Cytobin-10/Cytobin-50

Neoplastic conditions including breast, ovarian, gastric, lung & colorectal carcinomas, malignant lymphomas, leukaemias & multiple myeloma. Intravesical administration: Superficial bladder cancer, carcinoma-in-situ prophylaxis of recurrences after transurethral resection, superficial bladder cancer & advanced metastatic soft tissue sarcoma.

IV Conventional dose: Adult 60-90 mg/m² as single agent inj over 3-5 min, repeated at 21-day intervals. High dose: Small cell lung cancer (previously untreated) 120 mg/m² on day 1 every 3 wk. NSCLC (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/ +ve lymph node 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 chemotherapy or RT, age, or neoplastic bone marrow infiltration 60-75 mg/m² for conventional treatment & 105-120 mg/m² for high dose schedules. Total dose/cycle may be divided over 2-3 successive days. Liver impairment: Serum bilirubin >3 mg/100 mL 75% dose reduction, 1.4-3 mg/100 mL 50% dose reduction. Intravesical Therapy 8 times wkly instillations of 50 mg/50 mL. Local toxicity (chemical cystitis) Reduce dose to 30 mg/50 mL. Carcinoma-in situ May increase dose 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.

Hypersensitivity to epirubicin HCl, other anthracyclines or anthracenediones. Lactation. IV use: Patients w/ marked or persistent myelosuppression induced by previous treatment w/ either other antineoplastic agents or RT; patients w/ severe hepatic impairment; severe myocardial insufficiency; recent MI; severe arrhythmias; previous treatments w/ max cumulative doses of epirubicin &/or other anthracyclines eg, doxorubicin or daunorubicin & anthracenediones; previous history of cardiac impairment (including 4th degree muscular heart failure, acute & previous heart attack which led to 3rd & 4th degree muscular heart failure, acute inflammatory heart diseases, severe arrhythmia, myocardiopathy, recent MI) in patients w/ acute systemic infections; patients w/ unstable angina pectoris; myocardiopathy. Intravesical use: UTI; inflammation of the bladder; haematuria; invasive tumours penetrating the bladder; catheterisation problems; large vol of residual urine; contracted bladder.

Discontinue infusion immediately should signs or symptoms of extravasation occur. Not to be inj IM or intrathecally. Not to be used intravesically for invasive tumours which have penetrated the bladder wall where systemic therapy or surgery is more appropriate. Patients should recover from acute toxicities of prior cytotoxic treatment (eg, stomatitis, neutropenia, thrombocytopenia, & generalised infections) prior to treatment. Severity of neutropenia & stomatitis/mucosal inflammation may be increased in high doses. Cardiotoxicity; secondary leukaemia; mucosal inflammation/stomatitis; thrombophlebitis & thromboembolic phenomena including pulmonary embolism. May produce myelosuppression. May impart red colour to urine for 1-2 days after administration. May induce hyperuricaemia due to tumour-lysis syndrome. Venous sclerosis may result from inj into small vessel or from repeated inj into the same vein. Assess cardiac function, serum creatinine prior to & during treatment. Carefully monitor RBC, differential WBC, neutrophil & platelet counts prior to & during each cycle of therapy. Evaluate liver function (SGOT, SGPT, alkaline phosphatase, bilirubin) prior to & during treatment. Avoid vaccination w/ a live vaccine during treatment. Women of childbearing potential should avoid becoming pregnant & should use effective contraception during treatment. Men should adopt appropriate contraceptives during treatment. Pregnancy. Discontinue lactation during treatment. Safety & efficacy have not been established in childn. Intravesical: May produce symptoms of chemical cystitis. Intra-arterial: May produce localized or regional events including gastroduodenal ulcers & narrowing of bile ducts due to drug-induced sclerosing cholangitis.

Infection, conjunctivitis; myelosuppression (leucopenia, granulocytopenia & neutropenia, anaemia & febrile neutropenia, thrombocytopenia); keratitis; hot flashes, phlebitis; mucositis, stomatitis, vomiting, diarrhoea, nausea & abdominal pain; alopecia, skin toxicity; chromaturia; amenorrhoea; malaise, pyrexia; changes in transaminase levels; chemical cystitis. Bacterial cystitis; loss of appetite, dehydration; ventricular tachycardia, AV block, bundle-branch block, bradycardia, CHF; haemorrhage, flushing; oesophagitis, GI pain, erosion, haemorrhage & ulcer, abdominal & oral pain, oral mucosa erosion, mucosal burning sensation; rash, pruritus, nail hyperpigmentation, skin disorders & hyperpigmentation, local tissue toxicity; dysuria, haematuria, pollakiuria; chills, infusion site erythema; asymptomatic decreases in left ventricular ejection fraction.

Additive toxicity especially bone marrow/hematologic & GI effects w/ other cytotoxic drugs. Monitor cardiac function w/ other potentially cardiotoxic drugs & other cardioactive compd eg, Ca channel blockers. May increase risk of developing cardiotoxicity w/ other cardiotoxic agents. Response to killed or inactivated vaccines may be diminished. Increased AUC w/ cimetidine. Increased plasma conc w/ paclitaxel. Pharmacokinetics may be altered & bone marrow depressant effects be possibly increased w/ dexverapamil. Initial distribution from blood into the tissues may be accelerated & may have influence on the RBC partitioning w/ quinine. May cause reduction in both terminal t_1/2 & total clearance w/ interferon α2b. Possible marked disturbance of haematopoiesis w/ medications which influence bone marrow ie, cytostatic agents, sulphonamide, chloramphenicol, diphenylhydantoin, amidopyrine-derivatives, antiretroviral agents. Systemic clearance may be increased w/ dexrazoxane. Increased myelosuppression may occur w/ dexrazoxane. Potential risk of cardiotoxicity may be increased w/ concomitant cardiotoxic agents eg, 5-fluorouracil, cyclophosphamide, cisplatin, taxanes or concomitant (or prior) RT to the mediastinal area.

Cytotoxic Chemotherapy

L01DB03 - epirubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.

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