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Tavaborole

Medically reviewed by Drugs.com. Last updated on June 10, 2020.

Pronunciation

(ta va BOR ole)

Dosage Forms

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)

Brand Names: U.S.

  • Kerydin

Pharmacologic Category

  • Antifungal Agent, Topical

Pharmacology

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

Use: Labeled Indications

Onychomycosis: Topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Onychomycosis: Topical: Apply to affected toenail(s) once daily for 48 weeks.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Onychomycosis: Children ≥6 years and Adolescents: Topical: Apply to affected toenail(s) once daily for 48 weeks.

Administration

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.

Storage

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.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

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

Warnings/Precautions

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).

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies.

Patient Education

What is this drug used for?

• It is used to treat fungal infections of the toenails.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe application site irritation

• Ingrown toenail

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.