Anacaulase

Anacaulase is a topical gel used for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. 

• Anacaulase is available under the following different brand names: NexoBrid, anacaulase-bcdb

Common side effects of Anacaulase include:

• itching,
• fever,
• wound complications,
• anemia,
• vomiting,
• insomnia,
• urinary tract infection (UTI),
• fast heart rate, and
• rash.

Serious side effects of Anacaulase include:

• hives,
• difficulty breathing, and
• swelling of the face, lips, tongue, or throat,
• wound complication,
• anemia,
• urinary tract infection,
• fast or irregular heart rate,
• rash,
• bacteremia,
• scarring,
• bruising,
• fever,
• chills,
• sore throat,
• dizziness,
• fatigue,
• flushing,
• low body temperature,
• confusion,
• shortness of breath,
• little or no urination,
• sleepiness,
• skin discoloration,
• low blood pressure,
• abnormal blood values (Leukocytosis, Hepatic function),
• pressure ulcer,
• abdominal pain,
• nausea,
• diarrhea,
• vomiting, and
• difficulty sleeping (insomnia)

Rare side effects of Anacaulase include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Topical gel

• 8.8% topical gel as single-dose kits
• Supplied as lyophilized powder and gel that is mixed together before application
• 2 g of lyophilized powder (containing 1.94 g of anacaulase) mixed in 20 g gel vehicle
• 5 g lyophilized powder (containing 4.85 grams of anacaulase) mixed in 50 g gel vehicle

Eschar Removal

Adult dosage

• Dose
  • Determine dose by percent of affected body surface area (BSA)
  • BSA 1%: 2 g of lyophilized powder (containing 1.94 g of anacaulase) mixed in 20 g gel vehicle
  • BSA 2.5%: 5 g lyophilized powder (containing 4.85 grams of anacaulase) mixed in 50 g gel vehicle
• Regimen
  • Applied in up to 2 applications of 4 hours each
  • First application: May apply to an area up to 15% BSA
  • Second application: May be applied 24 hr later
  • Total treated area for both applications must not exceed 20% BSA

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Anacaulase has no noted severe interactions with any other drugs.
• Anacaulase has no noted serious interactions with any other drugs.
• Anacaulase has no noted moderate interactions with any other drugs.
• Anacaulase has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to anacaulase, bromelain, pineapples, or to any other components
• Hypersensitivity to papayas or papain because of the risk of cross-sensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Anacaulase?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Anacaulase?”

Cautions

• Eschar removal with anacaulase and treatment-related burn wound procedures are painful and require adequate analgesia and/or anesthesia; apply appropriate pain management for an extensive dressing change of burn wounds; ensure adequate pain control is in place at least 15 minutes before application
• Not recommended for treatment of burn wounds where medical devices (eg, implants, pacemakers, shunts) or vital structures (eg, large vessels); protect any open wounds (e.g., laceration, abraded skin and escharotomy incision) with skin protectant ointments or ointment gauze
• Coagulopathy
  • A reduction of platelet aggregation and plasma fibrinogen levels and a moderate increase in partial thromboplastin and prothrombin times have been reported in the literature as possible effects following oral administration of bromelain, a component of anacaulase
  • Avoid use 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 (e.g., septic ulcers, sepsis)
  • Monitor for possible signs of coagulation abnormalities and signs of bleeding
• Hypersensitivity reactions
  • Serious hypersensitivity reactions, including anaphylaxis, reported
  • If a hypersensitivity reaction occurs, remove anacaulase (if applicable) and initiate appropriate therapy
  • When preparing and handling drugs, take appropriate precautions (e.g., gloves, surgical masks, other coverings) as needed
  • If inadvertent skin exposure occurs, rinse the drug off with water to reduce the likelihood of skin sensitization
• Drug interaction overview
  • No drug interaction studies conducted
  • Bromelain, a component of anacaulase, exhibited CYP2C8 time-dependent inhibition in human hepatocytes and inhibited human microsomal CYP2C9

Pregnancy and Lactation

• Data are not available on use in pregnant females to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• Lactation
  • There are no data on the presence in either human or animal milk, its effects on breastfed infants, or its effects on milk production