NexoBrid® Safety Profile

The Safety of NexoBrid Was Evaluated in Two Phase 3 Clinical Trials.1

An integrated analysis of safety data from Studies 1 and 2 compared NexoBrid (n=177) to standard of care (SOC) (n=149). The SOC treatment included both surgical and non-surgical eschar removal methods. The most common adverse reactions in NexoBrid-treated patients (>10%) were pruritus (15%) and pyrexia (12%).

See Study Design 

Adverse Reactions Reported in ≥1% and Greater Incidence than SOC in NexoBrid-Treated Patients for Eschar Removal in DPT and/or FT Thermal Burns in Studies 1 and 2*

Patients n (%)
NexoBrid (N=177) 27 (15)
SOC† (N=149) 19 (13)

Patients n (%)
NexoBrid (N=177) 21 (12)
SOC† (N=149) 13 (9)

Patients n (%)
NexoBrid (N=177) 15 (9)
SOC† (N=149) 9 (6.0)

Patients n (%)
NexoBrid (N=177) 11 (6)
SOC† (N=149) 8 (5)

Patients n (%)
NexoBrid (N=177) 9 (5)
SOC† (N=149) 4 (3)

Patients n (%)
NexoBrid (N=177) 8 (5)
SOC† (N=149) 6 (4)

Patients n (%)
NexoBrid (N=177) 7 (4)
SOC† (N=149) 1 (1)

Patients n (%)
NexoBrid (N=177) 5 (3)
SOC† (N=149) 0 (0)

Patients n (%)
NexoBrid (N=177) 6 (3)
SOC† (N=149) 0 (0)

Patients n (%)
NexoBrid (N=177) 4 (2)
SOC† (N=149) 2 (1)

Patients n (%)
NexoBrid (N=177) 4 (2)
SOC† (N=149) 1 (1)

Patients n (%)
NexoBrid (N=177) 3 (2)
SOC† (N=149) 1 (1)

Patients n (%)
NexoBrid (N=177) 3 (2)
SOC† (N=149) 1 (1)

Patients n (%)
NexoBrid (N=177) 2 (1)
SOC† (N=149) 0

Patients n (%)
NexoBrid (N=177) 2 (1)
SOC† (N=149) 0

Patients n (%)
NexoBrid (N=177) 2 (1)
SOC† (N=149) 0

Patients n (%)
NexoBrid (N=177) 2 (1)
SOC† (N=149) 0

Patients n (%)
NexoBrid (N=177) 2 (1)
SOC† (N=149) 0

Patients n (%)
NexoBrid (N=177) 2 (1)
SOC† (N=149) 0
  NexoBrid
(N = 177)
 SOC†
(N = 149)
  Patients
n (%)		 Patients
n (%)
Pruritus 27 (15) 19 (13)
Pyrexia 21 (12) 13 (9)
Wound complication‡ 15 (9) 9 (6.0)
Anemia 11 (6) 8 (5)
Vomiting 9 (5) 4 (3)
Insomnia 8 (5) 6 (4)
Urinary tract infection 7 (4) 1 (1)
Tachycardia 5 (3) 0
Rash 6 (3) 0
Infection 4 (2) 2 (1)
Sepsis 4 (2) 1 (1)
Leukocytosis 3 (2) 1 (1)
Hypotension 3 (2) 1 (1)
Hepatic function abnormal 2 (1) 0
Drug hypersensitivity 2 (1) 0
Bacteremia 2 (1) 0
Scar 2 (1) 0
Subcutaneous hematoma 2 (1) 0
Decubitus ulcer 2 (1) 0

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of anacaulase-bcdb outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune system disorders: Hypersensitivity, including anaphylaxis and urticaria.

*During the time period from baseline to 3 months post wound closure.

†SOC treatment included both surgical and non-surgical eschar removal methods.

‡Wound complication includes skin graft failure, graft loss, graft complication, and wound decomposition.

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Clinical Efficacy

Review the Data 

Important Safety Information

Indication

NEXOBRID® (anacaulase-bcdb) is indicated for eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Limitations of Use

The safety and effectiveness of NEXOBRID have not been established for 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

NEXOBRID is not recommended for wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.

Important Safety Information

Contraindications

NEXOBRID is contraindicated in patients with: known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other components; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.

Important Safety Information

Indication

NEXOBRID® (anacaulase-bcdb) is indicated for eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Limitations of Use

The safety and effectiveness of NEXOBRID have not been established for 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

NEXOBRID is not recommended for wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.

Important Safety Information

Contraindications

NEXOBRID is contraindicated in patients with: known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other components; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.

Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarketing use of anacaulase-bcdb.

Pain Management

Manage pain as appropriate for an extensive dressing change of burn wounds. At least 15 minutes prior to NEXOBRID-related procedures ensure adequate pain control measures are in place.

Proteolytic Injury to Non-Target Tissues

NEXOBRID is not recommended for treatment of burn wounds where medical devices or vital structures could become exposed during eschar removal.

Coagulopathy

Avoid use of NEXOBRID in patients with uncontrolled disorders of coagulation. Use with caution in patients on anticoagulant therapy or other drugs affecting coagulation, and in patients with low platelet counts and increased risk of bleeding from other causes. Monitor patients for possible signs of coagulation abnormalities and signs of bleeding.

Adverse Reactions

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

Use in Special Populations
Geriatric Use

Clinical studies of NEXOBRID did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

To report negative side effects contact Vericel Corporation at 888-454-BURN (888-454-2876) or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

Please see Full Prescribing Information.

Reference: 1. NexoBrid Prescribing Information. Cambridge, MA. Vericel Corporation; 2023.