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. DOXILshould 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.
Doxil® (doxorubicin HCl liposome injection) is indicated for:
The treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. Refractory disease is defined as disease that has progressed while on treatment, or within 6 months of completing treatment.
The treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy.
These indications are based on objective tumor response rates. No results are available from controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms or increased survival.
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 Comparing the Combination of Doxil and Yondelis, to Doxil Alone for Subjects With Ovarian Cancer [Active, not recruiting]
The purpose of this research study is to determine if the combination of Yondelis and Doxil
is better at improving overall survival over Doxil alone in subjects with relapsed advanced
Vincristine, DOXILŽ (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [Completed]
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients
respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection)
and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and
Randomized Phase II Trial of Doxil With or Without Dexamethasone for Metastatic Hormone Refractory Prostate Cancer [Terminated]
The primary objective of this study is to assess disease response to Doxil in patients with
hormone refractory prostate cancer with or without dexamethasone pre-treatment.
We will perform an open labeled, parallel, randomized phase II study using a two-stage design
to determine if there is sufficient anti-tumor activity in either arm to warrant further
study. Assumptions made in this study: an unacceptable overall response rate is = 10% & we
will pursue further study if the overall response rate is >/= 30%. Fifteen patients will be
randomized in the first phase (to both Arm 1 and Arm 2). No further patients will be accrued
if <2/15 responses are noted in a given arm. Ten additional patients will be enrolled if >/=
2/15 responses are observed. If there are >/= 5/25 responses then further studies will be
pursued with that regimen. We will determine the overall incidence & severity of toxicities
in both arms.
Arm 1: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 2: Doxil:
Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 1 only: Dexamethasone:
Dose: 12 mg twice a day by mouth on days 1, 2, 3, 4, 5 of each 28 day cycle.
Number of Cycles for both Arm 1 & 2: until progression or unacceptable toxicity develops.
Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394) [Active, not recruiting]
To compare disease-free survival (DFS), overall survival (s), and toxicity of high-isk
primary breast cancer patients with negative axillary lymph nodes or with one to three
positive nodes treated with adjuvant high-dose chemotherapy with doxorubicin plus
cyclophosphamide (AC), versus high-dose sequential chemotherapy with doxorubicin followed by
Thalidomide + Dexamethasone vs. DOXIL (Doxorubicin HCl Liposome Injection) + Thalidomide + Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [Active, not recruiting]
The main purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL
(doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in
treating patients newly diagnosed with multiple myeloma. The number of patients whose
multiple myeloma disappears for a period of time (also called "Complete Response") will be
studied to make the determination of which treatment is more effective.
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