Lipo-Dox

Doxorubicin HCl (pegylated lipos doxorubicin)

AIDS-related Kaposi's sarcoma (AIDS-KS) in patients w/ low CD₄ counts (<200 CD₄ lymphocytes/mm³) & diseases in mucosa, skin & internal organs. Metastatic carcinoma of the ovary in patients w/ disease that is recurrent to both 1st-line platinum- & paclitaxel-based chemotherapy regimens. Monotherapy for patients w/ metastatic breast cancer, where there is increased cardiac risk.

IV infusion Breast/Ovarian cancer 50 mg/m² over 60 min once every 4 wk as long as disease does not progress & patient continues to tolerate treatment. AIDS-KS 20 mg/m² over 30 min every 2-3 wk at intervals not <10 days for 2-3 mth or as needed to maintain therapeutic response. 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 bilirubin or liver enzymes, cycle 2 dose may be increased to next dose level.

Hypersensitivity. AIDS-KS that may be effectively treated w/ local therapy or systemic α-interferon. Lactation.

Temporarily stop infusion if serious & sometimes life-threatening infusion reactions characterized by allergic or anaphylactoid-like reactions (asthma, flushing, urticarial rash, chest pain, fever, HTN, tachycardia, pruritus, sweating, shortness of breath, facial edema, chills, back pain, chest & throat tightness &/or hypotension) occur w/in min of starting infusion. Do not administer as bolus inj or undiluted soln; by IM or SC route. Not recommended in AIDS-KS patients w/ splenectomy. CHF due to cardiomyopathy w/o prior ECG changes may occur several wk after treatment discontinuation. Myelosuppression in patients w/ pre-existing HIV disease, concomitant or previous medications or bone marrow tumors. Patients w/ impaired cardiac function; previous or concomitant therapy w/ cardiotoxic compd (eg, other anthracyclines/anthraquinones or 5-fluorouracil); prior mediastinal irradiation or those receiving concurrent cyclophosphamide therapy; diabetes. Routinely monitor cardiac function [eg, ECG, left ventricular ejection fraction (LVEF) measurement by echocardiography or preferably by MUGA] before or during treatment. Evaluate hepatic function before administration using conventional clinical lab tests eg, ALT/AST, alkaline phosphatase, & bilirubin. Consider endomyocardial biopsy if test results indicate possible cardiac injury (eg, LVEF lower than pre-treatment baseline &/or <45%). Perform periodic blood counts during treatment, & at least before each dose; LVEF assessments before each additional administration. Administer initial dose at rate no >1 mg/min to minimize risk of infusion reactions. Manage palmar-plantar erythrodysesthesia, hematologic toxicity or stomatitis by dose reduction or delayed infusion. Avoid driving & operating machines if dizziness & somnolence occur. Reduce dose in patients w/ impaired hepatic function. Patients w/ CrCl <30 mL/min. Women of childbearing potential should avoid pregnancy while they or their male partner are in treatment & in 6 mth following discontinuation of therapy. Not recommended during pregnancy. Discontinue nursing. Ped patient <18 yr.

Allergic & anaphylactoid reaction, asthma, face edema, hypotension, vasodilation, urticaria, back & chest pain, chills, HTN, tachycardia, dizziness, dyspnea, pharyngitis, pruritus, sweating, inj site reaction, palmar-plantar erythrodysesthesia. Asthenia; fever, diarrhea, nausea, stomatitis; anemia; alopecia. Breast & ovarian cancer: Abdominal pain, anorexia, constipation, dyspepsia, vomiting; dry skin, rash, skin discoloration. Breast cancer & AIDS-KS: Flushing. Ovarian cancer & AIDS-KS: Leukopenia, neutropenia & thrombocytopenia. Breast cancer: Erythema, fatigue, weakness, wt loss; mouth ulceration, nasal mucosa, dyspnea; abnormal pigmentation, pruritus. Ovarian cancer: Mucous membrane disorder, pain; paresthesia, somnolence; angina; hand foot syndrome. AIDS-KS: Shortness of breath, facial edema, headache, chills, back pain, chest & throat tightness, &/or hypotension), candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumonia, & Mycobacterium avium complex.

Concomitant use w/ drugs known to interact w/ conventional doxorubicin HCl. Exacerbated cyclophosphamide-induced hemorrhagic cystitis & enhanced hepatotoxicity of 6-mercaptopurine. May increase toxicity of other anti-cancer drugs, especially those that may induce bone marrow suppression.

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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