Overview
11 DESCRIPTION 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 lyophilized. The drug substance, anacaulase-bcdb, is composed mainly (80% to 95% w/w) of the proteins: stem bromelain, ananain, jacalin-like lectin, bromelain inhibitors, and phytocystatin...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mixture of enzymes in NEXOBRID dissolves burn wound eschar. The specific components responsible for this effect have not been identified. 12.2 Pharmacodynamics The pharmacodynamics of NEXOBRID are unknown. Cardiac Electrophysiology At the approved recommended dose, NEXOBRID did not prolong the QT interval in humans to any clinically relevant extent. 12.3 Pharmacokinetics Absorption For adults and pediatric subjects 4 years of age and older, NEXOBRID applied to deep partial and full thickness burn wounds is absorbed, with median serum T max of 4 hours (during the treatment application). Systemic exposure (i.e.
Indications
- 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...
Common Doses
- 2 g
- 20 g
- 5 g
- 50 g
Dosage
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.
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 ).
Side Effects
- 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...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.