilepsy), amidopyrine (a type of painkiller) or certain antiretroviral agents (used to treat HIV infection/AIDS): These medicines can affect the production of blood cells
• dexverapamil (used to treat some heart conditions)
• dexrazoxane (used to prevent heart damage caused by epirubicin.
• interferon alpha-2b (used to treat cancers)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being using this medicine.

Pregnancy

No studies have been carried out on pregnant women; however, results from animal studies suggest that epirubicin may harm the foetus when used in pregnant women. It is therefore important to tell your doctor if you think you might be pregnant.

<Product name> must not be used during pregnancy unless your doctor considers immediate treatment to be absolutely necessary. Women of childbearing potential are advised to use a reliable form of contraception during treatment with epirubicin and for at least 6.5 months after the last dose. Men should be instructed to use a reliable form of contraception during treatment and for at least 3.5 months after the last dose. Genetic counselling is recommended if you become pregnant during treatment with Epirubicin.

Breast-feeding

Do not breast-feed during treatment with Epirubicin and for at least 7 days after the last dose.

Fertility

Men: there is a risk of sterility due to therapy with epirubicin and male patients should consider storage of sperm before treatment.

Women: epirubicin may cause lack of menstrual cycles or premature menopause in premenopausal women.

Both men and women should seek advice on preserving fertility prior to treatment.

Driving and using machines

The effects of Epirubicin on the ability to drive and use machines have not been studied in detail.

Epirubicin contains sodium.

A 5 ml vial contains 18 mg of sodium. This is equivalent to 0.9% of the recommended maximum daily dietary intake of sodium for an adult.

A 10 ml vial contains 36 mg of sodium. This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.

A 25 ml vial contains 90 mg of sodium. This is equivalent to 4.5% of the recommended maximum daily dietary intake of sodium for an adult.

A 50 ml vial contains 180 mg of sodium. This is equivalent to 9% of the recommended maximum daily dietary intake of sodium for an adult.

A 100 ml vial contains 360 mg of sodium. This is equivalent to 18% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine can be prepared using a solution that contains sodium. Tell your doctor if you are required to follow a low sodium (low salt) diet.

3. How to use Epirubicin

For intravenous or intravesical use

The dose of medicine given to you will depend on the type of cancer you have, your health, how well your liver and kidney are working and any other medicines you may be taking.

Epirubicin will only be given to you under the supervision of a doctor who is properly trained in this type of treatment. Before and during treatment with Epirubicin, your doctor will run various blood tests (e.g. number of blood cells, level of uric acid in your blood, liver function) and carefully monitor your heart function. Your heart function will continue to be monitored for a few weeks after your treatment with Epirubicin has ended.

The dose of Epirubicin depends on the condition that you have, your response to treatment, and any other medicines that you are taking.

By injection or infusion into a vein

The dose of Epirubicin is calculated based on your body surface area. This is calculated from your height and weight.

The standard dose of Epirubicin is 60–90 mg/m² body surface area.

You may receive higher doses (100–135 mg/m2 body surface area) as part of treatment for lung cancer or breast cancer.

The dose will be lower if you have a low number of white blood cells and platelets in your body, if you have liver or kidney problems, or if the medicine is used together with other cytotoxic medicines.

Epirubicin will be given to you as an intravenous injection, i.e. into a blood vessel, administered over three to five minutes.

Alternatively, the medicine can be diluted with glucose (sugar solution) or sodium chloride (salt solution) and then slowly infused. This is usually carried out as a 30-minute infusion into a vein. Epirubicin is usually administered every 3 (or 4) weeks.

During administration of Epirubicin, the infusion or syringe needle must be placed securely in the vein. If the needle slips out or becomes loose, the solution will flow into the tissue surrounding the vein. In this case you may experience discomfort or pain – please inform your doctor or nurse immediately.

By being put into the bladder (intravesical administration)

Epirubicin can also be administered (instilled) directly into the bladder to treat superficial bladder cancer or to prevent the recurrence of bladder cancer after surgery.

The dose depends on the type of bladder cancer.

With this type of treatment, you must not consume any fluid for 12 hours before each treatment to avoid the medicine being too diluted by the urine.

The solution must remain in the bladder for 1 to 2 hours after instillation. You will need to be occasionally repositioned during that time to ensure that all areas of the bladder come into equal contact with the medicine.

When you next need to empty your bladder, you must ensure that the drained fluid does not come into contact with your skin. If this happens, use soap and water to wash the affected area thoroughly, without rubbing or brushing.

