Key facts
- Active ingredient
- Lotilaner
- Drug class
- Ectoparasiticide
- Form
- Drops
- Strength
- Lotilaner 0.25%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Tarsus
- FDA application
- NDA217603
What is Xdemvy?
From the FDA label:Lotilaner is a member of the isoxazoline family of compounds. Its chemical name is 2-Thiophenecarboxamide, 5-[(5S)-4,5-dihydro-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-3-isoxazolyl]-3-methyl-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]-2-thiophenecarboxamide. The molecular formula is C 20 H 14 Cl 3 F 6 N 3 O 3 S. The molecular weight is 596.76 g/mol. The chemical structure is: XDEMVY is a sterile, preserved, multi-dose, slightly yellowish, slightly opalescent, topical ophthalmic solution containing lotilaner, 0.25% as the active ingredient. It is preserved with potassium sorbate and contains the following additional inactive ingredients: edetate disodium, hydroxypropyl methylcellulose (HPMC), polyoxyl 35 castor oil, glycerin, dibasic sodium phosphate, monobasic sodium phosphate, and water for injection. Chemical Structure
How to use
Instill one drop of XDEMVY in each eye twice daily (approximately 12 hours apart) for 6 weeks. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. If one dose is missed, treatment should continue with the next scheduled dose. Instill one drop of XDEMVY in each eye twice daily (approximately 12 hours apart) for 6 weeks. ( 2 )
Side effects
The most common adverse reaction was instillation site stinging and burning (10%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XDEMVY was evaluated in 833 patients with Demodex blepharitis in two randomized, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2) with 42 days of treatment. The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis.
Warnings
Important safety information
5.1 Risk of Contamination Do not allow the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions . 5.2 Use with Contact Lenses Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration.
Who should not take Xdemvy
None. None. ( 4 )
Drug class
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- Is there a coupon or discount for Xdemvy?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Xdemvy. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Xdemvy?
- Xdemvy is marketed by Tarsus. You can see Tarsus's full profile, rating, and other products on pharmaranks.
- Is Xdemvy a brand-name or generic drug?
- Xdemvy is a brand-name product with the active ingredient Lotilaner.
- Is Xdemvy available over the counter?
- No. Xdemvy is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Xdemvy come in?
- Xdemvy is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Xdemvy?
- Xdemvy is classified as ectoparasiticide, per the FDA's Established Pharmacologic Class.
- Is Xdemvy FDA-registered?
- Xdemvy is on record with the U.S. FDA under application number NDA217603. You can verify this on its official FDA label.
- Is Xdemvy safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Xdemvy. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Xdemvy?
- Xdemvy's side effects are taken directly from its FDA label. From the label: The most common adverse reaction was instillation site stinging and burning (10%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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