Nexobrid Powder Component (anacaulase-bcdb)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage and administration summary:

For topical use only.

Anacaulase-bcdb is only to be administered by a healthcare provider. Healthcare providers should take precautions to avoid exposure to anacaulase-bcdb during preparation and handling.

The lyophilized powder and gel vehicle must be mixed no more than 15 minutes prior to administration to provide an 8.8% w/w gel for topical use.

Use 2 g of lyophilized powder mixed with 20 g gel for treatment of up to 180 cm2 of treatedburn area; or 5 g of lyophilized powder mixed with 50 g gel for treatment of up to 450 cm2of treated burn area.

Prepare anacaulase-bcdb at the patient's bedside within 15 minutes of intended application. Discard anacaulase-bcdb if not used within 15 minutes of preparation, as the enzymatic activity of the product decreases progressively following mixing.

Apply anacaulase-bcdb to a clean, moist wound bed free of burned epidermis layer and blisters, and cover with an occlusive film dressing.

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

See Full Prescribing Information for additional details on preparation, administration, and removal of anacaulase-bcdb.

Apply a 3 mm thick layer of anacaulase-bcdb in one application to a burn wound area of up to 15% BSA for 4 hours. A second application may be applied 24 hours later after the first application to the same or new burn wound area. For both applications, the total treated area must not exceed 20% BSA.

Apply a 3 mm thick layer of anacaulase-bcdb in one application of 4 hours to an area of up to 10% BSA in one application. A second application is not recommended.

Apply a 3 mm thick layer of anacaulase-bcdb in one application of 4 hours to an area of up to 15% BSA in one application. A second application is not recommended.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*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.

There are no contraindication contraindications for this drug.

• Hemorrhage
• Increased risk of bleeding due to coagulation disorder
• Thrombocytopenic disorder

There are no moderate contraindications for this drug.

The most common adverse reactions (>10%) were pruritus and pyrexia.

Less Frequent

• Abnormal hepatic function tests
• Anemia
• Bacteremia
• Hypotension
• Infection
• Sepsis
• Skin graft complication

Rare or Very Rare

• Anaphylaxis
• Hypersensitivity drug reaction

More Frequent

• Fever
• Pruritus of skin

Less Frequent

• Constipation
• Decubital ulcer
• Hematoma
• Infection of ear
• Insomnia
• Leukocytosis
• Nausea
• Pharyngitis
• Scar of skin
• Skin rash
• Tachycardia
• Urinary tract infection
• Vomiting

Rare or Very Rare

• Urticaria

No enhanced messaging available.

The safety and effectiveness of anacaulase-bcdb for eschar removal have been established in pediatric patients with deep partial thickness and/or full thickness thermal burns. Use of anacaulase-bcdb for this indication is supported by evidence from one adequate and well-controlled trial in 69 pediatric subjects treated with the drug.

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

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% an 15 to 20%, respectively.

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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for anacaulase-bcdb and any potential adverse effects on the breastfed infant from anacaulase-bcdb or from the underlying maternal condition.

Of the 177 subjects exposed to anacaulase-bcdb for eschar removal in deep partial thickness (DPT) and/or full thickness (FT) thermal burns, 6 (3%) subjects were 65 years or older, and 1 (<1%) subject was 75 years or older. Clinical studies of anacaulase-bcdb did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.