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Drug overview for ILEVRO (nepafenac):
Generic name: NEPAFENAC (ne-PA-fen-ak)
Drug class: Ophthalmic NSAIDS
Therapeutic class: Ophthalmic Agents
Nepafenac is a prodrug of amfenac, a prototypical nonsteroidal anti-inflammatory agent (NSAIA) that also exhibits analgesic activity.
No enhanced Uses information available for this drug.
Generic name: NEPAFENAC (ne-PA-fen-ak)
Drug class: Ophthalmic NSAIDS
Therapeutic class: Ophthalmic Agents
Nepafenac is a prodrug of amfenac, a prototypical nonsteroidal anti-inflammatory agent (NSAIA) that also exhibits analgesic activity.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ILEVRO (nepafenac) have been approved by the FDA:
Indications:
Post-op ocular inflammation
Postoperative ocular pain
Professional Synonyms:
Post-op ocular pain
Postoperative eye pain
Postoperative ocular inflammation
Postoperative ophthalmic inflammation
Indications:
Post-op ocular inflammation
Postoperative ocular pain
Professional Synonyms:
Post-op ocular pain
Postoperative eye pain
Postoperative ocular inflammation
Postoperative ophthalmic inflammation
The following dosing information is available for ILEVRO (nepafenac):
The recommended dosage of nepafenac for the treatment of pain and inflammation associated with cataract surgery in adults and children 10 years of age or older is 1 drop of a 0.1% suspension in the affected eye(s) 3 times daily beginning one day prior to cataract surgery and continuing on the day of the surgery and for 2 weeks after surgery.
Nepafenac is applied topically to the eye as an ophthalmic suspension. Care should be taken to avoid contamination of the suspension container. Nepafenac ophthalmic suspension should be shaken well prior to administration.
The suspension should not be administered while wearing contact lenses. Nepafenac ophthalmic suspension may be used in conjunction with other topical ophthalmic medications such as beta-adrenergic blocking agents, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered 10 minutes apart from nepafenac administration.
The suspension should not be administered while wearing contact lenses. Nepafenac ophthalmic suspension may be used in conjunction with other topical ophthalmic medications such as beta-adrenergic blocking agents, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered 10 minutes apart from nepafenac administration.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ILEVRO 0.3% OPHTH DROPS | Maintenance | Adults instill 1 drop to the operated eye by ophthalmic route once daily ; start 1 day before cataract surgery; use for 14 days after surgery |
No generic dosing information available.
The following drug interaction information is available for ILEVRO (nepafenac):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ILEVRO (nepafenac):
Drug contraindication overview.
Known hypersensitivity to nepafenac or any ingredient in the formulation or to other nonsteroidal anti-inflammatory agents (NSAIAs).
Known hypersensitivity to nepafenac or any ingredient in the formulation or to other nonsteroidal anti-inflammatory agents (NSAIAs).
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Keratitis |
| Ocular hemorrhage |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Decreased corneal sensitivity |
| Diabetes mellitus |
| Impaired wound healing |
| Increased risk of bleeding |
| Rheumatoid arthritis |
| Tear film insufficiency |
The following adverse reaction information is available for ILEVRO (nepafenac):
Adverse reaction overview.
Adverse effects reported in 1% or more of patients receiving nepafenac ophthalmic suspension include capsular opacity, decreased visual acuity, ocular foreign body sensation, increased intraocular pressure, ocular sticky sensation, conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, vitreous detachment, headache, hypertension, nausea, vomiting, and sinusitis.
Adverse effects reported in 1% or more of patients receiving nepafenac ophthalmic suspension include capsular opacity, decreased visual acuity, ocular foreign body sensation, increased intraocular pressure, ocular sticky sensation, conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, vitreous detachment, headache, hypertension, nausea, vomiting, and sinusitis.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Corneal opacity Ocular hypertension Reduced visual acuity |
Chemosis Corneal edema Vitreous detachment |
| Rare/Very Rare |
|---|
|
Corneal erosion Corneal ulcer Impaired wound healing |
There are 15 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Foreign body sensation of eye Sticky sensation of eye |
Conjunctival hyperemia Dry eye Eye tearing Eyelid crusting Headache disorder Hypertension Nausea and vomiting Ocular irritation Ocular itching Ocular pain Photophobia Sinusitis |
| Rare/Very Rare |
|---|
|
Corneal dystrophy |
The following precautions are available for ILEVRO (nepafenac):
Safety and efficacy not established in children younger than 10 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) Avoid use in late pregnancy because of known effects on fetal cardiovascular system (possible closure of the ductus arteriosus).
Nepafenac (administered orally as a single 3-mg/kg dose) is distributed into milk in rats. It is not known whether nepafenac is distributed into human milk following topical application to the eye; caution if used in nursing women.
No substantial differences in safety and efficacy relative to younger adults.
The following prioritized warning is available for ILEVRO (nepafenac):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ILEVRO (nepafenac)'s list of indications:
| Post-op ocular inflammation | |
| H57.8 | Other specified disorders of eye and adnexa |
| Postoperative ocular pain | |
| H57.1 | Ocular pain |
| H57.10 | Ocular pain, unspecified eye |
| H57.11 | Ocular pain, right eye |
| H57.12 | Ocular pain, left eye |
| H57.13 | Ocular pain, bilateral |
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