1 ml contains 2 mg epirubicin hydrochloride.
Excipients with known effect: Sodium 3.54 mg/ml (in the form of sodium chloride).
Excipients/Inactive Ingredients: Sodium chloride, hydrochloric acid, water for injections.
Epirubicin is used as a single agent or in combination with other agents in the treatment of: breast cancer, ovarian carcinoma, hormone-resistant carcinoma of the prostate, carcinomas of the stomach, lymphoma and soft tissue sarcoma.
It is used in high doses for the treatment of lung cancer and advanced breast cancer.
It is used for the intravesical treatment of transitional cell carcinoma, papillary bladder tumours and in situ carcinoma, and for prophylactic intravesical instillation to prevent recurrences following transurethral resection of the tumour.
Standard dose: When used as a single agent for prophylaxis, a single dose of 75-90 mg/m² body surface area is administered and repeated after 21 days.
High-dose therapy: When used as a single agent in lung cancer: Small cell lung cancer (untreated): 120 mg/m² body surface area on Day 1, repeated every 21 days.
Non-small cell lung cancer (squamous, cell carcinoma, large cell cancer and adenocarcinoma, untreated): 135 mg/m² body surface area on Day 1 or 45 mg/m² body surface area on Days 1, 2, 3, repeated every 21 days.
Advanced breast cancer: 135 mg/m² body surface area as a single agent and 120 mg/m² body surface area in combination therapy every 21-28 days.
For adjuvant therapy in patients in early disease stages with lymph node involvement, doses of 100-120 mg/m² body surface area every 3-4 weeks are recommended.
Combination therapy: When used in combination with other agents, the dose should be reduced.
The total planned dose for a cycle can be given on two consecutive days. Where higher doses are used, the dose may also be divided into three and given on three consecutive days. For patients not pretreated with anthracyclines and who already show bone marrow depression caused by previous chemotherapy, radiotherapy or neoplastic bone marrow infiltration, the dose should be reduced: Dose reduction: 60-75 mg/m² for patients on standard dose regimens.
Dose reduction: 105-120 mg/m² for patients on high-dose regimens.
In order to reduce toxicity in patients in palliative care programmes or in whom epirubicin cannot be used at the above doses for medical reasons, the following reduced dose may be used: Weekly administration of 20-30 mg/m² body surface area.
When selecting the total epirubicin dose, it is also important to take into account previous treatment with similar substances such as doxorubicin, daunorubicin or anthracene derivatives.
In patients with impaired liver function (bilirubin 1.2-3 mg/100 ml or 9-15% BSP retention), a dose reduction of 50% is appropriate. In patients with severe liver impairment (bilirubin >3 mg/100 ml or >15% BSP retention), the dose must be reduced by 75%.
The dose should also be adapted according to blood count values.
In patients with moderate renal impairment, a dose reduction is not required because elimination via the kidneys is low.
Intravesical instillation: Therapy: Instillation of 50 mg/50 ml saline solution once weekly for a period of 8 weeks.
In the presence of local toxicity (chemical cystitis), the dose should be reduced to 30 mg/50 ml.
To avoid unwanted dilution with urine, the patient should not drink any fluid for 12 hours before instillation. This should limit urine production to around 50 ml per hour. While the product is in the bladder, the patient should be rotated through 90 degrees every 15 minutes. In genera l, the epirubicin solution should remain in the bladder for an hour. The patient should then urinate.
Treatment of in situ carcinoma: The dosage depends o n individual tolerability. The dose may be increased up to 80 mg/50 ml.
Prophylaxis: After treatment, once weekly instillation of 50 mg/50 ml for 4 weeks, then every 11 months.
Method of administration: Epirubicin must be administered intravenously. Epirubicin must not be administered orally or by intra-arterial, subcutaneous, intramuscular or intrathecal injection. For intravesical administration in patients with superficial bladder cancer, see Intravesical instillation stated previously.
It is important to ensure that epirubicin is administered into a vein because accidental extravasation causes local necrosis and thrombophlebitis.
Epirubicin is administered as an intravenous bolus into a fast-running infusion (3-5 minutes). Solutions of 30 to 80 mg epirubicin per 50 ml saline are used for intravesical administration (see Dosage & Administration). For single-use only. Only use clear solutions. Bring to room temperature before administration.