Regular checks by your doctor during Epirubicin treatment

During treatment your doctor will be making regular checks of your:

• Blood - to check for low blood cell counts that may need treatment
• Heart function - heart damage can occur when high doses of Epirubicin are given. This may not be detected for several weeks, so regular tests may be required during this period
• Liver – using blood tests to check that this medicine is not affecting the way it functions in a harmful way
• Blood uric acid levels – Epirubicin may increase uric acid levels in the blood, which might cause gout. Another medicine may be given if your uric acid levels are too high

If you receive high doses of Epirubicin

High doses can worsen side effects like sores in the mouth or may decrease the number of white blood cells (which fight infection) and platelets (these help the blood to clot) in the blood. Should this happen, you may need antibiotics or blood transfusions. Mouth ulcers can be treated to make them less uncomfortable as they heal.

If you forget to use Epirubicin

Epirubicin must be administered on a fixed schedule. Please therefore attend all appointments exactly as scheduled. If you miss a dose, please discuss this with your doctor. Your doctor will then determine when you will receive the next dose of Epirubicin.

If you stop using Epirubicin

If you stop treatment with Epirubicin, its effect on the growth of the tumour will cease. Please do not stop treatment with Epirubicin without consulting your doctor.

Special dosage instructions

If you have a liver and/or kidney problem, your doctor may adjust the dose accordingly.

In heavily pretreated patients or patients with neoplastic bone marrow infiltration, a dose reduction or prolongation of the treatment-free intervals between cycles may be necessary.

The dose must be adjusted accordingly when Epirubicin is used in combination with other cytotoxic medicines.

Use in children and adolescents

There are no available safety and efficacy data.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Information for the doctor

Please refer to the final sections of this patient leaflet for information about overdose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following side effects, tell your doctor straight away as you may need urgent medical attention or hospitalisation:

Very common (may affect more than 1 in 10 people)

• Low red blood cell count (anaemia) that can leave you feeling tired and lethargic
• Low whiteblood cell counts (leukopenia) that increases the chance of infections and fever
• Infections
• Reduced platelet count – platelets help with blood clotting ( (thrombocytopenia) which may make you more likely to bruise and bleed
• Reduction in the number of certain types of white blood cells – granulocytes and neutrophiles –( granulocytopenia and neutropenia)
• Reduction in certain types of white blood cells accompanied by fever (febrile neutropenia)
• Inflammation of the transparent part of the eye called cornea (keratitis)
• Eye inflammation with red, watery eyes (conjunctivitis)
• Skin damage
• Hot flushes
• Inflammation of a vein (phlebitis)
• Nausea
• Vomiting
• Inflammation of the mucous membranes in the mouth (stomatitis)
• Inflammation of the mucous membranes
• Diarrhoea
• Hair loss
• Red coloured urine for 1 to 2 days after administration (chromaturia)
• Absence of menstruation (amenorrhoea)
• General feeling of being unwell
• Fever
• Changes in the levels of certain liver enzymes (transaminases)
• Bladder inflammation (cystitis) following direct administration of epirubicin into the bladder

Common (may affect up to 1 in 10 people)

• Decreased appetite/loss of appetite
• Severe arrhythmia (ventricular tachycardia)
• Slow heart rhythm rate (bradycardia)
• Heart conduction disorder (AV block, bundle-branch block)
• Lose water or body fluids (dehydration)
• Risk of a reduced effect of the heart with as a result congestion of the blood (congestive heart failure), heart failure (short of breath (dysponea); accumulation of fluid in the whole body (oedema), enlargement of the liver, accumulation of fluid in the abdomen (ascites), accumulation of fluid in or around the lungs (lungs and airways swelling, pleural effusions, pulmonary oedema), abnormal rhythm of the heart (gallop rhythm) cardiotoxicity (e.g. ECG abnormalities, arrhythmias, heart muscle disease (cardiomyopathy)) or tachycardia (abnormally fast heart rate)
• Bleeding (haemorrhage)
• Insufficient pumping of blood by the heart which can cause shortness of breath, accumulation of fluid, and abnormal heart rhythm.
• Pain behind the breastbone, indigestion, and difficulty in swallowing due to inflammation in the oesophagus
• Pain or burning in the gastrointestinal tract
• Inflammation of the mucous membranes in the gastrointestinal tract (erosion)
• Ulcers in the gastrointestinal tract (gastrointestinal ulcer)
• Rash, itching
• Abnormal discolouration of nails
• Skin changes
• Skin redness
• Abnormal discolouration of skin
• Redness at the infusion site
• Chills
• Change in heart function without symptoms (reduced left ventricular ejection fraction)

Uncommon (may affect up to 1 in 100 people)

