WARNINGS
- 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.
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DAUNOXOME SUMMARY
DaunoXome®
(daunorubicin citrate liposome injection)
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.
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NEWS HIGHLIGHTS
Published Studies Related to Daunoxome (Daunorubicin)
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.
A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma. [Completed]
To compare the toxicity profiles (severity and time to onset from initiation of therapy)
between daunorubicin (liposomal) and combination chemotherapy with
doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with
antiretroviral therapy. To compare the duration of responses, response rates, and times to
response.
Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With De Novo Acute Myeloid Leukemia [Not yet recruiting]
The purpose of this research study is to determine if Plerixafor can release cells into the
blood and make them more sensitive to killing by Cytarabine and Daunorubicin, an anti-cancer
drug regimen referred to as "7+3" that is commonly used in treating acute myeloid leukemia
(AML). In this study, Plerixafor will be added to treatment with Cytarabine and
Daunorubicin. Subjects will be monitored to see how well they tolerate the use of these
drugs together and how well they work to treat the leukemia.
The study is divided into Part 1 and Part 2. The purpose of Part 1 of the study is to find
the highest dose of Plerixafor that can be given safely with Cytarabine and Daunorubicin.
The purpose of Part 2 of the study is to collect additional safety information for
Plerixafor when used with Cytarabine and Daunorubicin to see the effects the combination
treatment has on the subject and his/her leukemia.
Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML) [Completed]
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing
or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making
cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and
cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.
Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy [Completed]
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. SU5416 may stop the growth of hematologic cancer by stopping
blood flow to the cancer.
PURPOSE: Phase I/II trial to study the effectiveness of liposomal daunorubicin and SU5416 in
treating patients who have hematologic cancer that has not responded to initial therapy.
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Page last updated: 2009-10-20
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