Pronunciation:

la-tan-oh-PROS-teen BUE-nod

Brand Names:

• Vyzulta

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiglaucoma

Uses of This Medicine:

Latanoprostene bunod eye drops is used alone or together with other medicines to lower pressure inside the eye that is caused by open-angle glaucoma or ocular (eye) hypertension.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of latanoprostene bunod eye drops in children older than 16 years of age. Use of latanoprostene bunod eye drops in children 16 years of age and younger is not recommended.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of latanoprostene bunod eye drops in the elderly.

Other medicines—

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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aphakia (no lens in the eyes) or
• Eye inflammation (eg, iritis or uveitis), history of or
• Patients with torn artificial lenses—Use with caution. May make these conditions worse.

• Eye inflammation, active—Should not be used in patients with this condition.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

To use the eye drops (solution):

• Wash your hands with soap and water before and after you use this medicine.
• Shake the eye drops well just before each use.
• Tilt the head back. Press your finger gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the 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 medicines.

You should not use the eye drops if you have contact lenses in your eyes. Remove your contact lenses before you use this medicine. Wait at least 15 minutes after you use the medicine before putting the contact lenses back in.

If you will be using latanoprostene bunod eye drops with other eye medicines, use them at least 5 minutes apart from each other.

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 solution dosage form (eye drops):
  • For glaucoma or ocular hypertension:
    • Adults and children older than 16 years of age—One drop in the affected eye once a day in the evening.
    • Children 16 years of age and younger—Use is not recommended.

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—

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.

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

Store the unopened bottle in the refrigerator. You may keep the opened bottle in the refrigerator or at room temperature for 8 weeks.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you are allergic to this medicine.

This medicine may cause blurred vision or other vision problems. If these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these eye changes are bothersome, check with your doctor.

Side Effects of This Medicine:

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

Redness of the white part of the eyes or the inside of the eyelids

Less common

Eye irritation

Rare

Painful irritation of the clear front part of the eye swelling of the eye and the lining of the eyelid

Incidence not known

Blurred vision or other change in vision

decreased vision

eye pain

redness of the eye

sensitivity of the eye to light

tearing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Feeling of having something in the eye

Incidence not known

Increased brown color in the colored part of the eye longer, thicker, and darker eyelashes

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.