Epirubicin Teva
Epirubicin hydrochloride – Anthracycline cytotoxic agent for cancer treatment
Epirubicin Teva is an anthracycline chemotherapy medication used to treat breast cancer, gastric (stomach) cancer, and superficial bladder cancer. As a cytotoxic agent, it works by interfering with the DNA of rapidly dividing cancer cells, ultimately leading to their death. This medication is a closely related analogue of doxorubicin and is administered exclusively by healthcare professionals in hospital or clinic settings. Epirubicin is frequently used in multi-drug chemotherapy regimens, including the widely used FEC (fluorouracil, epirubicin, cyclophosphamide) protocol for breast cancer.
Quick Facts
Key Takeaways
- Epirubicin Teva is an anthracycline chemotherapy drug used to treat breast cancer, gastric cancer, and superficial bladder cancer, often in combination with other anticancer agents.
- The most serious risk is cardiotoxicity (heart damage), which can lead to congestive heart failure. Heart function must be monitored before, during, and after treatment with regular echocardiograms or MUGA scans.
- Severe myelosuppression (bone marrow suppression) is expected, with the lowest white blood cell counts typically occurring 10–14 days after administration and recovering by day 21.
- Hair loss occurs in 60–90% of patients but is usually reversible after treatment ends. Nausea and vomiting are also very common, especially within the first 24 hours.
- Effective contraception is mandatory during treatment and for at least 6.5 months (women) or 3.5 months (men) after the last dose, as epirubicin can cause birth defects and infertility.
What Is Epirubicin Teva and What Is It Used For?
Epirubicin is a semisynthetic derivative of doxorubicin and belongs to the anthracycline group of cytotoxic antibiotics, which are among the most effective and widely used anticancer agents worldwide. The drug exerts its anticancer effects through multiple mechanisms: it intercalates between DNA base pairs, inhibits the enzyme topoisomerase II (which is essential for DNA replication), and generates cytotoxic free radicals that damage cellular structures. Together, these actions prevent cancer cells from dividing and ultimately trigger programmed cell death (apoptosis).
Epirubicin Teva is approved for the treatment of several types of cancer. When administered intravenously (into a vein), it is used for breast cancer – one of the most common cancers globally – and gastric (stomach) cancer. In breast cancer treatment, epirubicin is a cornerstone of the widely used FEC regimen (fluorouracil, epirubicin, cyclophosphamide) and the EC regimen (epirubicin, cyclophosphamide), which are standard adjuvant and neoadjuvant chemotherapy protocols recommended by major international guidelines including the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO).
When administered intravesically (directly into the bladder through a catheter), epirubicin is used to treat early superficial bladder cancer and to help prevent cancer recurrence after transurethral resection (surgical removal of bladder tumors). Intravesical chemotherapy with epirubicin has been shown in clinical trials to significantly reduce the risk of bladder cancer recurrence compared to surgery alone.
Epirubicin is frequently used as part of polychemotherapy regimens – treatment protocols combining multiple anticancer drugs that work through different mechanisms. This combination approach has been demonstrated to improve treatment outcomes compared to single-agent therapy. The choice of combination regimen depends on the type and stage of cancer, the patient’s overall health, and prior treatment history.
Compared to its parent compound doxorubicin, epirubicin is associated with a somewhat more favorable side effect profile. While both drugs share similar efficacy against many cancers, epirubicin generally causes less severe nausea and vomiting, may have slightly lower cardiotoxicity at equivalent doses, and is eliminated from the body more rapidly. These pharmacological differences make epirubicin a preferred choice in many clinical settings, particularly in breast cancer treatment.
What Should You Know Before Taking Epirubicin Teva?
Before beginning treatment with Epirubicin Teva, your medical team will conduct a comprehensive evaluation to ensure that the potential benefits outweigh the risks. This includes detailed blood tests, heart function assessments, and a review of your complete medical history. It is essential that you provide your doctor with accurate information about all medications you are taking, any previous cancer treatments, and your overall health status.
