Kerydin

Generic Name: tavaborole
Date of Approval: July 7, 2014
Company: Anacor Pharmaceuticals, Inc.

Treatment for: Onychomycosis of the Toenails

FDA Approves Kerydin

The U.S. Food and Drug Administration (FDA) has approved Kerydin (tavaborole) topical solution, 5%, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails.

Patient Information

Important Information: Kerydin is for use on toenails only. Do not use Kerydin in your mouth, eyes, or vagina.

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What is Kerydin?

Kerydin is a prescription medicine used to treat fungal infections of the toenails.

It is not known if Kerydin is safe and effective in children.

Before using Kerydin

Before starting treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if Kerydin can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Kerydin passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the­counter medicines, vitamins, and herbal supplements.

How should I use Kerydin?

See the Instructions for Use at the end of this page.

  • Use exactly as your healthcare provider tells you to use it.
  • Apply solution to your affected toenails one time each day.
  • Treatment lasts for 48 weeks.

What should I avoid?

  • Avoid getting the solution on skin that is not surrounding the treated toenail.
  • Kerydin is flammable. Avoid heat and flame while applying the solution to your toenail.

Kerydin side effects

Kerydin may cause irritation at the treated site.

The most common side effects include: skin peeling, ingrown toenail, redness, itching, and swelling. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of Kerydin.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA­1088.

See also: Side effects (in more detail)

How should I store Kerydin?

  • Store at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Solution is flammable. Keep away from heat and flame.
  • Keep the bottle tightly closed.
  • Safely throw away remaining solution after three months of inserting the dropper.

Keep Kerydin and all medicines out of the reach of children.

General information about the safe and effective use

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Kerydin that is written for health professionals. Do not use Kerydin for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

Ingredients

Active ingredient: tavaborole

Inactive ingredients: alcohol, propylene glycol, and edetate calcium disodium

Instructions for Use

Read the Instructions for Use that comes with Kerydin before you start using it. Talk to your healthcare provider if you have any questions.

How to apply:

Your toenails should be clean and dry before you apply the solution.

Step 1:

Before you apply Kerydin to your affected toenail for the first time, remove the cap from the bottle and throw away the cap.

Step 2:

Remove the wrapping from the dropper and insert it into the bottle. Only apply Kerydin using the provided dropper. Do not use the dropper for any other purpose.

Step 3:

With the dropper inserted into the bottle, squeeze the bulb and then release the bulb to draw the solution into the dropper.

Step 4:

Remove the dropper from the bottle and hold the dropper tip over your affected toenail.

Step 5:

Slowly squeeze the bulb to apply the solution to your toenail. Apply enough solution to completely cover your toenail. You may need to use more than one drop.

Step 6:

Use the dropper tip to gently spread the solution to cover the entire toenail up to the edges of the toenail.

Step 7:

In addition to the top of the toenail, also apply the solution under the tip of the toenail. Use the dropper tip to gently spread the solution under the entire tip of the toenail.

Step 8:

Repeat Steps 3 to 7 to apply Kerydin to each affected toenail.

Step 9:

Let the solution dry completely. This may take a couple of minutes. If solution comes in contact with surrounding skin, carefully use a tissue to wipe any excess.

Step 10:

After applying Kerydin to your toenails, insert the dropper back into the bottle and screw it on tightly.

Step 11:

Wash your hands with soap and water after applying Kerydin.

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