Generic Name: efinaconazole
Date of Approval: June 6, 2014
Company: Valeant Pharmaceuticals North America LLC

Treatment for: Onychomycosis of the Toenails

FDA Approves Jublia

The U.S. Food and Drug Administration (FDA) has approved Jublia (efinaconazole 10% topical solution), a topical antifungal for the treatment of onychomycosis of the toenails.

Jublia (efinaconazole) is the first topical triazole antifungal agent. Oral triazole antifungals (such as fluconazole, itraconazole, posaconazole and voriconazole) are widely used for the treatment of systemic fungal infections, but of these, itraconazole (Sporanox, Onmel) is the only one approved for the treatment of onychomycosis. Like other approved oral prescription onychomycosis treatments such as griseofulvin and terbinafine (Lamisil), drug-drug interactions and side effects remain a concern.

Current over-the-counter or prescription topical treatments (such as ciclopirox (Penlac Nail Lacquer)) provide limited efficacy. Kerydin (tavaborole) approved in July 2014 became the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails.

Being a solution, Jublia is applied daily to the nail with a novel bottle that has a built-in flow-through brush applicator. It dries quickly and there is no need to remove excess product.

Side effects that have been reported are generally mild and transient, the most common being dermatitis at the site.

Jublia Patient Information

Important Information: Jublia is for use on toenails and surrounding skin only. Do not get Jublia in your mouth, eyes, or vagina.

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What is Jublia?

Jublia is a prescription medicine used to treat fungal infections of the toenails.

It is not known if it is safe and effective in children.

Before using Jublia

Before you use this treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if Jublia can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Jublia passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Jublia?

See the Instructions for Use at the end of this page.

Use exactly as your healthcare provider tells you to use it. Apply solution to your affected toenails one time each day. Wait for at least 10 minutes after showering, bathing, or washing before application. Treatment is for a period of 48 weeks.

What should I avoid?

The solution is flammable. Avoid heat and flame while applying the solution to your toenail. Avoid pedicures, use of nail polish, or cosmetic nail products, during treatment.

Jublia side effects

Jublia may cause irritation at the treated site. The most common side effects include: ingrown toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your healthcare provider if you have any side effects that bother you or that does not go away.

These are not all the possible side effects.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Storage information

Store at room temperature, between 68°F to 77°F (20°C to 25°C). Do not freeze .

Keep the bottle tightly closed and store in an upright position.

Keep away from heat and flame as solution is flammable.

Keep all medicines out of the reach of children.

General information

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about that is written for health professionals. Do not use it for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition you have. It may harm them.

What are the ingredients?

Active Ingredients: efinaconazole

Inactive Ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.

Instructions for Use

Important information: Jublia is for use on toenails and surrounding skin only. Do not use in your mouth, eyes or vagina.

Read the Instructions for Use that comes with product before you start using it. Talk to your healthcare provider if you have any questions.

How to apply:

Your toenails should be clean and dry before application.

Step 1: Remove the cap from the bottle.
Step 2: Hold the bottle directly over the affected toenail and gently squeeze the bottle to apply one drop of solution onto the toenail.
Step 3: For the big toenail, also apply a second drop to the end of the toenail.
Step 4: Use the brush attached to the bottle to gently spread solution around the entire toenail including: the cuticle, folds of the skin next to the sides of the toenail, and underneath the nail. Do not squeeze the bottle while spreading the solution with the brush.
Step 5: Repeat Steps 2 to 4 to apply solution to each affected toenail.
Step 6: Let solution dry completely.
Step 7: After applying solution to your affected toenails, place the cap on the bottle and screw it on tightly.
Step 8: Wash your hands with soap and water after application.