Epirubicin Ebewe

Epirubicin Ebewe

epirubicin

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Epirubicin HCl
Indications/Uses
Neoplastic conditions including breast carcinoma & gastric cancer. Administered intravesically in treatment of papillary transitional cell carcinoma & carcinoma-in situ of the bladder & in prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection.
Dosage/Direction for Use
IV Adult Conventional dose: 60-90 mg/m2 as single agent over 3-5 min. Repeat at 21-day intervals depending on patient's haematomedullary status. High dose: Small cell lung cancer (previously untreated) 120 mg/m2 on day 1 every 3 wk. Non-small cell lung cancer (squamous, large cell, & adenocarcinoma previously untreated) 135 mg/m2 on day 1 or 45 mg/m2 on days 1, 2 & 3 every 3 wk. Adjuvant treatment of early breast cancer Patient w/ positive lymph nodes 100 mg/m2 (as single dose on day 1) to 120 mg/m2 (in 2 divided doses on days 1 & 8) as IV bolus over 3-5 min or as infusion up to 30 min every 3-4 wk in combination w/ IV cyclophosphamide & 5-fluorouracil & oral tamoxifen. Patient whose bone marrow function has already been impaired by previous chemo- or radiotherapy, age, or neoplastic bone-marrow infiltration 60-75 mg/m2 for conventional treatment & 105-120 mg/m2 for high dose schedules. May divide total dose/cycle over 2-3 successive days. Moderate liver impairment (bilirubin 1.4-3 mg/100 mL) Reduce dose by 50%. Severe impairment (bilirubin >3 mg/100 mL) Reduce dose by 75%. Intravesical 8 times wkly instillations of 50 mg/50 mL. Local toxicity (chemical cystitis) Reduce dose to 30 mg/50 mL. Carcinoma-in situ May be increased up to 80 mg/50 mL. Prophylaxis 4 times wkly administrations of 50 mg/50 mL followed by 11 times mthly instillations at the same dose.
Contraindications
Hypersensitivity to epirubicin, other anthracyclines or anthracenediones. Lactation. IV use: Persistent myelosuppression; myocardiopathy; recent MI; severe arrhythmias; previous treatments w/ max cumulative doses of epirubicin &/or other anthracyclines & anthracenediones; acute systemic infections; unstable angina pectoris; severe hepatic impairment. lntravesical use: UTI; bladder inflammation; haematuria; invasive tumours penetrating the bladder; catheterisation problems.
Special Precautions
Not to be used intravesically for invasive tumours where systemic therapy or surgery is more appropriate. Discontinue if signs or symptoms of extravasation occur. Patients should recover from prior acute toxicities (eg, stomatitis, neutropenia, thrombocytopenia & generalised infections) prior to treatment. Secondary leukaemia; mucositis/stomatitis; thrombophlebitis & thromboembolic phenomena including pulmonary embolism. Possible complications w/ high doses. May induce hyperuricaemia due to tumour-lysis syndrome. Assess/evaluate cardiac function, haematological profiles including WBC counts, serum creatinine, serum total bilirubin & AST levels prior to & monitor throughout therapy. Avoid live vaccines. Men & women of child-bearing potential should use effective contraception during treatment. Pregnancy. Childn. Intravesical administration: May produce chemical cystitis.
Adverse Reactions
Myelosuppression (leukopenia, granulocytopenia & neutropenia, anaemia & febrile neutropenia); alopecia; red colouration of urine. Infection; anorexia, dehydration; hot flushes; mucositis, oesophagitis, stomatitis, vomiting, diarrhoea, nausea; infusion site erythema; chemical cystitis (intravesical).
Drug Interactions
Additive toxicity especially w/ bone marrow/haematologic & GI effects w/ other cytotoxic drugs. Monitor cardiac function throughout treatment w/ other potentially cardiotoxic drugs & other cardioactive compd eg, Ca channel blockers. May increase risk of developing cardiotoxicity in patients receiving anthracyclines after stopping treatment w/ other cardiotoxic agents eg, trastuzumab. Avoid vaccination w/ live vaccine. May diminish response to killed or inactivated vaccines. Increased AUC w/ cimetidine. Increased plasma conc w/ paclitaxel when given prior to epirubicin. Pharmacokinetics may be altered & bone marrow depressant effects may be increased w/ dexverapamil. Plasma conc may be increased w/ docetaxel. Initial distribution may be accelerated & RBC partitioning may be influenced by quinine. Terminal elimination half-life & total clearance may be reduced w/ interferon α2b. Possibility of marked disturbance of haematopoiesis w/ pretreatment w/ drugs influencing bone marrow ie, cytostatic & antiretroviral agents, sulphonamide, chloramphenicol, diphenylhydantoin, amidopyrine derivative. May increase myelosuppression w/ dexrazoxane.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB03 - epirubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Presentation/Packing
Form
Epirubicin Ebewe soln for inj 2 mg/mL
Packing/Price
25 mL x 10 × 1's;25 mL x 1's;25 mL x 5 × 1's;5 mL x 10 × 1's;5 mL x 1's;5 mL x 5 × 1's
Form
Epirubicin Ebewe soln for infusion 2 mg/mL
Packing/Price
25 mL x 10 × 1's;25 mL x 1's;25 mL x 5 × 1's;5 mL x 10 × 1's;5 mL x 1's;5 mL x 5 × 1's
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