Lotilaner (Ophthalmic)

Lotilaner eye drops are used to treat Demodex blepharitis, which is an eye condition caused by Demodex mites.

This medicine is available only with your doctor's prescription.

It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to make sure the medicine is working well and to look for any side effects.

In deciding to use a medicine, you and your doctor must weigh the risks of taking the medicine against its benefits. Consider the following for this medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Appropriate studies have not been done on how age affects the use of lotilaner eye drops in children. Safety and effectiveness have not been established.

Geriatric

Currently, studies have not shown any specific issues in older adults that would limit the use of lotilaner eye drops in the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together, even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Burning and stinging of the eye

Less common

• Blurred vision
• Feeling like there is something in your eye
• Increased sensitivity of the eyes to light
• Swelling, redness, pain, or tenderness of the eyelid
• Tearing and irritation of the eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Xdemvy

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

To use the eye drops:

• Wash your hands with soap and water before and after you use this medicine.
• While squeezing, turn the bottle upside down and release the pressure (drawing air into the bottle).
• Tilt the head back and, place the bottle above your eye and squeeze it again to release a drop into your eye.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.

Remove contact lenses before you use the eye drops. Wait for at least 15 minutes before putting the contact lenses back in.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage forms (eye drops): For Demodex blepharitis: Adults—Instill one drop into each eye 2 times a day for 6 weeks. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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