abametapir (Rx)

Brand and Other Names:Xeglyze
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical lotion

  • 0.74%

Head Lice

Indicated for topical treatment of head lice infestation

Apply to dry hair in an amount sufficient (up to the full content of one bottle) to thoroughly coat the hair and scalp

Use in context of overall lice management program

  • Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding, and towels
  • Wash personal care items (eg, combs, brushes, hair clips) in hot water
  • Use a fine-tooth comb or special nit comb to remove dead lice and nits

Dosage Forms & Strengths

topical lotion

  • 0.74%

Head Lice

Indicated for topical treatment of head lice infestation in children and adolescents aged ≥6 months

<6 months: Safety and efficacy not established

≥6 months

  • Apply to dry hair in an amount sufficient (up to the full content of one bottle) to thoroughly coat the hair and scalp
  • Use in context of overall lice management program

    • Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding, and towels
    • Wash personal care items (eg, combs, brushes, hair clips) in hot water
    • Use a fine-tooth comb or special nit comb to remove dead lice and nits
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Interactions

Interaction Checker

and abametapir

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Erythema (4%)

            Rash (3.2%)

            Scalp erythema/edema (3.2%)

            Skin burning sensation (2.6%)

            Vomiting (1.7%)

            Contact dermatitis (1.7%)

            Scalp pruritus (1.4%)

            Eye irritation (1.2-1.7%)

            Hair color changes (1%)

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            Warnings

            Contraindications

            None

            Cautions

            Lotion contains benzyl alcohol; systemic exposure to benzyl alcohol has been associated with serious and fatal adverse reactions including gasping syndrome in neonates and low-birth-weight infants

            Safety and effectiveness have not been established in pediatric patients aged <6 months

            Use is not recommended in pediatric patients aged <6 months because of the potential for increased systemic absorption

            In order to prevent accidental ingestion in pediatric patients, only administer under direct supervision of an adult

            Ingestion of benzyl alcohol in large quantities may result in gastrointestinal (eg, nausea, vomiting, diarrhea) and CNS (eg, headache, ataxia, convulsions, coma) adverse reactions; serious adverse reactions may include respiratory depression and death; if accidentally swallowed, advise to call Poison Control Center at 1-800-222-1222

            Drug interaction overview

            • In vitro studies suggest potential for abametapir to inhibit CYP3A4, CYP2B6, and CYP1A2 enzymes following a single application
            • Coadministration with 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 abametapir application
            • If this is not feasible, avoid abametapir use
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            Pregnancy & Lactation

            Pregnancy

            No data are available on use in pregnant females to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Animal data

            • In embryofetal development studies conducted with oral administration of abametapir during organogenesis, no evidence of fetal harm or malformations, independent of maternal toxicity, were observed in pregnant rats and rabbits at doses that produced exposures up to 50 times and equivalent to the maximum recommended human dose in rats and rabbits, respectively
            • Highest dose evaluated in rabbits was limited due to maternal toxicity associated with the vehicle used in the study

            Lactation

            No data are available regarding presence in human milk, effects on breastfed infants, or on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            • Metalloproteinase inhibitor
            • Metalloproteinases have a role in physiological processes critical to egg development and survival of lice

            Absorption

            Peak plasma time: 0.57-1.54 hr

            Peak plasma concentration

            • 6 months to <1 year: 228-418 ng/mL
            • 1 to <2 years: 147-209 ng/mL
            • 2 to <3 years: 160-206 ng/mL
            • 3 to 17 years: 52-121 ng/mL

            AUC

            • 6 months to <1 year: 688-1057 ng⋅hr/mL
            • 1 to <2 years: 406-446 ng⋅hr/mL
            • 2 to <3 years: 602-633 ng⋅hr/mL
            • 3 to 17 years: 194-330 ng⋅hr/mL

            Distribution

            Protein bound

            • Abametapir: 91.3-92.3%
            • Abametapir carboxyl (metabolite): 96-97.5%

            Metabolism

            Extensively metabolized, primarily by CYP1A2 to a mono-hydroxylated metabolite (abametapir hydroxyl) and further to a mono-carboxylated metabolite (abametapir carboxyl)

            Elimination

            Excretion of abametapir and its human metabolites was not examined

            Half-life (adults): 21 hr; ~71 hr or longer (abametapir carboxyl)

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            Administration

            Topical Administration

            Topical use only

            Not for oral, ophthalmic, or intravaginal use

            Treatment involves a single application

            Shake well before use

            Apply to dry hair in an amount (up to the full content of one bottle) sufficient to thoroughly coat the hair and scalp

            Massage into the scalp and throughout the hair

            Avoid contact with eyes

            Leave on the hair and scalp for 10 min and then rinse off with warm water

            Wash hands after application; shampoo hair any time after the treatment

            Discard any unused product; do not flush contents down sink or toilet

            Storage

            Store upright at room temperature, 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

            Do not refrigerate or freeze

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.