Latanoprostene bunod (Ophthalmic)

Latanoprostene bunod eye drops is used by itself or with other medications to reduce pressure in the eye caused by open-angle glaucoma or ocular (eye) hypertension.

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

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 you experience itching, redness, swelling, or other signs of irritation in your eye or eyelid, contact your doctor. These signs may mean that you are allergic to this medicine.

This medicine may cause blurred vision or other vision problems. If you have these issues, do not drive, operate machines, or do anything else that could be dangerous if you cannot see well. If these changes in your vision are bothersome, contact your doctor.

In deciding to use a medicine, you and your doctor will need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare 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

Studies conducted so far have not shown any specific problems in children older than 16 years that would limit the use of latanoprostene bunod eye drops. However, the use of latanoprostene bunod eye drops in children 16 years of age and younger is not recommended.

Geriatric

Studies conducted so far have not shown any specific problems in the elderly that would limit the use of latanoprostene bunod eye drops.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may change the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works for you. Be sure to let your doctor know if you have any other medical issues, especially:

• Aphakia (no lens in the eyes) or
• Eye inflammation (for example, iritis or uveitis), history of or
• Patients with torn artificial lenses—Use with caution. This may worsen these conditions.

• Active eye inflammation—Should not be used in patients with this condition.

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.

In the U.S.

• Vyzulta

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

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.