Elevated intraocular pressure: Ophthalmic: Instill 1 drop into affected eye(s) once daily in the evening; do not exceed the once daily dosage (may decrease the IOP-lowering effect)
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Latanoprostene bunod: Pediatric drug information")
Glaucoma, elevated intraocular pressure (IOP): Adolescents ≥17 years: Ophthalmic: Instill 1 drop into affected eye(s) once daily in the evening. Note: Do not exceed the once-daily dosing (may decrease the IOP-lowering effect).
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Local: Application-site pain (2%)
Ophthalmic: Conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%)
Frequency not defined: Ophthalmic: Blurred vision, conjunctival edema, conjunctival irritation, foreign body sensation of eye, ocular hyperemia, punctate keratitis
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to latanoprostene bunod or any component of the formulation.
Concerns related to adverse effects:
• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has caused bacterial keratitis.
• Ocular effects: May change/increase brown pigmentation of the iris, the eyelid skin, and eyelashes; length and/or number of eyelashes may also be increased. Pigmentation of the iris is likely to be permanent, although iris color change may not be noticeable for months to years; pigmentation of the periorbital tissue and eyelash changes may be reversible following discontinuation of therapy. Long-term consequences and potential injury to eye are not known. Use in pediatric patients (≤16 years) is not recommended by the manufacturer due to possible safety issues of increased pigmentation following long-term chronic use.
• Ocular inflammation: Intraocular inflammation and exacerbation of inflammation may occur; use with caution in patients with a history of intraocular inflammation (eg, iritis/uveitis) and generally avoid use in patients with active intraocular inflammation.
Disease-related concerns:
• Ocular disease: Use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with risk factors for macular edema (macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs).
Special populations:
• Contact lens wearers: Contains benzalkonium chloride, which may be absorbed by contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Vyzulta: 0.024% (2.5 mL, 5 mL) [contains benzalkonium chloride, edetic acid (edta), polysorbate 80]
No
Solution (Vyzulta Ophthalmic)
0.024% (per mL): $124.40
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Vyzulta: 0.024% (5 mL) [contains benzalkonium chloride, disodium edta, polysorbate 80]
To avoid contamination, do not allow tip of dropper to contact the eye, fingers, or other surfaces. May be used with other eye drops to lower IOP. If more than one topical ophthalmic drug is being used, administer the drugs at least 5 minutes apart. Remove contact lenses prior to administration and wait 15 minutes before reinserting.
Ophthalmic: To avoid contamination, do not allow tip of dropper to contact the eye, fingers, or other surfaces. May be used with other eye drops to lower intraocular pressure. If more than one topical ophthalmic drug is being used, administer the drugs at least 5 minutes apart. Apply gentle pressure to lacrimal sac immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration to decrease systemic absorption of ophthalmic drops (Ref). Remove contact lenses prior to administration and wait 15 minutes before reinserting.
Elevated intraocular pressure: Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Bimatoprost: May increase increased intraocular pressure paradoxical effects of Latanoprostene Bunod. Risk C: Monitor
Latanoprost: Prostaglandins (Ophthalmic) may increase increased intraocular pressure paradoxical effects of Latanoprost. Risk X: Avoid
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May decrease therapeutic effects of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may increase therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents: May decrease therapeutic effects of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor
Ophthalmic prostaglandins, such as latanoprostene bunod, have a theoretical risk of miscarriage. To decrease this risk, agents other than latanoprostene bunod may be preferred for the treatment of glaucoma in patients planning to become pregnant (Strelow 2020).
Ophthalmic prostaglandins, such as latanoprostene bunod, are generally avoided during pregnancy due to a theoretical risk of miscarriage and premature labor. Agents other than latanoprostene bunod may be preferred for the treatment of glaucoma during pregnancy, especially during the first trimester. In general, if ophthalmic agents are needed in pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease exposure to the fetus (Belkin 2020; Prum 2016; Strelow 2020).
It is not known if latanoprostene bunod is present in breast milk following ocular application.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
IOP; regularly examine patients who develop increased iris pigmentation
Latanoprostene bunod is rapidly metabolized in the eye to latanoprost acid, an F2 alpha prostaglandin analog and to butanediol mononitrate; latanoprost acid is thought to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes.
Onset of action: 1 to 3 hours; peak effect: 11 to 13 hours
Time to peak (plasma): Latanoprost acid: 5 minutes
Metabolism: Latanoprostene bunod is metabolized in the eye to latanoprost acid (active moiety) and butanediol mononitrate. After latanoprost acid reaches the systemic circulation, it is primarily metabolized hepatically 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; 1,4-butanediol is further oxidized to succinic acid which enters the tricarboxylic acid cycle.