Omidenepag Isopropyl

What is Omidenepag Isopropyl?

• Omidenepag Isopropyl (Omlonti) is a relatively selective prostaglandin EP2 receptor agonist with ocular hypotensive activity.

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Omidenepag isopropyl

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Omidenepag

What are the uses of this medicine?

• Omidenepag isopropyl ophthalmic solution 0.002% (Omlonti), is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

How does this medicine work?

Omidenepag is a relatively selective EP2 receptor agonist which decreases intraocular pressure (IOP). The exact mechanism of action is unknown at this time. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Omidenepag was approved for medical use in Japan in 2018, and in the United States in September 2022.

How should this medicine be used?

Recommended dosage:

• The recommended dosage is one drop in the affected eye once daily in the evening.

Administration:

• Omlonti is for use in the eye.
• Use Omlonti exactly as your healthcare provider tells you to use it.
• Gently shake the bottle prior to administration.
• If you use Omlonti with other eye medicines, you should wait at least 5 minutes between using Omlonti and the other medicines.
• If you wear contact lenses, remove your contact lenses before using Omlonti. You should wait 15 minutes after using Omlonti before placing your contact lenses back in your eye.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Ophthalmic solution containing 0.002% (0.02 mg/mL) of omidenepag isopropyl.

This medicine is available in fallowing brand namesː

• Omlonti

What side effects can this medication cause?

The most common side effects of this medicine may include:

• conjunctival hyperemia
• photophobia
• vision blurred
• dry eye
• instillation site pain
• eye pain
• ocular hyperemia
• punctate keratitis
• headache
• eye irritation
• and visual impairment

Less common, but serious side effects may include:

• Pigmentation
• Eyelash Changes
• Ocular Inflammation
• Macular Edema

What special precautions should I follow?

• Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which is usually reversible after discontinuation of Omlonti.
• Omlonti may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and the number of lashes or hairs. Eyelash changes are usually reversible upon discontinuation of treatment.
• Ocular inflammation has been reported in patients taking Omlonti. Omlonti should be used with caution in patients with active ocular inflammation, including iritis/uveitis.
• Omlonti should be used with caution in aphakic patients, in pseudophakic patients, or in patients with known risk factors for macular edema.
• Advise patients to avoid touching the tip of the bottle to the eye or any surface, as this may contaminate the solution. Advise patients to not touch the tip to their eye to avoid the potential for injury to the eye. The product should be refrigerated before opening, and once it is opened, it can be stored at room temperature for up to 31 days .
• Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes after administration.
• Patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
• There are no data on the presence of Omlonti in human milk, the effects on the breastfed infant, or the effects on milk production.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on the use of Omlonti in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Omlonti have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• omidenepag isopropyl

Inactive ingredients:

• glycerin, polyoxyl 35 castor oil, sodium citrate, citric acid monohydrate, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

Preservative:

• benzalkonium chloride.

Who manufactures and distributes this medicine?

• Manufactured for: Santen Inc.
• Manufactured by: Woodstock Sterile Solutions, Inc.

Distributed by:

• Santen Inc.
• Hollis Street, Suite 125
• Emeryville, CA
• United States

What should I know about storage and disposal of this medication?

• Store unopened bottle in the refrigerator at 2°C to 8°C (36°F to 46°F).
• Once a bottle is opened for use, it can be stored for up to 31 days at up to 30°C (86°F).

• Dailymed label info on Omidenepag Isopropyl
• FDA Omidenepag Isopropyl

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