Tavaborole (Topical application)

Tavaborole (Topical application) is used to treat fungal or yeast infections of the toenails. This medicine works by killing the fungus or yeast, or preventing it from growing.

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

It is very important that your doctor check you or your child's progress at regular visits to make sure this medicine is working properly and to check for any unwanted effects.

If your toenail problem does not improve or if it becomes worse, check with your doctor.

Check with your doctor right away if you have itching, swelling, redness, or irritation at the application site.

In deciding to use a medicine, you and your doctor must weigh the risks of taking the medicine against its benefits. Here are some things to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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.

Pediatric

There have not been appropriate studies on the effects of tavaborole topical solution in children younger than 6 years old. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not found any specific problems in older adults that would limit the usefulness of tavaborole topical solution. However, older patients may be more sensitive to the effects of this medicine than younger adults.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to 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

Some medicines should not be used at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed 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 immediately if any of the following side effects occur:

Less common

• Blistering, burning, itching, pain, stinging, or redness at the application site
• ingrown toenail

Incidence not known

• Crusting, dryness, or flaking of the skin
• fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness or swelling
• redness of the skin
• scaling, severe redness, soreness, or swelling of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

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.

• Kerydin

Available Dosage Forms:

• Solution

Therapeutic Class: Antifungal

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.

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

This medicine is for use on the toenails and surrounding skin only. It is not for use in the eyes, mouth, or vagina.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply to the affected toenail(s) by using the dropper tip to gently spread to the entire toenail and surrounding skin. Also, apply the medicine under the entire tip of the toenail.
• Your toenails must be clean and dry when you put the medicine. Wipe away any excess solution from the surrounding skin. Let the medicine dry completely after you apply it.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Ask your doctor before you use nail polish or other nail products while you are being treated with this medicine.

This medicine is flammable. Do not use it near heat, an open flame, or while smoking.

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 (solution):For treatment of fungal infection of the toenails: Adults and children 6 years of age and older—Apply to the affected toenail(s) once a day for 48 weeks. Children younger than 6 years 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.

Throw away any unused medicine after 3 months of inserting the dropper.