Jublia

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

Jublia belongs to a group of drugs called azole antifungals. These work by stopping the growth of fungi that cause infections.

This medication comes in a topical solution that is applied to the affected toenail once daily for 48 weeks.

Common side effects of Jublia include ingrown toenails and application site redness, pain, and irritation.

Jublia is a prescription medication used to treat fungal infections of the toenails caused by Trichophyton rubrum and Trichophyton mentagrophytes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Valeant Pharmaceuticals, Inc.

Serious side effects have been reported with Jublia. See the “Jublia Precautions” section.

Common side effects of Jublia include the following:

• Ingrown toenails
• Application site redness or swelling
• Application site blisters
• Application site pain

This is not a complete list of Jublia side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been Jublia identified by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Jublia including the following:

• Ingrown toenails
• Application site redness or swelling
• Application site blisters
• Application site pain

Do not take if you:

• are allergic to Jublia or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Jublia, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Jublia, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Jublia or to any of its ingredients
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Jublia falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Jublia crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Jublia.

Take Jublia exactly as prescribed.

Jublia comes in a topical solution and is applied to the affected toenail once daily for 48 weeks.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Jublia at the same time.

Do not use nail polish or cosmetic nail products while using Jublia.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

The recommended dose of Jublia for the treatment of fungal infections of the toenail is one application daily for 48 weeks. When applying the solution, make sure to completely cover the toenail, the toenail folds, the toenail bed, and the undersurface of the toenail plate. 

If you take too much Jublia, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Jublia at room temperature.

Keep this and all medicines out of the reach of children.

Solution is flammable; keep away from heat or flame.

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