efinaconazole (Rx)

Brand and Other Names:Jublia
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical solution

  • 10%

Onychomycosis

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

Apply to affected toenail(s) qDay for 48 weeks using the integrated flow-through brush applicator

Dosage Forms & Strengths

topical solution

  • 10%

Onychomycosis

Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes in children aged ≥6 yr

<6 years: Safety and efficacy not established

≥6 years

  • Apply to affected toenail(s) qDay for 48 weeks using the integrated flow-through brush applicator
Next:

Adverse Effects

1-10%

Ingrown toenail (2.3%)

Application site dermatitis (2.2%)

Application site vesicles (1.6%)

Application site pain (1.1%)

Previous
Next:

Warnings

Contraindications

None

Cautions

For topical use only

Not for oral, ophthalmic, or intravaginal use

Instruct patient to avoid using nail polish or cosmetic nail products

Persistent local pain, irritation, or dermatitis may develop; contact health provider if it occurs

Previous
Next:

Pregnancy & Lactation

Pregnancy

Data are not available for use during pregnancy to inform any drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Animal data

  • In animal reproduction studies, efinaconazole did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during organogenesis at SC doses up to 112 and 154 times, respectively, the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparisons

Lactation

Unknown if excreted in human milk; after repeated SC administration, efinaconazole was detected in milk of nursing rats

Consider developmental and health benefits of breastfeeding, along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant from drug

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.

Previous
Next:

Pharmacology

Mechanism of Action

Triazole antifungal agent; inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes

Pharmacokinetics

Peak plasma concentration (day 28): 0.67 ng/mL

AUC: 12.15 ng•h/mL

Metabolism: Neither inhibits nor induces CYP450 enzymes

Half-life (day 7): 29.9 hr

Previous
Next:

Administration

Topical Administration

For topical use only; not for oral, ophthalmic, or intravaginal use

When applying with flow-through brush applicator, ensure toenail, toenail folds, toenail bed, hyponychium, and undersurface of toenail plate are completely covered

Storage

Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

Solution is flammable; keep away from heat or flame

Protect from freezing

Keep out of reach of children

Keep bottle tightly closed

Store in upright position

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.