anacaulase

General

Pronunciation:
an-a-kawl-ase

Trade Name(s)

  • Nexobrid

Ther. Class.

none assigned

Pharm. Class.

enzymes

Indications

Eschar removal in patients with deep partial thickness and/or full thickness thermal burns.

Action

Acts as a proteolytic enzyme to dissolve burn wound eschar.

Therapeutic Effect(s):

Eschar removal.

Pharmacokinetics

Absorption: Rapidly absorbed into burn wound following topical administration.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: 12 hr.

TIME/ACTION PROFILE (plasma concentrations)

ROUTEONSETPEAKDURATION
Topicalunknown4 hrunknown

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity to anacaulase, bromelain, or pineapples
  • Hypersensitivity to papayas or papain (due to cross-sensitivity)
  • Burn wounds where medical devices or vital structures (e.g., large vessels) could become exposed during eschar removal
  • Uncontrolled coagulation disorder.

Use Cautiously in:

  • Thrombocytopenia, ↑ risk of bleeding, or concurrent use of antithrombotic therapy
  • OB:   Safety not established in pregnancy;
  • Lactation:  Safety not established in breastfeeding;
  • Pedi:   Safety and effectiveness not established in children.

Adverse Reactions/Side Effects

CV: hypotension, tachycardia

Derm: pruritus, decubitus ulcer, rash, scar, wound complication

GI: hepatic impairment, vomiting

Hemat: SUBQ hematoma, anemia, BLEEDING, leukocytosis

Neuro: insomnia

Misc: fever, HYPERSENSITIVITY REACTIONS (including anaphylaxis), INFECTION

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

Route/Dosage

Topical (Adults): Apply 3–mm thick layer to affected area of up to 15% body surface area (BSA) in a single application. If affected area >15% BSA, apply in two separate sessions (treat up to 15% BSA in one session and up to 5% BSA in second session). A second application may be applied 24 hours after the first application to the same or new wound area. Do not exceed 20% BSA (40 g) across two treatment sessions.

Availability

Topical gel: 8.8%

Assessment

  • Assess burn site periodically during therapy.
  • Monitor patients for signs of local or systemic allergic reactions. If a hypersensitivity reaction occurs, remove gel from treatment area and initiate appropriate therapy. Anacaulase is contraindicated in patients with a known hypersensitivity to pineapples, papayas, or papain.

Implementation

  • Gel is only to be administered by a health care professional. Take precautions to avoid exposure when preparing and handling gel (gloves, surgical masks, other protective coverings, as needed). If skin exposure occurs, rinse gel off with water to reduce likelihood of skin sensitization.
  • Eschar removal with anacaulase and treatment-related burn wound procedures are painful and require adequate analgesia and/or anesthesia. Provide pain management for an extensive dressing change of burn wounds at least 15 min prior to gel application ensure adequate pain control measures are in place to address anacaulase-related pain.
  • Thoroughly clean wound to remove any charred tissue, blisters, and any topical products. Apply a dressing soaked with an antibacterial solution to treatment area for at least 2 hr. Ensure wound bed is clear of any remnants of topical agents (silver sulfadiazine or povidone iodine). Apply an ointment skin protectant (petrolatum) 2 to 3 cm outside of treatment area to create an ointment barrier. Protect any open wounds (laceration, abraded skin and escharotomy incision) with skin protectant ointments or ointment gauze to prevent possible exposure to anacaulase. Avoid applying ointment to the treatment area itself, this would impede direct contact of gel with the eschar.
  • Prepare gel at patient's bedside within 15 mins of application. Using aseptic technique, mix anacaulase lyophilized powder and gel vehicle as follows: Pour lyophilized powder into gel vehicle jar. Thoroughly mix lyophilized powder and gel vehicle using a sterile instrument (tongue depressor or spatula) until the mixture is uniform. The mixed lyophilized powder and gel vehicle produce anacaulase in a final concentration of 8.8% w/w. Discard anacaulase if not used within 15 min of preparation, as the enzymatic activity of the product decreases progressively following mixing.
  • Anacaulase lyophilized powder and gel vehicle must be mixed prior to administration. Each vial of lyophilized powder, jar of gel vehicle, and the mixed anacaulase are for use for only one patient and for one application
  • Apply gel within 15 min of preparation as follows: Moisten treatment area by sprinkling sterile 0.9% NaCl irrigation onto burn wound. Using a sterile tongue depressor, completely cover the moistened treatment area with the mixed anacaulase in a 3 mm thick layer (approximate thickness of a tongue depressor) that completely covers the burn wound area to an area of up to 15% BSA in one application. 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 sterile ointment barrier and to achieve complete containment of anacaulase on the treatment area. Gel should fill the entire volume of the treatment area, and there should be no visible air under the occlusive film dressing. Cover the dressed wound with a sterile loose, thick, fluffy dressing and secure with a sterile bandage. Leave dressing and anacaulase in place for 4 hr. Discard any unused portions of anacaulase.
  • Remove gel after 4 hours. Gather the following supplies prior to gel removal. All supplies should be sterile: Blunt-edged instruments (tongue depressor), large dry gauze, gauze soaked with 0.9% NaCl irrigation. Dressing soaked with an antibacterial solution. Implement and maintain pain management as practiced for an extensive dressing change of burn wounds throughout the removal procedure: Remove occlusive film dressing using aseptic technique. Remove ointment barrier using a sterile blunt-edged instrument. Remove dissolved eschar from the wound by scraping it away with a sterile blunt edged instrument. Wipe wound thoroughly with a large sterile dry gauze, then wipe with a sterile gauze that has been soaked with sterile 0.9% NaCl irrigation. Rub treated area until the appearance of a clean dermis or subcutaneous tissues with pinpoint bleeding. To remove remnants of dissolved eschar, apply a dressing soaked with an antibacterial solution for at least 2 hr.
  • If the wound area is more than 15% BSA, apply anacaulase in 2 separate sessions (treat up to 15% BSA in one session and up to 5% BSA in a second session). Apply the second application of gel 24 hr after first application to the same or new burn wound area. The total treatment area must not exceed 20% BSA (40 grams of lyophilized powder) across two treatment sessions. Store and transport anacaulase package upright and refrigerated in original carton to protect from light; do not freeze.

Patient/Family Teaching

  • Explain purpose of anacaulase to patient.
  • Rep:  Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Eschar removal.