- Cardiac function should be monitored regularly in patients receiving DaunoXome (daunorubicin citrate liposome injection) because of the potential risk for cardiac toxicity and congestive heart failure. Cardiac monitoring is advised especially in those patients who have received prior anthracyclines or who have pre-existing cardiac disease or who have had prior radiotherapy encompassing the heart.
- Severe myelosuppression may occur.
- DaunoXome should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
- Dosage should be reduced in patients with impaired hepatic function. (See DOSAGE AND ADMINISTRATION)
- A triad of back pain, flushing, and chest tightness has been reported in 13.8% of the patients (16/116) treated with DaunoXome in the Phase III clinical trial, and in 2.7% of treatment cycles (27/994). This triad generally occurs during the first five minutes of the infusion, subsides with interruption of the infusion, and generally does not recur if the infusion is then resumed at a slower rate.
DaunoXome (daunorubicin citrate liposome injection) is a sterile, pyrogen-free, preservative-free product in a single use vial for intravenous infusion.
DaunoXome contains an aqueous solution of the citrate salt of daunorubicin encapsulated within lipid vesicles (liposomes) composed of a lipid bilayer of distearoylphosphatidylcholine and cholesterol (2:1 molar ratio), with a mean diameter of about 45 nm. The lipid to drug weight ratio is 18.7:1 (total lipid:daunorubicin base), equivalent to a 10:5:1 molar ratio of distearoylphosphatidylcholine:cholesterol:daunorubicin. Daunorubicin is an anthracycline antibiotic with antineoplastic activity, originally obtained from Streptomyces peucetius. Daunorubicin has a 4-ring anthracycline moiety linked by a glycosidic bond to daunosamine, an amino sugar. Daunorubicin may also be isolated from Streptomyces coeruleorubidus and has the following chemical name: (8 S-cis)-8-acetyl-10-[(3-amino-2,3,6-trideoxy-α-L- lyxo -hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride.
DaunoXome is indicated as a first line cytotoxic therapy for advanced HIV-associated Kaposi's sarcoma. DaunoXome is not recommended in patients with less than advanced HIV-related Kaposi's sarcoma.
Published Studies Related to Daunoxome (Daunorubicin)
Randomized study of induction therapy comparing standard-dose idarubicin with high-dose daunorubicin in adult patients with previously untreated acute myeloid leukemia: the JALSG AML201 Study. [2011.02.24]
We conducted a multi-institutional randomized study to determine whether high-dose daunorubicin would be as effective as standard-dose idarubicin in remission-induction therapy for newly diagnosed adult patients younger than 65 years of age with acute myeloid leukemia... Thus, high-dose daunorubicin and standard-dose idarubicin were equally effective for the treatment of adult acute myeloid leukemia, achieving a high rate of complete remission and good long-term efficacy.
Infectious complications in patients with acute myeloid leukemia treated according to the protocol with daunorubicin and cytarabine with or without addition of cladribine. A multicenter study by the Polish Adult Leukemia Group (PALG). [2010.02]
OBJECTIVES: The addition of cladribine to the standard regimen consisting of daunorubicin and cytarabine has been reported to increase the efficacy of induction therapy in acute myeloid leukemia (AML). The goal of this study was to determine the effect of this modification on the incidence and spectrum of infectious complications... CONCLUSIONS: The addition of cladribine to standard induction chemotherapy has no impact on the incidence and spectrum of infectious complications in newly diagnosed AML patients. Copyright 2009 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10. [2009.11.10]
PURPOSE: To compare the antitumor efficacy of three different anthracyclines in combination with cytarabine and etoposide in adult patients with newly diagnosed acute myeloid leukemia (AML)... CONCLUSION: In adult patients with AML who do not receive an allogeneic SCT, the use of mitoxantrone or idarubicin instead of daunorubicin enhances the long-term efficacy of chemotherapy.
