Bromelain (pharmacology)
| Clinical data | |
|---|---|
| Trade names | NexoBrid |
| AHFS/Drugs.com | UK Drug Information |
| Routes of administration |
Locally onto the wound |
| ATC code | |
| Legal status | |
| Legal status |
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| Pharmacokinetic data | |
| Bioavailability | Depends on would surface and depth |
| Protein binding | ~50% (bromelain) |
| Biological half-life | 11.7±3.5 (8.5–19.9) hrs |
| Identifiers | |
| ChemSpider |
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| Chemical and physical data | |
| Formula | Varies |
A concentrate of proteolytic enzymes from the pineapple plant enriched in bromelain is approved in Europe for the debridement (removal of eschar, that is dead and damaged tissue) of severe burn wounds under the trade name NexoBrid. In the US, it has completed Phase III clinical trials and has the tentative trade name Debrase. It was developed by MediWound, Germany; and Teva is responsible for development and marketing in the US.
The medicine has been granted orphan drug status by the European Medicines Agency (EMA).
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) and skin transplants (18% versus 34%) in a randomized controlled trial.
The concentrate is solved in a sterile gel 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 sterile paraffin ointment. The EMA recommends that the treatment should only be used in hospitals with specialised burns centres.
Predictably, the bromelain gel is contraindicated in persons allergic to pineapple or the enzyme papain.
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.
The enzymes in NexoBrid 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.
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