Adriamycin CS

Adriamycin CS

doxorubicin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH
Concise Prescribing Info
Contents
Doxorubicin HCl
Indications/Uses
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 the primary management of non-metastatic bladder carcinoma.
Dosage/Direction for Use
Adult & ped 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.
Contraindications
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 radiotherapy; 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 that penetrated the bladder wall; urinary infections; bladder inflammation & catheterisation (eg, due to massive intravesical tumours); haematuria.
Special Precautions
Not to be given IM or SC. Not an antimicrobial agent. Patients w/ prior mediastinal irradiation, hypertensive cardiomegaly. Severe myelosuppression; early & delayed cardiotoxicity; active or dormant CV disease; hematologic toxicity; secondary leukemia; mucositis/stomatitis; obesity; tumour-lysis syndrome. Alopecia; anorexia; hyperpigmentation. Inj site effects; extravasation; intravesical route may produce symptoms of chemical cystitis. Perform blood count & liver function tests prior to treatment. Assess cardiac function prior to & during treatment. Perform baseline ECG & periodic follow-up ECG during & immediately after treatment. Monitor WBC, RBC, platelet & blood uric acid, K, Ca phosphate & creatinine levels. May impart red discolouration of urine for 1-2 days after administration. Concurrent high-dose cyclophosphamide therapy. Prior or concomitant radiotherapy 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). Avoid use w/ live vaccine. May potentiate toxicity of other anticancer therapies. Hepatic impairment. May cause amenorrhea in women & infertility in men. Not to be used during pregnancy & lactation.
Adverse Reactions
Leucopenia, neutropenia, anemia, 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 by CYP3A4, CYP2D6 &/or P-glycoprotein (P-gp) inhibitors (eg, verapamil); decreased conc by 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 radiotherapy. Increased plasma conc by paclitaxel. Additive cardiotoxic effect w/ propranolol. Increased radiation toxicity ie, skin reactions & mucositis w/ radiotherapy.
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.
Presentation/Packing
Form
Adriamycin CS soln for inj 10 mg/5 mL
Packing/Price
5 mL x 1's
Form
Adriamycin CS soln for inj 50 mg/25 mL
Packing/Price
25 mL x 1's
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