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Drug overview for VYZULTA (latanoprostene bunod):
Generic name: latanoprostene bunod (la-TAN-oh-PROS-teen BUE-nod)
Drug class: Ophthalmic Prostaglandin Agonists
Therapeutic class: Ophthalmic Agents
Latanoprostene bunod, a synthetic analog of naturally occurring prostaglandin F2alpha (PGF2alpha), is an ocular hypotensive agent.
No enhanced Uses information available for this drug.
Generic name: latanoprostene bunod (la-TAN-oh-PROS-teen BUE-nod)
Drug class: Ophthalmic Prostaglandin Agonists
Therapeutic class: Ophthalmic Agents
Latanoprostene bunod, a synthetic analog of naturally occurring prostaglandin F2alpha (PGF2alpha), is an ocular hypotensive agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
VYZULTA 0.024% OPHTH SOLUTION
The following indications for VYZULTA (latanoprostene bunod) have been approved by the FDA:
Indications:
Ocular hypertension
Open angle glaucoma
Professional Synonyms:
Chronic glaucoma
Compensated glaucoma
Glaucoma simplex
Increased intraocular pressure
Increased IOP
Open-angle glaucoma
Raised intraocular pressure
Simple glaucoma
Indications:
Ocular hypertension
Open angle glaucoma
Professional Synonyms:
Chronic glaucoma
Compensated glaucoma
Glaucoma simplex
Increased intraocular pressure
Increased IOP
Open-angle glaucoma
Raised intraocular pressure
Simple glaucoma
The following dosing information is available for 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.)
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.
(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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VYZULTA 0.024% OPHTH SOLUTION | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route once daily in the evening |
No generic dosing information available.
The following drug interaction information is available for VYZULTA (latanoprostene bunod):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
BIMATOPROST, LATISSE |
The following contraindication information is available for VYZULTA (latanoprostene bunod):
Drug contraindication overview.
The manufacturer states there are no known contraindications to the use of latanoprostene bunod.
The manufacturer states there are no known contraindications to the use of latanoprostene bunod.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Iritis |
| Uveitis |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Aphakia |
| Conjunctivitis |
| Cystoid macular edema |
| Macular retinal edema |
| Pseudophakia |
The following adverse reaction information is available for VYZULTA (latanoprostene bunod):
Adverse reaction overview.
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.
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.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Punctate keratitis |
There are 10 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Conjunctival hyperemia Hyperpigmentation of eyelid Iris hyperpigmentation Ocular irritation Ocular pain |
Hypertrichosis of eyelid eyelashes Hypertrichosis of eyelid vellus hair |
| Rare/Very Rare |
|---|
|
Blurred vision Chemosis Foreign body sensation of eye |
The following precautions are available for VYZULTA (latanoprostene bunod):
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.)
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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).
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.
The following prioritized warning is available for VYZULTA (latanoprostene bunod):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for VYZULTA (latanoprostene bunod)'s list of indications:
| Ocular hypertension | |
| H40.05 | Ocular hypertension |
| H40.051 | Ocular hypertension, right eye |
| H40.052 | Ocular hypertension, left eye |
| H40.053 | Ocular hypertension, bilateral |
| H40.059 | Ocular hypertension, unspecified eye |
