JUBLIA® (efinaconazole)
Jublia
Efinaconazole
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JUBLIA® (efinaconazole)

What is JUBLIA® (efinaconazole)?

JUBLIA® is a topical 10% solution of efinaconazole that is used to treat fungal infections (onychomycosis) of the toenails. It is available for prescription only. Efinaconazole has been approved for use in the US, Canada, and Japan and was approved in 2020 as a generic medication in the US, although generic products are not yet available.

The solution is a clear, colorless liquid in a small white bottle that has a flow-through brush applicator tip covered by a lid. It comes in 4 ml and 8 ml sizes.

How Does it Work?

Efinaconazole acts as a 14?-demethylase inhibitor – this is an enzyme that plays a key role in the metabolism of organic substances. Efinaconazole is an antifungal acting specifically on the Trichophyton rubrum and Trichophyton mentagrophytes fungal organisms that cause onychomycosis of the toenails.

Dosage

One drop of the medication should be applied to each affected toenail and its surrounding skin once a day.

How to Use Jublia

  1. Wash and dry your feet thoroughly, paying particular attention to your toenails.
  2. Clip and debride the nails if necessary.
  3. To ensure your nails are properly dry, wait for at least 10 minutes after washing, bathing, or showering to apply the medication.
  4. Remove the lid from the bottle of Jublia and hold the bottle upside down over the affected toenail. This moistens the brush at the end of the bottle with the medicated solution.
  5. There is no need to squeeze the bottle or press or rub the brush too hard against the toenail. This could cause too much medication to come out or damage the brush.
  6. Apply a drop to the affected nail and use the brush to spread the solution all over the nail. Try to get it into the cuticle, the side edges of the nail, and underneath the top edge. Do this for each affected nail.
  7. When you are finished, put the lid back on the bottle.
  8. The solution dries rapidly and should be completely dry before putting on socks and shoes.
  9. Wash your hands with soap and water to remove any traces of medication.
  10. The solution should be applied once a day for 48 weeks or as prescribed by your doctor.
  11. It is important to apply Jublia at the same time each day so try to make it a part of your daily routine. For instance, apply it before putting on your shoes and socks every morning or last thing at night before getting into bed.
  12. Even if you see an improvement after a few weeks of treatment, be sure to continue using it for the entire 48 weeks.
  13. Foot care specialists (podiatrists) recommend regular debridement of the nails with a file as the treatment proceeds. This helps the solution to penetrate the nail more effectively. They also recommend changing the socks daily and keeping the feet as dry as possible. Wear cotton or bamboo socks rather than nylon or other synthetic materials. Leather shoes are better than plastic as these allow the feet to “breathe”.

Storage

Store your bottle of Jublia upright in a cool, dry place. It should not be frozen. It is unnecessary to refrigerate the bottle unless you live in an extremely hot climate.

Dosage

For adults and children over the age of 6, a drop of Jublia should be applied with the applicator brush to the affected toenail. Be sure to completely cover the entire nail, nail folds, nail bed, cuticle, and underside of the toenail plate with each application.

Side Effects

  • Some people may have an allergic reaction to the product. Signs of this will include hives and problems with breathing such as tightness of the throat. Swelling of the face, lips, or tongue may occur. Seek emergency medical assistance if any of these reactions occur.
  • Some users have occasionally experienced inflammation and itching of the toe area around the nail. Discontinue the medication and contact your doctor immediately if you experience this.
  • More common side effects to Jublia include pain, inflammation, a burning or stinging sensation, or blistering of the application site. Ingrown toenails may sometimes occur.
  • Side effects can be reported to the FDA at 1-800-FDA-1088.

