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EPIRUBICIN HYDROCHLORIDE is a brand name for Epirubicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Epirubicin is used in the treatment of a range of neoplastic conditions including; -- Carcinoma of the breast -- Gastric cancer When administered intravesically, epirubicin has been shown to be beneficial in the treatment of; -- Papillary transitional cell carcinoma of the bladder -- Carcinoma-in-situ of the bladder…
Verbatim from this product's MHRA label. Tap a section to expand.
Epirubicin Hydrochloride is for intravenous or intravesical use only. The safety and efficacy of Epirubicin Hydrochloride in children has not been established. Intravenous administration It is advisable to administer Epirubicin Hydrochloride via the tubing of a free- running intravenous saline infusion after checking that the needle is properly placed in the vein.
4). In case of extravasation, administration should be stopped immediately. Conventional dose When epirubicin hydrochloride is used as a single agent, the recommended dosage in adults is 60-90 mg/m2 body area. Epirubicin hydrochloride should be injected intravenously over 3-5 minutes.
The dose should be repeated at 21- day intervals, depending upon the patient’s haematological status and bone marrow function. If signs of toxicity, including severe neutropenia/neutropenic fever and thrombocytopenia occur (which could persist at day 21), dose modification or postponement of the subsequent dose may be required.
High dose For high dose treatment, epirubicin hydrochloride may be given as an intravenous bolus over 3-5 minutes or as an infusion of up to 30 minutes duration. Breast Cancer In the adjuvant treatment of early breast cancer patients with positive lymph nodes, intravenous doses of epirubicin hydrochloride ranging from 100 mg/m2 (as a single dose on day 1) to 120 mg/m2 (in two divided doses on days 1 and 8) every 3-4 weeks, in combination with intravenous cyclophosphamide and 5- fluorouracil and oral tamoxifen, are recommended.
Lower doses (60-75 mg/m2 for conventional treatment and 105-120 mg/m2 for high dose treatment) are recommended for patients whose bone marrow function has been impaired by previous chemotherapy or radiotherapy, by age, or neoplastic bone marrow infiltration.
The total dose per cycle may be divided over 2-3 successive days.
Doses for intravenous administration:
The following doses of epirubicin hydrochloride are commonly used in monotherapy and combination chemotherapy for various tumours, as shown: Epirubicin hydrochloride Dose (mg/m2)a Cancer Indication Monotherapy Combination Therapy Gastric cancer 60–90 50 a)Doses generally given Day 1 or Day 1, 2 and 3 at 21-day intervals Combination therapy If Epirubicin Hydrochloride is used in combination with other cytotoxic products, the dose should be reduced accordingly.
The following undesirable effects have been observed and reported during treatment with epirubicin with the following frequencies: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated form the available data) More than 10% of treated patients can expect to develop undesirable effects.
The most common undesirable effects are myelosuppression, gastrointestinal side effects, anorexia, alopecia, infection. System organ class Frequency Undesirable effects Common Infection Infections and infestations Not known Septic shock, sepsis, pneumonia Neoplasms benign, malignant and unspecified (incl.
g. 4) Intravesical administration As only a small amount of active ingredient is reabsorbed after intravesical instillation, severe systemic adverse drug reactions as well as allergic reactions are rare. 4 Special warnings and precautions for use).
These ADRs are mostly reversible.
General Epirubicin should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Patients should recover from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic treatment before beginning treatment with epirubicin.
g. ≥ 90 mg/m2 every 3 to 4 weeks) causes adverse events generally similar to those seen at standard doses (< 90 mg/m2 every 3 to 4 weeks), the severity of the neutropenia and stomatitis/mucositis may be increased. Treatment with high doses of epirubicin hydrochloride does require special attention for possible clinical complications due to profound myelosuppression.
e. e. delayed) events. e. acute) events Early cardiotoxicity of epirubicin consists mainly of sinus tachycardia and/or electrocardiogram (ECG) abnormalities such as non-specific ST-T wave changes. Tachyarrhythmias, including premature ventricular contractions, ventricular tachycardia and bradycardia, as well as atrioventricular and bundle- branch block have also been reported.
