Tavaborole

Tavaborole is a prescription medication used to treat fungal infections of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if tavaborole crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using tavaborole.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Kerydin (tavaborole) is one application once a day to affected toenail(s) for 48 weeks.

If you use too much tavaborole, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Onychomycosis

Topical treatment of onychomycosis of the toenails (tinea unguium, ringworm of the nail) caused by Trichophyton rubrum or T. mentagrophytes.1

Contraindications

• Manufacturer states none.1

Warnings/Precautions

Sensitivity Reactions

May cause skin irritation;1 13 no evidence that the drug causes contact sensitization.1

Administration Precautions

For topical use only.1 Do not use orally or intravaginally;1 do not apply to eyes.1

Selection and Use of Antifungals

Prior to treatment of onychomycosis, confirm diagnosis by direct microscopic examination of scrapings from infected toenails mounted in potassium hydroxide (KOH) or by culture.8 9 10 11 12

Specific Populations

Category C.1

Not known whether distributed into human milk following topical application.1 Use with caution in nursing women.1

Safety and efficacy not established in pediatric patients.1

No overall differences in safety and efficacy in older adults relative to younger adults observed in clinical trials, but greater sensitivity of some older individuals cannot be ruled out.1

Common Adverse Effects

Application site exfoliation,1 ingrown toenail,1 application site erythema,1 application site dermatitis.1

• If you have an allergy to tavaborole or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tavaborole with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use tavaborole as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• To gain the most benefit, do not miss doses.
• Do not take this medicine by mouth. Use on your nails only. Keep out of your mouth, nose, and eyes (may burn).
• Before putting tavaborole on, clean the nails and dry well.
• Put this medicine on the whole nail and under the tip of each treated nail.
• Let dry before covering with clothing.
• Wash hands after use.
• This medicine may catch on fire. Do not use near an open flame or while smoking.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

Applies to tavaborole topical: topical application solution

Along with its needed effects, tavaborole topical 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 immediately if any of the following side effects occur while taking tavaborole topical:

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

Safety and efficacy have not been established in patients younger than 18 years.