The chemical and physical stability of the ready-to-use Epirubicin Ebewe preparation, diluted with suitable infusion agents (5% glucose, 0.9% sodium chloride) to concentrations of 0.1 mg/ml and 1.0 mg/ml, has been proved to be 28 days at refrigerator temperature.
At room temperature, these solutions keep for 4 days, with or without light protection. The risk of microbial contamination should always be considered during handling.
Acute overdosage with epirubicin will result in severe myelosuppression (within 10 to 14 days - mainly leukopenia and thrombocytopenia), gastrointestinal toxic effects (mainly mucositis) and acute cardiac complications (within 24 hours). Latent cardiac insufficiency has been observed with anthracyclines several months to years after completion of treatment (see Precautions). Patients must be carefully monitored. If signs of cardiac insufficiency occur, patients should be treated according to conventional guidelines.
Treatment: Symptomatic; general measures such as blood transfusion, antibiotics and moving the patient to a germ-free environment may become necessary in the case of severe myelosuppression. Epirubicin cannot be removed by dialysis.
Hypersensitivity to epirubicin or any other component listed in Description, other anthracyclines or anthracenediones. Lactation period.
Parenteral use: Severe myelosuppression caused by previous chemotherapy and/or radiotherapy.
Use in patients who have already been treated with epirubicin and/or other anthracyclines (e.g. doxorubicin or daunorubicin) and anthracenediones and have reached the maximum cumulative dose (see Precautions).
Acute systemic infections.
Severe inflammations of the mucous membranes in the mouth and/or gastrointestinal tract.
Severely impaired liver function.
Current or previously recorded impaired cardiac function: including progressive cardiac insufficiency, level IV muscular cardiac insufficiency (insufficiency at rest), severe cardiac arrhythmia and conduction disturbance with severe haemodynamic effects, acute inflammatory cardiomyopathy, unstable angina pectoris, acute cardiac infarction which has caused level III and IV muscular cardiac insufficiency, cardiomyopathy.
Combined with yellow fever vaccine.
Intravesical use: Epirubicin must not be administered intravesically for the treatment of invasive tumours that have penetrated the bladder wall.
Urinary tract infections; inflammation of the bladder; large volume of residual urine; contracted bladder; catheterisation problems; haematuria.
Only physicians experienced in the treatment of tumours should administer the therapy. The instructions must be followed closely during administration.
Patients should recover from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic therapies before beginning treatment with epirubicin.
While treatment with high doses of epirubicin (e.g., ≥90 mg/m2 every 3 to 4 weeks) causes side effects 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 the substance does require special attention for possible clinical complications due to severe myelosuppression.
Equipment contaminated with epirubicin can be cleaned with a 10% sodium hypochlorite solution. The discolouration occurring during the cleaning process indicates epirubicin has been deactivated through oxidation. If the substance comes into contact with skin or mucous membranes, thoroughly clean the affected areas with water and soap.
Cardiac Function: Cardiotoxicity is a risk of anthracycline treatment that may be manifested by early (i.e. acute) or late (i.e. delayed) events.
Early (i.e. Acute) events: Non-specific ECG changes, regardless of dose.
Early cardiotoxicity of epirubicin consists mainly of sinus tachycardia and/or 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 reason for the discontinuation of epirubicin treatment.
Late (i.e. Delayed) events: Cumulative organ toxicity in the form of cardiomyopathy, regardless of dose.
This reaction usually develops late in the course of therapy with epirubicin or within 2 to 3 months after treatment termination.
However, later events (several months to years after completion of therapy) have also been reported.
It is commonly 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 in excess of 900 mg/m2; this cumulative dose should therefore only be exceeded with extreme caution. (See Description.)
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 following methods are recommended for diagnosing and controlling the progress of anthracycline-induced cardiomyopathy: a) Echocardiography (ECHO), b) Determination of the systolic time intervals (STI), c) Radionuclide angiography.
Although there is no known method for predicting anthracycline-induced CHF or cardiomyopathy, these events are usually accompanied by permanent low voltage in the QRS complex region, an increase of the systolic time interval (PEP/LVET) above normal and a decrease in the LVEF compared to the initial values prior to therapy.
