Kerydin

Drug overview for KERYDIN (tavaborole):

Generic name: TAVABOROLE (TA-va-BOR-ole)
Drug class: Topical Antifungals
Therapeutic class: Dermatological

Tavaborole, a boron-containing compound, is an oxaborole antifungal agent.

No enhanced Uses information available for this drug.

DRUG IMAGES

KERYDIN 5% TOPICAL SOLUTION

The following indications for KERYDIN (tavaborole) have been approved by the FDA:

Indications:
Toenail onychomycosis

Professional Synonyms:
Onychomycosis of toenail
Tinea unguium of toenail

The following dosing information is available for KERYDIN (tavaborole):

Dosing
Administration
Dosing Information
TAVABOROLE

No enhanced Dosing information available for this drug.

No enhanced Administration information available for this drug.

No dosing information available.

Generic dosing information for TAVABOROLE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
TAVABOROLE 5% TOPICAL SOLUTION	Maintenance	Adults apply to affected toenail(s) by topical route once daily

The following drug interaction information is available for KERYDIN (tavaborole):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 0 severe interactions.

There are 0 moderate interactions.

The following contraindication information is available for KERYDIN (tavaborole):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

The manufacturer states there are no known contraindications to use of tavaborole 5% topical solution.

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

The following adverse reaction information is available for KERYDIN (tavaborole):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in at least 1% of adults treated with tavaborole 5% topical solution and more frequently than with topical vehicle solution include application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis.

There are 1 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Contact dermatitis

There are 4 less severe adverse reactions.

More Frequent	Less Frequent
None.	Abnormal desquamation Erythema Ingrown fingernail or toenail Skin inflammation

Rare/Very Rare
None.

The following precautions are available for KERYDIN (tavaborole):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of tavaborole 5% topical solution have not been established in pediatric patients.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category C. (see Users Guide.)

It is not known whether tavaborole is distributed into human milk following topical application. The drug should be used with caution in nursing women.

Although no overall differences in safety or efficacy of tavaborole 5% topical solution were observed between geriatric and younger adults in clinical trials, the possibility of greater sensitivity of some older individuals cannot be ruled out.