Anacaulase

Important Administration Information NEXOBRID is only to be administered by a healthcare provider. Take precautions to avoid exposure to NEXOBRID during preparation and handling (e.g., use gloves, surgical masks, other protective coverings, as needed) [see Warnings and Precautions] . Use pain management as practiced for an extensive dressing change of burn wounds 15 minutes prior to and throughout all NEXOBRID-related procedures.

NEXOBRID is available as: 2 g of lyophilized powder (containing 1.94 grams of anacaulase-bcdb) with a 20 g gel vehicle, for treatment of up to 180 cm 2 of burn area after mixing. 5 g lyophilized powder (containing 4.85 grams of anacaulase-bcdb) with a 50 g gel vehicle, for treatment of up to 450 cm 2 of burn area after mixing.

NEXOBRID lyophilized powder and gel vehicle must be mixed no more than 15 minutes prior to administration. Discard NEXOBRID if not used within 15 minutes of preparation, as the enzymatic activity of the product decreases progressively following mixing. Each vial of lyophilized powder, jar of gel vehicle, and the mixed NEXOBRID are for use for only one patient and for one application [see Dosage and Administration] .

NEXOBRID is for topical use only. Apply an ointment skin protectant around the treatment area to create an ointment barrier [see Dosage and Administration].

Preparation of Patient and Burn Wound Treatment Area Prepare the wound area as follows: Thoroughly clean the wound to remove any charred tissue, blisters, and any topical products. Apply a dressing soaked with an antibacterial solution to the treatment area for at least 2 hours. Ensure the wound bed is clear of any remnants of topical agents (e.g., silver sulfadiazine, povidone iodine).

Apply an ointment skin protectant (e.g., petrolatum) 2 to 3 cm outside of the treatment area to create an ointment barrier. Avoid applying the protectant ointment to the treatment area itself, as this would impede direct contact of NEXOBRID with the eschar. Protect any other open wounds (e.g., laceration, abraded skin, escharotomy incision) with skin protectant ointments or ointment gauze to prevent possible exposure to NEXOBRID.

Preparation and Application of NEXOBRID Gather the following sterile supplies prior to NEXOBRID preparation and application: Instrument for mixing (e.g., spatula or tongue depressor) Tongue depressor for NEXOBRID application 0.9% Sodium Chloride Irrigation Occlusive film dressing Loose, thick fluffy dressing and bandage Preparation Prepare NEXOBRID at the patient’s bedside within 15 minutes of the intended application.

Using aseptic technique, mix NEXOBRID lyophilized powder and gel vehicle as follows: Pour the NEXOBRID lyophilized powder into the gel vehicle jar. Thoroughly mix the NEXOBRID lyophilized powder and gel vehicle using a sterile instrument (e.g., tongue depressor or spatula) until the mixture is uniform. The mixed lyophilized powder and gel vehicle produce NEXOBRID in a final concentration of 8.8% w/w.

DISCARD NEXOBRID IF NOT USED WITHIN 15 MINUTES OF PREPARATION, as the enzymatic activity of NEXOBRID decreases progressively following mixing. Application Apply NEXOBRID within 15 minutes of preparation as follows: Moisten the treatment area by sprinkling sterile 0.9% Sodium Chloride Irrigation onto the burn wound. Using a sterile tongue depressor, completely cover the moistened burn wound treatment area with the mixed NEXOBRID in a 3 mm thick layer (approximate thickness of a tongue depressor).

Ensure NEXOBRID covers the entire target treatment area. Cover the treated wound with a sterile occlusive film dressing. Gently press the occlusive film dressing at the area of contact with the ointment barrier to ensure adherence between the occlusive film dressing and the ointment barrier and to achieve complete containment of NEXOBRID on the treatment area.

There should be no visible air under the occlusive film dressing. Cover the occlusive film dressing with a sterile loose, thick, fluffy dressing and secure with a sterile bandage. Discard any unused portions of NEXOBRID.