Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

Indications¹

Eraxis® is indicated for the treatment of fungal infections: candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis)¹

Clinical Evidence

Eraxis® has greater efficacy than fluconazole in the treatment of invasive candidiasis and has a safety profile similar to that of fluconazole²
Treatment with Eraxis® was successful in 76% of patients versus 60% among those treated with fluconazole at the end of intravenous (IV) therapy² (p=0.01)

*p value for 6-week follow-up was not presented in Reboli et al²; mITT, modified intent-to-treat
Double-blind, randomized, non-inferiority study in patients aged ≥16 years (n=245) with invasive candidiasis; Primary efficacy analysis: Global response (clinical and microbiologic) at end of IV therapy in patients who had a positive baseline culture; Subjects received either IV Eraxis® (anidulafungin) (200 mg on day 1, then 100 mg/day) or IV fluconazole (800 mg on day 1, then 400 mg/day) for 14 to 42 days and for at least 14 days after a negative blood culture and improvement in signs and symptoms; Signs and symptoms were assessed at baseline, daily during treatment, at end of IV therapy, at end of oral therapy, and 2 and 6 weeks after end of all antifungal therapy

Randomized, multicenter, double-blind study of 256 patients with candidemia and/or other forms of invasive candidiasis; Patients received either Eraxis® (anidulafungin) (200-mg loading dose, 100-mg maintenance dose) or IV fluconazole (800-mg loading dose, 400-mg maintenance dose); either agent could be followed by oral fluconazole after ≥10 days of IV therapy
The increased response rates with Eraxis® were most likely a consequence of the fungicidal effects of Eraxis® rather than the fungistatic effects of fluconazole²
The majority of Candida isolates, including Candida glabrata, were sensitive to fluconazole²

Safety Profile¹

ADVERSE REACTIONS: Possible histamine-mediated symptoms, including rash, urticaria, flushing, pruritis, dyspnea, and hypotension. In the treatment of candidemia, the most common treatment related AEs include diarrhea (3.1%), hypokalemia (3.1%) and elevated ALT (2.3%).

INTERACTIONS: No known clinically relevant drug-drug interactions.

Dosages¹

Candidemia and other Candida infections: Single 200 mg loading dose on Day 1, followed by 100 mg daily dose thereafter. Antifungal therapy should be based on the patient’s clinical response.

Strengths¹

Vial 100 mg.

Packing¹

Single-use unit pack: Contains Eraxis® 100 mg vial

Important Safety Information¹

CONTRAINDICATIONS: Known hypersensitivity to anidulafungin, any components of ERAXIS, or other echinocandins.

SPECIAL PRECAUTIONS: Hepatic effects, monitor for evidence of worsening hepatic function and evaluate the risk/benefit ratio of continuing therapy; pediatric use.

ADVERSE REACTIONS: Possible histamine-mediated symptoms, including rash, urticaria, flushing, pruritis, dyspnea, and hypotention. In the treatment of candidemia, the most common treatment related AEs includes diarrhea (3.1%), hypokalemia (3.1%) and elevated ALT (2.3%).

PREGNANCY and LACTATION: Pregnancy Category C – should be used during pregnancy and administered to a nursing mother only if the potential benefit justifies the potential risk to the fetus. It is unknown whether anidulafungin is excreted in human milk.

Please refer to the full prescribing information for more safety information.

References

1. Eraxis® (anidulafungin) Prescribing Information. Pfizer Corporation Hong Kong Limited: 21 July 2009.

2. Reboli AC, Rotstein C, Pappas PG, et al. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med 356:2472-2482.

Please review the full product information or package insert before prescribing.

ERA11017P