Generic Medicine Info
Conventional formulation: IV: Recent MI (within past 4-6 weeks), severe myocardial insufficiency, severe persistent drug-induced myelosuppression or stomatitis, severe arrhythmias, generalised infection. Severe hepatic impairment (Child-Pugh class C or bilirubin >5 mg/dL). Prior treatment with Max cumulative doses of doxorubicin, epirubicin, daunorubicin, idarubicin, or other anthracyclines and anthracenediones. Intravesical: Invasive tumours that penetrated the bladder wall, bladder inflammation, catheterisation problems (e.g. due to massive intravesical tumours), haematuria, urinary infections. Pegylated liposomal formulation: AIDS-related Kaposi's sarcoma that may be effectively treated by local therapy or systemic alfa-interferon. Lactation.
Special Precautions
Patient with active, dormant or history of CV disease; previous or concurrently receiving radiotherapy to the mediastinal or pericardial area. Obese or heavily pre-treated patients; patient with neoplastic bone marrow infiltration. Concomitant administration with cardiotoxic agents (e.g. cyclophosphamide, trastuzumab). Not recommended for use in splenectomised patients with AIDS-related Kaposi's sarcoma (pegylated liposomal formulation). Different liposomal and conventional formulations must not be used interchangeably (refer to detailed product guideline). Avoid concurrent vaccination with live vaccines. Avoid extravasation. Hepatic impairment (particularly elevated bilirubin levels). Children and elderly. Pregnancy (avoid use of pegylated liposomal formulation during the 1st trimester). Monitoring Parameters Confirm pregnancy status before treatment initiation in females of reproductive potential. Monitor CBC with differential and platelet count, LFTs (AST/ALT, alkaline phosphatase, bilirubin) at baseline and periodically during treatment; cardiac function (ECG, LVEF by echocardiography or multi-gated radionuclide angiography [MUGA]) at baseline, periodically during and after therapy; serum electrolytes (e.g. Ca, K, phosphate), serum creatinine and uric acid; hydration status. Closely monitor the infusion site for extravasation; for infusion-related reactions, oral ulceration suggestive of secondary oral malignancy, hand-foot syndrome (liposomal formulation). Perform cystoscopic examination and monitor urine cytology at regular intervals (intravesical use).
Adverse Reactions
Significant: Cardiomyopathy (e.g. acute left ventricular failure), secondary malignancy (e.g. acute myelogenous leukaemia, acute myelodysplastic syndromes, oral cancers primarily squamous cell carcinoma), tumour lysis syndrome resulting in hyperuricaemia; nausea, vomiting, mucositis, radiation recall (in patients who received prior radiation therapy); impaired fertility, amenorrhoea, oligospermia or azoospermia; palmar-plantar erythrodysaesthesia (or hand-foot syndrome). Blood and lymphatic system disorders: Lymphophenia, pancytopenia. Cardiac disorders: CV disorder, sinus tachycardia, chest pain. Eye disorders: Conjunctivitis, retinitis, lacrimation, blurred vision. Gastrointestinal disorders: Diarrhoea, stomatitis, constipation, dyspepsia, abdominal pain, dysgeusia, oesophagitis, oral moniliasis, glossitis. General disorders and administration site conditions: Fatigue, asthenia, fever, chills, malaise, peripheral oedema, pain. Immune system disorders: Hypersensitivity reactions. Infections and infestations: Herpes simplex or zoster infection, sepsis. Investigations: Decreased or increased weight, increased AST/ALT and blood creatinine, ECG changes. Metabolism and nutrition disorders: Anorexia, decreased appetite, dehydration, hypocalcaemia, hypokalaemia, hyponatraemia. Musculoskeletal and connective tissue disorders: Back pain, musculoskeletal pain. Nervous system disorders: Dizziness, headache, paraesthesia, peripheral neuropathy, neuralgia. Psychiatric disorders: Somnolence, anxiety, insomnia, depression. Renal and urinary disorders: UTI, dysuria, red discolouration of urine; chemical cystitis, bladder contraction (intravesical use). Reproductive system and breast disorders: Breast pain, vaginitis. Respiratory, thoracic and mediastinal disorders: Pharyngitis, increased cough, dyspnoea, epistaxis, pneumonia. Skin and subcutaneous tissue disorders: Rash, alopecia, pruritus, dry skin, erythema, urticaria; skin or nail discolouration or hyperpigmentation; acne, skin ulcer, cellulitis. Vascular disorders: Hypotension, flushing, vasodilatation, syncope, thrombophlebitis.
Potentially Fatal: Severe myelosuppression (e.g. neutropenia, leucopenia, thrombocytopenia, anaemia), arrhythmias, CHF, pulmonary embolism; infusion-related reactions (liposomal formulations).
Drug Interactions
May cause profound and prolonged haematologic toxicity, seizures and coma with ciclosporin. Increased risk of cardiotoxic effect with trastuzumab. May potentiate the toxic effects of other anticancer therapies (e.g. exacerbated cyclophosphamide-induced haemorrhagic cystitis, enhanced hepatotoxicity of mercaptopurine). Increased plasma concentrations and clinical effects with inhibitors of CYP3A4, CYP2D6, and P-glycoprotein (P-gp) such as verapamil. May decrease plasma levels with CYP3A4 (e.g. phenobarbital, phenytoin) and P-gp inducers. Plasma levels of doxorubicin may be increased when paclitaxel is given initially.
CIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
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