Anacaulase

NEXOBRID is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns. Limitations of Use The safety and effectiveness of NEXOBRID have not been established for treatment of: Chemical or electrical burns Burns on the face, perineum, or genitalia Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease Circumferential burns Burns in patients with significant cardiopulmonary disease, including inhalation injury NEXOBRID is not recommended for: Wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.

The mixture of enzymes in NEXOBRID dissolves burn wound eschar. The specific components responsible for this effect have not been identified.

NEXOBRID lyophilized powder and gel vehicle must be mixed prior to administration. Use 2 g of Nexobrid lyophilized powder mixed with 20 g gel for treatment of up to 180 cm2 of treated burn area, or 5 g of Nexobrid lyophilized powder mixed with 50 g gel for treatment of up to 450 cm2 of treated burn area. For topical use only. Dosage in Adults: Apply a 3 mm thick layer of NEXOBRID in one application to an area of up to 15% body surface area (BSA) for four hours. A second application may be applied 24 hours later. For both applications, the total treated area must not exceed 20% BSA. Dosage in Pediatric Patients 6 Years of Age and Older: Apply a 3 mm thick layer of NEXOBRID in one application of 4 hours to an area of up to 15% BSA. Dosage in Pediatric Patients Less Than 6 Years of Age: Apply a 3 mm thick layer of NEXOBRID in one application of 4 hours to an area of up to 10% BSA.

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

Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarketing use of anacaulase-bcdb. If a hypersensitivity reaction occurs, remove NEXOBRID (if applicable) and initiate appropriate therapy. Coagulopathy: Avoid use of NEXOBRID in patients with uncontrolled disorders of coagulation. Use 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. Monitor patients for possible signs of coagulation abnormalities and signs of bleeding.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions The most common adverse reactions (>10%) were pruritus and pyrexia.

Store and transport NEXOBRID package upright and refrigerated at 2℃ to 8℃ (36 ℉ to 46 ℉) in the original carton to protect from light. DO NOT FREEZE.