Efinaconazole

Efinaconazole is a prescription medicine used for the topical treatment of onychomycosis of the toenail(s) caused due to Trichophyton rubrum and Trichophyton mentagrophytes.

• Efinaconazole is available under the following different brand names: Jublia

Common side effects of Efinaconazole include:

• ingrown toenail
• inflammation
• pain
• blisters at the application site

Serious side effects of Efinaconazole include:

• hives
• difficulty breathing 
• swelling of the face, lips, tongue, or throat
• severe redness, itching, or swelling of the affected toenail

Rare side effects of Efinaconazole include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical solution

• 10%

Onychomycosis

Adult dosage

• Apply to affected toenail(s) once a day for 48 weeks using the integrated flow-through brush applicator

Pediatric dosage

• Children aged younger than 6 years: Safety and efficacy not established.
• Children aged 6 years and older
• Apply to affected toenail(s) once a day for 48 weeks using the integrated flow-through brush applicator.

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Efinaconazole has no noted severe interactions with any other drugs.
• Efinaconazole has no noted serious interactions with any other drugs.
• Efinaconazole has no noted moderate interactions with any other drugs.
• Efinaconazole has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Efinaconazole?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Efinaconazole?”

Cautions

• For topical use only
• Not for oral, ophthalmic, or intravaginal use
• Instruct the patient to avoid using nail polish or cosmetic nail products
• Persistent local pain, irritation, or dermatitis may develop; contact a healthcare provider if it occurs

Pregnancy and Lactation

• Data are not available on the drug’s use during pregnancy to evaluate any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • Unknown if efinaconazole is excreted in human milk; after repeated subcutaneous administration, the drug was detected in the milk of nursing rats
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infants from the drug