Jublia

Toenail Fungal Infections

Jublia is specifically indicated for the treatment of onychomycosis, which is a fungal infection that affects the toenails. This condition can cause the nails to become thickened, brittle, ragged, or discolored.

Targeted Organisms

The medication is used to treat infections caused by specific types of fungi, including:

• Trichophyton rubrum
• Trichophyton mentagrophytes

It is intended for topical use only, meaning it is applied directly to the surface of the affected toenails and the skin immediately surrounding the nail. It is typically prescribed for adults and children aged 6 years and older who have been diagnosed with this specific type of fungal infection.

Mechanism of Action

Jublia contains efinaconazole, which belongs to a group of medicines called azole antifungals. It is designed to treat fungal infections of the toenails by targeting the specific biological processes the fungus needs to survive and grow.

How It Targets Fungus

The medication works by blocking the production of ergosterol, a vital component of the fungal cell membrane. Ergosterol acts similarly to cholesterol in humans, providing structure and integrity to the cell. Without enough ergosterol, the cell membrane becomes weak and develops holes, causing the fungal cell to break down and die.

Reaching the Infection

Because fungal infections often live deep within or under the nail, Jublia is formulated to penetrate the hard surface of the toenail. This allows the medicine to reach the nail bed where the infection is located. Key aspects of how it works include:

• Inhibition: It stops the specific enzyme responsible for building the fungal cell wall.
• Penetration: The solution is designed to pass through the nail plate to reach the site of the infection.
• Growth: By stopping the spread of the fungus, it allows a new, healthy nail to grow in over time to replace the infected nail.

Common Side Effects

Most side effects associated with Jublia are mild and occur at the site of application. These commonly include:

• Ingrown toenails
• Redness, itching, or swelling of the skin around the nail
• Blisters or small bumps
• Pain or tenderness
• Burning or stinging sensations

Serious Side Effects

Serious reactions to Jublia are rare. However, you should contact a healthcare provider immediately if you experience signs of a severe allergic reaction, such as:

• Hives or a widespread rash
• Swelling of the face, lips, tongue, or throat
• Trouble breathing or swallowing
• Severe dizziness

Proper Administration

Jublia is intended only for application to the toenails and the surrounding skin. It should not be used in the eyes, mouth, or vagina.

Flammability Warning

The solution is flammable. It should be kept away from heat, sparks, or open flames during application and until the medication has dried completely.

Local Skin Reactions

Some individuals may experience irritation at the site of application. Common local reactions include:

• Redness or swelling
• Itching
• Burning or stinging
• Blisters

If a severe skin reaction occurs, use of the medication should be paused and a healthcare provider consulted.

Use in Specific Populations

The safety and effectiveness of Jublia in pediatric patients under 6 years of age have not been established. There is limited evidence regarding the safety of this medication for individuals who are pregnant or breastfeeding.

Pregnancy

There are no adequate and well-controlled studies on the use of Jublia (efinaconazole) in pregnant women. In animal reproduction studies, high oral doses of efinaconazole were associated with developmental toxicity. However, the amount of medication absorbed into the bloodstream after topical application to the nails is very low in humans, which may limit the risk to a developing fetus. Because human data is unavailable, Jublia should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding

It is not known whether efinaconazole is excreted in human milk or if it has any effects on the breastfed infant or milk production. Because systemic absorption of the drug is minimal following topical application, the risk of significant exposure to a nursing infant is expected to be low. Patients should discuss the use of this medication with a healthcare provider to determine the most appropriate course of action while breastfeeding.

Available Forms

Jublia is supplied as a topical solution. It is a clear, colorless to pale yellow liquid intended for application to the toenails and the skin immediately surrounding the nail. It is not for use in the eyes, mouth, or vagina.

Strengths

This medication is available in the following strength:

• Topical solution: 10%

The solution is typically packaged in plastic squeeze bottles that feature an integrated brush applicator to help apply the medication to the affected area.

FDA Approval History

The U.S. Food and Drug Administration (FDA) first approved Jublia (efinaconazole) topical solution, 10% in June 2014. It was the first triazole antifungal approved for the topical treatment of toenail fungus.

Approved Indications

Jublia is indicated for the topical treatment of onychomycosis of the toenails caused by specific fungi, including:

• Trichophyton rubrum
• Trichophyton mentagrophytes

Initially approved for use in adults, the FDA expanded the approved indication in 2020 to include pediatric patients 6 years of age and older.

Regulatory Status and Safety

Jublia is available only by prescription. There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) associated with its use. The FDA has not issued any major safety communications or recalls for this medication since its initial approval.

Generic Availability

While the FDA has approved generic versions of efinaconazole topical solution, 10%, they may not be immediately available in all pharmacies due to patent protections and legal considerations. Currently, the medication is primarily available as the brand-name product Jublia.

Generic Availability

Jublia is currently available only as a brand-name medication. There is no FDA-approved generic version of efinaconazole topical solution at this time. Because brand-name drugs are protected by patents, generic alternatives are not expected to be available for several years, which typically keeps the retail price higher.

Insurance Coverage

Insurance plans vary in how they cover Jublia. Some insurance providers may classify it as a non-preferred drug, which can lead to higher co-pays. In some instances, insurance companies may require prior authorization or step therapy, where a patient must try less expensive antifungal treatments before the plan will cover Jublia.

Factors Influencing Price

The out-of-pocket cost for Jublia depends on several factors, including:

• The specific pharmacy and its location.
• The size of the bottle prescribed (typically 4 mL or 8 mL).
• Whether the patient is eligible for manufacturer savings cards or patient assistance programs.
• The details of an individual's prescription drug coverage or deductible status.

Patients without insurance or those with high-deductible plans may find the retail price to be substantial. Comparing prices at different pharmacies and checking for manufacturer-sponsored discounts may help manage these costs.