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|Product Name:||Epirubicin For Injection||Composition:||Each Vial Contains:Epirubicin HCl 10mg / 50mg|
|Indications:||Metastatic Malignant Melanoma. It Is Also Indicated For The Treatment Of Metastatic Sarcoma In Combination With Other Chemotherapeutic Drugs. Hodgkin's Disease. In Addition Dacarbazine For Injection Has Been Shown, When Used In Combination With Other Cytot||Storage Instructions:||EPIRUBICIN Is Indicated As Mono Chemotherapy For The Treatment Of A Wide Spectrum Of Neoplasms Including Breast And Gastric Carcinomas, Malignant Lymphomas And Soft Tissue Sarcomas. It May Have Some Benefit In Advanced Colorectal Carcinoma And In Malignant|
|Expiration Date:||2 Years|
Epirubicin for injection 10mg/50mg Anticancer medicine
Each vial contains:Epirubicin HCl 10mg / 50mg.
Epirubicin is an anthracycline antibiotic with antineoplastic activity. The exact mechanism of action is unclear, but it appears to be due to intercalation of anthracycline with DNA, eventually inducing DNA cleavage by topoisomerase II. Other cytotoxic mechanisms may be due to inhibition of DNA helicase, thus impairing DNA synthesis and free radical generation. These mechanisms inhibit cellular nucleic acid synthesis and mitosis, resulting in cell death.
Epirubicin, after intravenous administration is extensively distributed into tissues, resulting in a triphasic elimination pattern with half-lives of 3 minutes, 2,5 hours and 33 hours (mean half-life of 40 hours). Epirubicin undergoes hepatic biotransformation to less active metabolites or to metabolites with no inherent activity. It is highly bound to plasma albumin (77%) and is excreted via the biliary (35%) and renal (20%) systems. It does not cross the blood-brain barrier.
EPIRUBICIN is indicated as mono chemotherapy for the treatment of a wide spectrum of neoplasms including breast and gastric carcinomas, malignant lymphomas and soft tissue sarcomas. It may have some benefit in advanced colorectal carcinoma and in malignant melanoma. When given in combination with other chemotherapeutic agents, ASPEN EPIRUBICIN has been used in the treatment of lung and ovarian cancer.
EPIRUBICIN should not be mixed with heparin as incompatibility and precipitation of the medicines has been reported.
Concomitant administration of EPIRUBICIN with blood dyscrasia-causing medications, bone marrow suppressants or radiation therapy may potentiate the risk of bone marrow suppression.
Cimetidine –concomitant administration with EPIRUBICIN increases the concentration of EPIRUBICIN, by reducing plasma clearance by as much as 30%.
Cardio-active compounds such as calcium channel blockers may contribute to cardiotoxicity and may precipitate cardiac failure.
PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation have not been established.
Women of childbearing age should be advised not to fall pregnant while taking EPIRUBICIN and to consider using contraception.
It is unknown whether EPIRUBICIN is excreted into breast milk. Other anthracycline derivatives are excreted into breastmilk and breastfeeding is therefore not recommended because of potential harm to the infant.
DOSAGE AND DIRECTIONS FOR USE
Safety and efficacy in paediatric patients has not been established.
Regular testing of the haemoglobin, leukocyte count, platelet count and albumin are recommended at the start of therapy and before each subsequent dose.
EPIRUBICIN should be administered by intravenous injection only, not intrathecally or intramuscularly. The medicine is not pharmacologically active if given orally.
Monotherapy: 60 to 90 mg/m2 body surface area.
EPIRUBICIN should be given by slow intravenous injection over 3 to 5 minutes and, depending on the bone marrow response, can be repeated after a 21 day cycle.
In the treatment of advanced breast cancer doses of up to 135 mg/m2 body surface area can be used every 3 to 4 weeks.
Patients with inadequate marrow reserves (e.g. the elderly, doses given prior to other chemotherapy or radiotherapy and patients with neoplastic bone marrow infiltration) should be given lower doses of 60 to 75 mg/m2 body surface area. In these cases, the total dose per cycle can be divided over 2 to 3 consecutive days.
Combination therapy: When used in combination with other chemotherapeutic agents, the dose of EPIRUBICIN needs to be adjusted appropriately. In advanced breast cancer, when used in combination, doses of up to 120 mg/m2 body surface area can be used every 3 to 4 weeks.
• Moderate liver impairment.
Total serum bilirubin of 24 to 51,3 mmol/L requires a dose reduction of 50%.
Moderate renal impairment does not require a dosage adjustment for EPIRUBICIN because of the limited amount excreted by this route.
Concomitant or previous radiation to the mediastinal or pericardial area:
The maximum cumulative dose should be lowered to 400 to 450 mg/m2.
Caution should be exercised with handling and preparation of EPIRUBICIN. A designated area, preferably a laminar flow system, should be used for reconstitution.
The work surface should be covered by plastic-backed absorbent paper. All items used for reconstitution should be placed in high risk, waste-disposable bags for high temperature incineration. Skin reactions with accidental exposure to the powder or solution may occur and use of gloves and masks is recommended. If EPIRUBICIN does contact skin or mucosae, the area should be washed copiously with soap and warm water. Eyes should be irrigated with 0,9% saline.
