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Lotilaner: Drug information

Lotilaner: Drug information
(For additional information see "Lotilaner: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Xdemvy
Pharmacologic Category
  • Antiparasitic Agent, Ophthalmic
Dosing: Adult
Demodex blepharitis

Demodex blepharitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily for 6 weeks.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Ophthalmic: Burning sensation of eyes (10%), chalazion (<2%), hordeolum (<2%), punctate keratitis (<2%), stinging of eyes (10%)

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

There are no warnings listed in the manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Xdemvy: 0.25% (1.5 mL, 10 mL) [contains edetate (edta) disodium, polyoxyl/peg-35 castor oil(cremophor el)]

Generic Equivalent Available: US

No

Pricing: US

Solution (Xdemvy Ophthalmic)

0.25% (per mL): $222.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Ophthalmic: For topical administration only. If using more than one ophthalmic product, wait at least 5 minutes in between application of each medication. Remove contact lenses prior to administration and wait 15 minutes before reinserting. Do not touch tip of container to any surface, the eyelids or fingers, or surrounding areas.

Use: Labeled Indications

Demodex blepharitis: Treatment of Demodex blepharitis.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies following administration of oral lotilaner in doses >500 times the recommended human ophthalmic dose based on BSA.

Systemic exposure following ophthalmic use in humans is limited.

Breastfeeding Considerations

It is not known if lotilaner is present in breast milk following ophthalmic use.

Systemic exposure following ophthalmic use is limited. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Mechanism of Action

Lotilaner inhibits the gamma-aminobutyric acid (GABA)-gated chloride channels of mites resulting in paralysis and death of Demodex mites.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Minimal systemic absorption.

Protein binding: >99.9%.

Metabolism: Not metabolized by CYP enzymes.

Half-life elimination: 264 hours.

Time to peak: 1 to 2 hours.

  1. Xdemvy (lotilaner) [prescribing information]. Irvine, CA: Tarsus Pharmaceuticals Inc; July 2023.
Topic 142079 Version 12.0

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