Nexobrid (Topical application)

Anacaulase-bcdb topical gel is used to remove eschar (dead tissue) in patients with deep partial thickness or full thickness thermal burns.

This medicine is to be used only by or under the direct supervision of your doctor.

It is very important that your doctor monitor your progress closely to ensure this medicine is working properly and to check for side effects.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and needs immediate medical attention. Contact your doctor right away if you experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against its benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of anacaulase-bcdb topical gel in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of anacaulase-bcdb topical gel.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or near mealtime or with certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to bromelain, pineapples, papayas, or papain—Should not be used in patients with this allergy.

• Bleeding problems or
• Uncontrolled blood clotting problems or
• Low platelet count—Use with caution. This may worsen these conditions.

• Wounds contaminated with radioactive and hazardous substances—Use is not recommended for patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Pale skin
• Trouble breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Less common

• Bladder pain
• Bloody or cloudy urine
• Blurred vision
• Confusion
• Cough or hoarseness
• Difficult, burning, or painful urination
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Eye pain
• Fast, pounding, or irregular heartbeat or pulse
• Fever or chills
• Frequent urge to urinate
• General feeling of illness
• Headache
• Lower back or side pain
• Sore throat
• Stomach pain
• Sweating

Incidence not known

• Chest tightness
• Difficulty swallowing
• Hives, itching, skin rash
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Trouble sleeping
• Vomiting

Less common

• Scar

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Nexobrid

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Dermatological Agent

Pharmacologic Class: Anacaulase

A nurse or other trained health professional will give you this medicine in a medical facility. It is applied on the skin only.

Your doctor may apply ointments to protect open wounds (eg, laceration, abraded skin, incision) before applying the gel.

• What is bromelain used for?