Efinaconazole

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

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

Administration

Topical Administration

Apply 10% solution topically to affected toenails using flow-through brush applicator supplied by the manufacturer.1

Do not administer orally or intravaginally;1 do not apply topically to eyes.1

Clean and dry toenails prior to application; do not apply until ≥10 minutes after showering, bathing, or washing.1

Using the integrated flow-through brush applicator supplied by the manufacturer on the bottle, place 1 drop of solution on each affected toenail.1 Use attached brush applicator to gently spread solution evenly over entire toenail surface, including cuticle, folds of skin next to sides of toenail, toenail bed, hyponychium (thickened epidermis underneath toenail tip), and undersurface of toenail tip.1 For the big toenail, apply second drop at the end of the toenail.1 Do not squeeze applicator bottle while spreading solution over toenails.1

Allow solution to dry on the toenails.1

Wash hands with soap and water after applying the drug.1

Avoid pedicures and use of nail polish and other cosmetic nail products during efinaconazole treatment.1

Dosage

Adults

Apply 10% solution to affected toenails once daily for 48 weeks.1 Use amount sufficient to cover entire toenail surface and under toenail tip.1 (See Topical Administration under Dosage and Administration.)

Special Populations

No special population dosage recommendations.1

Storage

Topical

20–25°C (may be exposed to 15–30°C). 1 Do not freeze.1

The 10% solution contains alcohol and is flammable;1 do not store or use near heat or open flame.1

Keep bottle tightly closed.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before using nail polish or other nail products like fake nails while using efinaconazole.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Store upright at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Protect from heat or open flame.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take efinaconazole 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 brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to efinaconazole. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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

There are no contraindications listed in the U.S. manufacturer’s labeling.

Canadian labeling: Hypersensitivity to efinaconazole or any component of the formulation.

There are no known significant interactions.

Applies to efinaconazole topical: topical solution

Dermatologic

Common (1% to 10%): Ingrown toenail[Ref]

Local

Common (1% to 10%): Application site dermatitis, application site vesicles, application site pain[Ref]

Some side effects of efinaconazole topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.