NEXOBRID
ANACAULASE-BCDB · KIT · Vericel Corporation
NEXOBRID is a kit containing anacaulase-bcdb, taken topical. Manufactured by Vericel Corporation.
Key Facts
- Brand Name
- NEXOBRID
- Generic Name
- ANACAULASE-BCDB
- NDC Code (Product)
69866-2005- Manufacturer
- Vericel Corporation
- Dosage Form
- KIT
- Route
- TOPICAL
- Marketing Status
- Application #
- BLA761192
- Marketing Start
- 12/29/2022
Recall History
No Recall HistoryFull Prescribing Information
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 bee…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION NEXOBRID lyophilized powder and gel vehicle must be mixed prior to administration ( 2.1 ). 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 ( 2.1 ). For topical use only ( 2.1 ). 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 ( 2.2 ). 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 ( 2.2 ). 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 ( 2.2 ). Prepare NEXOBRID at patient’s bedside within 15 minutes of intended application ( 2.4 ). Apply NEXOBRID to a clean, moist wound bed free of burned epidermis layer and blisters, and cover with an occlusive film dressing ( 2.3 , 2.4 ).…
Contraindications
4 CONTRAINDICATIONS NEXOBRID is contraindicated in patients with [see Warnings and Precautions ( 5.1 ), Description ( 11 )] : 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 ( 4 ). Known hypersensitivity to papayas or papain because of the risk of cross-sensitivity ( 4 ).
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] The most common adverse reactions (>10%) were pruritus and pyrexia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Vericel Corporation at 1-888-454-BURN or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice. Adults: Studies 1 and 2 evaluated subjects undergoing eschar removal for deep partial thickness (DPT) and/or full thickness (FT) thermal burns [see Clinical Studies ( 14 )] . An integrated analysis of safety data from Studies 1 and 2 compared NEXOBRID (n=177) to standard of care (SOC) (n=149). The SOC treatment included both surgical and non-surgical eschar removal methods. The mean age of the safety population was 35.6 years; 73% were male; 81% were White, 9% were Black, 6% were other races, and 3% …
Frequently Asked Questions
What is NEXOBRID used for?
NEXOBRID contains ANACAULASE-BCDB. It is a kit taken topical. Consult your doctor for specific uses.
Is NEXOBRID a controlled substance?
NEXOBRID is not classified as a controlled substance by the DEA.
What is the generic name for NEXOBRID?
The generic name for NEXOBRID is ANACAULASE-BCDB. There are no other listed brand versions of ANACAULASE-BCDB.
What is the NDC code for NEXOBRID ?
The NDC (National Drug Code) for NEXOBRID is 69866-2005, listed by Vericel Corporation.
Other NEXOBRID Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)