WARNING: INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION
The use of DOXIL (doxorubicin HCl 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 HCl approaches 550 mg/m2. In a clinical study in patients with advanced breast cancer, 250 patients received DOXIL at a starting dose of 50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450–500 mg/m2 or between 500–550 mg/m2, the risk of cardiac toxicity for patients treated with DOXIL 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 DOXIL. 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. DOXIL 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 DOXIL for doxorubicin HCl has resulted in severe side effects. DOXIL should not be substituted for doxorubicin HCl on a mg per mg basis [see Dosage and Administration].
DOXIL (doxorubicin HCl liposome injection) is doxorubicin hydrochloride (HCl) encapsulated in STEALTH® liposomes for intravenous administration.
Doxorubicin is an anthracycline topoisomerase inhibitor isolated from Streptomyces peucetius var . caesius.
DOXIL (doxorubicin HCl liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
AIDS-Related Kaposi's Sarcoma
DOXIL is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
DOXIL in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
Published Studies Related to Doxil (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...
Clinical Trials Related to Doxil (Doxorubicin)
A Study of DOXIL/CAELYX in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer [Active, not recruiting]
Study of Pazopanib and Doxil in Patients With Advanced Relapsed Platinum-Sensitive or Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma [Terminated]
In this study, patients with relapsed or refractory ovarian cancer will receive treatment
with pazopanib and liposomal doxorubicin (Doxil) until disease progression or unacceptable
toxicity occurs. The Phase I portion will define the dose limiting toxicity (DLT) of
pazopanib and liposomal doxorubicin when administered in combination. Once the maximum
tolerated dose has been identified in the Phase I portion, the Phase II portion will
evaluate efficacy and safety of this combination in the same patient population.
A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer [Completed]
A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer [Active, not recruiting]
The purpose of this study is to find the answers to the following research question(s):
1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same
way in the body as the approved drug?
ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to
prove. All people who participate in this study will receive the research study medication
(ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).
The study drug being tested in this study works the same as the FDA (government) approved
drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being
delivered (given to the patient).
Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer [Terminated]
This study will test the feasibility of combining 3 drugs, Revlimid with Doxil and
Bevacizumab,and gather preliminary data on the potential activity of the combination in
patients with platinum resistant/refractory ovarian cancer.
Reports of Suspected Doxil (Doxorubicin) Side Effects
Failure TO Thrive (10),
Interstitial Lung Disease (10),
Ovarian Cancer Recurrent (9),
OFF Label USE (9),
Pancytopenia (9), more >>
Page last updated: 2013-02-10