Pharmorubicin CS

Breast, gastric, ovarian, small cell lung & superficial bladder (Tis, Ta) cancer, non-Hodgkin's lymphoma, advanced/metastatic soft tissue sarcoma. Prophylaxis of recurrence after transurethral resection of stage T1 papillary & stage Ta multifocal papillary cancers (grade 2 & 3).

75-90 mg/m² single IV inj at 21-day intervals. Breast cancer Up to 135 mg/m² as single & 120 mg/m² in combination every 3-4 wk. Adjuvant treatment of early breast cancer patient w/ +ve lymph nodes 100-120 mg/m² every 3-4 wk. Heavily pre-treated patient, w/ pre-existing bone marrow depression or neoplastic bone marrow infiltration Not to exceed 75-90 mg/m². Intravesical Papillary transitional cell bladder carcinoma 8 wkly instillations of 50 mg. Chemical cystitis Reduce dose to 30 mg. In situ carcinoma Increase dose to 80 mg. Prophylaxis of recurrences after transurethral resection of superficial tumours 4 wkly administrations of 50 mg followed by 11 mthly instillations at same dosage. Hepatic impairment serum bilirubin >50 micromol/L ¼ normal dose, 20-50 micromol/L ½ normal dose.

Hypersensitivity to epirubicin, other anthracyclines or anthracenediones. IV use: Persisting myelosuppression or severe stomatitis induced by previous drug therapy or RT, presence of generalised infections, previous history of or presence of cardiac impairment, unstable angina pectoris. Previous treatments w/ max cumulative doses of mitozantrone, mitomycin C or other anthracyclines. Marked hepatic impairment. Pregnancy & lactation. Intravesical use: Invasive tumours penetrating bladder wall, urinary infections, bladder inflammation, catheterisation problems, haematuria.

Not to be given IM, SC or PO. Not recommended as direct push inj. Not an antimicrobial agent. Initial treatment requires observation of patients & extensive lab monitoring including cardiac function assessment. Severe myelosuppression, haematologic toxicity; secondary leukaemia; early/delayed cardiotoxicity, active or dormant CV disease, hypertensive cardiomyopathy; mucositis/stomatitis; tumour-lysis syndrome; thrombophlebitis & thromboembolic phenomena. including pulmonary embolism. Increased risk of CHF if total cumulative dose is exceeded. Inj site effects, extravasation; intravesical route produce chemical cystitis & bladder constriction symptoms. May impart red discolouration to urine for 1-2 days after administration. Perform blood count, renal & LFTs prior to each treatment. Assess cardiac function; evaluate serum total bilirubin & AST prior & during treatment. Perform baseline ECG & periodic follow-up ECG during & immediately after drug therapy. Monitor WBC, blood uric acid, K, Ca phosphate & creatinine levels. Avoid contact w/ skin or mucosa. Not to be used in combination w/ other cardiotoxic agents. Avoid use w/ live vaccines. Concurrent use w/ other anti-neoplastic agents; prior or concomitant RT of mediastinal-pericardial area; previous therapy w/ anthracyclines or anthracenediones, concomitant use of drugs w/ ability to suppress cardiac contractility or cardiotoxic drugs eg, trastuzumab, high-dose cyclophosphamide or 5-fluorouracil. Not to be given in severe hepatic impairment. May cause amenorrhea in women & infertility. Women of childbearing potential should use effective contraception during & at least 6.5 mth after last dose. Men should use effective contraception during & for at least 3.5 mth after last dose. Not to be used during pregnancy. Not recommended during lactation & for at least 7 days after last dose. Fetal/neonatal cardiotoxic events including fetal death following in utero exposure.

Myelosuppression, leukopenia, neutropenia, febrile neutropenia, thrombocytopenia, mild anaemia, secondary infection; transient ECG changes eg, low QRS voltage, tachycardia, arrhythmias, T-wave flattening, ST depression & T inversion; nausea, vomiting, diarrhoea, mucositis; alopecia eg, beard growth interruption; erythematous streaking along infused vein; dehydration.

Additive toxicity w/ other cytotoxic drugs. Additive cardiotoxic effect w/ propranolol. Increased AUC by cimetidine. Increased plasma conc by paclitaxel. Enhanced myocardial toxicity w/ mediastinal RT. Incompatibility w/ heparin. Hydrolysis w/ alkaline pH soln. Close monitoring of cardiac function w/ 5-fluorouracil, cyclophosphamide, cisplatin, taxanes, trastuzumab, Ca-channel blockers.

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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