Prescribing Information

NexoBrid powder and gel for gel. Each pack contains 2g powder per vial and 20g gel per bottle or 5g powder per vial and 50g gel per bottle.

Qualitative and quantitative composition

One vial contains 2g or 5g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (2g/22g gel or 5g/55g gel). The proteolytic enzymes are a mixture of enzymes from the stem of Ananas comosus (pineapple plant).

Indication

NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns

Posology and method of administration

NexoBrid should only be applied by trained healthcare professionals in specialist burn centres. NexoBrid should not be applied to more than 15% Total Body Surface Area (TBSA). NexoBrid should be left in contact with the burn for duration of 4 hours. There is very limited information on the use of NexoBrid on areas where eschar remained after the first application. A second and subsequent application is not recommended.

Method of administration

Cutaneous use. Before use, the powder must be mixed with the gel producing a uniform gel. NexoBrid should be applied to a clean, keratin-free (blisters removed), and moist wound area. Topically applied medicinal products (such as silver sulfadiazine or povidone-iodine) at the wound site must be removed and the wound must be cleansed prior to NexoBrid application.

Contraindication

Hypersensitivity to the active substance, to pineapples or papain, or to any of the excipients.

List of excipients

NexoBrid powder: Ammonium sulphate, Acetic acid.
Gel: Carbomer 980; disodium phosphate anhydrous; Sodium hydroxide; Water for injections.

Special precautions

Concentrate of proteolytic enzymes enriched in bromelain is systemically absorbed from burn wound areas. NexoBrid is not recommended for use on penetrating burn wounds, chemical burn wounds, wounds contaminated with radioactive and other hazardous substances. NexoBrid should be used with caution in patients with cardiopulmonary and pulmonary disease. There is no experience of the use of NexoBrid on perineal and genital burns and electrical burns. There is no experience of the use of NexoBrid on perineal and genital burns; electrical burns. There is limited information on the use of NexoBrid on facial burn wounds.

 Prevention of wound complications

In NexoBrid studies wounds with visible dermal remnants were allowed to heal by spontaneous epithelialisation. In several cases adequate healing did not occur and autografting was required at a later date, leading to significant delays in wound closure which is associated with increased risk of wound-related complications. Therefore, wounds with areas of full-thickness and deep burn should be autografted as soon as possible after NexoBrid debridement. Careful consideration should also be given to placing permanent skin covers (e.g. autografts) on deep partial thickness wounds soon after NexoBrid debridement.

As in the case of surgically debrided bed, in order to prevent desiccation and/or formation of pseudoeschar and/or infection, the debrided area should be covered immediately by temporary or permanent skin substitutes or dressings. When applying a permanent skin cover (e.g., autograft) or temporary skin substitute (e.g., allograft) to a freshly enzymatically debrided area, care should be taken to clean and refresh the debrided bed by, e.g., brushing or scraping to allow dressing adherence

Hypersensitivity reactions, skin exposure

There are limited clinical data to assess the sensitisation potential of NexoBrid.

Allergic reactions to bromelain (including anaphylactic reactions and other immediate-type reactions with manifestations such as bronchospasm, angiooedema, urticaria, and mucosal and gastrointestinal reactions) have been reported in the literature. Suspected sensitisation following oral exposure and following repeated occupational airway exposure has been reported. In addition, a delayed-type allergic skin reaction (cheilitis) after longer-term dermal exposure (mouthwash) has been reported.- if too much the blue highlighted can be deleted

The potential of NexoBrid (a protein product) to cause sensitisation should be taken into account when re-exposing patients to bromelain-containing products at a later point in time. The use of NexoBrid in subsequent burn injury is not recommended.

In case of skin exposure, NexoBrid should be rinsed off with water to reduce the likelihood of skin sensitisation .

Cross-sensitivity

Cross-sensitivity between bromelain and papain as well as latex proteins (known as latex-fruit syndrome), bee venom, and olive tree pollen has been reported in the literature.

Coagulopthy

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NexoBrid should be used with caution in patients with disorders of coagulation, low platelet counts and increased risk of bleeding from other causes e.g. peptic ulcers and sepsis. Patients should be monitored for possible signs of coagulation abnormalities

Summary of the safety profile

The frequencies of the adverse reactions presented below reflect the use of NexoBrid in a regimen with local antibacterial prophylaxis, recommended analgesia, as well as coverage of the wound area after application of NexoBrid for 4 hours with an occlusive dressing for containment of NexoBrid on the wound. Very common adverse reactions: Pyrexia/hyperthermia. Common adverse reactions: Local pain, wound infection, wound complication.

Shelf life

3 years.

From a microbiological point of view and as the enzymatic activity of the product decreases progressively following mixing, the reconstituted product should be used immediately after preparation (within 15 minutes).

Special precautions for storage

Store and transport refrigerated (2°C‑8°C).

Store upright to keep the gel at the bottom of the bottle and in the original package to protect from light.

Do not freeze.

 

Marketing Authorisation Holder

MediWound GmbH, Germany. Authorisation number: EU/1/12/803/001 NexoBrid – 2g – Powder and gel for gel; EU/1/12/803/002 NexoBrid – 5g – Powder and gel for gel.