Doxoccord 20 LP/Doxoccord 50 LP

Doxorubicin HCl

Monotherapy for patients w/ metastatic breast cancer, where there is an increased cardiac risk. Advanced ovarian cancer in women who have failed a 1st-line platinum-based chemotherapy regimen. In combination w/ bortezomib for progressive multiple myeloma in patients who have received at least 1 prior therapy & who have already undergone or are unsuitable for bone marrow transplant. AIDS-related Kaposi's sarcoma (KS) in patients w/ low CD4 counts (<200 CD4 lymphocytes/mm³) & extensive mucocutaneous or visceral disease. 1st-line systemic chemotherapy, or as 2nd line chemotherapy in AIDS-KS patients w/ disease that has progressed w/, or in patients intolerant to, prior combination systemic chemotherapy comprising at least 2 of the following agents: a vinca alkaloid, bleomycin & standard doxorubicin (or other anthracycline).

Breast/ovarian cancer 50 mg/m² IV once every 4 wk for as long as disease does not progress & patient continues to tolerate treatment. Multiple myeloma 30 mg/m² on day 4 of bortezomib 3-wk regimen as 1-hr infusion administered immediately after bortezomib infusion. Bortezomib regimen: 1.3 mg/m² on days 1, 4, 8, & 11 every 3 wk. Repeat dose as long as patients respond satisfactorily & tolerate treatment. Day 4 dosing of both medicinal products may be delayed up to 48 hr as medically necessary. Doses of bortezomib should be at least 72 hr apart. AIDS-related KS 20 mg/m² IV every 2-3 wk. Avoid intervals <10 days as medicinal product accumulation & increased toxicity cannot be ruled out. Treatment of patients for 2-3 mth is recommended to achieve therapeutic response. Continue treatment as needed to maintain therapeutic response. Hepatic impairment: Bilirubin >3 mg/dL Initially reduce by 50%; 1.2-3 mg/dL Initially reduce by 25%.

Hypersensitivity. Not to be used to treat AIDS-KS that may be treated effectively w/ local therapy or systemic α-interferon.

Routinely undergo frequent ECG monitoring in all patients. Consider the most definitive test for anthracycline myocardial injury, ie, endomyocardial biopsy, if reduction of the QRS complex occurs. Apply measurement of left ventricular ejection fraction by echocardiography or preferably by multigated angiography routinely before initiation of therapy & repeated periodically during treatment. Patients w/ cardiac disease requiring treatment; impaired cardiac function who receive treatment. CHF due to cardiomyopathy may occur suddenly, w/o prior ECG changes & may be encountered several wk after discontinuation of therapy. Patients who have received other anthracyclines. Any previous (or concomitant) therapy w/ cardiotoxic compd eg, other anthracyclines/anthraquinones or eg, 5-fluorouracil. Cardiac toxicity at cumulative anthracycline doses <450 mg/m² in patients w/ prior mediastinal irradiation or in those receiving concurrent cyclophosphamide therapy. Myelosuppression. Perform periodic blood counts frequently during the course of therapy, & at a min, prior to each dose because of the potential for bone marrow suppression. Persistent severe myelosuppression may result in superinfection or haemorrhage. Opportunistic infections. Keep any patient treated w/ doxorubicin under haematological supervision for secondary haematological malignancies eg, secondary AML & myelodysplasias. Secondary oral neoplasms. Examine patients at regular intervals for presence of oral ulceration or any oral discomfort that may be indicative of secondary oral cancer. Infusion-associated reactions. Diabetic patients; contains sucrose. Do not give by IM or SC route. Evaluate hepatic function using conventional clinical lab tests eg, ALT/AST, alkaline phosphatase, & bilirubin prior to administration. Not recommended in AIDS-related KS patients w/ splenectomy. Avoid driving & operating machinery in patients who suffer from dizziness & somnolence. Hepatic & renal impairment. Avoid pregnancy while receiving therapy & in 6 mth following discontinuation of therapy in women of child-bearing potential or male partner. Not to be used during pregnancy unless clearly necessary. Discontinue nursing prior to beginning treatment. Not recommended in paed patients <18 yr.

Palmar-plantar erythrodysesthesia; stomatitis/mucositis & nausea; myelosuppression (mostly leukopaenia); diarrhoea, neutropaenia, thrombocytopaenia, vomiting, fatigue, & constipation.

Concomitant use w/ medicinal products known to interact w/ standard doxorubicin HCl; any other cytotoxic agents, especially myelotoxic agents. May potentiate the toxicity of other anti-cancer therapies eg, cyclophosphamide or taxanes. Exacerbation of cyclophosphamide-induced haemorrhagic cystitis & enhancement of hepatotoxicity of 6-mercaptopurine in patients w/ AIDS.

Cytotoxic Chemotherapy

L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.

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