Johnson & Johnson


Concise Prescribing Info
Pegylated liposomal doxorubicin HCl
As monotherapy for patients w/ metastatic breast cancer, where there is an increased cardiac risk. Treatment of metastatic breast cancer in women for whom an anthracycline would be considered or who have failed a taxane-containing regimen. Treatment of advanced ovarian cancer in women who have failed a 1st-line platinum-based chemotherapy regimen. In combination w/ bortezomib for the treatment of 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 & extensive mucocutaneous or visceral disease. 1st-line systemic chemotherapy or as 2nd-line chemotherapy in AIDS-related KS patients w/ disease that has progressed w/, or who are intolerant to, prior combination systemic chemotherapy comprising of at least 2 of these agents: Vinca alkaloid, bleomycin & standard doxorubicin (or other anthracyclines). Multiple myeloma.
Dosage/Direction for Use
Breast/ovarian cancer 50 mg/m2 IV once every 4 wk for as long as no disease progression & patient continues to tolerate treatment. Initial dose is given at a rate ≤1 mg/min. If no infusion reaction observed, subsequent doses may be infused over 60-min period. Multiple myeloma 30 mg/m2 as 1-hr infusion on day 4 of bortezomib 3-wk regimen. AIDS-KS 20 mg/m2 IV every 2-3 wk. Duration of treatment: 2-3 mth.
Hypersensitivity. Not for treatment of AIDS-related KS that may be effectively treated w/ local therapy or systemic α-interferon. Pregnancy & lactation.
Special Precautions
Do not administer IM, SC or as bolus inj. Cardiac disease or impaired cardiac function (frequent ECG monitoring or echocardiography/multigated angiography repeated periodically). Patients who have received other anthracyclines. Myelosuppression (perform periodic blood counts). Diabetic patients due to sucrose content. Discontinue temporarily if infusion reactions occur. Hepatic impairment. AIDS-KS patients w/ splenectomy. May impair ability to drive or operate machinery. Childn <18 yr.
Adverse Reactions
Breast cancer patients: Palmar-plantar erythrodysesthesia (PPE) & nausea. Ovarian cancer patients: PPE & stomatitis. Multiple myeloma patients: Thrombocytopenia, neutropenia, anemia; nausea, vomiting, constipation, diarrhea & stomatitis.
Drug Interactions
May potentiate toxicity of other anti-cancer therapies eg, cyclophosphamide, taxanes or vinorelbine. Exacerbation of cyclophosphamide-induced hemorrhagic cystitis & enhancement of 6-mercaptopurine hepatotoxicity in patients w/ AIDS-KS.
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Caelyx infusion 2 mg/mL
10 mL x 1's (P44,474/box);25 mL x 1's (P99,000/box)
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