Jublia FAQ

WHAT IS JUBLIA (efinaconazole) ANTIFUNGAL TOPICAL NAIL SOLUTION?

Jublia is a FDA-approved, TOPICAL nail solution to treat  mild to moderate TOENAIL fungal infections in the immunocompetent patient.   Jublia is a nail solution brushed on the nail to treat toenail fungus infections, onychomycosis. The solution is applied on, around and under the toenail inorder to fight the fungus that lives beneath the nail. The active ingredient in Jublia Topical Solution is efinaconazole 10%, specifically formulated to reach the site of onychomycosis, to treat toenail fungus.  Unlike oral Lamisil tablets which can result in liver failure,  Jublia Topical Solution works from the outside directly on the nail fungus. Nail the infection from the outside in with Jublia Topical Nail solution prescription.

WHAT IS A NAIL FUNGUS INFECTION, ONYCHOMYCOSIS?

Onyhomycosis or nail fungus infection is a medical condition that is treatable. Nail fungal infections are caused by dermatophytes, a fungus that infects skin, nails and hair.  Jublia is FDA approved only for the treatment of TOENAIL infections. Most often the fungus enters just under the top of the nail and moves steadily toward the cuticle, the white half-moon area. The infected nails become discolored, yellowish-brown, thickened, and misshaped. Eventually, if left untreated, the nail separate from the nail bed and crumbles off.

WHO IS SUSCEPTIBLE to NAIL FUNGAL INFECTIONS?

Over 30 million Americans are affected.  Nail fungus infection is most commonly seen on the toenails of men and the fingernails of women. Most infections occur in those between the ages of 40 to 65 but anyone can become infected. Some individuals have an inherited tendency to have nail fungal problems. Also, individuals with a compromised immune system and certain types of long-term conditions such as HIV-positive, diabetes etc. are at an increased risk. The following are some environmental factors increasing the risk of nail fungal infections: Continuous exposure of hands and feet to moisture, shoes fitting too tightly, not changing shoes often enough, injury to toe or fingernail. Jublia is FDA approved for the treatment of TOENAIL fungus.

WHY DO I NEED TO TREAT A MILD NAIL INFECTION? IF LEFT UNTREATED WILL IT GO AWAY BY ITSELF?

Onychomycosis is a progressive fungal infection. The fungus destroys tissue and organic debris accumulates under the nail leading to nail changes beginning with slight thickening and discoloration. If left untreated the nail plate eventually separates from its nail bed and crumbles off and the infections spreads to other nails.  The condition progresses from what initially appears to just be a “cosmetic” discoloration of the nail to a painful debilitating condition affecting ones ability to walk.

WHO QUALIFIES FOR AN ONLINE JUBLIA CONSULTATION?

If you have previously been diagnosed by a health care profession as suffering from mild to moderate nail fungal infection (click here for photos of nail fungal infection)  you may finally have find a safe and simple solution to the embarrassing condition of discolored, thickened and hardened nails due to a fungal infection. Jublia antifungal nail solution is applied directly at the site of the fungal infection and may work for you when other treatments have failed.  Jublia prescription is not for those with severe fungal infections. Severe infections involve the entire nail including the white half moon area at the top of the nail. In mild to moderate infections, more than half of the nail may be affected but does NOT include the white half moon area at the top where it joins onto the finger. If you have many nails affected, the entire nail is involved, brittle and has lifted off from the nail bed and is accompanied by ulceration of surrounding skin and pain you do NOT qualify for an online consultation. You must seek immediate medical attention from your own physician.  If you have long-term conditions affecting your immune system such as diabetes, organ-transplant recipient, HIV-positive, regular user of steroids or steroid inhalers you do not qualify for an online consultation.

WHEN & HOW OFTEN DO I USE JUBLIA (efinaconazole) TOPICAL SOLUTION?

Jublia Topical Solution is applied only once a day for 48 weeks to the affected nails with the applicator brush provided.

