Pharmorubicin CS

Pharmorubicin CS





Zuellig Pharma
Concise Prescribing Info
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).
Dosage/Direction for Use
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.
Special Precautions
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.
Adverse Reactions
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.
Drug Interactions
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.
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.
Pharmorubicin CS cytosafe soln for inj 50 mg/25 mL
(Cytosafe) 1's
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