An ECG and determination of the LVEF (UCG/MUGA scan) should therefore be carried out regularly before and during treatment with Epirubicin Ebewe (i.e. ideally before and after each therapy cycle), especially in patients with cardio toxicity risk factors. This is even more important when administering higher, cumulative doses of anthracycline. The method for assessing heart function should be consistent throughout follow-up.
Given the risk of cardiomyopathy, a cumulative dose of 900 mg/m2 epirubicin should be exceeded only with extreme caution.
This particularly applies if cumulative doses in excess of 600-700 mg of epirubicin hydrochloride/m2 KOF are administered or if patients have previously undergone radiotherapy in the mediastinal region and/or treatment with potentially cardiotoxic drugs.
Risk factors for cardiac toxicity include active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial region, previous therapy with other anthracyclines or anthracenediones, and the use of drugs with the ability to suppress cardiac contractility or cardiotoxic drugs (e.g. trastuzumab) (see The risk is increased in elderly patients under Interactions).
Cardiac insufficiency (New York Heart Association [NYHA] class II-IV) has been observed in patients receiving trastuzamab therapy alone or in combination with anthracyclines such as epirubicin. This may be moderate to severe and has been associated with fatal cases. Trastuzumab and anthracyclines such as epirubicin should not be used in combination except in a well-controlled clinical trial setting with cardiac monitoring. Patients who have previously received anthracyclines are also at risk of cardiotoxicity with trastuzumab treatment, although the risk is lower than with concurrent use of trastuzumab and anthracyclines.
Because the half-life of trastuzumab is approximately 4-5 weeks, trastuzumab may persist in the circulation for up to 20-25 weeks after stopping therapy. Patients who receive anthracyclines such as epirubicin after stopping trastuzumab may possibly be at increased risk of cardiotoxicity. If possible, physicians should avoid anthracycline-based therapy for up to 25 weeks after stopping trastuzumab. If anthracyclines such as epirubicin are used, the patient's cardiac function should be monitored carefully.
If symptomatic cardiac insufficiency develops during trastuzumab therapy after epirubicin therapy, it should be treated in the standard manner.
Cardiac function monitoring must be particularly strict in patients receiving high cumulative doses and in those with risk factors. However, cardiotoxicity with epirubicin may occur at lower cumulative doses whether or not cardiac risk factors are present.
It is probable that the toxicity of epirubicin and other anthracyclines or anthracenediones is additive.
Hematologic toxicity: As with other cytotoxic agents, epirubicin may produce myelosuppression. Heamatologic profiles (particularly leucocytes, neutrophils, thrombocytes, erythrocytes) should be assessed before and during each cycle of therapy A dose-dependent, reversible leukopenia and/or granulocytopenia (neutropenia) is the predominant manifestation of epirubicin haematologic toxicity and is the most common acute dose-limiting toxicity of this drug. Leukopenia and neutropenia are generally more severe with high-dose schedules, reaching the nadir in most cases between days 10 and 14 after drug administration; this is usually transient with the leukocyte/neutrophil counts returning to normal values in most cases by day 21. Thrombocytopenia and anaemia may also occur. Clinical consequences of severe myelosuppression include fever, infection, sepsis/septicaemia, septic shock, hemorrhage, tissue hypoxia and death.
Secondary Leukemia: Secondary leukemia, with or without a preleukemic phase, has been reported in patients treated with anthracyclines, including epirubicin.
Secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, in combination with radiotherapy, when patients have been heavily pre-treated with cytotoxic drugs, or when doses of the anthracyclines have been escalated. These leukemias can have a 1- to 3-year latency period (see Description).
Gastrointestinal tract: Epirubicin is emetic. Mucositis/stomatitis generally appears early after drug administration and, if severe, may progress over a few days to mucosal ulcerations. Most patients recover from these side effects by the third week of therapy.
Liver Function: The major route of elimination of epirubicin is the hepatobiliary system.
