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, polysorbate 80]
Pharmacology
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/Pharmacodynamics
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.
Dosage and Administration
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
Pregnancy
Pregnancy Considerations
Adverse events were observed in animal reproduction studies. Agents other than latanoprostene bunod may be preferred in pregnant women (Prum 2016; Sethi 2016).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience eyelash growth, eyelid skin discoloration, or eyelash changes. Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, or eye discoloration (brown) (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
