Eraxis (anidulafungin)

Eraxis (anidulafungin) is an antifungal antibiotic that treats candida (yeast) infections in the blood, or in the stomach or esophagus.

Common side effects of Eraxis include:

• flushing or hot flashes,
• dizziness,
• diarrhea,
• constipation,
• headache,
• nausea,
• vomiting, or
• injection site reactions (pain, swelling, or irritation).

Tell your doctor if you have serious side effects of Eraxis including

• shortness of breath,
• dark urine,
• severe stomach or abdominal pain,
• yellowing eyes or skin,
• persistent nausea or vomiting,
• muscle weakness or spasm,
• vision changes,
• pain/redness/swelling of arms or legs,
• new signs of infection (e.g., fever, persistent sore throat),
• easy bruising or bleeding,
• fast/slow/irregular heartbeat,
• seizures,
• increased urination or thirst, or
• mental/mood changes.

Recommended Dosage In Adults

Candidemia And Other Candida Infections (Intra-Abdominal Abscess And Peritonitis)

The recommended dose is a single 200 mg loading dose of Eraxis on Day 1, followed by a 100 mg once daily maintenance dose thereafter. Duration of treatment should be based on the patient’s clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.

Esophageal Candidiasis

The recommended dose is a single 100 mg loading dose of Eraxis on Day 1, followed by a 50 mg once daily maintenance dose thereafter. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms. Duration of treatment should be based on the patient’s clinical response. Because of the risk of relapse of esophageal candidiasis in patients with HIV infection, suppressive antifungal therapy may be considered after a course of treatment.

Recommended Dosage In Pediatric Patients (1 Month Of Age And Older)

Candidemia And Other Candida Infections (Intra-Abdominal Abscess And Peritonitis)

The recommended dose is a single loading dose of 3 mg/kg (not to exceed 200 mg) of Eraxis on Day 1, followed by a once daily maintenance dose of 1.5 mg/kg (not to exceed 100 mg) of Eraxis thereafter. Overall antifungal treatment should continue for at least 14 days after the last positive culture.

Cyclosporine

• Administration of multiple doses of anidulafungin and cyclosporine to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug.
• No dosage adjustment of cyclosporine or anidulafungin is needed when the two drugs are co-administered.

Voriconazole

• Administration of multiple doses of anidulafungin and voriconazole to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug.
• No dosage adjustment of voriconazole or anidulafungin is needed when the two drugs are co-administered.

Tacrolimus

• Administration of multiple doses of anidulafungin and a single-dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug.
• No dosage adjustment of tacrolimus or anidulafungin is needed when the two drugs are co-administered.

Rifampin

• Administration of multiple doses of anidulafungin and rifampin to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin.
• No dosage adjustment of anidulafungin is needed when it is co-administered with rifampin.

Amphotericin B Liposome For Injection

• Administration of multiple doses of anidulafungin and liposomal amphotericin B to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin.
• No dosage adjustment of anidulafungin is needed when it is co-administered with liposomal amphotericin B.

• Based on findings from animal studies, Eraxis can cause fetal harm when administered to a pregnant woman.
• There are no available human data on the use of Eraxis in pregnant women to inform a drug-associated risk of adverse developmental outcomes.
• In animal reproduction studies fetal toxicity was observed in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area.
• Inform pregnant woman of the risk to the fetus.
• There are no data on the presence of anidulafungin in human milk, the effects on the breastfed infant or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Eraxis and any potential adverse effects on the breastfed child from Eraxis or from the underlying maternal condition.