tavaborole (Rx)

Brand and Other Names:Kerydin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution

  • 43.5mg/mL (0.5%)

Onychomycosis of the Toenail

Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum or Trichophyton mentagrophytes

Clean and dry nails prior to use; apply to completely cover nail surface and under tip of each nail being treated; allow solution to dry following application

Apply to affected toenails qDay for 48 weeks

Dosage Forms & Strengths

solution

  • 43.5mg/mL (0.5%)

Onychomycosis of the Toenail

<6 years

  • Safety and efficacy not established

≥6 years

  • Indicated for onychomycosis of toenail(s) due to Trichophyton rubrum or Trichophyton mentagrophytes
  • Clean and dry nails prior to use; apply to completely cover nail surface and under tip of each nail being treated; allow solution to dry following application
  • Apply to affected toenails qDay for 48 weeks
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Adverse Effects

1-10%

Application site exfoliation (2.7%)

Ingrown toenail (2.5%)

Application site erythema (1.6%)

Application site dermatitis (1.3%)

Postmarketing Reports

Hypersensitivity, contact allergy

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Warnings

Contraindications

None reported by manufacturer

Cautions

Not for oral, ophthalmic, or intravaginal use

Avoid contact with eyes, mouth, vagina, or skin immediately surrounding treated nail; wipe away excess solution from surrounding skin

Product is flammable; avoid use near heat or open flame

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Pregnancy & Lactation

Pregnancy

There are no available data on use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes; in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons in rats and embryofetal toxicity at 155 times the MRHD based on AUC comparisons in rabbits; embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the MRHD based on AUC comparisons

Lactation

There is no information available on presence in human milk, effects on breastfed infant or on milk production in women who are breastfeeding; drug is systemically absorbed; lack of clinical data during lactation precludes a clear determination of risk of therapy to a breastfed infant; therefore, the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

An oxaborole antifungal (boron-containing compound); inhibits protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS)

Elimination

Excretion: Urine (primarily)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Kerydin topical
-
5 % solution
Kerydin topical
-
5 % solution

Copyright © 2010 First DataBank, Inc.

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.