Netarsudil and latanoprost (Ophthalmic)

Netarsudil and latanoprost combination eye drops is used by itself or with other medicines to reduce pressure inside the eye caused by open-angle glaucoma or ocular (eye) hypertension.

You can get this medicine only with a prescription from your doctor.

It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to ensure this medicine is working properly and to look for any unwanted effects.

If you experience itching, redness, swelling, or other signs of irritation in your eye or eyelid, contact your doctor immediately.

This medicine contains latanoprost, which can cause the iris (the colored part) of your treated eye to become browner. This is more likely if you have blue-brown, gray-brown, green-brown, or yellow-brown eyes. You may notice this change usually within several months or years after starting treatment. You may also notice darkening of the eyelid skin or longer, thicker, and darker eyelashes. These changes to the iris, eyelid, and lashes may be permanent even if you stop using this medicine. However, any of these changes will only affect the eye that is being treated. Contact your doctor if you have any concerns about this.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to the benefits. Here are some important things to think about for this medicine:

Allergies

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

Pediatric

There have not been appropriate studies on how netarsudil and latanoprost combination eye drops affect children. Safety and effectiveness in this age group have not been proven.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the use of netarsudil and latanoprost combination eye drops.

Interactions with Medicines

Some medicines should not be used together at all, while others may be combined even if an interaction might happen. If this is the case, your doctor may adjust the dose or take other precautions. Let your healthcare professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with some medicines can also cause interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor 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
• Herpes simplex eye infection, history of or
• Patients with torn artificial lenses—Use with caution. These conditions may worsen.

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

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

Check with your doctor right away if you notice any of the following side effects:

More common

• Bloody eye
• blurred vision or any other change in vision
• eye redness, irritation, or pain
• redness of the eye

Rare

• Body aches or pain
• burning and stinging of the eye
• change in color vision
• chills
• cough
• diarrhea
• difficulty in breathing
• difficulty seeing at night
• difficulty swallowing
• dizziness
• dry eye
• ear congestion
• excessive tearing
• eyelid discomfort, swelling, or redness
• fast heartbeat
• fever
• general feeling of discomfort or illness
• headache
• hives, itching, skin rash
• increased sensitivity of the eyes to sunlight
• joint pain
• loss of appetite
• loss of voice
• nausea
• painful irritation of the clear front part of the eye
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• runny or stuffy nose
• shivering
• sneezing
• sore throat
• sweating
• tightness in the chest
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Some side effects may happen that usually do not require medical attention. These side effects may go away as your body gets used to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Eye itching
• pain and discomfort at the instillation site

Less common

• Increase in brown color in the colored part of the eye
• redness of the white part of the eyes or the inside of the eyelids

Rare

• Back pain
• crusting in the corner of the eye
• difficulty in moving
• discoloration of the white part of the eye
• feeling of having something in the eye
• joint pain or swelling
• muscle pain, cramps, or stiffness

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.

• Rocklatan

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Prostaglandin

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

To use the eye drops:

• Wash your hands with soap and water before and after you use this medicine.
• 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 netarsudil/latanoprost 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—One drop in the affected eye(s) once a day in the evening. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 in the refrigerator. Do not freeze.

You may also store it at room temperature to higher temperatures for up to 14 days when travelling. Keep the opened bottle until the expiration date.