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Latanoprostene bunod: Drug information

Latanoprostene bunod: Drug information
(For additional information see "Latanoprostene bunod: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Vyzulta
Brand Names: Canada
  • Vyzulta
Pharmacologic Category
  • Ophthalmic Agent, Antiglaucoma;
  • Prostaglandin, Ophthalmic
Dosing: Adult
Elevated intraocular pressure

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)

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

Adolescents >16 years: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

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%)

Contraindications

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Hypersensitivity to latanoprostene bunod or any component of the formulation.

Warnings/Precautions

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.

• 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.

Dosage Forms: US

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]

Generic Equivalent Available: US

No

Pricing: US

Solution (Vyzulta Ophthalmic)

0.024% (per mL): $122.56

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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]

Administration: Adult

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.

Administration: Pediatric

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. Remove contact lenses prior to administration and wait 15 minutes before reinserting.

Use: Labeled Indications

Elevated intraocular pressure: Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension.

Metabolism/Transport Effects

None known.

Drug Interactions

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Bimatoprost: The concomitant use of Bimatoprost and Latanoprostene Bunod may result in increased intraocular pressure. Risk C: Monitor therapy

Latanoprost: The concomitant use of Prostaglandins (Ophthalmic) and Latanoprost may result in increased intraocular pressure. Risk X: Avoid combination

Nonsteroidal Anti-Inflammatory Agents: May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Reproductive Considerations

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).

Pregnancy Considerations

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).

Breastfeeding Considerations

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.

Monitoring Parameters

IOP; regularly examine patients who develop increased iris pigmentation

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Vyzulta;
  • (AR) Argentina: Vyzulta;
  • (BR) Brazil: Vyzulta;
  • (CO) Colombia: Cliropta;
  • (JO) Jordan: Vyzulta;
  • (LB) Lebanon: Vyzulta;
  • (MX) Mexico: Vyzulta;
  • (PR) Puerto Rico: Vyzulta;
  • (QA) Qatar: Vyzulta;
  • (TW) Taiwan: Vyzulta;
  • (UA) Ukraine: Vyzulta;
  • (ZA) South Africa: Vyzulta
  1. Belkin A, Chen T, DeOliveria AR, Johnson SM, Ramulu PY, Buys YM; American Glaucoma Society and the Canadian Glaucoma Society. A practical guide to the pregnant and breastfeeding patient with glaucoma. Ophthalmol Glaucoma. 2020;3(2):79-89. doi:10.1016/j.ogla.2019.12.004 [PubMed 32672600]
  2. Prum BE Jr, Rosenberg LF, Gedde SJ, et al. Primary open-angle glaucoma preferred practice pattern guidelines. Ophthalmology. 2016;123(1):P41-P111. doi: 10.1016/j.ophtha.2015.10.053. [PubMed 26581556]
  3. Strelow B, Fleischman D. Glaucoma in pregnancy: an update. Curr Opin Ophthalmol. 2020;31(2):114-122. doi:10.1097/ICU.0000000000000641 [PubMed 31922978]
  4. Vyzulta (latanoprostene bunod) [prescribing information]. Bridgewater, NJ: Bausch + Lomb, a division of Bausch Health US LLC; October 2019.
  5. Vyzulta (latanoprostene bunod) [product monograph]. Laval, Quebec, Canada: Valeant Canada LP: December 2018.
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