| Clinical data | |
|---|---|
| Trade names | Nexobrid |
| Other names | Anacaulase-bcdb |
| AHFS/Drugs.com | UK Drug Information |
| License data | |
| Routes of administration | Topical |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Protein binding | ~50% (bromelain) |
| Eliminationhalf-life | 11.7±3.5 (8.5–19.9) hrs |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| CompTox Dashboard(EPA) | |
| ECHA InfoCard | 100.029.599 |
Bromelain, a concentrate ofproteolytic enzymes from thepineapple plant, is used in medicine. It is approved in the European Union for thedebridement (removal ofeschar, that is dead and damaged tissue) of severeburn wounds under the brand nameNexobrid.[1][3] It was developed byMediWound.[4]
The medicine has been grantedorphan drug status by theEuropean Medicines Agency (EMA).[1][5]
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.[6]
In December 2022, anacaulase-bcdb (Nexobrid) was approved for medical use in the United States.[2][7][8]
In the United States, anacaulasegel isindicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns.[2][8]
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 significantly reduce the necessity of surgical debridement (15% versus 63% under standard treatment) andskin transplants (18% versus 34%) in arandomized controlled trial.[5][9]
The concentrate is solved in a sterilegel basis, applied onto the burn wound, covered with a wound dressing, and removed after four hours. The healthy surrounding skin has to be protected with a sterileparaffin ointment. The EMA recommends that the treatment should be used only in hospitals having specialised burns centres.[3]
The bromelain gel is contraindicated in persons allergic to pineapple or the enzymepapain.[3]
The most common side-effects arefever (19% of patients in studies) and local pain (3.6%). Wound infections occur no more frequently than under standard treatment.[3]
The enzymes in NexoBrid inhibit the liver enzymesCYP2C8 andCYP2C9 when ingested. These are involved in the breaking down of a number of drugs, includingamiodarone,chloroquine,ibuprofen, andwarfarin. It is not known whether this mechanism has any clinical relevance.[10]
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.[5][10]
The medication is extracted from the stem of the pineapple plant (Ananas comosus)[10] 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.[5]
The gel basis contains water,polyacrylic acid as agelling agent, and adisodium hydrogen phosphate/sodium hydroxidebuffer.[5]