High-dose daunorubicin in older patients with acute myeloid leukemia. [2009.09.24]
BACKGROUND: A complete remission is essential for prolonging survival in patients with acute myeloid leukemia (AML). Daunorubicin is a cornerstone of the induction regimen, but the optimal dose is unknown. In older patients, it is usual to give daunorubicin at a dose of 45 to 50 mg per square meter of body-surface area... CONCLUSIONS: In patients with AML who are older than 60 years of age, escalation of the dose of daunorubicin to twice the conventional dose, with the entire dose administered in the first induction cycle, effects a more rapid response and a higher response rate than does the conventional dose, without additional toxic effects. (Current Controlled Trials number, ISRCTN77039377; and Netherlands National Trial Register number, NTR212.) 2009 Massachusetts Medical Society
The value of the MDR1 reversal agent PSC-833 in addition to daunorubicin and cytarabine in the treatment of elderly patients with previously untreated acute myeloid leukemia (AML), in relation to MDR1 status at diagnosis. [2005.10.15]
To determine whether MDR1 reversal by the addition of the P-glycoprotein (P-gp) inhibitor PSC-833 to standard induction chemotherapy would improve event-free survival (EFS), 419 untreated patients with acute myeloid leukemia (AML) aged 60 years and older were randomized to receive 2 induction cycles of daunorubicin and cytarabine with or without PSC-833...
Clinical Trials Related to Daunoxome (Daunorubicin)
DaunoXome + Ara-C vs Daunorubicin + Ara-C in Elderly AML [Completed]
Overall results in the treatment of middle aged adults acute myelogenous leukemia (AML) are
substantially improved in the last decade, with complete remission (CR) rates established to
values of 70 to 80per cent and also encouraging long-term outcome, especially in patients
who can tolerate intensified post remissional treatment strategies. On the contrary, there
has been little progress in the treatment of older patients. In these patients the response
rate generally range between 40 and 60per cent, and overall survival at 2 years is often
less than 10 per cent.
Usually, a combination of anthracyclines daunomycin DNR or doxorubicin and cytarabyne Ara-C
has been utilized for the remission-induction treatment, with schedules similar to those
utilized in younger cases, for patients eligible to intensive treatments. Variation of the
dose of DNR has not brought any significant benefit. The EORTC HOVON randomized trial AML9
compared two drugs in induction for previously untreated patients. DNR versus Mithoxantrone
(MTZ). MTZ induction therapy produces a slightly better CR rate than DNR-containing regimen
(47per cent vs 38per cent, P equals 0. 069), without any significant effect on remission
duration and survival. The DFS probability between the two treatment arms was not different.
The median DFS estimates were 39 weeks in both groups. The DFS rate at 5 years was 8per
cent. Also the duration of survival was similar (p equals 0. 23) in the two treatment groups.
Median survival estimates were 36 weeks (DNR) and 39 weeks (MTZ). The percentage of patients
still alive at 5 years were 6per cent and 9per cent respectively.
Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia [Completed]
Phase I trial to study the effectiveness of combining oblimersen with cytarabine and
daunorubicin in treating older patients who have previously untreated acute myeloid
leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Oblimersen may help cytarabine and daunorubicin kill more
cancer cells by making them more sensitive to chemotherapy.
Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia [Recruiting]
This phase II trial studies how well daunorubicin hydrochloride, cytarabine, and nilotinib
work in treating patients newly diagnosed with acute myeloid leukemia. Drugs used in
chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to
stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Nilotinib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Giving daunorubicin hydrochloride with cytarabine and nilotinib may
kill more cancer cells.
A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML [Recruiting]
The main purpose of this study is to determine the safety of combining selinexor with
daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin
and cytarabine will also be established.
Pharmacokinetics of Daunorubicin in Treating Young Patients With Cancer [Active, not recruiting]
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the
laboratory may help doctors learn more about how patients respond to treatment with certain
PURPOSE: This laboratory study is looking at the pharmacokinetics of daunorubicin in
treating young patients with cancer.
Page last updated: 2011-12-09