Xdemvy (lotilaner)
Ophthalmic (Eye) Drops
Last reviewed · Source: First Databank (FDB) drug data
Overview
Lotilaner, a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor selective for mites, is an antiparasitic agent.
Lotilaner, a member of the isoxazoline family of compounds, is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor that is selective for mites. By inhibiting this channel, the drug causes a paralytic action in the target organism, leading to its death.
Maximum systemic exposure after topical ophthalmic administration of lotilaner ophthalmic solution occurs 2 hours after a single administration and by 1 hour after administration on day 42 of treatment. Plasma protein binding of lotilaner is high (>99%) in human plasma. Nonclinical studies in animals suggest that the drug is excreted in bile as mostly unmetabolized drug.
The effective half life of lotilaner when dosed every 12 hours is 264 hours. The drug is not metabolized by cytochrome P-450 (CYP) enzymes.
USES: This medication is used to treat a parasitic infection of the eye (Demodex blepharitis) that can especially affect the eyelids. It belongs to a class of drugs known as antiparasitics. Lotilaner works by killing parasites.
This medication treats only parasitic eye infections. It will not work for other types of eye infections.
Generic name: lotilaner
Pronunciation: (LOE-ti-LAN-er)
Therapeutic class: Ophthalmic Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Xdemvy
Indications
The following indications are listed for Xdemvy:
- Demodex Blepharitis
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Xdemvy 0.25% Drop | Maintenance | Instill 1 drop into both eyes by ophthalmic route every 12 hours for 6 weeks. |
No dosing information is available for this tab.
Drug interactions
In vitro studies demonstrate that lotilaner is not metabolized by cytochrome P-450 (CYP) enzymes nor is a substrate of organic cation transporter (OCT)1, organic anion transporting polypeptide (OATP) 1B1 or OATP1B3, P-glycoprotein, breast cancer resistance protein (BCRP), or bile salt export pump (BSEP). In vitro studies indicate that the potential for CYP-mediated drug interactions with lotilaner is minimal.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most common adverse reaction was instillation site stinging and burning (10%).
There are no severe adverse reactions for this drug.
More Frequent
- Acute pain at drug application site
- Treatment site sequelae
Less Frequent
- Hordeolum
- Punctate keratitis
Precautions
No enhanced messaging available.
Safety and efficacy of lotilaner 0.25% ophthalmic solution have not been established in pediatric patients <18 years of age.
There are no available data regarding use of lotilaner 0.25% ophthalmic solution in pregnant women to inform any drug associated risk; however, systemic exposure to the drug from ocular administration is low.
It is not known whether lotilaner 0.25% ophthalmic solution is distributed into human milk or whether the drug has any effects on the breast-fed infant or on milk production. The systemic exposure following ocular administration of lotilaner 0.25% ophthalmic solution for 6 weeks is low and is highly plasma protein bound. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breast-fed infant from lotilaner ophthalmic solution.
No overall differences in safety or efficacy were observed between geriatric patients and younger adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| Demodex blepharitis | ||
| B88.01 | ICD10CM | Infestation by demodex mites |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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