Daunoxome

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.

Action

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.

Availability

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

Contraindications

• Hypersensitivity to drug

Precautions

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

Administration

• 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

Interactions

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.

Daunoxome

A brand name for DAUNORUBICIN.
References in periodicals archive ?
DaunoXome is a liposomal preparation of daunorubicin formulated to maximise the selectivity of daunorubicin for solid tumours in situ.
Myocet, Caelyx/Doxil, Liposomal Doxorubicin SUN, and Lipo-Dox are liposomal formulations of doxorubicin whereas DaunoXome is the liposomal formulation of Daunorubicin.
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.
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.
As a result of the merger, Gilead now has a proven international development and commercialization team located in Europe and Australia, focused on the distribution, marketing and sales of AmBisome and DaunoXome.
The company currently markets two drugs in the United States and around the world, AmBisome and DaunoXome.
These products include, AmBisome (liposomal amphotericin B) an antifungal product approved in 38 countries for treatment of systemic fungal infections, and DaunoXome (liposomal daunorubicin) an anticancer product, approved in 23 countries for the treatment of advanced HIV-related Kaposi's sarcoma (a type of cancer that appears as lesions on the skin).
NeXstar has built an international development and commercialization team of 135 people in Europe and Australia, focusing on the distribution, marketing and sales of AmBisome and DaunoXome.