Once daily, set a schedule
When you wake up in the morning
or After you shower*
or Just before bed

*Wait for at least 10 minutes after showering, bathing, or washing before applying JUBLIA.

HOW LONG BEFORE I SEE RESULTS?

Nail infections are very difficult to cure and it may take many months of treatment to see the effects as toenails grows very slowly. Toenails can take 12 months or longer to completely regrow. Additionally, the time it takes for a healthy nail to grow back varies from person to person. Even after the fungus has been eliminated, nail regrowth can sometimes take a year or longer.   But don’t despair and discontinue treatment if you do not see improvement right away. It may take six months or longer to start to see improvement. For a cure which is defined as 10% or less residual nail involement, 48 weeks of treatment is required.

HOW IS JUBLIA DIFFER FROM THAN OTHER NAIL FUNGAL TREATMENTS?

Nail fungus are very difficult to clear up and if left untreated will only progress.  Jublia (efinaconazole) Topical Solution differs from oral medications because it is applied directly to the site of the infected nail. Most importantly, Jublia does NOT have systemic effects.  Since antifungal nail treatment needs to be continued for many months, Jublia is advantageous as it has no systemic toxicity. Therefore, it is much better tolerated and safer than other available treatments.  Jublia is a NEW FDA-approved topical prescription treatment proven effective for treating mild to moderate TOENAIL fungal infections in immunocompetent candidates.  Jublia is NOT approved for fingernail infections.

HOW DOES JUBLIA DIFFER FROM PENLAC NAIL LACQUER

Ciclopirox nail lacquer (Penlac) was the only topical treatment approved by the Food and Drug Administration for the treatment of onychomycosis in the United States, until the Jublia was FDA approved. Penlac (ciclopirox) nail lacquer has reported complete cure rates of only 5.5-8.5%. Also, Penlac requires frequent nail debridement and patients have to use alcohol to remove excess buildup of lacquer to avoid additional infection. Jublia has shown complete cure rates of 15-17%.   Jublia solution represents the next generation of topical therapies for at-risk patients.

CAN JUBLIA TOPICAL SOLUTION BE USED WITH OTHER ANTIFUNGAL NAIL TREATMENTS OR BE USED WITH NAIL POLISH?

Jublia Topical solution is NOT recommended to be used with any other systemic antifungal agents for nail fungus infection as there are no studies to determine their interactions. Also DO NOT use nail polish, acrylic nails, or any other cosmetic nail products during treatment regimen with Jublia. Avoid pedicures, use of nail polish and cosmetic nail products while using JUBLIA.

WHAT IF I MISS A JUBLIA (efinaconazole) TOPICAL SOLUTION APPLICATION?

If you miss a Jublia (efinaconazole) Topical Solution application it is best to just skip the missed dose and continue on with your daily nail care regimen. Never double-up  or use a greater amount to make- up for missed dose, this may only enhance the likelihood of more severe skin irritations.

WHAT ARE THE SIDE EFFECTS OF JUBLIA (efinaconazole) TOPICAL SOLUTION?

Jublia Nail solution does not have systemic effects when used appropriately. There are No know drug interactions. As a result, laboratory monitoring is not needed. The majority of patients using Jublia Topical Solution experience no side effects, and any side effects are mild if any. The most common side effects seen in about 2% of patients during clinical trials were ingrown toenails, redness, itching, swelling, burning or stinging, blisters, and pain. Jublia may cause other side effects.

If nails start to change shape or you have prolonged swelling and pain around your nails, discontinue use and contact your regular doctor.

If you get the medication in your eyes, rinse immediately with water and seek immediate emergency treatment!

WHO SHOULD NOT USE Jublia NAIL LACQUER?

• Do NOT use Jublia (efinaconazole) Topical Solution if you are pregnant or attempting to become pregnant or breast feeding.
• Do NOT use on advanced severe fungal nail infections involving the entire nail
• Do NOT use Jublia on fingernails. Jublia FDA-approved for the treatment of TOENAIL FUNGAL infections ONLY!

We will not prescribe Jublia Topical Solution to anyone under the age of 18.