Contraindications
Epirubicin Teva must not be given in the following situations:
- Hypersensitivity: Known allergy to epirubicin, other anthracyclines (such as doxorubicin or daunorubicin), anthracenediones, or any of the other ingredients in the formulation.
- Breastfeeding: Epirubicin must not be used during breastfeeding. Breastfeeding should be discontinued during treatment and for at least 7 days after the last dose.
Additional contraindications for intravenous (IV) administration:
- Previous treatment with high cumulative doses of other anthracyclines (such as doxorubicin or daunorubicin) due to increased risk of heart damage
- Current or history of heart disease, including heart failure, severe arrhythmias, or recent myocardial infarction
- Severely low blood cell counts (persistent myelosuppression)
- Severe liver impairment
- Acute severe systemic infection
Additional contraindications for intravesical (bladder) administration:
- Invasive tumors that have penetrated the bladder wall
- Urinary tract infection
- Inflammation of the bladder (cystitis)
- Difficulty inserting a catheter into the bladder
- Large residual urine volume after urination
- Blood in the urine (hematuria)
- Contracted (shrunken) bladder
Warnings and Precautions
Talk to your doctor before receiving Epirubicin Teva if any of the following apply to you:
Epirubicin can cause serious heart damage (cardiotoxicity) that may occur during treatment or months to years afterward. The risk increases with cumulative dose, age (elderly and children are at higher risk), prior anthracycline therapy, prior chest radiation, and concurrent use of other cardiotoxic drugs. Heart function (ejection fraction) will be monitored before and regularly during treatment using echocardiography or MUGA scan. Treatment may need to be stopped if heart function declines.
- Prior anthracycline treatment: If you have previously received doxorubicin, daunorubicin, or other anthracyclines, or treatments with trastuzumab, or chest radiation, your total lifetime dose of anthracyclines must be carefully calculated to minimize cardiotoxicity risk.
- Liver or kidney disease: Impaired liver or kidney function can increase drug exposure and side effects. Dose adjustments may be necessary, and function will be monitored regularly.
- Bone marrow suppression: Epirubicin suppresses bone marrow function, reducing white blood cells (increasing infection risk), red blood cells (causing anemia), and platelets (increasing bleeding risk). Blood counts are typically lowest 10–14 days after administration and generally recover by day 21. Regular blood tests are mandatory.
- Infections and bleeding: Due to myelosuppression, you may be more susceptible to infections and bleeding. Report any fever, sore throat, unusual bruising, or bleeding to your medical team immediately.
- Vaccinations: Live vaccines must not be given during epirubicin treatment, as there is a risk of fatal vaccine-related disease due to immunosuppression. Discuss any planned vaccinations with your doctor.
- Uric acid levels: Rapid destruction of cancer cells can elevate uric acid levels in the blood (tumor lysis syndrome). Your doctor may monitor and treat this if necessary.
- Thromboembolism: Chemotherapy increases the risk of blood clots, including deep vein thrombosis and pulmonary embolism.
- Mouth sores (mucositis): Severe inflammation and ulceration of the mouth and gastrointestinal tract can occur.
- Extravasation: If the drug leaks outside the vein during intravenous administration, it can cause severe tissue damage and necrosis. Immediately inform your healthcare team if you feel any burning or pain at the injection site.
Pregnancy and Breastfeeding
Epirubicin can cause severe harm to an unborn baby. Animal studies have demonstrated that the drug causes birth defects and embryo-fetal toxicity. Some case reports in humans have indicated cardiac problems in newborns and fetal death associated with epirubicin exposure during pregnancy.
Women of childbearing potential must use effective contraception during treatment 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. Epirubicin may cause permanent infertility in both men and women. Both men and women are advised to seek genetic counseling and consider fertility preservation options before starting treatment.
Epirubicin may cause amenorrhea (absence of menstruation) or premature menopause in premenopausal women. In men, it may cause azoospermia (absence of sperm in semen). These effects may be permanent in some cases. If you plan to have children in the future, discuss fertility preservation with your oncologist before treatment begins.
It is not known whether epirubicin passes into breast milk. Breastfeeding must be discontinued during treatment and for at least 7 days after the last dose.
