Anacaulase
Brand names: Nexobrid
Drug class:
Antineoplastic Agents , Antineoplastic Agents
Usage of Anacaulase
Anacaulase-bcdb has the following uses:
Anacaulase-bcdb is indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns.
The safety and effectiveness of anacaulase-bcdb 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; and burns in patients with significant cardiopulmonary disease, including inhalation injury.
Anacaulase-bcdb 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.
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How to use Anacaulase
General
Anacaulase-bcdb is available in the following dosage form(s) and strength(s):
Dosage
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Adults
Dosage and AdministrationWarnings
Contraindications
Warnings/Precautions
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarketing use of anacaulase-bcdb. If a hypersensitivity reaction occurs, remove anacaulase-bcdb (if applicable) and initiate appropriate therapy.
Anacaulase-bcdb is contraindicated in patients with a known hypersensitivity to anacaulase-bcdb, bromelain, pineapples or to any other component of anacaulase-bcdb. Anacaulase-bcdb is also contraindicated in patients with known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.
Healthcare personnel should take appropriate precautions to avoid exposure when preparing and handling anacaulase-bcdb (e.g., gloves, surgical masks, other protective coverings, as needed). In the event of inadvertent skin exposure, rinse the product off with water to reduce the likelihood of skin sensitization.
Pain Management
Eschar removal with anacaulase-bcdb and treatment-related burn wound procedures are painful and require adequate analgesia and/or anesthesia. Pain management should be appropriate for an extensive dressing change of burn wounds. At least 15 minutes prior to application ensure adequate pain control measures are in place to address anacaulase-related pain.
Proteolytic Injury to Non-target Tissues
Anacaulase-bcdb is not recommended for treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal.
Protect any open wounds (e.g., laceration, abraded skin and escharotomy incision) with skin protectant ointments or ointment gauze to prevent possible exposure to anacaulase-bcdb.
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-bcdb. In vitro and animal data suggest that bromelain can also promote fibrinolysis.
Avoid use of anacaulase-bcdb in patients with uncontrolled disorders of coagulation. Use anacaulase-bcdb 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., peptic ulcers and sepsis). Patients should be monitored for possible signs of coagulation abnormalities and signs of bleeding.
Specific Populations
PregnancyThere are no available data on anacaulase-bcdb use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% an 15 to 20%, respectively.
In embryofetal developmental studies in rats and rabbits, intravenous doses up to 4 and 0.1 mg/kg/day of anacaulase-bcdb were administered to pregnant rats and rabbits, respectively, during organogenesis. No significant developmental toxicities were observed in these studies. However, severe maternal toxicities were noted and the tolerable maternal exposure levels were much lower compared with the maximum human exposure in clinical setting.
LactationThere are no data on the presence of anacaulase-bcdb in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for anacaulase-bcdb and any potential adverse effects on the breastfed infant from anacaulase-bcdb or from the underlying maternal condition.
Pediatric UseThe safety and effectiveness of anacaulase-bcdb in pediatric patients have not been established.
Geriatric UseOf the 177 subjects exposed to anacaulase-bcdb for eschar removal in deep partial thickness (DPT) and/or full thickness (FT) thermal burns, 6 (3%) subjects were 65 years or older, and 1 (<1%) subject was 75 years or older. Clinical studies of anacaulase-bcdb did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
Common Adverse Effects
The most common adverse reactions (>10%) were pruritus and pyrexia.
What other drugs will affect Anacaulase
Specific Drugs
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Please see product labeling for drug interaction information.
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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