Jublia

Pregnancy Category: C

Lactation: Unknown if distributed in human breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Adverse effects associated with the use of Jublia may include, but are not limited to, the following:

• Ingrown toenails
• Dermatitis
• Application site vesicles
• Inflammation
• Pain

Tell your doctor if you experience persistent irritation, such as redness, itching, or swelling in the area or surrounding areas where you apply Jublia.

If you develop any signs of an allergic reaction to Jublia (such as difficulty breathing; hives; swelling of the mouth, face, or throat), stop using the product and contact your doctor or get emergency medical help immediately.

Jublia comes in a topical solution, and contains 100 milligrams (mg) of efinaconazole in each gram of the clear, colorless (or pale yellow) solution.

Jublia is for topical use only and should not be taken orally or applied to any other area of the body.

The usual dose consists of applying Jublia once daily to clean, dry toenails for 48 weeks, using the bottle's flow-through brush applicator. Wait for at least 10 minutes after showering, bathing, or washing before you apply the solution.

When you're applying Jublia, make sure that you completely cover the entire toenail, the toenail folds, and the gap beneath the end of the toenail (also called the "quick" or hyponychium).

Children and Jublia

The safety and effectiveness of Jublia in children has not been established, so it might not be safe to apply the drug to children's toenails (or anywhere else). Keep Jublia out of the reach of children.

Geriatric Use of Jublia

Of the total number of subjects in clinical trials of Jublia, 11.3 percent were 65 years and over, and none were 75 years and over.

No overall differences in safety and effectiveness were seen between these subjects and younger subjects, and other studies have not identified any differences in responses to Jublia between older and younger subjects. However, it's possible that some older people may have greater sensitivity to Jublia.

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.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Efinaconazole topical is usually applied once daily for 48 weeks (approximately 11 months).

Before you apply this medicine, wash and thoroughly dry your toenails.

Apply this medicine over the entire toenail and under the tip of the nail. Allow the medicine to dry completely before putting on a sock or shoe.

After you apply efinaconazole topical, wait at least 10 minutes before you take a bath or shower.

Avoid getting this medicine on any other skin besides the cuticles or the skin around your toenail.

Call your doctor if your symptoms do not improve, or if they get worse while using efinaconazole topical.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Store in an upright position at room temperature, away from moisture and heat. Do not freeze.

Keep the bottle tightly closed when not in use.

Efinaconazole topical is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your nail.

• It is used to treat fungal infections of the toenails.

Use Jublia as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• To gain the most benefit, do not miss doses.
• Do not take this medicine by mouth. Use on your nails and the skin around your nails only. Keep out of your mouth, nose, ears, and eyes.
• Before putting Jublia on, clean the nails and dry well. Wait at least 10 minutes after you bathe, shower, or wash before putting this drug on.
• Wash your hands after use.
• This medicine may catch on fire. Do not use near an open flame or while smoking.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where this medicine is used.
• Ingrown toenail.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two clinical trials, 1227 subjects were treated with Jublia, 1161 for at least 24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of treatment and in at least 1% of subjects treated with Jublia and those reported in subjects treated with the vehicle are presented in Table 1.

Jublia (efinaconazole) topical solution, 10% is a clear colorless to pale yellow solution for topical use. Each gram of Jublia contains 100 mg of efinaconazole. Efinaconazole is an azole antifungal with a chemical name of ((2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl) butan-2-ol). The structural formula for efinaconazole is represented below:

Jublia contains the following inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.