Dosing and uses of Abelcet (amphotericin B phospholipid complex)
Adult dosage forms and strengths
injectable, lipid complex
- 5mg/mL
Systemic Fungal Infection
Indicated for invasive fungal infection refractory to conventional amphotericin B desoxycholate therapy or when renal impairment or unacceptable toxicity precludes use conventional amphotericin B
5 mg/kg IV qDay; infuse IV at rate of 2.5 mg/hr
Renal Impairment
CrCl <10 mL/min: 5 mg/kg IV q24-36hr
Other Indications & Uses
Activity shown in vitro for Aspergillus and Candida species
Activity shown in animal models for Cryptococcus sp, Coccidioidomyces sp, Histoplasma sp, and Blastomyces sp
Pediatric dosage forms and strengths
injectable, lipid complex
- 5mg/mL
Systemic Fungal Infection
Indicated for invasive fungal infection refractory to conventional amphotericin B desoxycholate therapy or when renal impairment or unacceptable toxicity precludes use conventional amphotericin B
As adults; 5 mg/kg IV qDay; infuse IV at rate of 2.5 mg/hr
Renal Impairment
CrCl <10 mL/min: 5 mg/kg IV q24-36hr
Other Indications & Uses
Activity shown in vitro for Aspergillus and Candida species
Activity shown in animal models for Cryptococcus sp, Coccidioidomyces sp, Histoplasma sp, and Blastomyces sp
Abelcet (amphotericin B phospholipid complex) adverse (side) effects
>10%
Chills (18%)
Fever (14%)
Multiple organ failure (11%)
Serum creatinine increased (11%)
1-10%
Nausea (9%)
Hypotension (8%)
Respiratory Failure (8%)
Vomiting (8%)
Dyspnea (7%)
Sepsis (7%)
Diarrhea (6%)
Headache (6%)
Heart Arrest (6%)
Hypertension (5%)
Hypokalemia (5%)
Infection (5%)
Kidney Failure (5%)
Pain (5%)
Thrombocytopenia (5%)
Abdominal Pain (4%)
Anemia (4%)
Bilirubinemia (4%)
Gastrointestinal Hemorrhage (4%)
Leukopenia (4%)
Rash (4%)
Respiratory Disorder (4%)
Chest Pain (3%)
Nausea (3%)
Warnings
Contraindications
Hypersensitivity
Cautions
Indicated for patients with progressive and potentially fatal fungal infections
Do not use for noninvasive fungal infections (eg, oral thrush, vaginal candidiasis, esophageal candidiasis) in patients with normal neurophil counts
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown whether distributed in breast milk, caution advised
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 Abelcet (amphotericin B phospholipid complex)
Half-Life: 173.4 hr
Vd: 131 L/kg
AUC: 14 mcg•h/mL
Peak Plasma Concentration: 1.7 mcg/mL
Trough Plasma Concentration: 0.6 mcg/mL
Clearance: 436 mL/hr•kg
Mechanism of action
Acts by binding to sterols in fungal cell membrane
Administration
IV Incompatibilities
Solution: NaCl solutions or electrolyte solutions
IV Compatibilities
Solution: Dextrose solutions
Y-site: anidulafungin
IV Preparation
Shake vial gently until no yellow sediment visible at bottom
Withdraw dose from vial(s) into 1 or more 20 mL syringes using 18-gauge needle
Remove needle from syringe and attach 5-micron filter needle provided; 1 filter may be used for up to 4 vials
Insert filter needle into D5W IV bag of appropriate volume for dose and empty contents
Final concentration should not exceed 1 mg/mL; concentration of 2 mg/mL may be appropriate for children or fluid restricted patients
Do not use NaCl or electrolyte-containing fluids
Do not admix with other drugs or electrolytes
Do not use if precipitate or foreign matter present
IV Administration
Administer using separate infusion line; if an existing IV line is used, flush with D5W before infusion
Do not use inline filter during administration
Infusion rate: 2.5 mg/kg/hr
Prior to infusion initiation, gently shake IV container of diluted drug until contents are thoroughly mixed; infusion container should then be shaken every 2 hr if infusion time >2 hr
Do not mix with 0.9% NaCl or infuse in same IV line as other drugs
Storage
Prior to admixture, store refrigerated at 36-46°F (2- 8°C) and protected from light
Admixed with D5W, stable up to 48 hr when refrigerated at 36-46°F (2- 8°C) or up to 6 hr at room temp
Do not freeze