Driving and Operating Machinery
Epirubicin frequently causes nausea and vomiting, which may impair your ability to drive or operate machinery safely. You should assess your own fitness before driving or performing tasks that require alertness. Do not drive if you feel unwell after treatment.
Sodium Content
Epirubicin Teva contains 3.5 mg (0.154 mmol) sodium per ml of solution. This should be considered for patients on a sodium-restricted diet, particularly at higher dose volumes. A 100 ml vial contains 354 mg sodium, corresponding to approximately 17.7% of the WHO recommended maximum daily sodium intake for adults.
How Does Epirubicin Teva Interact with Other Drugs?
Drug interactions are critically important with epirubicin because many of its interactions can increase the risk of serious or life-threatening side effects, particularly cardiotoxicity and myelosuppression. Your oncologist will carefully evaluate all your current medications before starting treatment and will monitor for interactions throughout your therapy.
Major Interactions
| Drug / Class | Effect | Clinical Significance |
|---|---|---|
| Other anthracyclines (doxorubicin, daunorubicin) | Additive cardiotoxicity and myelosuppression | Cumulative lifetime anthracycline dose must be calculated. Concurrent use is contraindicated. |
| Trastuzumab | Significantly increased cardiotoxicity risk | Concurrent use should be avoided. A washout period of at least 7 months is recommended before starting trastuzumab after anthracycline therapy. |
| Cyclophosphamide, 5-fluorouracil, cisplatin, taxanes | Enhanced cardiotoxicity and myelosuppression | Used in combination regimens with careful dose monitoring. Additional cardiac surveillance required. |
| Paclitaxel | Increased epirubicin plasma concentrations when paclitaxel is given before epirubicin | Sequence of administration matters. May require dose adjustment. |
| Docetaxel | Increased epirubicin plasma concentrations when given immediately after epirubicin | May increase side effects. Timing of administration should be planned carefully. |
| Live vaccines (e.g., MMR, varicella, yellow fever) | Risk of fatal vaccine-related disease | Live vaccines must not be given during treatment. Use only inactivated vaccines. |
| Radiation therapy | Enhanced radiation effects and radiation recall reactions | Epirubicin can potentiate radiation damage. Even long after radiation, severe reactions can occur in the irradiated area. |
Minor Interactions
| Drug | Effect | Action |
|---|---|---|
| Cimetidine | Increases epirubicin blood levels by up to 50% | Discontinue cimetidine during epirubicin treatment |
| Dexverapamil | May increase bone marrow toxicity | Monitor blood counts more frequently |
| Quinine | Accelerates epirubicin clearance; may damage red blood cells | Avoid concurrent use if possible |
| Dexrazoxane | Cardioprotective but may reduce epirubicin efficacy | Used selectively; may decrease epirubicin retention |
| Interferon alfa-2b | Altered epirubicin pharmacokinetics | Monitor for increased toxicity |
| Calcium channel blockers | Potential additive cardiotoxicity | Additional cardiac monitoring required |
| Hepatotoxic drugs | Impaired epirubicin metabolism; increased toxicity | Monitor liver function; dose adjustment may be needed |
When epirubicin is given intravesically (into the bladder), systemic drug interactions are generally minimal due to limited absorption into the bloodstream. However, patients should not drink any fluids for 12 hours before intravesical treatment to avoid diluting the drug in the bladder.
What Is the Correct Dosage of Epirubicin Teva?
Epirubicin Teva is always administered under the supervision of a physician experienced in cancer chemotherapy. Your dose is calculated based on your body surface area (expressed in mg/m²), the type and stage of your cancer, your overall health, liver function, kidney function, and any previous cancer treatments you have received. Your doctor will also monitor your blood counts and heart function to determine whether dose adjustments are necessary.
Intravenous Administration (Into a Vein)
Monotherapy (Epirubicin Alone)
When epirubicin is used as the sole chemotherapy agent, the recommended dose is 60–90 mg/m² body surface area, administered as a single intravenous dose or divided over 2–3 consecutive days. This cycle is repeated every 21 days, provided that blood counts and heart function have adequately recovered.
