Doxoccord LP

Doxorubicin HCl (pegylated lipos doxorubicin)

Monotherapy for metastatic breast cancer in patients w/ increased cardiac risk. Advanced ovarian cancer in women who have failed 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 or 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: vinca alkaloid, bleomycin & standard doxorubicin (or other anthracycline).

IV infusion Doses ≥90 mg: Dilute in 500 mL 5% glucose soln for infusion, <90 mg: Dilute in 250 mL 5% glucose soln for infusion. Breast/ovarian cancer 50 mg/m² once every 4 wk for as long as the 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, w/ each dose at least 72 hr apart & repeated as long as patient responds satisfactorily & tolerate treatment. May delay day 4 dosing of both medicinal products up to 48 hr as medically necessary. AIDS-related KS 20 mg/m² every 2-3 wk for 2-3 mth or continue as needed. Hepatic impairment w/ bilirubin >3 mg/dL Reduce initial dose by 50%, 1.2-3 mg/dL Reduce initial dose by 25%. If patient tolerates 1st dose w/o increase in serum bilirubin or liver enzymes, cycle 2 dose may be increased to next dose level.

Hypersensitivity to doxorubicin HCl, peanut or soya. AIDS-KS that may be treated effectively w/ local therapy or systemic α-interferon.

Temporarily stop treatment if infusion-related reactions characterised by allergic-like or anaphylactoid-like reactions (eg, asthma, flushing, urticarial rash, chest pain, fever, HTN, tachycardia, pruritus, sweating, shortness of breath, facial oedema, chills, back pain, tightness in chest & throat &/or hypotension) occur. Not to be used interchangeably w/ other formulations of doxorubicin HCl. Not to be administered as bolus inj or undiluted soln; by IM or SC route. Administer initial dose at rate no >1 mg/min to minimise risk of infusion reactions. Not recommended in AIDS-related KS patients who have had splenectomy. Persistent severe myelosuppression may result in superinfection or haemorrhage. Opportunistic infections; secondary AML & myelodysplasias. CHF due to cardiomyopathy may occur suddenly, w/o prior ECG changes & may also be encountered several wk after discontinuation of therapy. Cardiac toxicity at cumulative anthracycline doses <450 mg/m² in patients w/ prior mediastinal irradiation or in those receiving concurrent cyclophosphamide therapy. Patients w/ impaired cardiac function; who have received other anthracyclines. Diabetic patients. Consider endomyocardial biopsy & evaluate benefit of continued therapy against risk of developing irreversible cardiac damage whenever cardiomyopathy is suspected. Examine patients at regular intervals for the presence of oral ulceration or any oral discomfort that may be indicative of secondary oral cancer. Routinely perform frequent ECG monitoring; measure left ventricular ejection fraction by echocardiography or preferably by Multigated Angiography before initiation & repeated periodically during treatment. Evaluate hepatic function using conventional clinical lab tests eg, ALT/AST, alkaline phosphatase & bilirubin prior administration; left ventricular function before each additional treatment that exceeds lifetime cumulative anthracycline dose of 450 mg/m². Frequently perform periodic blood counts during, & at min, prior to each dose. Avoid driving & operating machinery in patients suffering dizziness & somnolence. Reduce dose in patients w/ impaired hepatic function. Patients w/ CrCl <30 mL/min. Pregnancy. Women of childbearing potential must avoid pregnancy while they or their male partner are receiving therapy & in 6 mth following discontinuation of therapy. Discontinue nursing prior to beginning treatment. HIV-infected women should not breast-feed under any circumstances to avoid HIV transmission. Not recommended in ped patients <18 yr.

Infusion-associated reactions (allergic & anaphylactoid reaction, asthma, face oedema, hypotension, vasodilatation, urticaria, back & chest pain, chills, fever, HTN, tachycardia, dyspepsia, nausea, dizziness, dyspnoea, pharyngitis, rash, pruritus, sweating, inj site reaction & medicinal product interaction); myelosuppression associated w/ anaemia, thrombocytopenia, leukopenia; stomatitis; CHF; secondary AML & myelodysplasias. Breast/ovarian cancer: Palmar-plantar erythrodysesthesia, stomatitis/mucositis & nausea. AIDS-related KS: Infusion-related reactions characterised by flushing, shortness of breath, headache, chest & throat tightness. Myelosuppression (mostly leukopenia). Opportunistic infections (eg, candidiasis, CMV, herpes simplex, Pneumocystis carinii pneumonia & mycobacterium avium complex). In combination w/ bortezomib: Nausea, diarrhoea, neutropenia, thrombocytopenia, vomiting, fatigue & constipation.

Concomitant use w/ medicinal products known to interact w/ standard doxorubicin HCl; any other cytotoxics, especially myelotoxic agents. May potentiate toxicity of other anti-cancer therapies. Exacerbated cyclophosphamide-induced haemorrhagic cystitis & enhanced hepatoxicity 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.

S