Preparation for intravenous infusion:
EPIRUBICIN may be dissolved in sterile water for injection or 0,9% sodium chloride solution and reconstituted as follows:
|FREEZE-DRIED PREP||DILUENT ADDED||FINAL CONCENTRATION|
|10 mg||5 mL||2 mg/mL|
|50 mg||25 mL||2 mg/mL|
After adding the diluent, shake the vial to ensure all the medicine has been completely dissolved. The reconstituted solution must be used immediately after first penetration of the rubber stopper. Storage of the reconstituted solution is not recommended. Any unused portion of the solution should be discarded. EPIRUBICIN should be administered into the tubing of a freely running intravenous infusion set containing normal saline, after checking that the needle is well placed in the vein. If extravasation into the surrounding tissue occurs, severe tissue lesions, including necrosis may occur.
Venous sclerosis may result from injections into small calibre veins or from repeated injections into the same vein.
Hypersensitivity to EPIRUBICIN, other anthracyclines or to any components of the formulation.
Patients with myelosuppression induced by previous chemotherapeutic agents or radiation therapy.
Patients treated with maximal cumulative doses of other anthracycline derivatives such as daunorubicin and doxorubicin.
Buccal ulceration –EPIRUBICIN should not be administered if present, or if a buccal burning sensation is present, which can precede the onset of buccal ulceration.
Patients with current or previous history of cardiac dysfunction.
Pregnancy, particularly in the first trimester and during lactation.
Severe hepatic function impairment.
Baseline neutrophil count <1,500 cells/mL.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
|•||Frequent: Leukopenia, neutropenia.|
|•||Less frequent: Thrombocytopenia, bleeding|
|•||Rare: Cardiotoxicity (may manifest as an acute, transient alteration of normal cardiac function, or as a delayed, potentially fatal chronic congestive cardiac failure and may occur up to 6 months after administration), acute life-threatening arrhythmias (during or within a few hours of intravenous administration).|
|•||The following side-effects have been reported and frequencies are unknown: Hypotension.|
|•||The following side-effects have been reported and frequencies are unknown: Headache.|
|•||The following side-effects have been reported and frequencies are unknown: Gynaecomastia, suppression of ovarian or testicular function leading to amenorrhoea or inhibition of spermatogenesis respectively.|
|•||Frequent: Buccal ulceration, nausea, vomiting, stomatitis, oesophagitis.|
|•||Less frequent: Diarrhoea.|
|•||The following side-effects have been reported and frequencies are unknown: abdominal pain, gastrointestinal bleeding, ulceration or perforation.|
|•||Frequent: Nephrotoxicity, red discolouration of the urine for 1 to 2 days after administration|
|•||Rare: Acute renal failure due to uric acid nephropathy as a result of rapid tumour lysis causing hyperuricaemia.|
|•||Rare: Weakness, malaise.|
• Less frequent: Conjunctivitis, increased lacrimation.
|•||Rare: Erythema (often at sites of prior irradiation), darkening of the soles, palms or nails, tissue necrosis due to extravasation from the vein, thrombophlebitis.|
|•||The following side-effects have been reported and frequencies are unknown: Facial flushing, poor wound healing, rashes, pruritus.|
|•||Rare: Allergic reactions, anaphylaxis|
EPIRUBICIN has been associated with:-
|•||Bone marrow suppression –Myelosuppression may occur, particularly in those who have previously had chemotherapy or radiotherapy. The nadir in the white cell count is approximately 10 days post administration and usually recovers by day 21.|
|If thrombocytopenia occurs as a consequence of administration of EPIRUBICIN, patients should be observed carefully for signs of bleeding (skin, intravenous puncture sites, mucosae, unusual bruising, melaena stools, haematuria). Intramuscular injections, alcohol, aspirin and contact sports should be avoided. Platelet transfusions may be required.|
|•||Patients who develop leukopenia should be carefully observed for signs of infection.|
|•||Antibiotic support may be necessary. In neutropenic patients who develop fever, empiric broad spectrum antibiotics should be initiated, pending bacterial culture results.|
|•||Immunisations should be avoided unless approved by the attending doctor.|
|•||Cardiac toxicity –The risk of cadiotoxicity appears to be related to prior mediastinal radiation therapy, pre-existing cardiac disease and a total cumulative dose of EPIRUBICIN that exceeds 550 mg/m2 body surface area. Cardiac monitoring is strongly recommended with the use of noninvasive techniques such as ECG, echocardiography and if indicated, measurement of ejection fraction by radionuclide angiography. An ECG should be performed before and after each treatment cycle. Alterations in the ECG tracing like flattening or inversion of the T wave, new onset arrhythmias, S-T segment depression may occur, but are not necessarily indicators to stop treatment. Anthracycline-induced cardiomyopathy is characterised by a persistent reduction in the QRS voltages on ECG, prolonged systolic intervals (PEP/LVET) and a diminished ejection fraction. The benefit derived from exceeding the cumulative dose of EPIRUBICIN, versus the risk of anthracycline-induced cardiomyopathy and congestive heart failure should be carefully weighed.|
|•||Hyperuricaemia – Administration of EPIRUBICIN may induce hyperuricaemia from lysis of tumour cells. Uric acid levels should be monitored and appropriately treated if indicated.|
Store the freeze-dried product in a dry place below 25ºC. Protect from light. The reconstituted solution must be used immediately after first penetration of the rubber stopper.
Storage of the reconstituted solution is not recommended.
Any unused portion must be discarded.
Do not remove the vial from the carton until required for use.
KEEP OUT OF THE REACH OF CHILDREN