Venus Remedies


Concise Prescribing Info
Doxorubicin HCl
Regression in neoplastic conditions eg, acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue & bone sarcomas, hepatomas, breast, bronchogenic (lung), thyroid & ovarian carcinoma, Hodgkin's & non-Hodgkin's type lymphomas. Intravesically in primary management of non-metastatic bladder carcinoma.
Dosage/Direction for Use
60-75 mg/m2 as single IV inj at 21-day intervals or 30 mg/m2 on each of 3 successive days repeated every 4 wk. Cumulative lifetime dose limit: 550 mg/m2. Intra-arterial infusion 45-100 mg/m2 for 1-3 days. Adult ≥70 yr Total cumulative dose: 450 mg/m2. Hepatic impairment serum bilirubin >50 micromol/L ¼ normal dose, 20-50 micromol/L ½ normal dose.
Hypersensitivity to doxorubicin, other anthracyclines or anthracenediones. Pregnancy & lactation. IV use: Persistent myelosuppression or severe stomatitis induced by previous treatment w/ other antitumour agents or by RT; presence of generalised infection; severe arrhythmias, myocardial insufficiency & hepatic impairment; recent MI. Previous treatment w/ max cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin &/or other anthracyclines & anthracenediones. Intravesical use: Invasive tumours penetrating bladder wall; urinary infections; bladder inflammation & catheterisation (eg, due to massive intravesical tumours); haematuria.
Special Precautions
Not to be given IM or SC; intrathecally, IM or by long-term infusion; direct IV infusion. Not an antimicrobial agent. Patients w/ prior mediastinal irradiation, hypertensive cardiomegaly; early or delayed cardiotoxicity; active or dormant CV disease; haematologic toxicity, severe myelosuppression; secondary leukaemia; mucositis/stomatitis; obesity; tumour-lysis syndrome. Increased risk of CHF if total cumulative dose is exceeded. Alopecia; anorexia; hyperpigmentation. Inj site effects; extravasation; intravesical route may produce symptoms of chemical cystitis & bladder constriction. May impart red discolouration to urine for 1-2 days after administration. Avoid contact w/ skin or mucosa. Perform blood count & LFTs prior to treatment. Assess cardiac function prior to & during treatment. Perform baseline & periodic follow-up ECG during & immediately after treatment. Monitor WBC, RBC, platelet & blood uric acid, K, Ca phosphate & creatinine levels. Perform cystoscopic exam regularly & monitor urine cytologies mthly. Avoid use w/ live or live-attenuated vaccine. Concurrent high-dose cyclophosphamide therapy. Prior or concomitant RT to mediastinal/pericardial area, previous therapy w/ anthracyclines or anthracenediones. Concomitant use of drugs w/ ability to suppress cardiac contractility or other cardioactive compd (eg, Ca-channel blockers) or other potentially cardiotoxic drugs (eg, cyclophosphamide, 5-fluorouracil or trastuzumab). May potentiate toxicity of other anticancer therapies. Hepatic impairment. May cause amenorrhea in women & infertility in men. Men undergoing treatment should use effective contraception. Not to be used during pregnancy & lactation. Paed. Elderly.
Adverse Reactions
Leucopenia, neutropenia, anaemia, thrombocytopenia; mucosal inflammation/stomatitis, diarrhoea, vomiting, nausea; pyrexia, asthenia, chills; infection; decreased ejection fraction, abnormal ECG & transaminases, increased wt; decreased appetite; palmar-plantar erythrodysaesthesia syndrome, alopecia. Cardiomyopathy, congestive cardiac failure, sinus tachycardia; conjunctivitis; oesophagitis, abdominal pain; infusion site reaction, extravasation; sepsis, cellulitis; urticaria, rash, skin & nail hyperpigmentation.
Drug Interactions
Increased conc & clinical effect w/ CYP3A4, CYP2D6 &/or P-gp inhibitors (eg, verapamil). Decreased conc w/ CYP3A4 (eg, phenobarb, phenytoin, St. John's wort) & P-gp inducers. Additive toxicity w/ other cytotoxic agents. Sensitized heart to doxorubicin cardiotoxicity w/ concurrent cyclophosphamide treatment & exacerbated cyclophosphamide cystitis. Increased AUC by cyclosporin. Precipitation w/ heparin & fluorouracil. Enhanced myocardial toxicity w/ mediastinal RT. Increased plasma conc by paclitaxel. Additive cardiotoxic effect w/ propranolol. Increased radiation toxicity ie, skin reactions & mucositis w/ RT. Hydrolysis w/ alkaline soln.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Robol infusion conc 2 mg/mL
100 mL x 1's;25 mL x 1's;5 mL x 1's
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