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Latanoprostene Bunod

Medically reviewed by Drugs.com. Last updated on Sep 1, 2020.

Pronunciation

(la tan oh PROS teen BU nod)

Dosage Forms

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]

Brand Names: U.S.

  • Vyzulta

Pharmacologic Category

  • Ophthalmic Agent, Antiglaucoma
  • Prostaglandin, Ophthalmic

Pharmacology

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.

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.

Onset of Action

Onset of action: 1 to 3 hours; peak effect: 11 to 13 hours

Time to Peak

Latanoprost acid: 5 minutes

Use: Labeled Indications

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

Contraindications

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

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

Dosing: Adult

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: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Adolescents >16 years: Refer to adult dosing.

Administration

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.

Storage

Store unopened bottles refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Once a bottle is opened it may be stored at 2ºC to 25ºC (36ºF to 77ºF) for 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 and freezing.

Drug Interactions

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

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). 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). Monitor therapy

Adverse Reactions

1% to 10%:

Local: Application site pain (2%)

Ophthalmic: Conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%)

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.

Monitoring Parameters

IOP; regularly examine patients who develop increased iris pigmentation

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).

Patient Education

What is this drug used for?

• It is used to treat glaucoma.

• It is used to lower high eye pressure.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eyelash growth

• Eyelid skin discoloration

• Eyelash changes

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Eye discoloration (brown)

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.