• Blood poisoning (sepsis) (with symptoms such as fever, chills and shivering, general malaise, a fast heartbeat, fast breathing
• Serious lungs infection with fever, chills, shortness of breath, cough, phlegm and occasionally blood (pneumonia)
• When epirubicin is used at the same time with certain anti-cancer medicines (so-called DNA-damaging antineoplastic substances) can in rare cases lead to certain forms of cancer of the blood (secondary acute myeloid leukaemia (AML) with or without pre-leukaemia phase). These certain forms of cancer of the blood can only be observed after 1-3 years
• Blockage of a blood vessel by a blood clot formed elsewhere in the body (embolism)
• Blockage of an artery by a blood clot (arterial embolism)
• Inflammation of a vein due to a blood clot (thrombophlebitis)
• Blockage of a blood vessel in the lungs by a blood clot (pulmonary embolism) with chest pain and breathlessness
• Gastrointestinal tract bleeding
• Hives (urticaria)
• Skin redness (erythema)
• Weakness (asthenia)

Please contact your doctor or nurse immediately if you notice any of the following side effects.

Although they are rare these symptoms can be serious:

Rare (may affect up to 1 in 1,000 people)

• Sudden life-threatening allergic reaction (anaphylactic/anaphylactoid reaction). Symptoms include sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body shortness of breath, wheezing or trouble breathing
• High uric acid level in the blood (hyperuricaemia)
• Heart damage resulting in effects such as changes in ECG, various heart forms of heart rhythm disorders (arrhythmias) or diseases of the heart muscle (cardiomyopathy)
• Light headedness/dizziness
• Absence of sperm in the seminal fluid (azoospermia)

Not known (frequency cannot be estimated from the available data)

• Shock due to blood poisoning (septic shock) with symptoms such as a dangerous decrease in blood pressure which may be life-threatening; rapid shallow breathing, cold clammy skin, dizziness, weakness, fainting and a rapid weak pulseInsufficient oxygen supply to the tissue due to inhibited blood cell production in the bone marrow
• Shock (life-threatening condition with high blood pressure)
• Abdominal discomfort
• Dark spots in the mouth (oral pigmentation)
• Pain or burning in the gastrointestinal tract
• Photosensitivity reaction
• Skin redness/warmth, increased pigmentation of the skin and nails, photosensitivity, increased sensitivity of skin treated with radiotherapy (“recall phenomenon”)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Epirubicin

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

Store in a refrigerator (2°C – 8°C).

Keep the vial in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the vial label and outer carton after ‘EXP’. The expiry date refers to the last day of that month.

Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product.

This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15° to 25°C).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Epirubicin contains

• The active substance is epirubicin hydrochloride.
• The other ingredients are sodium chloride, water for injections and hydrochloric acid used as a pH adjuster.

What Epirubicin looks like and contents of the pack

Epirubicin is in the form of a solution for injection.

Each mililitre (ml) of solution contains 2 milligrams (mg) of epirubicin hydrochloride. The medicine is presented in glass containers called vials, containing 10 mg (5 ml), 20 mg (10 ml), 50 mg (25 ml) and 200 mg (100 ml) of epirubicin hydrochloride.

The vials are available in packs of 1, 5 or 10 vials of 5 ml, 10 ml, 25 ml or 100 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer(s)

Viatris Santé, 1 Rue de Turin, 69007 Lyon, France

Or

Pharmadox Healthcare Limited, KW20A, Kordin Industrial Park, Paola, PLA 3000, Malta

This leaflet was last revised in May 2026

The following information is intended for healthcare professionals only:

For intravenous injection and intravesical administration

Incompatibilities

Prolonged contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of the drug, which includes sodium bicarbonate containing solutions. Only the diluents detailed in ‘Dilution Instructions’ should be used.

Neither the injection nor any diluted solution should be mixed with any other drugs (a physical incompatibility with heparin has been reported).

Dilution Instructions

The injection may be given via the tubing of a free-running intravenous saline infusion. Where the injection is to be administered after dilution, the following instructions should be followed.

Epirubicin (hydrochloride) may be diluted under aseptic conditions in glucose 5% or sodium chloride 0.9% and administered as an intravenous infusion. The infusion solution should be prepared immediately before use.

The injection solution contains no preservative and any unused portion of the vials should be discarded immediately.

Safe Handling

This is a cytotoxic product, please follow your local policy guidelines for instructions on the safe handling/disposal of cytotoxics.

Storage

Store in a refrigerator (2°C - 8°C).

Keep the vial in the outer carton in order to protect from light.

In use: Epirubicin (hydrochloride) 2 mg/ml injection may be further diluted as detailed above. The infusion solution is chemically stable when stored in infusion bags prepared under full aseptically controlled conditions for 60 minutes at 25°C. From a microbiological point of view however, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless dilution has taken place in controlled and validated aseptic conditions.

Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product.

This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15° to 25°C).