Liver function should be evaluated before and during treatment with epirubicin to rule out liver insufficiency (SGOT, SGPT, alkaline phosphatase, bilirubin). Patients with elevated liver function readings (bilirubin, AST) may experience an increase in epirubicin toxicity due to a shower clearance of the drug. Lower doses are recommended in these patients (see Incompatibilities and Dosage & Administration). Patients with severe hepatic impairment should not receive epirubicin (see Contraindications).
Renal Function: Serum creatinine should be assessed before and during therapy. Dosage adjustment is necessary in patients with serum creatinine >5 mg/dl (see Dosage & Administration).
Skin reaction at site of injection: Phlebosclerosis may result from an injection into a small vessel or from repeated injections into the same vein. Following the recommended administration procedures for epirubicin may minimize the risk of phlebitis/thrombophlebitis at the injection site (see Dosage & Administration).
Extravasation: Epirubicin must be administered intravascular at all times; paravenous injection may result in local necrosis and thrombophlebitis. Extravasation of epirubicin during intravenous injection may produce local pain, severe tissue lesions (vesication, severe cellulitis) and necrosis.
Should signs or symptoms of extravasation occur during intravenous administration of epirubicin, the infusion should be discontinued immediately.
The side effects of extravasation of anthracyclines may be prevented or reduced by immediate use of a specific treatment e.g. dexrazoxane (please refer to relevant labels for use).
The cannula should be left in place initially to be removed after a short aspiration. The extravasation site should then be cooled to reduce the patient's pain, the best method being cold compresses that are to be changed regularly at short intervals. Cooling should continue for approximately 24 hours and the arm has to be placed in a raised position. These measures should be continued for around 2 days and thereafter, depending on the severity of the swelling. There is no clear evidence of the effectiveness of the local application of 1% hydrocortisone cream, hyaluronic acid, high percentage dimethyl sulfoxide (DMSO) and sodium carbonate or the intravenous application of corticosteroids.
Local subcutaneous injections with additives (e.g. cortisone, heparin) or without are not recommended.
The patient should be monitored closely during the subsequent period of time, as necrosis may occur after several weeks.
A plastic surgeon should also be consulted with a view to possible excision of the affected area.
Other: As with other cytotoxic agents, thrombophlebitis and thromboembolic phenomena, including pulmonary embolism (in some cases fatal), have been coincidentally reported with the use of epirubicin.
Tumor-lysis syndrome: Epirubicin may induce hyperuricemia because of the extensive purine catabolism that accompanies rapid drug-induced lysis of neoplastic cells (tumor-lysis syndrome). Blood uric acid levels, potassium, calcium phosphate, and creatinine should be evaluated after initial treatment. Hydration, urine alkalinisation, and prophylaxis with allopurinol to prevent hyperuricemia may minimise potential complications of tumor-lysis syndrome.
Immunosuppressant effects/Increased susceptibility to infections: Administration of (attenuated) live vaccines in patients immunocompromised by chemotherapeutic agents including epirubicin, may result in serious or fatal infections (see Interactions). Vaccination with a live vaccine should be avoided in patients receiving epirubicin. Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Reproductive system: Epirubicin can cause genotoxicity. Men and female patients should therefore use effective contraception during therapy and up to 6 months thereafter. Patients desiring to have children after completion of therapy should be advised to obtain genetic counselling (see Use in Pregnancy & Lactation).
Additional warnings and precautions for other routes of administration: Intravesical route: Administration of epirubicin may produce symptoms of chemical cystitis (such as dysuria, polyuria, nocturia, stranguria, hematuria, bladder discomfort, necrosis of the bladder wall) and bladder constriction. Special attention is required for catheterization problems (e.g., uretheral obstruction due to massive vesical tumours).
Intra-arterial route: Intra-arterial administration of epirubicin (transcatheter arterial embolisation for the localized or regional therapies of primary hepatocellular carcinoma or liver metastases) may produce (in addition to systemic toxicity qualitatively similar to that observed following intravenous administration of epirubicin) localised or regional events which include gastro-duodenal ulcers (probably due to reflux of the drugs into the gastric artery) and narrowing of bile ducts due to drug-induced sclerosing cholangitis.
This route of administration can lead to widespread necrosis of the perfused tissue and is recommended.