Combination Chemotherapy
When used in combination with other anticancer drugs (polychemotherapy), the dose of epirubicin is typically reduced compared to monotherapy. The exact dose depends on the specific regimen. For example, in the FEC regimen for breast cancer, epirubicin is typically given at 60–100 mg/m² alongside fluorouracil and cyclophosphamide.
High-Dose Breast Cancer Regimens
For adjuvant treatment of early breast cancer, higher doses of 100–120 mg/m² body surface area may be used per cycle. These high-dose regimens have been shown to improve disease-free survival in clinical trials, but carry an increased risk of side effects including myelosuppression and require careful monitoring and supportive care, including growth factor support.
The drug is administered either as an intravenous injection over 3–5 minutes or as an intravenous infusion over up to 30 minutes, via a catheter or a side port of a freely running IV infusion of normal saline or 5% glucose solution. Correct venous access is critical to prevent extravasation (leakage outside the vein), which can cause severe tissue damage.
Intravesical Administration (Into the Bladder)
Bladder Cancer Treatment
For intravesical use, the typical dose is 30–80 mg diluted in normal saline or sterile water to a total volume of approximately 50 ml. The concentration after dilution must be 0.6–1.6 mg/ml. The solution is instilled into the bladder via a catheter and retained for 1–2 hours. Patients must not drink fluids for 12 hours before treatment to minimize urine volume. During the retention period, the patient should change position periodically to ensure all parts of the bladder mucosa are exposed to the drug.
Dose Adjustments
- Liver impairment: Dose reduction is required in patients with elevated bilirubin or transaminases, as the liver is the primary route of epirubicin elimination.
- Kidney impairment: Dose reduction may be necessary in patients with significant renal impairment (serum creatinine > 5 mg/dl).
- Myelosuppression: Treatment may be delayed or doses reduced if blood counts have not recovered sufficiently from the previous cycle.
- Elderly patients: Starting doses may be at the lower end of the range, with close monitoring for cardiotoxicity.
Children
Safety and efficacy of epirubicin in children have not been established. Epirubicin use in pediatric patients is not routinely recommended, and any such use would be under strict specialist supervision in clinical trial or compassionate use settings.
Missed Dose
Since epirubicin is administered by healthcare professionals in a clinical setting, missed doses are unlikely. If a scheduled treatment cycle is delayed, your doctor will determine the appropriate timing for the next dose based on your blood counts and overall condition.
Overdose
Overdose of epirubicin can cause severe, potentially life-threatening effects including acute heart failure, severe myelosuppression, and gastrointestinal toxicity (particularly mucositis with severe mouth and GI ulceration). There is no specific antidote. Treatment is supportive: cardiac monitoring, blood transfusions, growth factor support, and treatment of infection. If overdose is suspected, contact your medical team immediately.
What Are the Side Effects of Epirubicin Teva?
Like all cytotoxic medications, epirubicin causes side effects in a significant proportion of patients. Side effects are expected in more than 10% of patients receiving treatment. The most common adverse reactions include myelosuppression (bone marrow suppression), gastrointestinal disturbances, loss of appetite, hair loss, and infections. Understanding these potential side effects allows patients and their medical team to monitor for and manage them effectively.
The severity and incidence of side effects generally correlate with the dose administered and the cumulative dose received over time. Many side effects are temporary and resolve after treatment is completed, though some (particularly cardiotoxicity) may be permanent.