These effects do not usually predict subsequent development of delayed cardiotoxicity, are rarely of clinical importance, and are generally not a consideration for the discontinuation of epirubicin treatment. e. delayed) events Delayed cardiotoxicity usually develops late in the course of therapy with epirubicin or within 2 to 3 months after treatment termination, but later events (several months to years after completion of treatment) have also been reported.
Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF) such as dyspnea, pulmonary edema, dependent edema, cardiomegaly and hepatomegaly, oliguria, ascites, pleural effusion and gallop rhythm.
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 developing CHF increases rapidly with increasing total cumulative doses of epirubicin hydrochloride in excess of 900 mg/m2; this cumulative dose should only be exceeded with extreme caution.
Hypersensitivity to epirubicin or any other component of the product, other anthracyclines or antracenediones. 4) - Recent myocardial infarction Severe arrhythmias - Patients with acute systemic infections - Sever hepatic impairment - Unstable angina pectoris - Severe mucositis of the mouth, pharynx, oeasophagus, and gastro- intestinal tract.
Intravesical use - Urinary tract infections - Inflammation of the bladder - Hematuria - Invasive tumours penetrating the bladder - Catheterisation problems - Vesical inflammation - Large volume of residual urine - Contracted bladder.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Epirubicin in United Kingdom.
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Commonly used doses are shown in the table above. In establishing the maximal cumulative doses of epirubicin hydrochloride (usually: 720 – 1000 mg/m2), any concomitant therapy with potentially cardiotoxic drugs should be taken into account.
Impaired liver function The major route of elimination of epirubicin hydrochloride is the hepatobiliary system. In patients with impaired liver function the dose should be reduced based on serum bilirubin levels as follows: Serum Bilirubin Dose Reduction 24 - 51 μmol/l 50% > 51 μmol/l 75% Impaired renal function Moderate renal impairment does not appear to require a dose reduction in view of the limited amount of epirubicin hydrochloride excreted by this route.
However, dosage adjustment may be necessary in patients with serum creatinine >5 mg/dL. Intravesical administration Epirubicin hydrochloride can be given by intravesical administration for the treatment of superficial bladder cancer and carcinoma-in-situ.
3). Epirubicin hydrochloride has also been successfully used intravesically as a prophylactic agent after transurethral resection of superficial tumours to prevent recurrence.
Doses for intravesical administration:
The following doses of epirubicin hydrochloride are commonly used in monotherapy for bladder cancer: Monotherapy Bladder cancer 50 mg/50 ml or 80 mg/50 ml (carcinoma in situ) Prophylaxis: 50 mg/50 ml weekly for 4 weeks then monthly for 11 months For the treatment of superficial bladder cancer the following regimen is recommended, using the dilution table below: 8 weekly instillations of 50 mg/50 ml (diluted with saline or distilled sterile water).
If local toxicity is observed:
A dose reduction to 30 mg/50 ml is advised.
Carcinoma-in-situ of the bladder:
Up to 80 mg/50 ml (depending on individual tolerability of the patient) For prophylaxis: 4 weekly administrations of 50 mg/50 ml followed by 11 monthly instillations at the same dose. 9% sterile saline Total volume for bladder installation 30 mg 15 ml 35 ml 50 ml 50 mg 25 ml 25 ml 50 ml 80 mg 40 ml 10 ml 50 ml The solution should be retained intravesically for 1-2 hours.
To avoid undue dilution with urine, the patient should be instructed not to drink any fluid in the 12 hours prior to instillation. During the instillation, the patient should be rotated occasionally and should be instructed to void urine at the end of the instillation time.
1) Cardiac function should be assessed before patients undergo treatment with epirubicin and must be monitored throughout therapy to minimize the risk of incurring severe cardiac impairment. The risk may be decreased through regular monitoring of LVEF during the course of treatment with prompt discontinuation of epirubicin at the first sign of impaired function.
The appropriate quantitative method for repeated assessment of cardiac function (evaluation of LVEF) includes multi-gated radionuclide angiography (MUGA) or echocardiography (ECHO). A baseline cardiac evaluation with an ECG and either a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiotoxicity.
Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses. The technique used for assessment should be consistent throughout follow-up. Given the risk of cardiomyopathy, a cumulative dose of 900 mg/m2 epirubicin hydrochloride should be exceeded only with extreme caution.
g. trastuzumab) (see section