Xeglyze

Last updated on RxList: 8/3/2020
Xeglyze Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xeglyze?

Xeglyze (abametapir) 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 (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towel; wash personal care items such as combs, brushes and hair clips in hot water; and use a fine-tooth comb or special nit comb to remove dead lice and nits.

What Are Side Effects of Xeglyze?

Side effects of Xeglyze include:

Dosage for Xeglyze

Apply Xeglyze to dry hair in an amount sufficient (up to the full content of one bottle) to thoroughly coat the hair and scalp. Avoid contact with eyes. Massage Xeglyze into the scalp and throughout the hair; leave on the hair and scalp for 10 minutes and then rinse off with warm water. Treatment with Xeglyze involves a single application.

Xeglyze In Children

The safety and effectiveness of Xeglyze have been established in pediatric patients 6 months of age and older. The safety and effectiveness of Xeglyze have not been established in pediatric patients below the age of 6 months. Xeglyze is not recommended in pediatric patients under 6 months of age because of the potential for increased systemic absorption due to a high ratio of skin surface to body mass and the potential for an immature skin barrier.

Xeglyze contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants.

Because of the risk of accidental ingestion, Xeglyze should be administered to pediatric patients only under direct adult supervision.

What Drugs, Substances, or Supplements Interact with Xeglyze?

Xeglyze may interact with other medicines such as:

  • drugs that are substrates of CYP3A4, CYP2B6, or CYP1A2 used within 2 weeks of Xeglyze

Tell your doctor all medications and supplements you use.

Xeglyze During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Xeglyze; it is unknown how it would affect a fetus. It is unknown if Xeglyze passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Xeglyze (abametapir) Lotion, for Topical Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Xeglyze Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

The data described below reflect exposure to a single 10-minute treatment of XEGLYZE in 349 subjects (6 months of age and older) with head lice infestation in randomized, double-blind, vehicle-controlled trials (Trials 1 and 2). Of these subjects, 21 were 6 months to 4 years of age, 166 subjects were 4 to 12 years of age, 57 subjects were 12 to 18 years of age, and 105 subjects were 18 years of age or older.

Table 1 provides adverse reactions that occurred in at least 1% of subjects in the XEGLYZE group and at a greater frequency than in the vehicle group.

Table 1: Adverse Reactions Occurring in ≥ 1% of the XEGLYZE Group and at a Greater Frequency than in the Vehicle Group (Trials 1 and 2)

Adverse ReactionsXEGLYZE
N=349
Subjects (%)
Vehicle
N=350
Subjects (%)
Erythema14 (4.0)6 (2)
Rash11 (3.2)8 (2.3)
Skin burning sensation9 (2.6)0 (0.0)
Contact dermatitis6 (1.7)4 (1.1)
Vomiting6 (1.7)2 (0.6)
Eye irritation4 (1.2)2 (0.6)
Hair color changes3 (1)0 (0.0)

During the trials, subjects were monitored for new onset of scalp erythema/edema, scalp pruritus, and eye irritation. The number and percentage of subjects who developed these local adverse reactions after treatment are presented in Table 2.

Table 2: Monitored Local Adverse Reactions with New Onset on Day 1 Post-Treatment (Trials 1 and 2)

Adverse ReactionsXEGLYZE
Subjects (%)*
Vehicle
Subjects (%)*
Scalp Erythema/Edema11 (3.2)5 (1.4)
Scalp Pruritus2 (1.4)1 (0.7)
Eye Irritation6 (1.7)5 (1.4)
* For the calculation of the percentages, the denominators are the number of subjects who did not have the monitored local adverse reaction at baseline.

Read the entire FDA prescribing information for Xeglyze (Abametapir Lotion)

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© Xeglyze Patient Information is supplied by Cerner Multum, Inc. and Xeglyze Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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