NEXOBRID

What it is

NEXOBRID is anacaulase-bcdb 4.85 g powder vial with diluent gel bottle composite pack. One vial contains 5 g lyophilised powder (containing 4.85 grams of anacaulase-bcdb) and one bottle of 50 g gel vehicle per composite pack. The drug substance in NEXOBRID, anacaulase-bcdb, is a mixture of proteolytic enzymes extracted from the stems of pineapple plants (Ananas comosus [L.] Merr.) that has been sterile filtered and lyophilised. NEXOBRID is a preparation for treatment of wounds and ulcers, classified as a proteolytic enzyme.

Approved indications

— Eschar removal in adults and paediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Dosing overview

For adults, apply a 3 mm thick layer of NEXOBRID to an area of up to 15% body surface area (BSA) in one application. If the wound area is more than 15% BSA, apply NEXOBRID in two separate sessions (treating up to 15% BSA in one session and up to 5% BSA in a second session), with the second application twenty-four hours after the first. The total treatment area must not exceed 20% BSA (40 grams of NEXOBRID lyophilised powder) across two treatment sessions. For paediatric patients aged 0 to less than 6 years, apply a 3 mm thick layer to an area of up to 10% BSA in one application. For paediatric patients aged 6 to 17 years, apply a 3 mm thick layer to an area of up to 15% BSA in one application.

Key safety warnings

Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarketing use of NEXOBRID. If a hypersensitivity reaction occurs, NEXOBRID should be removed and appropriate therapy initiated. A reduction of platelet aggregation and plasma fibrinogen levels and a moderate increase in partial thromboplastin and prothrombin times have been reported following oral administration of bromelain, a component of NEXOBRID. In vitro and animal data suggest that bromelain can also promote fibrinolysis. NEXOBRID should be avoided in patients with uncontrolled disorders of coagulation and used with caution in patients on anticoagulant therapy or other drugs affecting coagulation, and in patients with low platelet counts and increased risk of bleeding from other causes. Eschar removal with NEXOBRID and treatment-related burn wound procedures are painful and require adequate analgesia and/or anaesthesia. Pain management should be appropriate for an extensive dressing change of burn wounds. NEXOBRID should be used with caution in patients with cardiopulmonary and pulmonary disease, including pulmonary burn trauma and suspected pulmonary burn trauma.

Contraindications

NEXOBRID is contraindicated in patients with known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other component. NEXOBRID is also contraindicated in patients with known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.

Regulatory history

The TGA approved NEXOBRID for registration on 8 September 2025. NEXOBRID anacaulase-bcdb 4.85 g powder vial with diluent gel bottle composite pack was first listed on the ARTG on 15 September 2025. The TGA's evaluation found that NEXOBRID met acceptable standards of quality, safety and efficacy for its proposed use, and concluded that the benefits of NEXOBRID for eschar removal in thermal burns outweigh its risks.