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Injections containing epirubicin hydrochloride

Drugs List

  • epirubicin hydrochloride 100mg/50ml injection
  • epirubicin hydrochloride 10mg/5ml injection
  • epirubicin hydrochloride 200mg/100ml injection
  • epirubicin hydrochloride 50mg/25ml injection
  • PHARMORUBICIN 10mg/5ml injection solution
  • PHARMORUBICIN 200mg/100ml injection solution
  • PHARMORUBICIN 50mg/25ml injection solution
  • Therapeutic Indications


    Carcinoma of breast
    Carcinoma-in-situ of the bladder
    Myeloma - multiple
    Prophylaxis of bladder cancer recurrences after transurethral resection
    Treatment of carcinoma of the ovary
    Treatment of colorectal carcinoma
    Treatment of gastric carcinoma
    Treatment of lung carcinoma
    Treatment of papillary transitional cell carcinoma of the bladder

    Unlicensed Uses

    Acute lymphoblastic leukaemia in relapsed or refractory paediatric patients
    Childhood rhabdomyosarcoma
    Soft tissue tumours of childhood


    Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.
    Doses may vary significantly if this agent is used as monotherapy or different combinations.
    When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.


    Not licensed for use in children.

    Is used for the treatment of acute lymphoblastic leukaemia, rhabdomyosarcoma and other soft tissues tumours of childhood.

    Doses should be in accordance with local treatment protocols.

    Patients with Renal Impairment

    The manufacturers recommend a dose reduction in patients with severe renal impairment (serum creatinine greater than 450 micromol/l or 5 mg/dl).

    The Renal Drug Handbook recommends using non specified lower doses when glomerular filtration rate is below 10 ml/minute.

    Patients with Hepatic Impairment

    Serum bilirubin less than 24 micromol/l: Dose as normal.
    Serum bilirubin between 24 to 51 micromol/l (1.4 to 3 mg/100 ml): Reduce dose by 50%.
    Serum bilirubin greater than 51 micromol/l (or AST more than 4 x ULN): Reduce dose by 75%.

    Additional Dosage Information

    If signs of toxicity, including neutropenia/neutropenic fever and thrombocytopenia occur (which could persist at day 21), dose modification or postponement of the subsequent dose may be required.

    A cumulative dose of 900 to 1000 mg/square metre should only be exceeded with extreme caution as above this level, the risk of irreversible congestive heart failure is greatly increased.


    For intravenous infusion or injection via tubing of fast running infusion.

    Alternatively, it may be given intravesically for superficial bladder carcinoma and carcinoma-in-situ. This route is not suitable for tumours that have penetrated the bladder wall.


    Acute infection
    Cardiac impairment
    Cystitis - if for intravesical use
    Haematuria - if for intravesical use
    History of myocardial infarction
    Large residual volume of urine - if for intravesical use
    Long QT syndrome
    Myocardial infarction
    Severe hepatic impairment
    Torsade de pointes
    Urethral stenosis preventing urethral catheterisation-If intravesical use
    Urinary tract infection - if for intravesical use

    Precautions and Warnings

    Children under 18 years
    Family history of long QT syndrome
    History of cardiotoxic drug
    History of mediastinal radiotherapy
    History of treatment with anthracyclines
    Within 7 months of discontinuing trastuzumab
    Electrolyte imbalance
    Hepatic impairment
    History of torsade de pointes
    Renal impairment - glomerular filtration rate below 10ml/minute

    Administration of live vaccines is not recommended
    Correct electrolyte disorders before treatment
    Sodium content of formulation may be significant
    Advise ability to drive/operate machinery may be affected by side effects
    Cardiotoxic -Avoid anthracyclines for up to 7 months after last trastuzumab
    Consider premedication with hypouricaemic agent
    Exclude invasive tumours penetrating the bladder wall before treatment
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Maintain adequate hydration of patient prior / during treatment
    Not all available brands are licensed for all indications
    Treatment to be prescribed under the supervision of a specialist
    Consult local policy on the safe use of anti-cancer drugs
    Do not use intravesical route if bladder is contracted
    Do not use intravesical route if catheterisation problems occur
    If extravasation occurs follow local policy & seek expert help immediately
    Staff: Not to be handled by pregnant staff
    Baseline & follow-up ECGs during & immediately after administration advised
    Measurement of LV ejection fraction recommended before and during treatment
    Monitor full blood count and differential WBC before and during therapy
    Perform echocardiography before commencing therapy
    Perform liver function tests before commencing therapy and during therapy
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor cardiac function
    Monitor patients for signs of tumour lysis syndrome
    Monitor serum creatinine
    Monitor serum electrolytes
    Monitor uric acid levels
    Advise patient to report symptoms of infection immediately
    Risk of cardiomyopathy increases with high cumulative dosage
    May colour urine red
    Not licensed for use in children under 18 years
    Lifetime cumulative dose should be limited to 1000mg/m squared
    May cause impaired fertility
    Female: Ensure adequate contraception during treatment
    Male: Contraception required during and for 6 months after treatment
    Breastfeeding: Do not breastfeed & discard milk for 1 week after therapy

