Dosing & Uses
Dosage Forms and Strengths
ophthalmic solution
- 0.024%
Elevated Intraocular Pressure
Indicated for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
Instill 1 drop in affected eye(s) qDay in the evening
Dosing Considerations
Do not administer latanoprostene bunod ophthalmic solution more often than qDay since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect
If latanoprostene bunod ophthalmic solution is to be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure, administer each drug product at least 5 minutes apart
Dosage Forms and Strengths
ophthalmic solution
- 0.024%
Elevated Intraocular Pressure
Indicated for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
≤16 years: Not recommended due to potential safety concerns related to increased pigmentation following long-term chronic use
>16 years: Instill 1 drop in affected eye(s) qDay in the evening
Adverse Effects
1-10%
Hyperemia (6%)
Eye irritation (4%)
Eye pain (3%)
Instillation site pain (2%)
Warnings
Contraindications
None
Cautions
Increased pigmentation to tissues may occur; most frequently reported changes with prostaglandin analogs have been of the iris and periorbital tissue (eyelid) and is expected to increase for the duration of treatment; regularly examine patients who develop noticeably increased iris pigmentation
Gradual increases in length, thickness, and number of lashes have been reported
Caution with a history of intraocular inflammation (iritis/uveitis); avoid if active intraocular inflammation exists, as it may exacerbate this condition
Macular edema, including cystoid macular edema, reported; caution in patients with aphakia pseudophakia with a torn posterior lens capsule, or with known risk factors for macular edema
Bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products has been reported; containers may be inadvertently contaminated by patients who typically had a concurrent corneal disease or an ocular epithelial surface disruption
Remove contact lenses before administration because product contains benzalkonium chloride; lenses may be reinserted 15 minutes after administration
Pregnancy
Pregnancy
There are no available human data for the use during pregnancy to inform any drug associated risks
Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits; when administered IV to pregnant rabbits at exposures ≥0.28 times the clinical dose was shown to be abortifacient and teratogenic
Doses ≥20 mcg/kg/day (23 times the clinical dose) produced 100% embryofetal lethality; structural abnormalities (eg, anomalies of the great vessels and aortic arch vessels, domed head, sternebral and vertebral skeletal anomalies, limb hyperextension and malrotation, abdominal distension and edema) were observed in rabbit fetuses
Latanoprostene bunod was not teratogenic rats when administered IV at 150 mcg/kg/day (87 times the clinical dose)
Lactation
There are no data on the presence of latanoprostene bunod in human milk, the effects on the breastfed infant, or the effects on milk production
Developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for latanoprostene bunod, and any potential adverse effects on the breastfed infant from latanoprostene bunod
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Believed to lower intraocular pressure by increasing outflow of aqueous humor through the trabecular meshwork and uveoscleral routes
Intraocular pressure is a major risk factor for glaucoma progression; reduction of intraocular pressure reduces risk of glaucomatous visual field loss
Absorption
Peak plasma time, post Day 1 and Day 28 administration: 5 minutes
Peak plasma concentration, latanoprost acid [LLOQ] 30 pg/mL: 59.1 pg/mL (Day 1); 51.1 pg/mL (Day 28)
Metabolism
After topical ocular administration, latanoprostene bunod is rapidly metabolized in the eye to latanoprost acid (active moiety), an F2-alpha prostaglandin analog, and butanediol mononitrate
After latanoprost acid reaches the systemic circulation, it is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid beta-oxidation Butanediol mononitrate is metabolized to 1,4-butanediol and nitric oxide
The metabolite 1,4-butanediol is further oxidized to succinic acid and enters the tricarboxylic acid (TCA) cycle
Excretion
Elimination of latanoprost acid from human plasma is rapid as latanoprost acid plasma concentration dropped below the LLOQ (30 pg/mL) in the majority of subjects by 15 min following ocular administration of latanoprostene bunod 0.024% in human
Administration
Ophthalmic Administration
For ophthalmic use only
Remove contact lenses before administering ophthalmic solution (if applicable)
If ≥1 topical ophthalmic drug is being used, wait least 5 minutes between applications
Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections
Storage
Unopened bottle: Store in refrigerator at 2-8ºC (36-46ºF)
Opened bottles: Store at 2-25ºC (36-77ºF) for up to 8 weeks
During shipment, bottles may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days
Protect from light
Do not freeze
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Vyzulta ophthalmic (eye) - | 0.024 % drops | ![]() | |
Vyzulta ophthalmic (eye) - | 0.024 % drops | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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