ERAXIS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ERAXIS (ERAXIS).
Echinocandin antifungal that inhibits the synthesis of 1,3-beta-D-glucan, an essential component of fungal cell walls, by noncompetitive inhibition of the enzyme 1,3-beta-D-glucan synthase.
| Metabolism | Hepatic metabolism via CYP3A4 and non-CYP pathways (degradation). |
| Excretion | Primarily excreted unchanged in feces (~70%) and urine (~10% as unchanged drug and metabolites). Biliary excretion is the major route for unchanged drug. |
| Half-life | Terminal elimination half-life is approximately 50 hours (range 40-70 hours), supporting once-weekly intravenous dosing. |
| Protein binding | Highly protein-bound (>99%), primarily to albumin. |
| Volume of Distribution | Volume of distribution is approximately 30 L (0.4-0.5 L/kg), indicating extensive distribution into tissues, including the brain and CSF. |
| Bioavailability | Only available intravenously; oral bioavailability is negligible due to poor absorption. |
| Onset of Action | Intravenous: Clinical effect (antifungal activity) begins within hours of first dose; steady-state reached by day 2-4 with weekly dosing. |
| Duration of Action | Duration of action is approximately 7 days due to long half-life, allowing once-weekly dosing. Sustained antifungal effect persists for the dosing interval. |
| Action Class | Fungal cell wall synthesis inhibitor (Echiocandins) |
| Brand Substitutes | Dulafix 100mg Injection, Dulaedge 100mg Injection, Anidulan Injection, Canidula Injection, Dulazar 100mg Injection |
50 mg intravenously once daily for invasive candidiasis; 100 mg intravenously once daily for esophageal candidiasis.
| Dosage form | POWDER |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl 30-89 mL/min). For severe renal impairment (CrCl <30 mL/min), data insufficient; use with caution. |
| Liver impairment | No dose adjustment required for Child-Pugh A or B. For Child-Pugh C, data insufficient; use with caution. |
| Pediatric use | Children 2-16 years: 1 mg/kg (max 50 mg) intravenously once daily for invasive candidiasis; 1.5 mg/kg (max 100 mg) once daily for esophageal candidiasis. Children <2 years: safety not established. |
| Geriatric use | No specific dose adjustment, but caution due to age-related renal impairment; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ERAXIS (ERAXIS).
| Breastfeeding | It is not known whether anidulafungin is excreted in human milk. However, in lactating rats, anidulafungin was detected in milk. The M/P ratio is not established in humans. The manufacturer recommends caution due to potential for adverse effects in the nursing infant. Consider the benefits of breastfeeding and the mother's need for the drug. |
| Teratogenic Risk | Eraxis (anidulafungin) is classified as FDA Pregnancy Category B. In animal studies, no evidence of fetal harm was observed at doses up to 3 times the human exposure. However, there are no adequate and well-controlled studies in pregnant women. Based on animal data, the risk is considered low, but caution is advised during the first trimester. Use only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to anidulafungin or any component of the formulation.
| Precautions | ["Hepatic effects: abnormal liver function tests; monitor LFTs","Hypersensitivity reactions: anaphylaxis and anaphylactoid reactions","Coadministration with cyclosporine increases risk of elevated LFTs; monitor LFTs"] |
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| Fetal Monitoring | No specific fetal monitoring is required, but standard pregnancy monitoring is recommended. The mother should be observed for infusion-related reactions and liver function test abnormalities during treatment. |
| Fertility Effects | Animal studies have shown no impairment of fertility in male or female rats at doses up to 3 times the human exposure. There are no human data on fertility effects. Likely minimal impact, but data are limited. |