Crisaborole (Topical application)

Crisaborole (Topical application) is used to treat mild to moderate atopic dermatitis (eczema).

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks how you or your child are doing at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not get better within a few days, or if they get worse, contact your doctor.

This medicine may cause serious allergic reactions, including contact urticaria. Contact your doctor immediately if you or your child have a skin rash, severe itching, burning, redness, stinging, swelling, or irritation on the skin where the medicine is applied.

Do not use cosmetics or other skin care products on the treated areas.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. Here are some important points to think about for this medicine:

Allergies

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

Pediatric

So far, studies have not shown any specific problems in children that would limit the use of crisaborole ointment. However, safety and effectiveness have not been proven in children younger than 3 months old.

Geriatric

Studies on how age affects the effects of crisaborole ointment have not been done in older adults. No specific problems have been reported in this age group so far.

Interactions with Medicines

While some medicines should not be used together, in other situations, two different medicines can be used together even if there might be an interaction. In these cases, your doctor may adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk with your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Infection of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site—These conditions may increase the risk of side effects.

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

Check with your doctor right away if any of the following side effects occur:

Less common

• Burning, pain, redness, stinging, swelling, or skin irritation where the medicine is applied
• Difficulty with breathing or swallowing
• Fast heartbeat
• Hives or welts, itching, or skin rash
• Swelling of the face, throat, or tongue

Incidence not known

• Blistering, crusting, dryness, flaking, scaling, or soreness of the skin

Other side effects not listed may also happen 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.

• Eucrisa

Available Dosage Forms:

• Ointment

Therapeutic Class: Dermatological Agent

Pharmacologic Class: Phosphodiesterase Inhibitor

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use the ointment:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (ointment):For mild to moderate atopic dermatitis: Adults and children 3 months of age and older—Apply a thin layer to the affected area of the skin 2 times a day. Your doctor may adjust your dose (apply once a day) as needed. Children younger than 3 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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