Kerydin 5% Topical Solution 4ml
It is used to treat fungal infections of the toenails.
Drug Class
Antifungal
Pharmacologic Class
Oxaborole antifungal
Pregnancy Category
Category C
FDA Approved
Jul 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Kerydin is a topical medicine used to treat fungal infections of the toenails, called onychomycosis. It works by stopping the fungus from growing and spreading, allowing healthy nail to grow in.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your nails, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and eyes, as it may cause irritation or burning.
Before applying the medication, clean and dry your nails thoroughly.
Apply the medication to the entire nail surface and under the tip of each treated nail.
Allow the medication to dry completely before covering the area with clothing.
Wash your hands after applying the medication.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms.
Protect the medication from heat and open flames.
Discard any unused medication 3 months after first opening the dropper.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your nails, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and eyes, as it may cause irritation or burning.
Before applying the medication, clean and dry your nails thoroughly.
Apply the medication to the entire nail surface and under the tip of each treated nail.
Allow the medication to dry completely before covering the area with clothing.
Wash your hands after applying the medication.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms.
Protect the medication from heat and open flames.
Discard any unused medication 3 months after first opening the dropper.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply the solution to the entire toenail, including under the nail and the cuticle area, once daily.
- Allow the solution to dry completely before putting on socks or shoes.
- Avoid contact with eyes, mouth, and nose. If contact occurs, rinse thoroughly with water.
- Do not use on fingernails unless directed by a doctor.
- Keep nails trimmed and clean.
- Wear breathable footwear and change socks daily.
- Avoid sharing nail clippers or files.
- Be patient, as treatment for toenail fungus can take a long time (up to 48 weeks) to see full results because nails grow slowly.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected toenails once daily for 48 weeks.
Condition-Specific Dosing:
onychomycosis:
Apply to affected toenails once daily for 48 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment recommended due to minimal systemic absorption.
Moderate:
No dosage adjustment recommended due to minimal systemic absorption.
Severe:
No dosage adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific recommendations; minimal systemic absorption makes dialysis unlikely to be relevant for drug removal.
Hepatic Impairment:
Mild:
No dosage adjustment recommended due to minimal systemic absorption.
Moderate:
No dosage adjustment recommended due to minimal systemic absorption.
Severe:
No dosage adjustment recommended due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Tavaborole is an oxaborole antifungal that inhibits fungal leucyl-tRNA synthetase (LeuRS). LeuRS is an enzyme essential for protein synthesis in fungi. By inhibiting LeuRS, tavaborole prevents the incorporation of leucine into fungal proteins, leading to the inhibition of protein synthesis and ultimately fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption (Cmax < 1 ng/mL after topical application)
Tmax:
Not applicable for systemic effect; local concentration is key.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not extensively distributed systemically due to low absorption.
ProteinBinding:
Not extensively studied due to low systemic levels; likely low.
CnssPenetration:
Limited/No (due to low systemic absorption).
Elimination:
HalfLife:
Not well-defined for systemic elimination due to low absorption; local half-life in nail is prolonged.
Clearance:
Not clinically relevant due to minimal systemic absorption.
ExcretionRoute:
Primarily renal excretion of unchanged drug if systemically absorbed.
Unchanged:
Not applicable for systemic; primarily unchanged in nail.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed over several weeks to months.
PeakEffect:
Full therapeutic effect may take 48 weeks (duration of treatment).
DurationOfAction:
Effect persists as long as treatment continues and nail grows out.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Ingrown toenail
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the drug was applied
Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Ingrown toenail
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the drug was applied
Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe irritation, redness, or swelling at the application site
- Allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue)
- Pain or discomfort that worsens
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using nail polish or any other nail care products, such as artificial nails, consult with your doctor to discuss any potential interactions. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor immediately. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption.
What to Do:
If accidental ingestion occurs, contact a poison control center (Call 1-800-222-1222) or seek medical attention immediately. For topical overdose, wash the area with soap and water.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of Onychomycosis
Rationale: Confirm fungal infection before initiating treatment.
Timing: Prior to starting treatment
Assessment of affected nails
Rationale: To establish baseline severity and extent of infection.
Timing: Prior to starting treatment
Routine Monitoring
Clinical assessment of nail improvement
Frequency: Every 3-6 months during treatment
Target: Visible reduction in affected nail area, clearer nail growth.
Action Threshold: Lack of improvement or worsening may warrant re-evaluation of diagnosis or treatment adherence.
Adverse reactions (e.g., application site reactions)
Frequency: At each follow-up visit
Target: Absence or mildness of reactions.
Action Threshold: Severe irritation, pain, or allergic reactions may require discontinuation.
Symptom Monitoring
- Nail discoloration
- Nail thickening
- Nail brittleness
- Subungual debris
- Pain or discomfort at application site
- Ingrown toenail
- Dermatitis around the nail
Special Patient Groups
Pregnancy
Tavaborole is Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; human data lacking.
Second Trimester:
Potential risk based on animal data; human data lacking.
Third Trimester:
Potential risk based on animal data; human data lacking.
Lactation
It is not known whether tavaborole is excreted in human milk. Due to minimal systemic absorption, the risk to a breastfed infant is considered low. Caution should be exercised when administering to a nursing mother.
Infant Risk:
Low risk (L3) due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients under 18 years of age have not been established.
Geriatric Use
No dosage adjustment is necessary in geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, but no overall differences in safety or effectiveness were observed.
Clinical Information
Clinical Pearls
- Kerydin is a topical treatment for onychomycosis, which requires consistent daily application for up to 48 weeks for optimal results.
- Patients should be advised that complete clearance of the nail may not occur and that treatment aims to improve the appearance of the nail.
- Ensure patients understand the importance of applying the solution to the entire nail plate, including the nail fold, nail bed, and hyponychium (under the nail).
- Due to its low systemic absorption, Kerydin has a favorable safety profile with minimal drug-drug interactions.
- Consider adjunctive measures like proper foot hygiene, breathable footwear, and regular nail trimming to enhance treatment outcomes and prevent recurrence.
Alternative Therapies
- Efinaconazole (Jublia) topical solution
- Ciclopirox (Penlac) topical solution
- Terbinafine (Lamisil) oral tablets
- Itraconazole (Sporanox) oral capsules
- Laser therapy for onychomycosis
- Nail avulsion (surgical removal of the nail)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per 4ml bottle
Insurance Coverage:
Specialty Tier (often requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.