Anacaulase

What is Anacaulase?

• Anacaulase (Nexobrid) 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 of the proteins: stem bromelain, ananain, jacalin-like lectin, bromelain inhibitors, and phytocystatin inhibitor; and saccharides, as both free monosaccharides and the N-linked glycan of stem bromelain, and small molecule metabolites.

What are the uses of this medicine?

Anacaulase (Nexobrid) is used for eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Limitations of use: Anacaulase (Nexobrid) cannot be used for the 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.

How does this medicine work?

• The mixture of enzymes in Nexobrid dissolves burn wound eschar. The specific components responsible for this effect have not been identified.
• 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 inhibitor; and saccharides, as both free monosaccharides and the N-linked glycan of stem bromelain, and small molecule metabolites.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• 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.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• In December 2022, anacaulase-bcdb (Nexobrid) was approved for medical use in the United States.

How should this medicine be used?

Recommended dosage:

• Nexobrid may be applied in up to two applications of 4 hours each.
• A first application may be applied to an area of up to 15% body surface area (BSA).
• A second application may be applied 24 hours later. The total treated area for both applications must not exceed 20% BSA.
• Use 1.94 g of anacaulase-bcdb in 2 g powder mixed with 20 g gel per 1% BSA, or 4.85 g of anacaulase-bcdb in 5 g powder mixed with 50 g gel per 2.5% BSA.

Administration:

• For topical use only.
• Prepare Nexobrid at patient’s bedside within 15 minutes of intended application.
• Apply Nexobrid to a clean, moist wound bed free of burned epidermis layer and blisters, and cover with an occlusive film dressing for 4 hours.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As topical gel: 8.8%

This medicine is available in fallowing brand namesː

• Nexobrid

What side effects can this medication cause?

The most common side effects of this medicine may include:

• Pruritus
• Pyrexia
• Wound complication
• Anemia
• Vomiting
• Insomnia
• Urinary tract infection
• Tachycardia
• Rash
• Infection
• Sepsis
• Leukocytosis
• Hypotension
• Hepatic function abnormal
• Drug hypersensitivity
• Bacteremia
• Scar
• Subcutaneous hematoma
• Decubitus ulcer

Less common, but serious side effects may include: Hypersensitivity Reactions

What special precautions should I follow?

• Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarketing use of Nexobrid. If a hypersensitivity reaction occurs, remove Nexobrid and initiate appropriate therapy.
• Eschar removal with Nexobrid and treatment-related burn wound procedures are painful and require adequate analgesia and/or anesthesia. At least 15 minutes prior to Nexobrid application ensure adequate pain control measures are in place to address Nexobrid-related pain.
• Nexobrid is not recommended for treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal. 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.
• A reduction of platelet aggregation and plasma fibrinogen levels and a moderate increase in partial thromboplastin and prothrombin times have been reported in the literature as possible effects following oral administration of bromelain, a component of Nexobrid. Avoid use of Nexobrid in patients with uncontrolled disorders of coagulation. Patients should be monitored for possible signs of coagulation abnormalities and signs of bleeding.
• There are no data on the presence of anacaulase-bcdb in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Nexobrid use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Nexobrid in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• anacaulase-bcdb

Inactive ingredients:

• acetic acid
• ammonium sulfate
• water

Who manufactures and distributes this medicine?

Distributed by:

• Vericel Corporation
• Cambridge, MA
• Sidney Street

Manufactured by:

• MediWound LTD
• 42 Hayarkon Street,
• Yavne

What should I know about storage and disposal of this medication?

• Store and transport Nexobrid package upright and refrigerated at 2℃ to 8℃ (36 ℉ to 46 ℉) in the original carton to protect from light.
• DO not freeze.
• Do not use if the vial or jar are damaged.

• Dailymed label info on Anacaulase
• FDA Anacaulase

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