Pharmorubicin CS

Epirubicin HCl

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-days 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. Intravesical Papillary transitional cell bladder carcinoma 8 wkly instillations of 50 mg. Prophylaxis of recurrences after transurethral resection of superficial tumours 4 wkly administrations of 50 mg followed by 11 mthly instillations at same dosage.

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 (severe arrhythmias & cardiomyopathy, previous MI), unstable angina pectoris. Previous treatments w/ max cumulative doses of mitozantrone, mitomycin C or other anthracyclines eg, doxorubicin or daunorubicin. 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 an antimicrobial agent. Initial treatment requires observation of patients & extensive lab monitoring including cardiac function assessment. Severe myelosuppression, hematologic toxicity; secondary leukemia; early/delayed cardiotoxicity, active or dormant CV disease, hypertensive cardiomyopathy; mucositis/stomatitis; tumor-lysis syndrome; thrombophlebitis and thromboembolic phenomena. Perform blood count, renal & LFTs prior to each treatment. Assess cardiac function 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. Inj site effects, extravasation. Avoid contact w/ skin or mucosa. Red urine discolouration for 1-2 days after administration. Intravesical route produce chemical cystitis & bladder constriction symptoms. 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. Renal & hepatic impairment. May affect male fertility. Women of childbearing potential should use effective contraception during & at least 6.5 mth after last dose. Not to be used during pregnancy. Not recommended during lactation. Fetal/neonatal cardiotoxic events including fetal death following in utero exposure.

Myelosuppression, leukopaenia, neutropaenia, febrile neutropaenia, thrombocytopaenia, 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.

Close monitoring of cardiac function w/ 5-fluorouracil, cyclophosphamide, cisplatin, taxanes, trastuzumab, Ca-channel blockers. Additive cardiotoxic effect w/ propranolol. Increased AUC by cimetidine. Increased plasma conc by paclitaxel. Enhanced myocardial toxicity w/ RT. Not to be mixed w/ heparin.

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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