Very Common
- Bone marrow suppression (reduced white blood cells, red blood cells, and platelets) leading to increased infection risk, anemia, bruising, and bleeding
- Infections due to immunosuppression
- Eye inflammation (conjunctivitis or keratitis)
- Hot flushes, redness along the veins (phlebitis)
- Nausea and vomiting (usually within the first 24 hours)
- Mouth sores (stomatitis) and mucositis, typically appearing 5–10 days after treatment
- Diarrhea, which can cause dehydration
- Hair loss (alopecia) – occurs in 60–90% of patients, including reduced facial hair in men; usually reversible
- Skin changes and tissue damage
- Red-orange discoloration of urine for 1–2 days (harmless)
- Absence of menstruation (amenorrhea)
- General malaise and fever
- Elevated liver enzyme levels (transaminases)
- Bladder inflammation (cystitis), sometimes with bleeding, after intravesical administration
Common
- Loss of appetite (anorexia), dehydration
- Heart failure (shortness of breath, fluid retention, edema, liver enlargement, ascites, pleural effusion, pulmonary edema)
- Heart rhythm disturbances (tachycardia, ventricular tachycardia, bradycardia, AV block, bundle branch block)
- Reduced heart ejection fraction
- Bleeding, skin redness
- Esophageal inflammation (esophagitis), stomach pain, gastrointestinal ulceration
- Skin rash, severe itching (pruritus), skin changes
- Increased skin and nail pigmentation (hyperpigmentation)
- Redness at injection/infusion site, chills
- Local reactions (burning, increased urination) with intravesical administration
Uncommon
- Blood poisoning (sepsis), pneumonia
- Secondary leukemia (acute lymphoblastic leukemia, acute myeloid leukemia) – may occur months to years after treatment
- Thrombophlebitis (vein inflammation with blood clot)
- Thromboembolism, including pulmonary embolism (in rare cases fatal)
- Gastrointestinal bleeding
- Urticaria (hives), skin redness (erythema)
- Weakness (asthenia)
Rare
- Severe immediate allergic reactions (anaphylaxis) with or without shock, including rash, itching, fever, and chills
- Elevated uric acid (hyperuricemia) due to tumor lysis
- Dizziness
- Cardiomyopathy (heart muscle disease), abnormal ECG, cardiac arrhythmias
- Absence of sperm (azoospermia)
- Extremely high fever (hyperpyrexia)
Frequency Not Known
- Septic shock as a result of myelosuppression
- Hemorrhage and tissue oxygen deprivation
- Peripheral neuropathy (nerve damage), headache
- Shock
- Oral discomfort, mouth ulcers, oral pain, burning sensation, oral mucosal bleeding, cheek pigmentation
- Photosensitivity (skin sensitivity to sunlight), radiation recall reaction
- Proteinuria (protein in urine) with high-dose treatment
- Local pain, cellulitis, tissue necrosis, phlebosclerosis (thickening of vein walls) after accidental extravasation
When epirubicin is administered directly into the bladder, systemic side effects and severe allergic reactions are rare. Local effects such as bladder irritation, burning sensation, and increased urination frequency are the most commonly reported adverse events.
If you experience any side effects, especially those that are severe or persistent, inform your medical team promptly. Some side effects require immediate medical intervention, particularly signs of infection (fever, chills, sore throat), unusual bleeding or bruising, breathing difficulties, chest pain, or signs of heart failure (swollen ankles, unexplained weight gain, shortness of breath at rest).
How Should Epirubicin Teva Be Stored?
Epirubicin Teva is stored and handled exclusively by healthcare professionals in hospital pharmacies and oncology units. Patients do not need to store this medication at home, but understanding the storage requirements helps ensure medication safety and efficacy.
- Storage temperature: Refrigerate at 2–8°C (36–46°F). Store and transport cold.
- Do not freeze: Freezing can alter the chemical composition and render the product ineffective or unsafe.
- After opening: The product should be used immediately. From a microbiological standpoint, if not used immediately, storage time should not normally exceed 24 hours at 2–8°C.
- Shelf life of diluted solutions: When diluted in 0.9% sodium chloride or 5% glucose in non-PVC bags, the solution is stable for up to 28 days refrigerated or 14–28 days at room temperature (15–25°C), depending on the diluent.
- Gel formation: Refrigeration may cause a gel-like consistency to form. This gel returns to a slightly viscous or free-flowing solution within 2–4 hours after reaching room temperature (15–25°C). This is normal and does not affect the product’s quality.
- Expiry date: Do not use after the expiry date printed on the label and carton.
- Disposal: Unused medication and waste materials must be disposed of according to local requirements for cytotoxic drug waste. Do not dispose of via household waste or sewage systems.
