daunorubicin citrate liposome

FDA Box Warning

Monitor cardiac function regularly during therapy, because of potential cardiotoxicity and congestive heart failure. Also monitor cardiac function in patients who have cardiac disease or received previous anthracyclines.

Severe myelosuppression may occur.

Give under supervision of experienced physician.

Reduce dosage in patients with hepatic impairment.

Drug may cause triad of back pain, flushing, and chest tightness. Triad usually occurs within first 5 minutes of infusion, subsides with infusion interruption, and doesn't recur when infusion resumes at slower rate.


Inhibits DNA synthesis and DNA-dependent RNA synthesis through intercalation. Formulation increases selectivity of daunorubicin for solid tumors; may increase permeability of tumor neovasculature to some particles in drug's size range.


Injection: 2 mg/ml

Indications and dosages

First-line cytotoxic therapy for advanced Kaposi's sarcoma associated with human immunodeficiency virus (HIV)

Adults: 40 mg/m2 I.V. over 1 hour. Repeat q 2 weeks until evidence of disease progression or other complications occur.

Dosage adjustment

• Renal or hepatic impairment


• Hypersensitivity to drug


Use cautiously in:
• renal or hepatic impairment, bone marrow depression, cardiac disease, gout, infections
• pregnant or breastfeeding patients.


• Follow facility policy for preparing and handling antineoplastics.
• Dilute 1:1 with 5% dextrose injection.
• Don't use in-line filter for I.V. infusion.
• If prescribed, premedicate with allopurinol to help prevent hyperuricemia.
• Take steps to prevent extravasation.
• Protect solution from light.

Adverse reactions

CNS: headache, fatigue, malaise, confusion, depression, dizziness, drowsiness, emotional lability, anxiety, hallucinations, syncope, tremors, rigors, insomnia, neuropathy, amnesia, hyperactivity, abnormal thinking, meningitis, seizures

CV: hypertension, chest pain, palpitations, myocardial infarction, cardiac arrest

EENT: abnormal vision, conjunctivitis, eye pain, hearing loss, earache, tinnitus, rhinitis, sinusitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, gastritis, enlarged spleen, fecal incontinence, hemorrhoids, tenesmus, melena, difficulty swallowing, dry mouth, mouth inflammation, GI hemorrhage

GU: dysuria, nocturia, polyuria

Hematologic: thrombocytopenia, neutropenia

Hepatic: hepatomegaly

Metabolic: hyperuricemia, dehydration

Musculoskeletal: joint pain, myalgia, muscle rigidity, back pain, abnormal gait

Respiratory: dyspnea, cough, hemoptysis, increased sputum, pulmonary infiltrations, pulmonary hypertension

Skin: pruritus, dry skin, seborrhea, folliculitis, alopecia, sweating

Other: bleeding gums, dental caries, altered taste, lymphadenopathy, opportunistic infections, fever, hot flashes, hiccups, thirst, infusion site inflammation, edema, allergic reactions


Drug-diagnostic tests.Granulocytes: decreased count

Uric acid: increased level

Patient monitoring

• Assess cardiac, renal, and hepatic function before each course of treatment.
• Determine left ventricular ejection fraction before and during therapy.
• Evaluate CBC with white cell differential before each dose. Withhold dose if granulocyte count is below 750 cells/mm3.
• Monitor serum uric acid level.

Patient teaching

Instruct patient to immediately report swelling, pain, burning, or redness at infusion site, as well as persistent nausea, vomiting, diarrhea, chest pain, arm or leg swelling, difficulty breathing, palpitations, rapid heartbeat, yellowing of skin or eyes, abdominal pain, or bloody stools.
• Tell patient drug makes him more susceptible to infection. Advise him to avoid crowds and exposure to illness.
• Advise patient to minimize GI upset by eating small, frequent servings of healthy food, drinking plenty of fluids, and chewing gum.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.


A brand name for DAUNORUBICIN.
References in periodicals archive ?
Nanoparticles such as Abraxane (paclitaxel), Megace ES (megestrol acetate), DepoCyt (liposomal cytarabine), Myocet (doxorubicin), DaunoXome (daunorubicin citrate), and Doxil (doxorubicin) have already received approval as NDDS in cancer therapy.
DaunoXome by Galen Ltd is also a liposomal formulation used for the treatment of HIV relates Kaposi sarcoma and clinical trials for utilization of this medicine for leukemia is also under investigation.
Over the past two decades, many nanoparticles such as Doxil (doxorubicin), Megace ES (megestrol acetate), Abraxane (paclitaxel), Myocet (doxorubicin), DepoCyt (liposomal cytarabine), and DaunoXome (daunorubicin citrate) have been approved as drug delivery systems for cancer therapy.
DaunoXome is marketed in Kaposi's sarcoma and under review for the treatment of acute leukaemia in Europe.
Abraxane - Abraxis BioScience/AstraZeneca - DaunoXome - Gilead Sciences/Diatos - CellSearch Circulating Tumor Cell Kit - Immunicon - Bio-barcode and Verigen platform - Nanosphere - Caelyx/Doxil - Ortho Biotech - Myocet - Zeneus Pharma Novel research by academic institutions evaluated.
These non-cash charges were primarily driven by the decision to terminate liposomal research and development activities and discontinue the DaunoXome product line.
If you have a medical information inquiry or wish to report a side effect relating to DaunoXome [sup.
AmBisome, DaunoXome and Vistide are registered trademarks, and Viread is a trademark of Gilead Sciences, Inc.
Note to Editors: AmBisome, VISTIDE and DaunoXome are registered trademarks of Gilead Sciences, Inc.
The company currently markets two drugs in the United States and around the world, AmBisome and DaunoXome.
Encouraging results were observed with DaunoXome as a single agent or in combination therapies for lymphoma and leukemia.