Trade Names:DaunoXome- Solution for injection 2 mg/mL (equivalent to 50 mg daunorubicin base)
Anthracycline antibiotic formulated to increase selectivity for solid tumors in situ.
Vd is approximately 6.4 L. Distribution t ½ approximately 4.41 h.
Metabolized to daunorubicinol (active).
The t ½ is 4.4 h. Plasma Cl approximately 17.3 mL/min.
Advanced HIV-associated Kaposi sarcoma.
IV 40 mg/m 2 /dose (of daunorubicin base) administered over 1 h every 2 wk. The dose of daunorubicin citrate liposomal is different from the dose of daunorubicin hydrochloride.Dosage Adjustment for Renal or Hepatic Function Impairment
If serum bilirubin is 1.2 to 3 mg/dL, then give 75% of adjusted dose from prior course. If serum bilirubin is more than 3 mg/dL or serum creatinine is more than 3 mg/dL, then give 50% of adjusted dose from prior course.
Store vials in refrigerator (36° to 46°F). If not used immediately, store diluted solution in refrigerator for up to 6 h. Do not freeze. Protect from light.
Antimicrobial effects may be reduced.
None well documented.
Hot flashes, hypertension, palpitation, syncope, tachycardia (at least 5%).
Fatigue (43%); headache (22%); neuropathy (13%); malaise (9%); dizziness (8%); depression (7%); insomnia (6%); amnesia, anxiety, ataxia, confusion, convulsions, emotional lability, abnormal gait, hallucination, hyperkinesias, hypertonia, meningitis, somnolence, abnormal thinking, tremor (at least 5%).
Alopecia (8%); pruritus (7%); folliculitis, seborrhea, dry skin (at least 5%).
Rhinitis (12%); abnormal vision (3%); conjunctivitis, deafness, earache, eye pain, taste perversion, tinnitus (at least 5%).
Nausea (51%); diarrhea (34%); anorexia (21%); vomiting, abdominal pain (20%); stomatitis (9%); constipation (7%); tenesmus (4%); increased appetite, dysphagia, GI hemorrhage, gastritis, gingival bleeding, hemorrhoids, hepatomegaly, melena, dry mouth, tooth caries (at least 5%).
Dysuria, nocturia, polyuria (at least 5%).
Neutropenia (less than 1,000 cells/mm 3 [36%]); neutropenia (less than 500 cells/mm 3 [15%]); lymphadenopathy, splenomegaly (at least 5%).
Injection site inflammation (at least 5%).
Dehydration, thirst (at least 5%).
Rigors (19%); back pain (16%); arthralgia, myalgia (7%).
Cough (26%); dyspnea (23%); sinusitis (8%); hemoptysis, hiccups, pulmonary infiltration, increased sputum (at least 5%).
Fever (42%); opportunistic infection (40%); allergic reactions (21%); triad of back pain, flushing, and chest tightness (14%); increased sweating (12%); edema, chest pain (9%); flu-like symptoms (5%).
Cumulative dose related.Decreased left ventricular ejection fraction (LVEF)
Anthracycline-induced cardiomyopathy is associated with decreased LVEF.Hepatic impairment
Assess hepatic function before initiating therapy; adjust dose as necessary. Reduce dosage for hepatic function impairment.Infusion reaction
Back pain, flushing, and chest tightness can occur. Usually occurs within first 5 min of infusion and subsides with infusion interruption. Does not usually recur if infusion is restarted at a slower rate. Appears to be related to lipid component.Myelosuppression
The primary toxicity of daunorubicin is myelosuppression, especially of the granulocytic series, which may be severe, with much less marked effects on the platelets and erythroid series.
Ensure CBC with differential is evaluated prior to starting therapy and before each dose. Withhold therapy if absolute neutrophil count is less than 750 cells/mm 3 . Monitor patient for signs or symptoms of infection.
Category D .
HIV-infected mothers should not breast-feed infants.
Safety and efficacy not established.
Assess renal function before initiating therapy; adjust dose as necessary. Reduce dosage for renal function impairment.
Ensure cardiac function is evaluated and documented by a history and physical examination before starting therapy and before each course of therapy. Ensure that LVEF is determined at a total cumulative dose of 320 mg/m 2 and every 160 mg/m 2 thereafter in patient with no prior therapy with anthracyclines, no evidence of cardiac disease, and no prior radiotherapy encompassing the heart. Ensure that LVEF is determined before starting therapy and at every total cumulative dose of 160 mg/m 2 in patient with prior therapy with anthracyclines (doxorubicin dose greater than 300 mg/m 2 or equivalent), preexisting cardiac disease, or prior radiotherapy encompassing the heart.
The dose of daunorubicin citrate liposomal is different from the dose of daunorubicin hydrochloride.
Local irritation or phlebitis may occur. Refer to your institution-specific protocol.
Symptoms of acute overdosage are increased severities of the observed dose-limiting toxicities of therapeutic doses, myelosuppression (especially granulocytopenia), fatigue, nausea, and vomiting.
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