TAVABOROLE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TAVABOROLE (UNII: K124A4EUQ3) (TAVABOROLE - UNII:K124A4EUQ3)

Available from:

Aleor Dermaceuticals Limited

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . None. Risk Summary There are no available data on tavaborole topical solution use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons in rats and embryofetal toxicity at 155 times the MRHD based on AUC comparisons in rabbits. Embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the MRHD based on AUC comparisons [see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, lo

Product summary:

Tavaborole topical solution, 5% is a clear, colorless solution supplied in an amber glass bottle with a screw cap. At initial use, the screw cap is replaced with the dropper assembly. Tavaborole topical solution, 5% is supplied in the following presentations: NDC 71589-010-10: One bottle containing 10 mL of solution with one glass pointed-tip dropper. NDC 71589-010-04: One bottle containing 4 mL of solution with one glass pointed-tip dropper. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame. Discard product within 3 months after insertion of the dropper. Keep bottle tightly closed. Keep out of reach of children. The Packaging of This Product Contains Dry Natural Rubber .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TAVABOROLE - TAVABOROLE SOLUTION
ALEOR DERMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAVABOROLE TOPICAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TAVABOROLE TOPICAL
SOLUTION.
TAVABOROLE TOPICAL SOLUTION
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
Tavaborole topical solution is an oxaborole antifungal indicated for
the topical treatment of onychomycosis
of the toenails due to _Trichophyton rubrum_ or _Trichophyton
mentagrophytes_. (1)
DOSAGE AND ADMINISTRATION
Apply tavaborole topical solution to affected toenails once daily for
48 weeks. (2)
Tavaborole topical solution should be applied to the entire toenail
surface and under the tip of each
toenail being treated. (2)
For topical use only. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Solution, 5%. (3)
CONTRAINDICATIONS
None. (4)
ADVERSE REACTIONS
Common adverse reactions occurring in ≥1% in subjects treated with
tavaborole topical solution included
application site exfoliation, ingrown toenail, application site
erythema, and application site dermatitis. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FDA AT 1-800-FDA-1088
OR
_WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*
FULL