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. |
| Molecular Weight | 1222.5 Da |
| 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 | No adequate studies in humans; animal studies show fetal harm. Use only if benefit outweighs risk. |
| 2nd trimester | No adequate studies in humans; based on mechanism, potential for fetal harm. Use cautiously. |
| 3rd trimester | No adequate studies in humans; avoid use near term due to possible neonatal effects. |
Clinical note
Comprehensive clinical and safety monograph for ERAXIS (ERAXIS).
| Placental transfer | Limited data; likely crosses placenta due to molecular size. Not studied in humans. |
| Breastfeeding | Excreted in animal milk; unknown in humans. Caution advised due to potential for systemic absorption in infant. |
| Lactation Rating |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to anidulafungin or any excipient
| 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 |
| Food/Dietary | No known food interactions. ERAXIS is administered intravenously, so oral intake does not affect absorption. However, patients should maintain a balanced diet during treatment. |
| Clinical Pearls |
Loading safety data…
| L3 (Moderately Safe) |
| 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. |
| 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. |
| ERAIS (anidulafungin) is an echinocandin antifungal used primarily for invasive candidiasis and candidemia. It has a long half-life (~24 hours) allowing once-daily dosing. No dose adjustment is needed for renal or hepatic impairment. It is a poor substrate for CYP450 enzymes, minimizing drug interactions. Monitor liver function tests periodically. Administer loading dose (200 mg) on day 1, then 100 mg daily. |
| Patient Advice | Take this medication exactly as prescribed by your healthcare provider. · Do not stop taking it without consulting your doctor, even if you feel better. · Report any signs of allergic reactions (rash, itching, swelling, difficulty breathing) immediately. · Notify your doctor if you experience symptoms of liver problems (nausea, vomiting, abdominal pain, jaundice). · This medication is given intravenously; you will receive it in a healthcare setting. · Inform your doctor about all other medications you are taking, including over-the-counter drugs and supplements. |