WARNING: INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION
The use of doxorubicin hydrochloride liposome injection may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin hydrochloride approaches 550 mg/m2. In a clinical study in patients with advanced breast cancer, 250 patients received doxorubicin hydrochloride liposome injection at a starting dose of 50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450 to 500 mg/m2 or between 500 to 550 mg/m2, the risk of cardiac toxicity for patients treated with doxorubicin hydrochloride liposome injection was 11%. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy [see Warnings and Precautions ].
- Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with doxorubicin hydrochloride liposome injection. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoid- like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. Doxorubicin hydrochloride liposome injection should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions [see Warnings and Precautions].
- Severe myelosuppression may occur [see Warnings and Precautions ].
- Dosage should be reduced in patients with impaired hepatic function [see Dosage and Administration and Use in Specific Populations].
- Accidental substitution of doxorubicin hydrochloride liposome injection for doxorubicin hydrochloride has resulted in severe side effects. Doxorubicin hydrochloride liposome injection should not be substituted for doxorubicin hydrochloride on a mg per mg basis [see Dosage and Administration].
Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride encapsulated in pegylated liposomes for intravenous administration.
Doxorubicin is an anthracycline topoisomerase inhibitor isolated from Streptomyces peucetius var . caesius.
Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
AIDS-Related Kaposis Sarcoma
Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposis sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
Published Studies Related to Doxorubicin
First-line treatment of metastatic or locally advanced unresectable soft tissue
sarcomas with conatumumab in combination with doxorubicin or doxorubicin alone: a
phase I/II open-label and double-blind study. 
sarcoma... INTERPRETATION: Addition of conatumumab to doxorubicin appeared to be safe but
A randomized controlled study into the efficacy and toxicity of pegylated liposome encapsulated doxorubicin as an adjuvant therapy in dogs with splenic haemangiosarcoma. [2011.12]
Safety and efficacy of pegylated liposome encapsulated doxorubicin (PL-DOX) was compared with free doxorubicin as an adjuvant monotherapy in dogs with splenic haemangiosarcoma after splenectomy in a randomized prospective clinical trial. A total of 17 dogs in each group were treated... Cardiotoxicity was not seen in either treatment groups.
Hepatic arterial infusion of doxorubicin-loaded microsphere for treatment of hepatocellular cancer: a multi-institutional registry. [2011.10]
BACKGROUND: Hepatic intra-arterial therapy for unresectable hepatocellular cancer (HCC) has been shown to improve overall survival, but can have significant toxicity. A recent prospective randomized controlled trial demonstrated superior response rates and significantly less morbidity and doxorubicin-related adverse events with drug-eluting beads with doxorubicin (DEBDOX) compared with conventional chemoembolization. The aim of this study was to confirm the efficacy of DEBDOX for the treatment of unresectable HCC... CONCLUSIONS: Hepatic intra-arterial injection of DEBDOX is safe and effective in the treatment of HCC, as demonstrated by a minimal complication rate and robust and durable tumor response. Copyright (c) 2011 American College of Surgeons. Published by Elsevier Inc. All rights reserved.
Rapid early monoclonal protein reduction after therapy with bortezomib or bortezomib and pegylated liposomal doxorubicin in relapsed/refractory myeloma is associated with a longer time to progression. [2011.08.15]
BACKGROUND: A rapid and early monoclonal (M) protein response during initial therapy in patients with multiple myeloma had been identified as a predictor of superior long-term outcome in some--but not all--studies... CONCLUSIONS: These analyses supported the possibility that a robust early M protein response is a good prognostic factor for long-term outcome of myeloma patients with relapsed and/or refractory disease receiving bortezomib or PLD + bortezomib. Copyright (c) 2011 American Cancer Society.
Lyso-thermosensitive liposomal doxorubicin: an adjuvant to increase the cure rate of radiofrequency ablation in liver cancer. [2011.08]
Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide...
Page last updated: 2013-02-10