| Open angle glaucoma | |
| H40.1 | Open-angle glaucoma |
| H40.10 | Unspecified open-angle glaucoma |
| H40.10x0 | Unspecified open-angle glaucoma, stage unspecified |
| H40.10x1 | Unspecified open-angle glaucoma, mild stage |
| H40.10x2 | Unspecified open-angle glaucoma, moderate stage |
| H40.10x3 | Unspecified open-angle glaucoma, severe stage |
| H40.10x4 | Unspecified open-angle glaucoma, indeterminate stage |
| H40.11 | Primary open-angle glaucoma |
| H40.111 | Primary open-angle glaucoma, right eye |
| H40.1110 | Primary open-angle glaucoma, right eye, stage unspecified |
| H40.1111 | Primary open-angle glaucoma, right eye, mild stage |
| H40.1112 | Primary open-angle glaucoma, right eye, moderate stage |
| H40.1113 | Primary open-angle glaucoma, right eye, severe stage |
| H40.1114 | Primary open-angle glaucoma, right eye, indeterminate stage |
| H40.112 | Primary open-angle glaucoma, left eye |
| H40.1120 | Primary open-angle glaucoma, left eye, stage unspecified |
| H40.1121 | Primary open-angle glaucoma, left eye, mild stage |
| H40.1122 | Primary open-angle glaucoma, left eye, moderate stage |
| H40.1123 | Primary open-angle glaucoma, left eye, severe stage |
| H40.1124 | Primary open-angle glaucoma, left eye, indeterminate stage |
| H40.113 | Primary open-angle glaucoma, bilateral |
| H40.1130 | Primary open-angle glaucoma, bilateral, stage unspecified |
| H40.1131 | Primary open-angle glaucoma, bilateral, mild stage |
| H40.1132 | Primary open-angle glaucoma, bilateral, moderate stage |
| H40.1133 | Primary open-angle glaucoma, bilateral, severe stage |
| H40.1134 | Primary open-angle glaucoma, bilateral, indeterminate stage |
| H40.119 | Primary open-angle glaucoma, unspecified eye |
| H40.1190 | Primary open-angle glaucoma, unspecified eye, stage unspecified |
| H40.1191 | Primary open-angle glaucoma, unspecified eye, mild stage |
| H40.1192 | Primary open-angle glaucoma, unspecified eye, moderate stage |
| H40.1193 | Primary open-angle glaucoma, unspecified eye, severe stage |
| H40.1194 | Primary open-angle glaucoma, unspecified eye, indeterminate stage |
| H40.12 | Low-tension glaucoma |
| H40.121 | Low-tension glaucoma, right eye |
| H40.1210 | Low-tension glaucoma, right eye, stage unspecified |
| H40.1211 | Low-tension glaucoma, right eye, mild stage |
| H40.1212 | Low-tension glaucoma, right eye, moderate stage |
| H40.1213 | Low-tension glaucoma, right eye, severe stage |
| H40.1214 | Low-tension glaucoma, right eye, indeterminate stage |
| H40.122 | Low-tension glaucoma, left eye |
| H40.1220 | Low-tension glaucoma, left eye, stage unspecified |
| H40.1221 | Low-tension glaucoma, left eye, mild stage |
| H40.1222 | Low-tension glaucoma, left eye, moderate stage |
| H40.1223 | Low-tension glaucoma, left eye, severe stage |
| H40.1224 | Low-tension glaucoma, left eye, indeterminate stage |
| H40.123 | Low-tension glaucoma, bilateral |
| H40.1230 | Low-tension glaucoma, bilateral, stage unspecified |
| H40.1231 | Low-tension glaucoma, bilateral, mild stage |
| H40.1232 | Low-tension glaucoma, bilateral, moderate stage |
| H40.1233 | Low-tension glaucoma, bilateral, severe stage |
| H40.1234 | Low-tension glaucoma, bilateral, indeterminate stage |
| H40.129 | Low-tension glaucoma, unspecified eye |
| H40.1290 | Low-tension glaucoma, unspecified eye, stage unspecified |
| H40.1291 | Low-tension glaucoma, unspecified eye, mild stage |
| H40.1292 | Low-tension glaucoma, unspecified eye, moderate stage |
| H40.1293 | Low-tension glaucoma, unspecified eye, severe stage |
| H40.1294 | Low-tension glaucoma, unspecified eye, indeterminate stage |
| H40.13 | Pigmentary glaucoma |
| H40.131 | Pigmentary glaucoma, right eye |
| H40.1310 | Pigmentary glaucoma, right eye, stage unspecified |
| H40.1311 | Pigmentary glaucoma, right eye, mild stage |
