Kerydin 5% Topical Solution 10ml
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 solution used to treat fungal infections of the toenails, also known as onychomycosis. It works by stopping the growth of the fungus. You apply it directly to your affected toenails once a day for a long period, usually 48 weeks.
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 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 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 skin around it.
- Wash hands immediately after applying the solution.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Do not ingest the solution.
- Allow the solution to dry completely before putting on socks or shoes.
- Keep nails trimmed and clean.
- Wear breathable footwear and change socks regularly.
- Avoid sharing nail clippers or files.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected toenails once daily for 48 weeks.
Condition-Specific Dosing:
onychomycosis:
Apply a thin layer of Kerydin 5% Topical Solution to the affected toenail(s) and the skin under and around the nail(s) once daily for 48 weeks. Ensure the entire nail plate, nail bed, and hyponychium are covered.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients under 18 years of age.)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Dialysis:
No dosage adjustment necessary; systemic exposure is minimal.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
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 fungal growth and replication.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption (plasma concentrations are very low after topical application).
Tmax:
Variable (due to low systemic absorption, Tmax is not clinically relevant for efficacy).
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not available (due to minimal systemic absorption).
ProteinBinding:
Approximately 99% (in vitro).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not precisely determined for systemic elimination due to low exposure; however, the effective half-life in the nail is prolonged.
Clearance:
Not precisely determined for systemic clearance due to low exposure.
ExcretionRoute:
Primarily renal (as metabolites).
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Gradual (clinical improvement observed over weeks to months).
PeakEffect:
Not applicable (clinical efficacy is observed over the 48-week treatment period).
DurationOfAction:
Sustained effect due to accumulation in the nail plate, but requires continuous application for 48 weeks for full efficacy.
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
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- 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
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about 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
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- 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
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about 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 reactions (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat - seek immediate medical attention).
- Worsening of the nail condition.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Do not start, stop, or change 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Do not start, stop, or change 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 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 breastfeeding, notify your doctor. 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:
- Not expected to cause systemic toxicity due to minimal absorption. Local irritation may occur with excessive application.
What to Do:
In case of accidental ingestion or significant irritation, contact a poison control center or seek medical attention. For accidental ingestion, call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of Onychomycosis
Rationale: Confirm fungal infection before initiating treatment.
Timing: Prior to treatment initiation
Assessment of affected nails
Rationale: To establish baseline severity and extent of infection.
Timing: Prior to treatment initiation
Routine Monitoring
Clinical assessment of nail appearance
Frequency: Periodically (e.g., every 3-6 months)
Target: Improvement in nail clarity, reduction in subungual debris, and healthy nail growth.
Action Threshold: Lack of improvement or worsening of condition may warrant re-evaluation of diagnosis or treatment adherence.
Symptom Monitoring
- Application site reactions (e.g., exfoliation, erythema, dermatitis, irritation)
- Ingrown toenail
- Pruritus
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of Kerydin 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 studies; human data lacking.
Second Trimester:
Potential risk based on animal studies; human data lacking.
Third Trimester:
Potential risk based on animal studies; human data lacking.
Lactation
It is not known whether tavaborole is excreted in human milk. Due to minimal systemic absorption, risk to a breastfed infant is considered low. Caution should be exercised when Kerydin is administered to a nursing woman.
Infant Risk:
Low risk (L3 - Moderately safe, no human data, low 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 for elderly 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 requires a long treatment duration (48 weeks) for optimal efficacy, emphasizing the importance of patient adherence.
- Cosmetic improvement of the nail may take time and may not be fully evident until the new, healthy nail grows out.
- Ensure patients understand proper application technique: covering the entire nail plate, nail bed, and hyponychium.
- This medication is for topical use only and should not be ingested or applied to other body parts.
- Patients should be advised to avoid using nail polish or other cosmetic nail products during treatment, as they may interfere with the medication's effectiveness.
Alternative Therapies
- Efinaconazole topical solution (Jublia)
- Ciclopirox topical solution (Penlac)
- Terbinafine oral (Lamisil)
- Itraconazole oral (Sporanox)
- Laser therapy for onychomycosis
- Surgical nail avulsion
Cost & Coverage
Average Cost:
Varies widely, typically high for brand-name topical solutions per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty drug, may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.