Tavaborole 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?
Tavaborole is a topical solution used to treat fungal infections of the toenails, called onychomycosis. It works by stopping the growth of the fungus. You apply it directly to your affected toenails once a day.
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, 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's 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, 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's 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 clean, dry nails.
- Ensure the entire nail surface, nail bed, and underside of the nail are covered.
- Allow the solution to dry completely before putting on socks or shoes.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use on open wounds or irritated skin.
- Wash hands thoroughly after application.
- Do not use nail polish or other cosmetic nail products on treated nails unless advised by your doctor.
- Trim nails regularly and keep feet clean and dry to help prevent reinfection.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected toenails and surrounding skin once daily for 48 weeks.
Condition-Specific Dosing:
onychomycosis:
Apply a thin layer to the entire toenail surface, the toenail bed, and the underside of the toenail, as well as the skin folds surrounding the toenail. Allow to dry for several minutes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 6 years of age)
Adolescent:
Apply to affected toenails and surrounding skin once daily for 48 weeks (for patients 6 years of age and older)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Tavaborole is an oxaborole antifungal that inhibits fungal protein synthesis by inhibiting fungal leucyl-tRNA synthetase (LeuRS). This inhibition prevents the acylation of tRNAleu, which is essential for protein synthesis, leading to the disruption of fungal growth and replication.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 0.5% of applied dose)
Tmax:
Not clinically relevant due to minimal systemic absorption
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not clinically relevant due to minimal systemic absorption
ProteinBinding:
Not clinically relevant due to minimal systemic absorption
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant due to minimal systemic absorption
Clearance:
Not clinically relevant due to minimal systemic absorption
ExcretionRoute:
Primarily renal (unchanged) for the small amount absorbed
Unchanged:
High percentage of absorbed drug
Pharmacodynamics
OnsetOfAction:
Clinical improvement may be observed over several weeks to months
PeakEffect:
Full therapeutic effect typically seen after 48 weeks of continuous treatment
DurationOfAction:
Effect persists as long as treatment continues and for a period after cessation, but recurrence is possible if treatment is stopped prematurely or if new infection occurs.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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
- 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:
- Irritation at the site where the drug was applied
- Any other side effects that bother you or do not go away
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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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
- 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:
- Irritation at the site where the drug was applied
- Any other side effects that bother you or do not go away
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 reaction symptoms (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Worsening of the nail infection despite treatment
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.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this drug in conjunction with them. Never start, stop, or adjust 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.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this drug in conjunction with them. Never start, stop, or adjust 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 breastfeeding, notify your doctor immediately. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Not expected with topical application due to minimal systemic absorption. Ingestion may cause gastrointestinal upset.
What to Do:
For accidental ingestion, seek medical attention. For topical overdose, wash off excess. Call 1-800-222-1222 for poison control.
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: Establish baseline severity and extent of infection
Timing: Prior to treatment initiation
Routine Monitoring
Clinical improvement of nails
Frequency: Every 4-12 weeks
Target: Reduction in nail discoloration, thickness, and debris
Action Threshold: Lack of improvement or worsening may indicate treatment failure or need for re-evaluation
Local adverse reactions (e.g., irritation, redness)
Frequency: At each follow-up visit
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent reactions may require temporary discontinuation or re-evaluation
Symptom Monitoring
- Redness or irritation around the nail
- Swelling or pain at the application site
- Itching or burning sensation
- Worsening of nail appearance
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected, but human data are limited.
Trimester-Specific Risks:
First Trimester:
Limited data; consider risk vs. benefit.
Second Trimester:
Limited data; consider risk vs. benefit.
Third Trimester:
Limited data; consider risk vs. benefit.
Lactation
It is not known whether tavaborole is excreted in human milk. Due to minimal systemic absorption, excretion into breast milk is expected to be low. Exercise caution when administering to a nursing mother.
Infant Risk:
Low risk expected due to minimal systemic absorption, but monitor infant for potential adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients younger than 6 years of age. For patients 6 years and older, dosing is the same as adults. Clinical studies included a limited number of pediatric patients (6-17 years of age).
Geriatric Use
No dosage adjustment is necessary based on age. Clinical studies included patients 65 years and older, and no overall differences in safety or effectiveness were observed compared to younger patients.
Clinical Information
Clinical Pearls
- Tavaborole is a long-term treatment; patients should be counseled on the importance of adherence for 48 weeks for optimal results.
- The solution is flammable; advise patients to avoid heat and flame during and immediately after application.
- Ensure patients understand proper application technique to cover the entire nail unit, including the nail bed and underside of the nail.
- Regular debridement of the affected nail by a healthcare professional can enhance treatment efficacy.
- Improvement is gradual; complete clearance may not occur, but significant improvement in appearance is the goal.
Alternative Therapies
- Efinaconazole topical solution (Jublia)
- Ciclopirox topical solution (Penlac)
- Amorolfine topical lacquer (not FDA approved in US)
- Oral antifungals (e.g., Terbinafine, Itraconazole) for more severe cases or when topical therapy fails.
Cost & Coverage
Average Cost:
$1000 - $1500 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.