Pronunciation:

an-a-KAW-lase - bcdb

Brand Names:

• Nexobrid

Dosage Forms:

• Gel/Jelly

Classifications:

Therapeutic—

Dermatological Agent

Pharmacologic—

Anacaulase

Uses of This Medicine:

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 given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of anacaulase-bcdb topical gel in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anacaulase-bcdb topical gel in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

• Bleeding problems or
• Blood clotting problems, uncontrolled or
• Low platelet count—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely to make sure this medicine is working properly and to check for unwanted effects.

This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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 or 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.