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Antharin-50

Antharin-50

doxorubicin

Manufacturer:

Admac Lifesciences

Distributor:

Suhitas
Concise Prescribing Info
Contents
Doxorubicin HCl
Indications/Uses
Used to produce regression in neoplastic conditions including acute leukaemia, lymphomas, soft-tissue & osteogenic sarcomas, paed malignancies & adult solid tumours; in particular breast & lung carcinomas.
Dosage/Direction for Use
Give soln via IV infusion not <3 min & not >10 min. As single agent Adult 60-75 mg/m2/cycle. Total starting dose/cycle may be given as single dose or divided over 3 successive days or in divided doses given on days 1 & 8. Each cycle can be repeated every 3-4 wk under conditions of normal recovery from drug-induced toxicity (particularly bone marrow depression & stomatitis). In combination w/ other antitumour agent having overlapping toxicity Dose may need to be reduced to 30-60 mg/m2 every 3 wk. Hepatic impairment, serum bilirubin level >3 mg/100 mL 25% normal dose, 1.2-3 mg/100 mL 50% normal dose.
Contraindications
Hypersensitivity to doxorubicin, or other anthracyclines or anthracenediones. IV: Persistent myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent MI, severe arrhythmias, & previous treatment w/ max cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, &/or other anthracyclines & anthracenediones.
Special Precautions
Direct push inj is not recommended. Reduced systemic clearance in obese patients ie, >130% ideal body wt. Risk of cardiotoxicity which may be manifested by early (ie, acute) or late (ie, delayed) events. Secondary leukaemia, w/ or w/o a preleukaemic phase, more common when used w/ DNA-damaging antineoplastic agents, in patients heavily pretreated w/ cytotoxic drugs or when anthracycline doses have been escalated. Tumour-lysis syndrome. Assess cardiac function prior to treatment & monitor throughout therapy; haematologic profiles prior to & during each cycle of therapy, including differential WBC counts. Carefully monitor cardiac function in patients receiving high cumulative doses & those w/ risk factors. Evaluate serum total bilirubin prior to & during treatment; blood uric acid levels, K, Ca phosphate & creatinine after initial treatment. Avoid vaccination w/ a live vaccine. May potentiate toxicity of other anticancer therapies. Response to killed or inactivated vaccines may be diminished. Not to be administered to patients w/ severe hepatic impairment. May cause infertility (during time of administration) & amenorrhoea in women. Use effective contraception in men & women of childbearing potential undergoing treatment. Not to be used during pregnancy unless clearly necessary. Do not breastfeed during treatment. Increased risk for developing delayed cardiotoxicity following administration in females, childn & adolescents.
Adverse Reactions
Infection; leukopenia, neutropenia, anaemia, thrombocytopenia; decreased appetite; mucosal inflammation/stomatitis, diarrhoea, vomiting, nausea; palmar-plantar erythrodysaesthesia syndrome, alopecia; pyrexia, asthenia, chills; decreased ejection fraction, abnormal ECG & transaminases, increased wt. Sepsis; conjunctivitis; congestive cardiac failure, sinus tachycardia; oesophagitis, abdominal pain; urticaria, rash, skin & nail hyperpigmentation; infusion site reaction.
Drug Interactions
Increased conc & clinical effect w/ CYP3A4, CYP2D6 &/or P-gp (eg, verapamil) inhibitors. Conc may be decreased w/ CYP3A4 (eg, phenobarb, phenytoin, St. John's wort) & P-gp inducers. Increased serum levels & myelotoxicity w/ high-dose cyclosporine. Additive toxicity may occur especially w/ regard to bone marrow/haematologic & GI effects w/ other cytotoxic drugs. Monitor cardiac function in concomitant use w/ other potentially cardiotoxic drugs & other cardioactive compd eg, Ca channel blockers. Metabolism, pharmacokinetics, therapeutic efficacy &/or toxicity may be affected by hepatic function changes induced by concomitant therapies. Increased plasma conc w/ paclitaxel. Increased cardiotoxic risk w/ trastuzumab. Increased AUC w/ sorafenib.
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
Antharin-50 lyo powd for inj 50 mg
Packing/Price
1's
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