Before Proceeding to the Medical Consultation Form  please read
CONTRAINDICATIONS, PRECAUTIONS and WARNINGS
and accept the Waiver of Liability

CONTRAINDICATIONS

Jublia ANTIFUNGAL Topical Solution is a newly FDA-approved TOPICAL prescription medication for the treatment mild to moderate toenail fungal infections.  Jublia is NOT approved for fingernail fungal infections. Jublia use is CONTRAINDICATED and must NOT be used in anyone with the following conditions:

• Do NOT use Jublia if you are pregnant, attempting to become pregnant, or at a high risk of becoming pregnant. Jublia (efinaconazole) is a Pregnancy JUBLIA is pregnancy category C, and should be used during pregnancy.
• Do NOT use Jublia if you are breast feeding.
• Do NOT use Jublia if you are allergic or sensitive to any of the ingredients: efinaconazole in a solution base alcohol, butylated hydroxytoluene, C12-15 alkyl lactate, citric acid, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.
• Jublia is contraindicated if you have diabetes, diabetic neuropathy
• Jublia is contraindicated if you have a history of immunosuppression or immune system disease, if you are HIV-positive if you are on cancer chemotherapy treatment.
• Jublia is contraindicated if you are an organ or bone marrow transplant recipient.
• Jublia is contraindicated if you are taking anti-seizure medication to control epilepsy
• Jublia is contraindicated if use topical corticosteroids on a repeated monthly basis or you use steroid inhalers regular basis. There is a high potential for complications and superinfection.
• Do NOT use Jublia on advanced severe fungal nail injections involving the entire nail. If you have severe case of nail fungus infection involving the entire nail to the cuticle with the nail crumbling and lifting from the nail bed accompanied by pain, you need to been seen by your physician or a podiatrist.
• Jublia is NOT approved for pediatric use, and we do NOT prescribe Jublia to anyone under the age of 18
• Jublia is ONLY approved for use on toenails. Do NOT use on fingernails.
• Do NOT use in eyes, orally, on mucous membranes or in vaginal area.

IMPORTANT WARNINGS AND PRECAUTIONS

• Jublia Topical Solution is for EXTERNAL USE ONLY. Avoid getting Jublia in your eyes, nose or mouth. Flush with water and seek immediate medical attention!
• JUBLIA is for use on TOENAILS and surrounding skin only.
• Do NOT apply Jublia to other areas of skin or to fingernails.
• Do not use JUBLIA in your mouth, eyes, or vagina. Use it exactly as instructed by your physician.
• Do NOT use nail polish, artificial nails, or any other cosmetic nail product on the nails with Jublia Topical Solution.
• Do NOT combine topical Jublia Topical Solution with any other systemic antifungal NAIL treatment.
• If the area of application shows signs of increased irritation such as increased redness, swelling, burning, blistering, or oozing, DISCONTINUE USE and seek immediate medical attention from your regular physician.
• Jublia is to be used as part of a comprehensive nail care program.
• Jublia topical solution is flammable. Keep away from heat and flame. Avoid heat and flame while applying JUBLIA to your toenail.
• Keep away from children.
• If you get the medication in your eyes, rinse immediately with water and contact your regular physician or seek emergency medical treatment!
• There are NO systemic effects when used appropriately

JUBLIA is a topically applied solution with negligible systemic absorption and no liver monitoring required

• No need for patient counseling for potential liver toxicity
• No need for liver function tests
• In vitro liver enzyme studies show that drug interactions are not expected.

SIDE EFFECTS

The majority of patients using Jublia Topical Solution experience no side effects, any side effects are mild if any. The side effects, when used topically as directed, are limited to:

Adverse events reported by >1% of subjects in Phase 3 studies:

• Ingrown toenail (2.3% vs 0.7% with vehicle)
• Application-site dermatitis (2.2% vs 0.2% with vehicle)
• Application-site vesicles (1.6% vs 0% with vehicle)
• Application-site pain (1.1% vs 0.2% with vehicle)