Excipients: This drug contains 0.154 mmol (3.54 mg) sodium/ml. This must be taken into consideration when treating patients following a controlled sodium diet.
Epirubicin may cause urine to appear red in colour for one or two days after administration.
Effects on the ability to drive and operate machinery: The effect of epirubicin on the ability to drive and operate machinery have not been studied. Epirubicin may cause acute nausea and vomiting, which can temporarily lead to an impairment of ability to drive or operate machinery.
Pregnancy: Women of child-bearing age should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods.
Experimental data in animals suggest that epirubicin may cause foetal harm when administered to a pregnant woman. If epirubicin is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus.
There are no studies in pregnant women. Epirubicin should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Impairment of fertility: Epirubicin could induce chromosomal damage in human spermatozoa. Male patients undergoing treatment with epirubicin are advised not to father any children during treatment and up to 6 months thereafter and seek advice on sperm preservation prior to treatment due to the possibility of irreversible infertility caused by therapy.
Epirubicin may cause amenorrhea or premature menopause in premenopausal women.
Lactation period: It is not known whether epirubicin is excreted in human milk. Because many drugs, including other anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a risk to nursing infants cannot be excluded. Mothers should therefore discontinue nursing prior to taking epirubicin.
The following side 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 (frequency cannot be estimated form the available data).
More than 10% of treated patients can expect to develop side effects. The most common side effects are myelosuppression, gastrointestinal side effects, anorexia, alopecia and infection.
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As usually only a small amount of active ingredient is reabsorbed after intravesical instillation, severe systemic adverse drug reactions and allergic reactions are rare.
Commonly reported are local reactions like burning sensation and frequent voiding (pollakisuria). Occasional bacterial or chemical cystitis have been reported (see Precautions). These side effects are mostly reversible.
Reporting suspected side effects:
It is very important to report any suspected side effects after the drug has been approved. It makes it possible to continuously monitor the use/risk ratio of the medicinal product. Members of the healthcare profession are requested to report all suspected cases of side effects through the national reporting system.
Epirubicin is mainly used in combination with other cytotoxic drugs. Additive toxicity may occur especially with regard to bone marrow, haematologic and gastro-intestinal effects (see Precautions). The use of epirubicin in combination with other potentially cardiotoxic drugs as well as other cardioactive compounds (e.g., calcium channel blockers), requires monitoring of cardiac function throughout treatment.
Epirubicin is extensively metabolized by the liver. Changes in hepatic function induced by concomitant therapies may therefore affect metabolism, pharmacokinetics, therapeutic efficacy and/or toxicity (see Precautions).
Anthracyclines including epirubicin should not be administered in combination with other cardiotoxic agents unless the patient's cardiac function is closely monitored. Patients receiving anthracyclines after stopping treatment with other cardiotoxic agents, especially those with long half-lives (e.g. trastuzumab), may also be at an increased risk of developing cardiotoxicity.
The half-life of trastuzumab is approximately 28.5 days and the drug may persist in the circulation for up to 25 weeks. Therefore, physicians should avoid anthracycline-based therapy for up to 25 weeks after stopping trastuzumab when possible. If anthracyclines are used before this time, careful monitoring of cardiac function is recommended.
The possibility of a marked disturbance of haematopoiesis needs to be kept in mind with a (pre) treatment with medications which influences the bone marrow (i.e. cytostatic agents, sulphonamide, chloramphenicol, diphenylhydantion, amidopyrine derivatives, antiretroviral agents).
The drugs cimetidine, dexverapamil, dexrazoxane, docetaxel, interferon α2b, paclitaxel and quinine have been found to interact with epirubicin: Cimetidine administered via the peroral route increases the AUC values of epirubicin (50%) and epirubicinol (41%) and should therefore be discontinued during treatment with epirubicin.
Dexverapamil may impact the pharmacokinetics of epirubicin and thus potentially increase its bone marrow-suppressing effect.
The previous administration of increased doses (900mg/m2 and 1200mg/m2) of dexrazoxane may lead to the systemic clearance of epirubicin and a decrease in AUC. Myelosuppression may be increased in patients receiving a combination therapy of anthracyclines and dexrazoxane.
