Nexobrid Dosage

Dosage and Administration Overview

NEXOBRID is only to be administered by a healthcare provider. Healthcare providers should take precautions to avoid exposure to NEXOBRID during preparation and handling (e.g., use of gloves, surgical masks, other protective coverings, as needed) [see Warnings and Precautions (5.1)].

NEXOBRID lyophilized powder and gel vehicle must be mixed prior to administration. 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 (2.3)].

NEXOBRID is available as:

• 2 g of lyophilized powder (containing 1.94 grams of anacaulase-bcdb) mixed in 20 g gel vehicle per 1% body surface area (BSA), or
• 5 g lyophilized powder (containing 4.85 grams of anacaulase-bcdb) mixed in 50 g gel vehicle per 2.5% BSA.

NEXOBRID is for topical use only.

Apply an ointment skin protectant around the treatment area to create an ointment barrier [see Dosage and Administration (2.2), Warnings and Precautions (5.3)].

Apply 3 mm thick layer (approximate thickness of a tongue depressor) of NEXOBRID to an area of up to 15% body surface area (BSA) in one application.

If the wound area is more than 15% BSA, apply NEXOBRID in 2 separate sessions (e.g., treat up to 15% BSA in one session and up to 5% BSA in a second session). Apply the second application of NEXOBRID twenty-four (24) hours after the first application to the same or new burn wound area. The total treatment area must not exceed 20% BSA (40 grams of NEXOBRID lyophilized powder) across two treatment sessions [see Dosage and Administration (2.3, 2.4, 2.5)].

Preparation of Patient and Burn Wound Treatment Area

Use pain management as practiced for an extensive dressing change of burn wounds 15 minutes prior to all NEXOBRID related procedures.

Prepare the wound area as follows:

1. Thoroughly clean the wound to remove any charred tissue, blisters, and any topical products.
2. Apply a dressing soaked with an antibacterial solution to the treatment area for at least 2 hours.
3. Ensure the wound bed is clear of any remnants of topical agents (e.g. silver sulfadiazine or povidone iodine).
4. Apply an ointment skin protectant (e.g., petrolatum) 2 to 3 cm outside of the treatment area to create an ointment barrier.
5. 5. Protect any open wounds (e.g., laceration, abraded skin and escharotomy incision) with skin protectant ointments or ointment gauze to prevent possible exposure to NEXOBRID [see Warnings and Precautions (5.3)].
6. Avoid applying the ointment to the treatment area itself, as this would impede direct contact of NEXOBRID with the eschar.

Preparation and Application of NEXOBRID

Gather the following supplies prior to NEXOBRID preparation and application. All supplies should be sterile:

• 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

Maintain pain management throughout the application as practiced for an extensive dressing change of burn wounds. At least 15 minutes prior to NEXOBRID application, ensure adequate pain control measures are in place to address NEXOBRID-related pain.

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:

1. Pour the NEXOBRID lyophilized powder into the gel vehicle jar.
2. 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 the product decreases progressively following mixing.

Application

Apply NEXOBRID within 15 minutes of preparation as follows:

1. Moisten the treatment area by sprinkling sterile 0.9% Sodium Chloride Irrigation onto the burn wound.
2. Using a sterile tongue depressor, completely cover the moistened treatment area with the mixed NEXOBRID in a 3 mm thick layer (approximate thickness of a tongue depressor) that completely covers the burn wound area.
3. Cover the treated wound with a sterile occlusive film dressing.
4. 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 sterile ointment barrier and to achieve complete containment of NEXOBRID on the treatment area. NEXOBRID gel should fill the entire volume of the treatment area, and there should be no visible air under the occlusive film dressing.
5. Cover the dressed wound with a sterile loose, thick, fluffy dressing and secure with a sterile bandage.
6. Leave the dressing and NEXOBRID in place for 4 hours.
7. Discard any unused portions of NEXOBRID.

Removal of NEXOBRID

Remove NEXOBRID after 4 hours. Gather the following supplies prior to NEXOBRID removal. All supplies should be sterile:

• Blunt-edged instruments (e.g., tongue depressor)
• Large dry gauze
• Gauze soaked with 0.9% Sodium Chloride Irrigation
• Dressing soaked with an antibacterial solution

Implement and maintain pain management as practiced for an extensive dressing change of burn wounds throughout the following removal procedure:

1. Remove the occlusive film dressing using aseptic technique.
2. Remove the ointment barrier using a sterile blunt-edged instrument.
3. Remove the dissolved eschar from the wound by scraping it away with a sterile blunt-edged instrument.
4. Wipe the wound thoroughly with a large sterile dry gauze, then wipe with a sterile gauze that has been soaked with sterile 0.9% Sodium Chloride Irrigation. Rub the treated area until the appearance of a clean dermis or subcutaneous tissues with pinpoint bleeding.
5. To remove remnants of dissolved eschar, apply a dressing soaked with an antibacterial solution for at least 2 hours.

Second Application of NEXOBRID

A second application of NEXOBRID may be applied 24 hours following the first application to either the same area previously treated with NEXOBRID or to a new area [see Dosage and Administration (2.2, 2.3,2.4)]. A second application may be considered if:

• The wound area is more than 15% BSA, or
• Multiple wound areas on different body surfaces require two treatments for logistical reasons such as body position, or
• The first application’s eschar removal was not complete.

The total treated area must not exceed 20% BSA, inclusive of both applications [see Dosage and Administration (2.1)].

Wound Care after Eschar Removal

Wound care following eschar removal should be based on the healthcare provider’s clinical judgement (e.g., observe for spontaneous reepithelization or proceed with autograft).

Monitoring

Monitor patients for signs of local or systemic allergic reactions. If a hypersensitivity reaction occurs, remove NEXOBRID (if applicable) from the treatment area and initiate appropriate therapy [see Contraindications (4), Warnings and Precautions (5.1)].