Xdemvy (lotilaner ophthalmic solution 0.25%) is an FDA-approved medication for the treatment of Demodex blepharitis, an inflammatory condition of the eyelids. The generic name for Xdemvy is lotilaner, and it comes in the form of eye drops. Xdemvy is an ectoparasiticide or anti-parasitic that paralyzes and kills the Demodex mite. It must be administered correctly to ensure the medication is effective in alleviating symptoms.
Xdemvy eye drops are typically used twice daily in each eye for six weeks. However, it should always be used as directed by a healthcare provider. Incorrectly administering the medication may lead to adverse effects and prolonged symptoms of the condition. Read on to learn more about the standard Xdemvy dosage and some things to keep in mind when administering the medication.
The available dosage form and strength for Xdemvy are as follows:
Ophthalmic solution: 0.25% (2.5 mg/mL)
Xdemvy is manufactured by Tarsus Pharmaceuticals, Inc. As an ophthalmic solution, it is formulated to be administered to the eyes only. It should not be administered in any other way, such as the mouth or the skin.
Xdemvy has shown promising results in clinical trials, such as SATURN-2. A dosage of one drop twice daily in each eye for six weeks resulted in the eradication of mites at Day 43 in 50% of patients.
Therefore, the standard dosage for Xdemvy in adults is one drop in each eye twice daily (approximately 12 hours apart) for six weeks. Follow this dosage schedule to ensure the medication effectively treats Demodex blepharitis.
Xdemvy dosage chart |
|||
---|---|---|---|
Indication | Starting dosage | Standard dosage | Maximum dosage |
Demodex blepharitis | 1 drop in each eye twice daily, or around 12 hours apart, for 6 weeks | 1 drop in each eye twice daily, or around 12 hours apart, for 6 weeks | 1 drop in each eye twice daily, or around 12 hours apart, for 6 weeks |
The prescribing information provides detailed instructions on how to administer Xdemvy, including proper hand-eye coordination, eye drop instillation, and preventing contamination of the solution.
The safety and effectiveness of Xdemvy in pediatric patients have not been established. As a result, Xdemvy is not currently approved for use in patients younger than 18 years old.
Further research and clinical trials may be needed to determine if an appropriate pediatric dosage for Xdemvy can be used. Consult a healthcare professional for the most appropriate treatment option for children with a Demodex infestation in their eyes.
Xdemvy is FDA-approved for adults. It has been reported to be safe for most adults, including older adults.
There are currently no dosage restrictions for those with kidney or liver problems.
There is no sufficient data on how Xdemvy affects an unborn baby or a breastfeeding child. However, animal reproduction studies showed that Xdemvy in clinically appropriate doses did not cause birth defects. In addition, Xdemvy is not expected to be extensively absorbed into the bloodstream. The use of Xdemvy is likely safe during pregnancy or breastfeeding with guidance from a healthcare provider.
When administering Xdemvy, keep in mind the following steps:
Ensure your hands and the area around your eyes are clean before applying the drops.
Do not touch the tip of the eye drop dispenser to any surface to reduce the risk of contamination. Vision problems and damage to the eye are possible if the solution is contaminated.
Wait at least five minutes before applying any other eye drops or ointments.
If you wear contact lenses, remove them before administering Xdemvy and wait at least 15 minutes before reinserting them.
If you happen to miss a dose, skip the missed dose and continue with the next scheduled dose. Do not double up on doses to make up for the missed one.
The most common side effects include instillation site stinging and burning. Other side effects may include adverse reactions such as small inflamed lumps along the eyelid (chalazion/hordeolum) and inflammation of the cornea (punctate keratitis). Consult a healthcare provider if you experience any severe eyelid reactions or side effects that persist or worsen.
Xdemvy works by blocking the gamma-aminobutyric acid (GABA)-gated chloride channel in mites, which leads to paralysis and death. It starts working and reaches maximum levels in the affected area within two hours after administration. However, it generally takes six weeks for Xdemvy to completely clear the infection.
If you miss a dose of Xdemvy, skip the missed dose and continue with the next scheduled dose. Do not take two doses to make up for the missed dose.
Xdemvy is typically prescribed for six weeks. It should be taken as directed by a healthcare provider.
You should not use Xdemvy more than instructed by a healthcare provider. Misusing the medication or instilling more doses than recommended may increase the risk of side effects. However, serious effects of an overdose on Xdemvy are unlikely as systemic exposure is minimal.
Xdemvy is not known to interact with other medications. However, when using multiple eye drops or solutions, it's recommended to wait a minimum of five minutes between each application. Using multiple eye drops together may increase the risk of adverse effects or decrease the ocular absorption of Xdemvy and decrease its effectiveness.
Introducing Xdemvy, Tarsus Rx (2023)
Are tiny mites causing your blepharitis? American Academy of Ophthalmology
Lotilaner ophthalmic solution 0.25% for Demodex blepharitis: Randomized, vehicle-controlled, multicenter, phase 3 trial (saturn-2), American Academy of Ophthalmology Journal
Highlights of prescribing information, U.S. Food and Drug Administration (2023)
How to put in eye drops, American Academy of Ophthalmology
Gerardo Sison, Pharm.D., graduated from the University of Florida. He has worked in both community and hospital settings, providing drug information and medication therapy management services. As a medical writer, he hopes to educate and empower patients to better manage their health and navigate their treatment plans.
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