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🏅 FDA Orphan Designation

NexoBrid

anacaulase-bcdb

Manufacturer: Vericel Corporation

Indicated for:
Localized junctional epidermolysis bullosaOrphanPartial deep dermal and full thickness burns

FDA-Approved Indications (2)

eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns

NEXOBRID is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns

Population: adults and pediatric patients

Indications & Usage

1 INDICATIONS AND USAGE 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. Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal. NEXOBRID contains proteolytic enzymes and is indicated for eschar removal in adults and pediatric patients with deep partial thickness and/or full thickness thermal burns ( 1 ). Limitations of Use The safety and effectiveness of NEXOBRID have not been established for treatment of: Chemical or electrical burns ( 1 ). Burns on the face, perineum, or genitalia ( 1 ). Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease ( 1 ). Circumferential burns ( 1 ). Burns in patients with significant cardiopulmonary disease, including inhalation injury ( 1 ). 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 ( 1 ) Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal ( 1 ).

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NexoBrid
Vericel Corporation

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.