A study showed that docetaxel may increase the plasma concentrations of epirubicin metabolites if administered immediately after treatment with epirubicin.
Concomitant administration of interferon α2b may cause a reduction in both terminal half-life and total clearance of epirubicin.
Taxanes reduce the p-glycoprotein-induced biliary clearance of anthracyclines. Depending on the application sequence, the maximum plasma values are increased, especially those of epirubicinol, which is however neither toxic nor active. These interactions primarily occur when first paclitaxel, then anthracycline is administered. In therapy patterns containing anthracycline and taxane, anthracycline should therefore be administered first, followed by taxane. The combined administration of paclitaxel or docetaxel did not have any effects on the pharmacokinetics of epirubicin when epirubicin was administered before the taxanes. Paclitaxel may optionally be administered 24 to 48 hours after epirubicin to keep the indications of interaction-related side effect low.
Quinine may accelerate the initial distribution of epirubicin from the blood into the tissue and influence the absorption of epirubicin in the red blood cells.
Epirubicin is primarily metabolized by the liver. Any supplementary medication with a liver impairing effect may also impact the metabolisation and pharmacokinetics of epirubicin and thus affect its effectiveness and/or toxicity.
Vaccination with a live vaccine should be avoided in patients receiving epirubicin. Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Drug which delay uric acid excretion (e.g. sulphonamide, certain diuretics) may cause serious hyperuricemia if used at the same time as epirubicin.
Special precaution for disposal and other information on handling: Advice for medical staff: The infusion solution must only be prepared by specially trained staff under aseptic conditions.
Pregnant women must not handle this medicinal product.
Protective clothing (goggles, gown, disposable gloves and mask) must be worn when preparing the solution in a designated work area, preferably well ventilated.
Preparation of an infusion solution should be performed in a specially designated aseptic area, preferably well ventilated. The work area should be covered with absorbing, plastic-coated, disposable paper.
The handling and disposal directions applicable to cytostatics should be followed.
All items used for administration or cleaning, including gloves, must be disposed of in high-risk waste containers and incinerated at a high temperature.
Handle with care, avoid contact with skin.
In case of skin contact, thoroughly wash the affected area with soap and water or sodium bicarbonate solution. However, do not abrade the skin by using a scrubbing brush or similar items. Always wash hands after removing gloves.
Suitable precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes. If necessary, irrigate eyes with large amounts of water and/or 0.9% saline solution. Then seek medical attention from a physician.
For single use only. Discard any surplus.
Use only freshly prepared solutions.
Use only clear solutions.
If solution has been spilt or has leaked, the affected areas or materials must be treated with sodium hypochlorite solution (1% available chlorine) (preferably by soaking then rinsing with water).
Incompatibilities: Epirubicin Ebewe Should not be mixed with heparin as the two agents are chemically incompatible. Epirubicin should not be mixed directly it is administered in combination with other cytostatic drugs. Epirubicin should also not come into contact with any alkaline solutions (hydrolysis).
Store in a refrigerator (2°C-8°C).
Store in the original packaging in order to protect the contents from light.
For single use only. Discard any surplus. Use only clear solutions. Warm up to room temperature before use.
Shelf life: 2 years.
Solution for infusion after dilution: The chemical and physical stability of the ready-to-use Epirubicin Ebewe preparation, diluted with suitable infusion agents (5% glucose, 0.9% sodium chloride) to concentrations of 0.1 mg/ml and 1.0 mg/ml, has been proved to be 28 days at refrigerator temperature.
At room temperature, these solutions keep for 4 days, with or without light protection.
From a microbiological viewpoint, the ready-to-use preparation should be used immediately. If the ready-to-use preparation is not used immediately, the user i s responsible for the duration and conditions of storage. If the ready-to-use solution is not prepared under controlled and validated aseptic conditions, it must not be stored for longer than 24 hours at 2°C to 8°C.
When applied intravesically, solutions of 30 to 80 mg epirubicin per 50 ml saline solution are used (see Dosage & Administration).
When manipulating the drug in any way, care has to be taken to avoid the risk of microbial contamination.
L01DB03 - epirubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Conc for infusion soln 10 mg/5 mL x 1's. 50 mg/25 mL x 1's.