Vyzulta (latanoprostene bunod)

For the treatment of open-angle glaucoma or ocular hypertension, 1 drop of latanoprostene bunod 0.024% solution should be instilled into the conjunctival sac of the affected eye(s) once daily in the evening. Latanoprostene bunod should not be administered more frequently than once daily since more frequent dosing may diminish the intraocular pressure (IOP)-lowering effect of the drug.

If the target IOP is not achieved, alternative or additional ocular hypotensive agents may be required. (See Uses: Ocular Hypertension and Glaucoma.)

Latanoprostene bunod is applied topically to the eye(s) as a 0.024% ophthalmic solution.

Care should be taken to avoid contaminating the solution container. (See Bacterial Keratitis under Cautions: Warnings/Precautions.)

Contact lenses should be removed prior to administration of latanoprostene bunod; contact lenses may be reinserted 15 minutes following administration of the dose. (See Use with Contact Lenses under Cautions: Warnings/Precautions.)

If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered at least 5 minutes apart.

No dosing information is available for this tab.

No formal drug interaction studies using latanoprostene bunod have been performed to date. However, interactions are not expected because of limited systemic exposure following topical application to the eye.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Iop-Lowering Prostaglandin Analogs/Bimatoprost Topical

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: When used ophthalmically to lower intraocular pressure, prostaglandin analogs may be at the top of the dose-response curve. Use of an additional prostaglandin may result in decreased effectiveness.(1)

CLINICAL EFFECTS: Concurrent use of topical bimatoprost may result in decreased effectiveness of ophthalmic prostaglandin analogs and an increase in intraocular pressure.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients using ophthalmic prostaglandin analogs to lower intraocular pressure should be monitored for changes in their intraocular pressure.(1) Use of topical bimatoprost may need to be discontinued in patients who stop responding to their ophthalmic prostaglandin analogue.

DISCUSSION: Studies have shown that the ophthalmic administration of bimatoprost twice daily is less effective at lowering intraocular pressure than ophthalmic bimatoprost administered once daily. Concurrent use of topical bimatoprost may decrease the effectiveness of ophthalmic prostaglandin analogs.(1)

The manufacturer states there are no known contraindications to the use of latanoprostene bunod.

There are no contraindication contraindications for this drug.

• Iritis
• Uveitis

• Aphakia
• Conjunctivitis
• Cystoid macular edema
• Macular retinal edema
• Pseudophakia

Adverse effects occurring in 2% or more of patients receiving latanoprostene bunod ophthalmic solution include conjunctival hyperemia, eye irritation, eye pain, and instillation site pain.

Approximately 0.6% of patients receiving latanoprostene bunod ophthalmic solution in clinical trials discontinued therapy because of adverse ocular reactions, including ocular hyperemia, conjunctival irritation, conjunctival edema, eye irritation, blurred vision, punctate keratitis, and foreign body sensation.

Rare or Very Rare

• Punctate keratitis

More Frequent

• Conjunctival hyperemia
• Hyperpigmentation of eyelid
• Iris hyperpigmentation
• Ocular irritation
• Ocular pain

Less Frequent

• Hypertrichosis of eyelid eyelashes
• Hypertrichosis of eyelid vellus hair

Rare or Very Rare

• Blurred vision
• Chemosis
• Foreign body sensation of eye

No enhanced messaging available.

Use of latanoprostene bunod ophthalmic solution in pediatric patients 16 years of age or younger is not recommended because of potential safety concerns related to increased pigmentation following long-term use. (See Pigmentation under Cautions: Warnings/Precautions.)

There are no available data regarding use of latanoprostene bunod ophthalmic solution in pregnant women to inform any drug-associated risk.

Latanoprostene bunod has caused miscarriages, abortions, and fetal harm in rabbits. The drug was shown to be abortifacient and teratogenic when administered IV to pregnant rabbits at exposures 0.28 times or greater than the clinical dose. Dosages of 20 mcg/kg daily or greater (23 times or greater the clinical dose) produced 100% embryofetal lethality in rabbits. In rats, no treatment-related teratogenic effects were observed when the drug was administered IV at a dosage of 150 mcg/kg daily (87 times the clinical dose).

It is not known whether latanoprostene bunod and/or its metabolites are distributed into human milk following topical application to the eye. Data also are not available on the effects of the drug on the breast-fed child or on milk production.

The benefits of breast-feeding should be considered along with the importance of the drug to the woman and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition.

No overall differences in safety or efficacy of latanoprostene bunod ophthalmic solution have been observed between geriatric patients and younger adults.