Anacaulase

Anacaulase
Names
Trade namesNexobrid
Other namesAnacaulase-bcdb, concentrate of proteolytic enzymes enriched in bromelain[1]
Clinical data
Main usesBurns[2]
Side effectsFever, itchiness[2]
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Routes of
use		Topical
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
  • UK: POM (Prescription only)
  • US: ℞-only [2]
  • EU: Rx-only [1]
  • In general: ℞ (Prescription only)
Pharmacokinetics
BioavailabilityDepends on wound surface and depth
Protein binding~50% (bromelain)
Elimination half-life11.7±3.5 (8.5–19.9) hrs

Anacaulase, sold under the brand name Nexobrid, is a medication used in burns.[2] Specifically it is used to help remove dead tissue that has dried out on deep partial-thickness and full-thickness burns.[1] It is applied to the affected area of skin.[1]

Common side effects include fever and itchiness.[2] Other side effects may include allergic reactions, including anaphylaxis, pain, and injury to other tissue.[2] It is a concentrate of proteolytic enzymes enriched in bromelain.[1]

Anacaulase was approved for medical use in Europe in 2012 and the United States in 2022.[1][2] It is made from the stem of the pineapple plant.[1] It is expected to become available in the United States in the middle of 2023.[3] In the United Kingdom it is listed as high cost as of 2022.[4]

Medical uses

It is used for eschar removal in adults with deep partial thickness or full thickness thermal burns.[2][5] It decreases the need for surgery, decreasing skin grafting from 34% to 18%.[1]

The medication is approved for burns of degrees IIb, i.e. deep partial skin thickness burns, to III, i.e. full thickness burns, and has been shown to reduce the need for surgical debridement (15% versus 63% under standard treatment) and skin transplants.[6][7]

The concentrate is solved in a sterile gel basis, applied onto the burn wound, covered with a wound dressing, and removed after four hours.[1] The healthy surrounding skin has to be protected with a sterile paraffin ointment. The EMA recommends that the treatment should be used in only hospitals having specialised burns centres.[8]

Side effects

Predictably, the bromelain gel is contraindicated in persons allergic to pineapple or the enzyme papain.[8]

The most common side-effects are fever (19% of patients in studies) and local pain (3.6%). Wound infections occur no more frequently than under standard treatment.[8]

Interactions

The enzymes inhibit the liver enzymes CYP2C8 and CYP2C9 when ingested. These are involved in the breaking down of a number of drugs, including amiodarone, chloroquine, ibuprofen, and warfarin. It is not known whether this mechanism has any clinical relevance.[9]

Pharmacokinetics

Depending on the surface area and depth of the wound, bromelain blood serum concentrations of no more than 40 µg/ml are expected, with peak concentrations reached after 2 to 4 hours. The terminal half-life varied between 8.5 and 19.9 hours in studies. These data have been obtained from 15 patients with comparatively shallow wounds.[6][9]

Chemistry

The medication is extracted from the stem of the pineapple plant (Ananas comosus)[9] by a standardised process, and each lot has to be analysed for its chemical composition. It contains a mixture of proteolytic enzymes, the main compound being stem bromelain. Bromelain is thought to be the active ingredient, but this has not been determined in studies.[6]

The gel basis contains water, polyacrylic acid as a gelling agent, and a disodium hydrogen phosphate/sodium hydroxide buffer.[6]

History

It was developed by MediWound.[10]

Research

In other contexts, bromelain has been researched for possible anti-inflammatory effects in treating a range of conditions or diseases, but results of these studies are mixed and regarded as preliminary.[11]

References

  1. 1 2 3 4 5 6 7 8 9 "NexoBrid EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 30 December 2022. Retrieved 29 December 2022.
  2. 1 2 3 4 5 6 7 8 "NexoBrid- anacaulase-bcdb kit". DailyMed. 10 January 2023. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  3. ↑ "Specialty Pipeline Monthly Update: January 2023". Prime Therapeutics LLC. Archived from the original on 27 January 2023. Retrieved 11 April 2023.
  4. ↑ "High Cost Drug Manual (K&M Health Economy NTE Drugs Manual)". www.eastkentformulary.nhs.uk. Archived from the original on 8 March 2023. Retrieved 12 April 2023.
  5. ↑ "Archive copy" (PDF). Archived (PDF) from the original on 2023-02-09. Retrieved 2023-01-30.{{cite web}}: CS1 maint: archived copy as title (link)
  6. 1 2 3 4 Klement A (2 February 2015). "NexoBrid". Österreichische Apothekerzeitung (in German) (3/2015): 10f.{{cite journal}}: CS1 maint: unrecognized language (link)
  7. ↑ Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ (May 2014). "A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT". Burns. 40 (3): 466–74. doi:10.1016/j.burns.2013.08.013. PMID 24074719.
  8. 1 2 3 "EPAR summary for the public: NexoBrid" (PDF). European Medicines Agency. December 2012. Archived (PDF) from the original on 2018-06-17. Retrieved 2023-01-30.
  9. 1 2 3 "Summary of Product Characteristics: NexoBrid" (PDF). European Medicines Agency. Archived (PDF) from the original on 2018-06-17. Retrieved 2023-01-30.
  10. ↑ "New Drugs Online Report for bromelain". Uk Medicines Information. Archived from the original on 2 April 2015. Retrieved 28 March 2015.
  11. ↑ "Bromelain". National Center for Complementary and Integrative Health, US National Institutes of Health. 24 September 2017. Archived from the original on 17 December 2018. Retrieved 17 December 2018.
Identifiers:
  • "Bromelain". Drug Information Portal. U.S. National Library of Medicine.
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