    Treatment in the presence of pre-existing heart disease or reduced cardiac function should be carefully considered. Cardiac function should be assessed before patients undergo treatment and must be monitored throughout therapy to minimise the risk of incurring severe cardiac impairment (e.g. by LVEF, ECG, ECHO, MUGA as appropriate). The risk of cardiotoxicity may be decreased through regular monitoring and prompt discontinuation of epirubicin at the first sign of impaired function.

    Acute cardiotoxicity is usually a transient disturbance of cardiac function marked by ECG abnormalities (including severe arrhythmias) and does not usually predict subsequent development of delayed cardiomyopathy.

    Delayed cardiotoxicity may manifest, towards the end of therapy, within 2 to 3 months of finishing treatment or even years following the completion of treatment. Delayed cardiomyopathy is manifested by reduced LVEF and/or signs and symptoms of congestive heart failure (CHF). Subacute effects such as pericarditis/myocarditis have also been reported. Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug.

    The risk of delayed cardiomyopathy rises with increasing exposure to anthracyclines (e.g. doxorubicin). The maximum cumulative lifetime doses of epirubicin is 900 mg/square. Above this dosage, the risk of irreversible congestive cardiac failure increases greatly, however cardiotoxicity may occur at doses lower than the recommended cumulative limit. Epirubicin cardiotoxicity is enhanced by previous or concurrent use of other anthracyclines and anthracenediones (e.g. mitoxantrone).

    White blood cell count reaches a nadir between days 10 to 14 after administration, and usually recovers by about 21 days.

    Secondary leukaemia is more common when anthracyclines are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pre-treated with cytotoxic drugs or when doses of the anthracyclines have been escalated. These leukaemias can have a 1 to 3 year latency period.

    Pregnancy and Lactation


    Epirubicin is contraindicated in pregnancy.

    Reports of epirubicin in combination with other cytotoxic agents in human pregnancy has resulted in miscarriage, stillborns, intrauterine growth restriction, transient leukopaenia.

    It has been shown to be genotoxic, embryotoxic and carcinogenic in rats.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Epirubicin is contraindicated in breastfeeding.

    The molecular weight is low enough that excretion into human breast milk should be expected, a risk to neonates cannot be excluded.

    Schaefer recommends suspending breast feeding for at least 7 days following treatment with epirubicin.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Allergic reaction
    Atrioventricular block
    Bundle branch block
    Burning sensation
    Congestive cardiac failure
    Cystitis - chemical (transient)
    Decreased ejection fraction
    ECG changes
    Erythema at injection site
    Erythematous rash
    Extravasation necrosis
    Febrile neutropenia
    Haemorrhagic cystitis
    Hot flushes
    Increase of liver transaminases
    Increased susceptibility to infection
    Local pain (injection site)
    Peripheral neuropathy
    Pleural effusion
    Pulmonary embolism
    Pulmonary oedema
    Radiation recall dermatitis
    Red urine
    Septic shock
    Skin reddening
    Thromboembolic disorders
    Tumour lysis syndrome
    Ventricular tachycardia


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2015

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 14 August 2015.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 14 August 2015.

    Summary of Product Characteristics: Epirubicin 2mg/ml Injection. Teva UK Ltd. Revised January 2013.
    Summary of Product Characteristics: Epirubicin 2mg/ml Injection. Hospira UK Ltd. Revised June 2015.
    Summary of Product Characteristics: Epirubicin 2mg/ml Solution for Injection. Medac GmbH. Revised April 2014.
    Summary of Product Characteristics: Epirubicin Hydrochloride 2mg/ml Solution for Injection or infusion. Accord healthcare limited. Revised September 2012.
    Summary of Product Characteristics: Pharmorubicin 2mg/ml Solution for Injection. Pfizer Ltd. Revised October 2012.

    The Cytotoxics Handbook Fourth Edition (2002), ed. Allwood, Stanley, Wright. Radcliffe Medical Press, Abingdon.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

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