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Latanoprostene Bunod (Monograph)

Brand name: Vyzulta
Drug class: Prostaglandin Analogs
Chemical name: 4-(Nitrooxy) butyl (5Z)-7-{(1R,2R,3R,5S)-3,5- dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl] cyclopentyl}hept-5-enoate
Molecular formula: C27H41NO8
CAS number: 860005-21-6

Medically reviewed by on Oct 23, 2023. Written by ASHP.


Ocular hypotensive agent; synthetic analog of prostaglandin F (PGF).

Uses for Latanoprostene Bunod

Ocular Hypertension and Glaucoma

Reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.

Once-daily latanoprostene bunod 0.024% ophthalmic solution appears to be more effective than or at least as effective as twice-daily timolol 0.5% ophthalmic solution in reducing IOP in adults with open-angle glaucoma or ocular hypertension.

When selecting an initial ocular hypotensive agent, consider extent of the required IOP reduction, coexisting medical conditions, and drug characteristics (e.g., dosing frequency, adverse effects, cost). With single-agent regimens, the reduction in IOP is approximately 25–33% with topical prostaglandin analogs; 20–25% with topical β-adrenergic blocking agents, α-adrenergic agonists, or miotic (parasympathomimetic) agents; 20–30% with oral carbonic anhydrase inhibitors; 18% with topical rho kinase inhibitors; and 15–20% with topical carbonic anhydrase inhibitors.

A prostaglandin analog frequently is considered for initial therapy in the absence of other considerations (e.g., contraindications, cost considerations, intolerance, adverse effects, patient refusal) because of relatively greater activity, once-daily administration, and low frequency of systemic adverse effects; however, ocular adverse effects can occur.

Goal is to maintain an IOP at which visual field loss is unlikely to substantially reduce quality of life during the patient's lifetime.

Reduction of pretreatment IOP by ≥25% shown to slow progression of primary open-angle glaucoma. Set an initial target IOP (based on extent of optic nerve damage and/or visual field loss, baseline IOP at which damage occurred, rate of progression, life expectancy, and other considerations) and reduce IOP toward this goal. Adjust target IOP up or down as needed over course of disease.

Combination therapy with drugs from different therapeutic classes often required to control IOP.

Latanoprostene Bunod Dosage and Administration


Ophthalmic Administration

Apply topically to the affected eye(s).

Avoid contaminating solution container. (See Bacterial Keratitis under Cautions.)

Remove contact lenses prior to administration of each dose; may reinsert contact lenses 15 minutes after the dose. (See Use with Contact Lenses under Cautions.)

If more than one topical ophthalmic drug used, administer the drugs at least 5 minutes apart.



Ocular Hypertension and Glaucoma

Latanoprostene bunod 0.024% ophthalmic solution: One drop into conjunctival sac of affected eye(s) once daily in the evening.

More frequent dosing may diminish the IOP-lowering effect of the drug.

If target IOP not achieved, may initiate additional or alternative ocular hypotensive agents. (See Ocular Hypertension and Glaucoma under Uses.)

Special Populations

No special population dosage recommendations.

Cautions for Latanoprostene Bunod




Increased pigmentation of the iris and periorbital tissue (eyelid) reported with prostaglandin analogs, including latanoprostene bunod. Pigmentation expected to increase as long as latanoprostene bunod is administered. Following discontinuance of the drug, pigmentation of the iris is likely to be permanent, while pigmentation of periorbital tissue likely to be reversible in most patients. Long-term effects of increased pigmentation unknown.

Increased pigmentation of the iris may not be evident until after several months to years of therapy.

May continue latanoprostene bunod in patients who develop noticeably increased iris pigmentation; however, examine such patients regularly.

Eyelash Changes

Possible gradual change in eyelashes and vellus hair in the treated eye, including increased length, thickness, pigmentation, and number of eyelashes and/or misdirected growth of eyelashes. Usually reversible upon discontinuance of the drug.

Intraocular Inflammation

Use with caution in patients with a history of intraocular inflammation (e.g., iritis/uveitis); generally do not use in patients with active intraocular inflammation since therapy may exacerbate the condition.

Macular Edema

Macular edema, including cystoid macular edema, reported with prostaglandin analogs.

Use with caution in aphakic patients, in pseudophakic patients with torn posterior lens capsule, and in those with known risk factors for macular edema.

Bacterial Keratitis

Bacterial keratitis reported with use of multiple-dose containers of topical ophthalmic preparations. These containers were inadvertently contaminated by patients who, in most cases, had concurrent corneal disease or disruption of the ocular epithelial surface.

Improper handling of ophthalmic solutions can result in contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic solutions. (See Advice to Patients.)

Use with Contact Lenses

Remove contact lenses prior to administration of each dose since the preparation contains benzalkonium chloride preservative; may reinsert contact lenses 15 minutes after the dose.

Specific Populations


No data available regarding use in pregnant women.

Has caused miscarriages, abortions, and fetal harm in rabbits. No treatment-related teratogenic effects observed in rats.


Not known if distributed into milk following topical application to the eye. Data not available on effects of the drug on the breast-fed child or on milk production.

Consider benefits of breast-feeding along with importance of the drug to the woman and any potential adverse effects on the breast-fed child from the drug.

Pediatric Use

Use in pediatric patients <16 years of age not recommended because of potential safety concerns related to increased pigmentation following long-term use. (See Pigmentation under Cautions.)

Geriatric Use

No overall differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Conjunctival hyperemia, eye irritation, eye pain, instillation site pain.

Drug Interactions

No formal drug interaction studies to date. Interactions not expected because of limited systemic exposure following topical application to the eye.

Latanoprostene Bunod Pharmacokinetics



Prodrug; absorbed through the cornea following ocular instillation and hydrolyzed to active metabolites, latanoprost acid (prostaglandin agonist) and butanediol mononitrate (nitric oxide donor).

Following once-daily topical application of latanoprostene bunod 0.024% to the eyes for 28 days, no quantifiable plasma concentrations of latanoprostene bunod or butanediol mononitrate observed; low plasma concentrations of latanoprost acid detected.

Mean time to peak plasma concentrations of latanoprost acid occur approximately 5 minutes following administration of the prodrug. Mean maximal plasma concentrations of latanoprost acid observed above the lower limit of quantitation (30 pg/mL) were 59.1 and 51.1 pg/mL on days 1 and 28, respectively.


Reduction in IOP generally occurs within 1–3 hours after ocular instillation and peaks within 11–13 hours.



Not known whether the drug or its metabolites distribute into milk in humans following topical ocular administration.



Prodrug; metabolized in the eye by cellular esterases to latanoprost acid and butanediol mononitrate.

Elimination of latanoprost acid from human plasma is rapid; plasma concentrations dropped below the lower limit of quantitation (30 pg/mL) in most individuals by 15 minutes following administration of the prodrug.

Systemically, latanoprost acid is further metabolized in the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid β-oxidation. Butanediol mononitrate is metabolized to 1,4-butanediol and nitric oxide; the 1,4-butanediol metabolite is further oxidized to succinic acid and enters the tricarboxylic acid cycle.





Unopened bottles: 2–8°C; protect from light and freezing. During shipment, may be maintained at up to 40°C for ≤14 days.

Opened bottles: 2–25°C for 8 weeks.


Advice to Patients


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Latanoprostene Bunod


Dosage Forms


Brand Names






Bausch & Lomb

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