Version May 2024
Onychomycosis: Children ≥6 years and Adolescents: Topical: Apply to affected toenail(s) once daily for 48 weeks.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment may not be necessary as systemic absorption is low.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment may not be necessary as systemic absorption is low.
(For additional information see "Tavaborole: Drug information")
Onychomycosis, mild to moderate:
Note: For patients with distal subungual onychomycosis involving ≤50% of the nail and sparing the matrix/lunula (Ref).
Topical: Apply to affected toenail(s) once daily for 48 weeks; ensure complete coverage of the toenail surface and under the tip of each affected toenail (Ref).
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Ingrown nail (3%)
Local: Local skin exfoliation (3%), application site erythema (2%), application-site dermatitis (1%)
<1%, postmarketing, and/or case reports: Allergic contact dermatitis
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse events:
• Local irritation: Persistent local irritation, erythema, exfoliation, or dermatitis may develop; instruct the patient to contact their health care provider if this occurs.
Dosage form specific issues:
• Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).
Other warnings/precautions:
• Appropriate use: For topical use only; avoid contact with eyes or mucous membranes. Avoid contact with skin (other than skin immediately surrounding treated toenail).
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Kerydin: 5% (4 mL, 10 mL) [contains edetate (edta) calcium disodium, propylene glycol]
Generic: 5% (4 mL, 10 mL)
Yes
Solution (Kerydin External)
5% (per mL): $181.30
Solution (Tavaborole External)
5% (per mL): $10.80 - $162.99
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical: For external use only; not for oral, ophthalmic, or intravaginal use. Avoid use near heat or open flame; product is flammable. Prior to application, affected toenails should be cleaned and dried. Apply solution using the provided dropper and completely cover affected toenail surface; more than 1 drop may be needed. Use the tip of the dropper to spread the solution to the edges of the toenail; also apply under the tip of each affected toenail. Avoid contact with skin other than skin surrounding the treated toenails; wipe away excess solution from surrounding skin and allow solution to dry. Wash hands with soap and water after application.
Topical: Affected toenails should be clean and dry. Apply to completely cover affected toenail surface using provided dropper; also apply under the tip of each affected toenail. Avoid contact with skin other than skin surrounding the treated toenails; wipe away excess solution from surrounding skin and allow solution to dry. Wash hands with soap and water after application.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep away from heat or flame. Discard bottle within 3 months of insertion of the dropper.
Treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum or Trichophyton mentagrophytes (FDA approved in ages ≥6 years and adults).
None known.
There are no known significant interactions.
Adverse events were observed in some animal reproduction studies.
Tavaborole is an oxaborole antifungal that inhibits fungal protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS).
Metabolism: Extensive
Excretion: Urine
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