Epirubicin is a cytotoxic drug that requires special handling precautions. Healthcare personnel preparing or administering the drug must wear protective gloves, eye protection, and a face mask. Spillages should be treated with 1% sodium hypochlorite solution. Pregnant women must avoid handling cytotoxic drugs.
What Does Epirubicin Teva Contain?
Epirubicin Teva 2 mg/ml solution for injection/infusion is a clear red liquid provided in colorless glass vials (Type I glass) with bromobutyl rubber stoppers, aluminum seals, and snap-off caps. Understanding the composition is important for healthcare professionals to identify incompatibilities and for patients with known sensitivities to excipients.
Active Ingredient
Each 1 ml of solution contains 2 mg epirubicin hydrochloride.
Other Ingredients (Excipients)
- Sodium chloride
- Hydrochloric acid (for pH adjustment)
- Water for injections
Available Pack Sizes
| Vial Volume | Epirubicin Content | Sodium Content |
|---|---|---|
| 5 ml | 10 mg | 18 mg (0.9% of daily intake) |
| 10 ml | 20 mg | 35 mg (1.8% of daily intake) |
| 25 ml | 50 mg | 89 mg (4.4% of daily intake) |
| 75 ml | 150 mg | 266 mg (13.3% of daily intake) |
| 100 ml | 200 mg | 354 mg (17.7% of daily intake) |
Not all pack sizes may be marketed in all countries. Each carton contains one glass vial.
Incompatibilities
Epirubicin hydrochloride must not be mixed with heparin due to the risk of precipitation. Prolonged contact with alkaline solutions must be avoided as it causes hydrolysis (chemical breakdown) of the drug. Epirubicin may only be diluted with 0.9% sodium chloride solution, 5% glucose solution, or sterile water for injections (intravesical use only). Do not mix with any other medications.
Frequently Asked Questions
References
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List (2023). Epirubicin is included as an essential cytotoxic medicine. who.int
- European Medicines Agency (EMA). Epirubicin hydrochloride – Summary of Product Characteristics. European regulatory documentation for epirubicin-containing products. ema.europa.eu
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer (Version 2.2025). FEC and EC regimen protocols including epirubicin dosing guidelines. nccn.org
- British National Formulary (BNF). Epirubicin hydrochloride – Drug Monograph. National Institute for Health and Care Excellence (NICE). Comprehensive prescribing information including dosage, warnings, and interactions. bnf.nice.org.uk
- French Epirubicin Study Group. Epirubicin-based adjuvant chemotherapy in node-positive breast cancer patients: 10-year follow-up results of the FEC trials. Journal of Clinical Oncology. 2005;23(12):2686-2693. doi:10.1200/JCO.2005.10.326 – Level 1A evidence from randomized controlled trials.
- Fumoleau P, Kerbrat P, Romestaing P, et al. Randomized trial comparing six versus three cycles of epirubicin-based adjuvant chemotherapy in premenopausal, node-positive breast cancer patients. J Clin Oncol. 2003;21(2):298-305. doi:10.1200/JCO.2003.09.127
- Sylvester RJ, Oosterlinck W, Holmang S, et al. Systematic review and individual patient data meta-analysis of randomized trials comparing a single immediate instillation of chemotherapy after transurethral resection with transurethral resection alone in patients with stage pTa-pT1 urothelial carcinoma. Eur Urol. 2016;69(2):231-244. doi:10.1016/j.eururo.2015.05.050
- Ryberg M, Nielsen D, Cortese G, et al. New insight into epirubicin cardiac toxicity: competing risks analysis of 1097 breast cancer patients. J Natl Cancer Inst. 2008;100(15):1058-1067. doi:10.1093/jnci/djn206
- U.S. Food and Drug Administration (FDA). Epirubicin hydrochloride for injection – Prescribing Information. FDA-approved labeling for epirubicin products. fda.gov
- Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012;379(9814):432-444. doi:10.1016/S0140-6736(11)61625-5
The information on this page is based on Level 1A evidence from systematic reviews, randomized controlled trials, and official regulatory documentation (WHO, EMA, FDA, BNF). All referenced guidelines follow the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) framework for assessing evidence quality and strength of recommendations.
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