Version May 2024
Dosing guidance:
Clinical considerations: To be applied by a health care provider only. Monitor for signs of local or systemic allergic reactions; if reactions occur, remove gel from treatment area and initiate appropriate therapy.
Burn, eschar removal: Topical: Apply 3 mm thick layer (approximately the thickness of a tongue depressor) to affected area of up to 15% BSA in a single application; if affected area is >15% BSA, apply in 2 separate sessions (treat up to 15% BSA in one and up to 5% BSA). A second application may be applied 24 hours after the first application if: The wound area is >15% BSA; multiple wound areas on different body surfaces require 2 treatments for logistical reasons (eg, body position); or the first application’s eschar removal was not complete. Do not exceed 20% BSA (40 g) across 2 treatment sessions.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Dermatologic: Pruritus (15%)
Miscellaneous: Fever (2%)
1% to 10%:
Cardiovascular: Hypotension (2%), tachycardia (3%)
Dermatologic: Cicatrix of skin (1%), pressure ulcer (1%), skin rash (3%)
Gastrointestinal: Vomiting (5%)
Genitourinary: Urinary tract infection (4%)
Hematologic & oncologic: Anemia (6%), leukocytosis (2%), subcutaneous hematoma (1%)
Hepatic: Hepatic impairment (1%)
Hypersensitivity: Hypersensitivity reaction (1%; including severe hypersensitivity reaction)
Infection: Bacteremia (1%), infection (2%), sepsis (2%)
Nervous system: Insomnia (5%)
Postmarketing: Hypersensitivity: Anaphylaxis
Hypersensitivity to anacaulase, bromelain, pineapples, or any component of the formulation; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.
Concerns related to adverse effects:
• Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis, have occurred.
Disease-related concerns:
• Coagulation disorders: Avoid use in patients with uncontrolled coagulation disorders; reduced platelet aggregation, reduced plasma fibrinogen levels, and an increase in partial thromboplastin/prothrombin time have been reported with oral use of bromelain (a component of anacaulase). Use with caution in patients at increased risk of bleeding (eg, concomitant anticoagulant therapy, peptic ulcers, sepsis).
Other warnings/precautions:
• Appropriate use: For topical use only. For application by a health care provider only; use gloves, surgical masks, and other protective coverings as needed to avoid exposure during preparation and handling. Do not use on wounds where medical devices (eg, implants, pacemakers, shunts) or vital structures (eg, large vessels) may become exposed during eschar removal; protect open wounds (eg, laceration, abraded skin, escharotomy incision) with skin protectants to prevent possible exposure. Eschar removal is painful and requires adequate analgesia and/or anesthesia; ensure adequate pain control measures for an extensive dressing change at least 15 minutes prior to application. Wound care after eschar removal is based on health care provider's clinical judgement.
Nexobrid: FDA approved December 2022; availability anticipated in the second quarter of 2023.
Topical: For topical use only. Do not use on wounds where medical devices (eg, implants, pacemakers, shunts) or vital structures (eg, large vessels) may become exposed during eschar removal. Monitor for signs of local or systemic allergic reactions; if reactions occur, remove gel from treatment area and initiate appropriate therapy.
Prior to applying anacaulase: Prepare the burn wound treatment area prior to applying anacaulase by: thoroughly cleaning and removing any charred tissue, blisters, or topical products; applying an antibacterial-soaked dressing for at least 2 hours; ensuring wound area is clear of any topical agent remnants (eg, silver sulfadiazine, povidone iodine; some recommend to avoid using anacaulase when silver sulfadiazine is used as pretreatment due to the interference with enzymatic activity) (Ref); applying an ointment skin protectant (eg, petrolatum) 2 to 3 cm outside of the treatment area (avoid treatment area); and protecting any open wounds (eg, lacerations, abraded skin, escharotomy incision) with skin protectant ointment or ointment gauze. Use pain management as practiced for extensive dressing changes of burn wounds 15 minutes prior to application (Ref).
Anacaulase application: Apply within 15 minutes of preparation (must be mixed prior to use). Moisten the burn wound by sprinkling with 0.9% NS irrigation; completely cover the moistened burn wound with a 3 mm thick layer (approximately the thickness of a tongue depressor) of gel using a sterile tongue depressor, then cover with a sterile occlusive film dressing, pressing gently to ensure adherence and complete containment on the burn wound (no visible air under the occlusive film dressing). Discard any unused amount. Cover the dressed wound with a sterile, loose, thick, fluffy dressing and secure with a sterile bandage; leave in place for 4 hours. After 4 hours, remove the occlusive film dressing and then the ointment barrier and dissolved eschar from the wound using a sterile blunt-edged instrument; wipe treated wound thoroughly with a large, sterile dry gauze and then wipe with a sterile gauze soaked in 0.9% NS irrigation, rubbing treated area until the appearance of a clean dermis or subcutaneous tissue with pinpoint bleeding. Apply a dressing soaked with an antibacterial solution for at least 2 hours to remove any dissolved eschar remnants.
Burn, eschar removal: For eschar removal in adults with deep partial thickness and/or full thickness thermal burns.
Limitations of use:
Safety and effectiveness 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.
Use 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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Anticoagulants: Anacaulase may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Animal reproduction studies were not conducted using topical anacaulase. Maternal toxicity but not developmental toxicity was observed following IV administration to pregnant rats and rabbits.
Use of a multidisciplinary team (burn specialist, OB/GYN, etc) is recommended for burn management in pregnant patients. Maternal and fetal outcomes vary by the total burned surface area and trimester of pregnancy. Topical agents other than anacaulase are commonly used in persons who are pregnant (Dijkerman 2022; Karimi 2020). A case report describes use of a topical bromelain-based enzymatic debridement in a postpartum patient (Wallner 2017).
It is not known if anacaulase is present in breast milk.
A case report describes use of a topical bromelain-based enzymatic debridement in a postpartum patient who was breastfeeding on the day of application (Wallner 2017). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Signs of local or systemic allergic reaction; signs of coagulation abnormalities; signs of bleeding; pain management.
The enzymatic mixture of anacaulase aids in the dissolution of burn wound eschar.
Absorption: Rapid.
Half-life elimination: Terminal: Bromelain: 12 ± 4.4 hours.
Time to peak: 4 hours (during treatment application).
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