Brand Name
Xeglyze
Generic Name
Abametapir
View Brand Information FDA approval date: January 29, 2021
Form: Lotion
What is Xeglyze (Abametapir)?
XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. XEGLYZE should be used in the context of an overall lice management program: Wash or dry-clean all recently worn clothing, hats, used bedding and towels Wash personal care items such as combs, brushes, and hair clips in hot water Use a fine-tooth comb or special nit comb to remove dead lice and nits XEGLYZE is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older. XEGLYZE should be used in the context of an overall lice management program: Wash or dry-clean all recently worn clothing, hats, used bedding and towels Wash personal care items such as combs, brushes and hair clips in hot water Use a fine-tooth comb or special nit comb to remove dead lice and nits.
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Brand Information
Xeglyze (abametapir)
1INDICATIONS AND USAGE
XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
XEGLYZE should be used in the context of an overall lice management program:
Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towels Wash personal care items such as combs, brushes, and hair clips in hot water
Use a fine-tooth comb or special nit comb to remove dead lice and nits
2DOSAGE AND ADMINISTRATION
For topical use only. XEGLYZE is not for oral, ophthalmic, or intravaginal use. Treatment with XEGLYZE involves a single application.
Shake well before use. Apply XEGLYZE to dry hair in an amount (up to the full content of one bottle) sufficient to thoroughly coat the hair and scalp. Massage XEGLYZE into the scalp and throughout the hair. Avoid contact with eyes. Leave on the hair and scalp for 10 minutes and then rinse off with warm water. Wash hands after application. Hair may be shampooed any time after the treatment.
Discard any unused product. Do not flush contents down sink or toilet.
3DOSAGE FORMS AND STRENGTHS
Lotion, 0.74% [weight by weight], a viscous white to off-white oil in water emulsion, containing abametapir.
4CONTRAINDICATIONS
None.
5DRUG INTERACTIONS
In vitro studies suggest there is a potential for inhibition of cytochrome P450 (CYP) 3A4, 2B6 and 1A2 enzymes following a single application of XEGLYZE. Use of XEGLYZE with drugs that are substrates of these enzymes may lead to increased systemic concentrations of the interacting drugs. Avoid administration of drugs that are substrates of CYP3A4, CYP2B6, or CYP1A2 within 2 weeks after application of XEGLYZE. If this is not feasible, avoid use of XEGLYZE [
6OVERDOSAGE
If accidentally swallowed, advise patients to seek medical advice immediately and to call their local Poison Control Center at 1-800-222-1222.
7DESCRIPTION
The active pharmacological ingredient in XEGLYZE (abametapir) Lotion is the pediculicide, abametapir, which is a dipyridyl compound. The chemical name of abametapir is 5,5'-dimethyl-2,2'-bipyridinyl.
The structural formula is:
The empirical formula is C
XEGLYZE is a white to off-white oil in water emulsion, containing 0.74% [weight by weight] of abametapir, intended for topical administration. XEGLYZE contains the following inactive ingredients: benzyl alcohol 2.0% , butylated hydroxytoluene, Carbomer Homopolymer Type C, light mineral oil, polysorbate 20, trolamine and water.
8CLINICAL STUDIES
Two identical multi-center, randomized, double-blind, vehicle-controlled trials (Trials 1 and 2) were conducted in 704 subjects 6 months of age and older with head lice infestation. All subjects received a single application of either XEGLYZE or vehicle control. For the evaluation of efficacy, the youngest subject from each household was considered to be the index subject of the household (N=216). Other enrolled infested household members received the same treatment as the youngest subject and were evaluated for all efficacy and safety parameters. Index subjects ranged from 6 months to 49 years of age (mean 7 years), and approximately 85% of the index subjects were female, and 95% of the index subjects were Caucasian.
Efficacy was assessed as the proportion of index subjects who were treated with a single 10-minute application and were free of live lice at all follow-up visits on Days 1, 7, and 14. Subjects with live lice at any time up to the final evaluation were considered treatment failures. Table 4 presents the proportion of subjects who were free of live lice at all visits Day 1 through Day 14 in Trials 1 and 2.
Table 4: Proportion of Index Subjects Free of Live Lice at All Visits Days 1 Through 14 After Treatment
9HOW SUPPLIED/STORAGE AND HANDLING
XEGLYZE is a white to off-white oil in water emulsion containing 0.74% [weight by weight] abametapir and supplied in a polyvinyl chloride (PVC) safety-coated single-use round amber glass bottle affixed with a polypropylene child resistant cap (NDC # 43598-921-11) featuring a tri-foil inner liner. The container is filled to a nominal 200 g (approximately 7 oz. or 210 mL) of the lotion.
Store upright at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
Do not refrigerate or freeze.
10PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Inform the patient and caregiver of the following instructions:
- Do not ingest XEGLYZE.
- Keep out of reach of children. Use on children should be under the direct supervision of an adult because of the risk of benzyl alcohol toxicity [
- Avoid contact with eyes.
- Wash hands after application.
- Hair may be shampooed any time after the treatment.
- Treatment with XEGLYZE involves a single application. Do not re-treat.
- Discard any unused portion. Do not flush contents down sink or toilet.
Manufactured by Groupe Parima Inc., for Dr. Reddy’s Laboratories, S.A. Elisabethenanlage 11, 4051 Basel, Switzerland
Distributed by Dr. Reddy’s Laboratories Inc., 107 College Road East, Princeton, NJ 08540
Xeglyze
Issued: 01 / 2022