Dosing and uses of DaunoXome (daunorubicin liposomal)
Adult dosage forms and strengths
injectable solution
- 2mg/mL
Advanced HIV-Associated Kaposi Sarcoma
July 20, 2016: FDA notice of discontinuation; no other daunorubicin liposome product available
40 mg/m² IV (infuse over 1 hr) q2Weeks
Withold treatment if ANC <750/cu.mm
Continue treatment until evidence of progressive disease
Acute Myeloid Leukemia (Orphan)
Orphan indication sponsor
- Diatos USA, LLC; 15310 Amberly Drive; Tampa, FL 33647
Hepatic Impairment
Serum bilirubin 1.2-3 mg/dL [20.5-51.3 micromoles/L]: Give 75% normal dose
Serum bilirubin or creatinine >3 mg/dL [bili >51.3 micromoles/L; Cr >265 micromoles/L]: Give 50% normal dose
Monitor
CBC prior to each administration
LVEF prior to & at every cumulative 160 mg/sq.meter
Renal & hepatic function
Pediatric dosage forms and strengths
Safety & efficacy not established
DaunoXome (daunorubicin liposomal) adverse (side) effects
>10%
Nausea (54%)
Fatigue (49%)
Fever (47%)
Diarrhea (38%)
Cough (28%)
Dyspnea (26%)
Headache (25%)
Neuropathy
Increased sweating
Depression
Back pain
Malaise
Rigors
Triad of back pain, flushing and chest tightness
Chest pain
Edema
Rhinitis
Abdominal pain
Anorexia
Stomatitis
Vomiting
Allergic reactions
1-10%
Abnormal vision
Dizziness
Insomnia
Sinusitis
Constipation
Flu-like Symptoms
Myalgia
Arthralgia
Alopecia
Pruritus
Tenesmus
Frequency not defined
Cardiotoxicity
Myelosuppression
Warnings
Black box warnings
Monitor cardiac function, especially in patients who have received prior anthracyclines, have had preexisting cardiac disease, or who have had prior radiotherapy encompassing the heart. Severe myelosuppression may occur.
The drug should be administered under the supervision of an experienced chemotherapy physician
Reduce dose in patients with impaired hepatic function
A triad of back pain, flushing, and chest tightness may occur during the first 5 minutes of the infusion. It subsides with interruption of the infusion and generally does not recur when resumed at a slower rate.
Contraindications
Hypersensitivity
Prior tx max dose of doxorubicin, daunorubicin, idarubicin, or other anthracyclines
Not recommended for less than advanced Kaposi's sarcoma
Cautions
Risk of myelosuppression & cardiotoxicity with CHF
Irritant
Safety not established for pts with renal/hepatic impairment
Avoid pregnancy
Pregnancy and lactation
Pregnancy category: d
Lactation: excretion in milk unknown/not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of DaunoXome (daunorubicin liposomal)
Half-Life: 4.4±2.3 hr
Vd: 6.4 L
Clearance: 17 mL/min
Metabolism: to daunorubicinoL
Excretion: N/A
Mechanism of action
Anthracycline; intercalates between DNA base pairs, impairs topo II function & DNA replication
Administration
IV Incompatibilities
Do not mix with other drugs
IV Preparation
Use strict aseptic technique-contains no preservatives or antibacterials
Solution in vial is a red translucent dispersion
Dilute ONLY in D5W; do not mix with any other fluid or bacteriostatic agent
Withdraw required amount from vial (containing 50 mg at 2 mg/mL) & add to an infusion bag containing an equal amount of D5W for a 1:1 dilution (final conc 1 mg/mL)
Administer immediately although diluted soln may be refrigerated at 2-8°C for 6 hr
IV Administration
Infuse over 1 hr
Extravasation Management
Stop infusion immediately, aspirate back as much as possible, & restart in another vein
Apply ice for 30 min over extravasation site
May produce redness/edema, low ulceration potentiaL
If ulceration begins or pain/redness/edema persists, treat like daunorubicin extravasation
See also Totect
Storage
Refrigerate vials at 2-8°C; do not freeze
Protect from light
