Epirubicin

Epirubicin is a prescription medication used as an adjuvant in the treatment of breast cancer.

• Epirubicin is available under the following different brand names: Ellence, Pharmorubicin

Adult dosage

Injectable solution

• 2mg/mL

Powder for reconstitution

• 50 mg
• 200 mg

Adjuvant Breast Cancer Treatment

Adult dosage

• Option 1 (Day 1 dose schedule)
  • Day 1: Epirubicin 100 mg/m² Intravenous, AND 5-fluorouracil 500 mg/m² Intravenous, AND cyclophosphamide 500 mg/m² Intravenous  
  • Repeat every 21 days into 6 cycles
• Option 2 (Divided dose schedule)
  • The first dose was divided equally between days 1 & 8: Epirubicin 60 mg/m² Intravenous, AND 5-fluorouracil 500 mg/m² Intravenous, AND
  • Days 1-14: Cyclophosphamide 75 mg/m² orally
  • Repeat every 28 days for 6 cycles

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Epirubicin include:

• nausea,
• vomiting,
• diarrhea,
• temporary hair loss,
• blisters or ulcers in the mouth,
• red or swollen gums,
• trouble swallowing,
• hot flashes,
• missed menstrual periods,
• discoloration of the skin or nails,
• lack of energy, and
• red-colored urine for 1 or 2 days after each injection

Serious side effects of Epirubicin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• swelling,
• rapid weight gain,
• shortness of breath,
• fast or slow heartbeats,
• easy bruising,
• unusual bleeding,
• purple or red spots under the skin,
• unusual tiredness,
• lightheadedness,
• cold hands and feet,
• pain, blistering, redness, or skin changes at the injection site,
• severe vomiting,
• feeling very thirsty or hot,
• inability to urinate,
• heavy sweating,
• hot and dry skin,
• pain while breathing,
• wheezing,
• gasping for breath,
• cough with foamy mucus,
• cold and clammy skin,
• anxiety,
• tiredness,
• weakness,
• muscle cramps,
• nausea,
• vomiting,
• diarrhea,
• tingling in the hands and feet or around the mouth,
• fever,
• chills,
• flu symptoms,
• mouth sores,
• shallow breathing, and
• pale or blue-colored skin

Rare side effects of Epirubicin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Epirubicin has severe interactions with no other drugs
• Epirubicin has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • deferiprone
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
  • palifermin
  • ropeginterferon alfa 2b
  • tofacitinib
  • trastuzumab
  • trastuzumab deruxtecan
• Epirubicin has moderate interactions with the following drugs:
  • acalabrutinib
  • belatacept
  • bevacizumab
  • cholera vaccine
  • cimetidine
  • dengue vaccine
  • denosumab
  • fingolimod
  • hydroxyurea
  • meningococcal group B vaccine
  • ofatumumab SC
  • olaparib
  • siponimod
  • sipuleucel-T
  • trastuzumab
  • trastuzumab deruxtecan
• Epirubicin has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Severe hypersensitivity to the drug, other anthracyclines, or anthracenediones
• Baseline ANC below 1500/mm³
• Cardiomyopathy and/or heart failure, recent MI, or severe arrhythmias
• Severe myocardial insufficiency
• Cumulative dose achieved in previous anthracycline treatment
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment (Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Epirubicin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Epirubicin?”

Cautions

• Lysis syndrome may occur; evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment; consider hydration, urine alkalinization, and prophylaxis with allopurinol to minimize potential complications of hyperuricemia and tumor lysis syndrome
• Thrombophlebitis and thromboembolic events, including pulmonary embolism (in some cases fatal), are reported with therapy; venous sclerosis may result from an injection into a small vessel or from repeated injections into the same vein
• Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents may result in serious or fatal infections
• Administration after previous radiation therapy may induce an inflammatory recall reaction at the site of irradiation
• Therapy can cause fetal harm; advise patients of the potential risk to a fetus and to use effective contraception
• Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods

Pregnancy & Lactation

• Verify pregnancy status in female patients of reproductive potential before initiating
• Based on findings from animal studies and mechanism of action, the drug can cause fetal harm when administered to a pregnant woman; avoid use during the 1st trimester
• Available human data do not establish the presence or absence of major birth defects and miscarriage related to use during the 2nd and 3rd trimesters; there are reports of fetal and/or neonatal cardiotoxicity following in utero exposure to epirubicin
• There have been rare reports of fetal and/or neonatal transient ventricular hypokinesia, transient elevation of cardiac enzymes, and a case of fetal demise from suspected anthracycline-induced cardiotoxicity following in utero exposure to epirubicin in 2nd and/or 3rd trimesters
• Cardiotoxicity is a known risk of anthracycline treatment in adults; monitor fetus and/or neonate for cardiotoxicity and perform testing consistent with community standards of care
• Advise pregnant women and females of reproductive potential of the potential risk to a fetus
• Contraception
  • Can cause fetal harm in females when administered to a pregnant woman; advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the last dose
  • Based on its mechanism of action and genotoxicity studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose
  • Advise male patients with pregnant partners to use condoms during treatment and for at least 7 days after the last dose
• Infertility
  • Based on clinical findings and animal studies, therapy may impair female fertility and result in amenorrhea; premature menopause can occur; recovery of menses and ovulation is related to age at treatment
  • Based on clinical findings and animal studies in males, therapy may cause oligospermia, azoospermia, and permanent loss of fertility; sperm counts have been reported to return to normal levels in some men; may occur several years after the end of therapy
• Lactation
  • There are no data on the presence of the drug in human milk, effects on the breastfed children, or milk production; the drug is present in rat milk; when a drug is present in animal milk it is likely the drug will be present in human milk
  • Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment and for at least 7 days after the last dose.