Warnings & Special Precautions

  • Jublia solution is flammable. Do not use it near a heat source or open flame.
  • Jublia is not for internal use. Do not apply it anywhere near the eyes, in the mouth, or the vagina. It must only be applied to toenails and the skin immediately surrounding them.
  • While using Jublia, do not have pedicures or apply cosmetic nail products such as polish or cuticle remover. Simply cut and file the toenails.
  • Ensure that you inform all of your healthcare providers about this and other medications you may be using as well as any allergies or medical conditions you may have.
  • If you have an allergy to efinaconazole, you should not use Jublia.
  • The effect of efinaconazole on the fetus is unknown. Inform your doctor if you are pregnant.
  • It is unknown whether efinaconazole is passed into the breastmilk. Inform your doctor if you are breastfeeding.
  • Jublia should not be used by children under the age of 6.

Interactions

Jublia has no known drug interactions.

Contraindications

  • Pregnant
  • Breastfeeding
  • Under 6 years old
  • Efinaconazole allergy

Frequently Asked Questions

Jublia is an efinaconazole solution that has been approved by the FDA for the treatment of toenail fungus. It is applied topically on and under the toenail and surrounding skin.

It is unknown if efinaconazole affects the fetus. Ask your doctor and leave it to his discretion whether you should proceed with treatment.

It is unknown whether efinaconazole passes through breastmilk. Please inform your doctor if you are breastfeeding or donating breastmilk.

No. Only small amounts are applied to the skin and very little of the active ingredient is absorbed into the bloodstream. Your doctor will not need to monitor your liver function while you are using this medication.

Only 2% of people using Jublia in one clinical trial got ingrown toenails, redness, itching, a burning or stinging sensation, or pain at the application site.

Jublia’s safety in children under 6 years has not been studied. Therefore, it is not recommended for this age group.

Pregnant and nursing mothers should use it at their doctor’s discretion.

In clinical studies, more than half of the participants were cured of fungal growth on their nails. About a quarter of participants had 5% or less of the affected toenail still with traces of fungal infection. The results of Jublia are better than most other topical antifungals.

Toenail fungal infections need time and patience to treat. An improvement in symptoms may be seen after a couple of weeks or months. However, the parts of the nail that have already been damaged cannot be repaired and will need to grow out and be cut off. If you use the medication daily, you will start to see healthy nail growth from the nail base.

Even if your nails look healthy, it is imperative to finish the entire 48-week course otherwise the fungus can return.

Efinaconazole is not especially effective in severe toenail fungal infections. These include those that have been in situ for a long period and are affecting the entire nail.

Clinical studies on Jublia were only done on participants with just 20-50% of the nail being affected.

If your fungal infection is severe, your doctor may prescribe an oral antifungal instead or use Jublia in conjunction with oral medication.

Your doctor will probably first prescribe an oral antifungal medication. If this is unsuccessful, laser therapy or surgery may be recommended. Sometimes the entire nail is removed if it is badly damaged or severely ingrown.

Although the FDA has approved a generic version of Jublia, there is currently no commercially available alternative. This is likely due to drug patents and exclusivity. However, there are other FDA-approved products with the same active ingredient as Jublia –

Topical efinaconazole solutions 10%:

  • Manufactured by ACRUX DDS
  • Manufactured by LUPIN LTD
  • Manufactured by TEVA PHARMS USA

Be careful when looking online for alternatives to Jublia as fraudulent online drug stores may try to sell you illegal generic versions. These are potentially harmful. Ask your doctor for advice before buying from an online pharmacy.

  • It gets better results than OTC antifungal preparations.
  • Jublia is a treatment of choice for those who don’t wish to take oral medication, use laser therapy, or have surgery.
  • Very little is absorbed into the bloodstream so the side effects are minimal when compared to oral antifungals.
  • The use of the medication prevents the fungal infection from spreading to other family members or those you come into contact with at the gym etc.

Under no circumstances should you attempt to skip doses or use the medication for less than 48 weeks. However, some users suggest that cutting the application brush shorter helps the product to last longer because less of it dries on the brush and gets wasted.

Yes, Jublia is safe for diabetics to use. Jublia boasts similar cure rates in studies for both diabetics and non-diabetics. Foot care is vital for diabetics as uncontrolled ulcers can lead to amputations.