Pharmorubicin CS

Pharmorubicin CS

epirubicin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH
Concise Prescribing Info
Contents
Epirubicin HCl
Indications/Uses
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 135 mg/m2 as single & and 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.
Contraindications
Hypersensitivity to epirubicin or other anthracyclines & anthracenediones. IV use: Persisting myelosuppression or severe stomatitis induced by previous drug therapy or radiotherapy, presence of generalised infections, marked liver function impairment, previous history of, or in the 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. Pregnancy & lactation. Intravesical use: Invasive tumours that have penetrated the bladder wall, urinary infections, bladder inflammation, catheterisation problems, haematuria.
Special Precautions
Not to be given IM or SC. Not an antimicrobial agent. Initial treatment requires observation of patient & extensive laboratory monitoring including cardiac function assessment. Severe myelosuppression. Hematologic toxicity, secondary leukemia, mucositis/stomatitis, tumor-lysis syndrome, early/delayed cardiotoxicity, active or dormant CV disease, prior or concomitant radiotherapy of mediastinal-pericardial area, hypertensive cardiomyopathy, 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. 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. Perform blood count, renal & liver function tests prior to each treatment. Inj site effects, extravasation. Avoid use w/ live vaccines. Red urine discolouration for 1-2 days after administration. Intravesical route produce chemical cystitis & bladder constriction symptoms. Severe hepatic impairment. Renal impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Not recommended during lactation.
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/ radiotherapy. Not to be mixed w/ heparin.
ATC Classification
L01DB03 - epirubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Presentation/Packing
Form
Pharmorubicin CS cytosafe inj (vial) 50 mg/25 mL
Packing/Price
1's
Form
Pharmorubicin CS cytosafe inj (vial) 10 mg/5 mL
Packing/Price
(Cytosafe vial) 1's
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