The US FDA has approved a new injectable antifungal, rezafungin, for the treatment of candidemia and invasive candidiasis. This is the first long-acting antifungal to be approved in a decade. It belongs to the echinocandin group of antifungal drugs. It is available in a single-dose vial of 200 mg for reconstitution.

The approval is based on the findings of the phase 3 ReSTORE trial, which showed that weekly rezafungin was comparable in efficacy to daily caspofungin administration.

Indication: Treatment of candidemia and invasive candidiasis in patients aged ≥18 years who have limited or no alternative options

Dosage & administration: 400 mg loading dose intravenously, followed by 200 mg doses once a week x 4 weeks

Contraindication: Patients with known hypersensitivity to the drug or other echinocandins like caspofungin, micafungin and anidulafungin 

Side effects: Diarrhea, nausea, vomiting, anemia, pyrexia, pain abdomen, constipation, hypokalemia, hypomagnesemia and hypophosphatemia

Warnings & Precautions

• Treatment should be stopped if infusion related reactions occur such as flushing, sensation of warmth, urticaria, nausea, or chest tightness
• Photosensitivity may occur; hence, patients must be cautioned to adopt adequate sun protective measures.
• Monitor liver function tests in patients being treated with rezafungin

Sources

1. https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/103684. Dated March 23, 2023. Accessed on March 25, 2023.
2. https://health.ucdavis.edu/news/headlines/new-treatment-for-invasive-fungal-infection-candidiasis-approved-by-fda/2023/03. Dated March 23, 2023. Accessed on March 25, 2023.