Kerydin

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use tavaborole topical if you are allergic to it.

FDA pregnancy category C. It is not known whether tavaborole topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether tavaborole topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe redness, swelling, or other irritation of the affected toenail.

Common side effects may include:

• skin peeling or redness where the medicine was applied;

• itching; or

• ingrown toenail.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Storage

Topical

20–25°C (may be exposed to 15–30°C).1

The 5% solution contains alcohol and is flammable;1 do not store or use near heat or open flame.1

Keep bottle tightly closed;1 discard bottle within 3 months after insertion of dropper.1

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this medicine is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from heat or open flame.
• Store in a dry place. Do not store in a bathroom.
• Throw away any part of Kerydin not used 3 months after first putting in the dropper.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

In vitro studies have shown that tavaborole, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral carcinogenicity study in Sprague-Dawley rats, oral doses of 12.5, 25, and 50 mg/kg/day tavaborole were administered to rats once daily for 104 weeks. No drug related neoplastic findings were noted at oral doses up to 50 mg/kg/day tavaborole (14 times the MRHD based on AUC comparisons).

In a dermal carcinogenicity study in CD-1 mice, topical doses of 5%, 10%, and 15% tavaborole solution were administered to mice once daily for 104 weeks. No drug related neoplastic findings were noted at topical doses up to 15% tavaborole solution (89 times the MRHD based on AUC comparisons).

Tavaborole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (rat micronucleus assay).

No effects on fertility were observed in male and female rats that were administered oral doses up to 300 mg/kg/day tavaborole (107 times the MRHD based on AUC comparisons) prior to and during early pregnancy.

See FDA-approved patient labeling (Patient Information and Instructions for Use)

The patient should be told the following:

• Use Kerydin as directed by a health care professional.
• Kerydin is for external use only. Avoid contact with eyes, mouth, or vagina. Avoid contact with skin other than skin immediately surrounding the treated nail(s). Wipe away excess solution from surrounding skin.
• Clean and dry nails prior to Kerydin use. Kerydin should be applied to completely cover the nail surface and also applied under the tip of each nail being treated. Allow solution to dry following application.
• The impact of nail polish or other cosmetic nail products on the efficacy of Kerydin has not been evaluated.
• Inform a health care professional if the area of application shows signs of persistent irritation (for example, redness, itching, swelling).
• Forty-eight (48) weeks of daily application with tavaborole is considered the full treatment for toenail onychomycosis.
• Do not use Kerydin for any disorder other than that for which it is prescribed.
• Product is flammable. Avoid use near heat or open flame.

________________________________________________________________________

Manufactured for:
Anacor Pharmaceuticals, Inc.
Palo Alto, CA 94303 USA

Distributed by:

A division of Fougera Pharmaceuticals Inc.

Melville, New York 11747 USA

Issued: 03/2015

Kerydin® is a trademark of Anacor Pharmaceuticals, Inc.
© 2015 Anacor Pharmaceuticals, Inc.

U.S. Patent Nos. 7,767,657 and 7,582,621

Instructions for Use
Kerydin® (ker' i din)
(tavaborole) Topical Solution, 5%

Read the Instructions for Use that comes with Kerydin before you start using it. Talk to your healthcare provider if you have any questions.

How to apply Kerydin:

Your toenails should be clean and dry before you apply Kerydin.

Step 1: Before you apply Kerydin to your affected toenail for the first time, remove the cap from the Kerydin bottle. (See Figure A) Throw away the cap.

Step 2: Remove the wrapping from the dropper that comes with Kerydin. Insert the dropper into the Kerydin bottle. (See Figure B)

Figure A                                                                  Figure B

Only apply Kerydin using the provided dropper. Do not use the dropper for any other purpose.

Step 3: With the dropper inserted into the Kerydin, squeeze the bulb and then release the bulb to draw Kerydin into the dropper.

Step 4: Remove the dropper from the bottle and hold the dropper tip over your affected toenail.

Step 5: Slowly squeeze the bulb to apply Kerydin to your toenail. Apply enough solution to completely cover your toenail. You may need to use more than one drop. (See Figure C)

Figure C

Step 6: Use the dropper tip to gently spread Kerydin to cover the entire toenail up to the edges of the toenail. (See Figure D)

Figure D

Step 7: In addition to the top of the toenail, also apply Kerydin under the tip of the toenail. Use the dropper tip to gently spread Kerydin under the entire tip of the toenail. (See Figures E and F)

Figure E                                                                  Figure F

Step 8: Repeat Steps 3 to 7 to apply Kerydin to each affected toenail.

Step 9: Let the Kerydin dry completely. This may take a couple of minutes.

If Kerydin comes in contact with surrounding skin, use a tissue to wipe any excess solution from the surrounding skin. Do not wipe Kerydin off of your toenails.

Step 10: After applying Kerydin to your toenails, insert the dropper back into the bottle and screw it on tightly.

Step 11: Wash your hands with soap and water after applying Kerydin.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for: Anacor Pharmaceuticals, Inc., Palo Alto, CA, 94303 USA
Distributed by: PharmaDerm®, a division of Fougera Pharmaceuticals, Inc., Melville, New York 11747 USA
Issued: 03/2015

Principal Display Panel - Representative Packaging

PharmaDerm® NDC 10337-905-10

Kerydin™
(TAVABOROLE)

TOPICAL SOLUTION, 5%

For Topical Use Only

Not for oral, ophthalmic,
or intravaginal use

10 mL

Rx only

An overdose of Kerydin is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Applies to tavaborole topical: topical solution

Dermatologic

Common (1% to 10%): Application site exfoliation, ingrown toenail, application site erythema, application site dermatitis[Ref]

Potential for skin irritation; no evidence of contact sensitization.[Ref]

Some side effects of Kerydin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.