| H40.1312 | Pigmentary glaucoma, right eye, moderate stage |
| H40.1313 | Pigmentary glaucoma, right eye, severe stage |
| H40.1314 | Pigmentary glaucoma, right eye, indeterminate stage |
| H40.132 | Pigmentary glaucoma, left eye |
| H40.1320 | Pigmentary glaucoma, left eye, stage unspecified |
| H40.1321 | Pigmentary glaucoma, left eye, mild stage |
| H40.1322 | Pigmentary glaucoma, left eye, moderate stage |
| H40.1323 | Pigmentary glaucoma, left eye, severe stage |
| H40.1324 | Pigmentary glaucoma, left eye, indeterminate stage |
| H40.133 | Pigmentary glaucoma, bilateral |
| H40.1330 | Pigmentary glaucoma, bilateral, stage unspecified |
| H40.1331 | Pigmentary glaucoma, bilateral, mild stage |
| H40.1332 | Pigmentary glaucoma, bilateral, moderate stage |
| H40.1333 | Pigmentary glaucoma, bilateral, severe stage |
| H40.1334 | Pigmentary glaucoma, bilateral, indeterminate stage |
| H40.139 | Pigmentary glaucoma, unspecified eye |
| H40.1390 | Pigmentary glaucoma, unspecified eye, stage unspecified |
| H40.1391 | Pigmentary glaucoma, unspecified eye, mild stage |
| H40.1392 | Pigmentary glaucoma, unspecified eye, moderate stage |
| H40.1393 | Pigmentary glaucoma, unspecified eye, severe stage |
| H40.1394 | Pigmentary glaucoma, unspecified eye, indeterminate stage |
| H40.14 | Capsular glaucoma with pseudoexfoliation of lens |
| H40.141 | Capsular glaucoma with pseudoexfoliation of lens, right eye |
| H40.1410 | Capsular glaucoma with pseudoexfoliation of lens, right eye, stage unspecified |
| H40.1411 | Capsular glaucoma with pseudoexfoliation of lens, right eye, mild stage |
| H40.1412 | Capsular glaucoma with pseudoexfoliation of lens, right eye, moderate stage |
| H40.1413 | Capsular glaucoma with pseudoexfoliation of lens, right eye, severe stage |
| H40.1414 | Capsular glaucoma with pseudoexfoliation of lens, right eye, indeterminate stage |
| H40.142 | Capsular glaucoma with pseudoexfoliation of lens, left eye |
| H40.1420 | Capsular glaucoma with pseudoexfoliation of lens, left eye, stage unspecified |
| H40.1421 | Capsular glaucoma with pseudoexfoliation of lens, left eye, mild stage |
| H40.1422 | Capsular glaucoma with pseudoexfoliation of lens, left eye, moderate stage |
| H40.1423 | Capsular glaucoma with pseudoexfoliation of lens, left eye, severe stage |
| H40.1424 | Capsular glaucoma with pseudoexfoliation of lens, left eye, indeterminate stage |
| H40.143 | Capsular glaucoma with pseudoexfoliation of lens, bilateral |
| H40.1430 | Capsular glaucoma with pseudoexfoliation of lens, bilateral, stage unspecified |
| H40.1431 | Capsular glaucoma with pseudoexfoliation of lens, bilateral, mild stage |
| H40.1432 | Capsular glaucoma with pseudoexfoliation of lens, bilateral, moderate stage |
| H40.1433 | Capsular glaucoma with pseudoexfoliation of lens, bilateral, severe stage |
| H40.1434 | Capsular glaucoma with pseudoexfoliation of lens, bilateral, indeterminate stage |
| H40.149 | Capsular glaucoma with pseudoexfoliation of lens, unspecified eye |
| H40.1490 | Capsular glaucoma with pseudoexfoliation of lens, unspecified eye, stage unspecified |
| H40.1491 | Capsular glaucoma with pseudoexfoliation of lens, unspecified eye, mild stage |
| H40.1492 | Capsular glaucoma with pseudoexfoliation of lens, unspecified eye, moderate stage |
| H40.1493 | Capsular glaucoma with pseudoexfoliation of lens, unspecified eye, severe stage |
| H40.1494 | Capsular glaucoma with pseudoexfoliation of lens, unspecified eye, indeterminate stage |
| H40.15 | Residual stage of open-angle glaucoma |
| H40.151 | Residual stage of open-angle glaucoma, right eye |
| H40.152 | Residual stage of open-angle glaucoma, left eye |
| H40.153 | Residual stage of open-angle glaucoma, bilateral |
| H40.159 | Residual stage of open-angle glaucoma, unspecified eye |
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