ILEVRO
Generic: NEPAFENAC
Basic Information
Manufacturer
Harrow Eye, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
10f411d3-a81e-074a-e063-6294a90ab547
Indications & Usage
1 INDICATIONS AND USAGE ILEVRO ® 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery.
ILEVRO ® 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery ( 1 ).
ILEVRO ® 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery ( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC at 1-833-4HARROW or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Serious and Otherwise Important Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of labeling.
Increased Bleeding Time [see Warnings and Precautions (5.1) ] Delayed Healing [see Warnings and Precautions (5.2) ] Corneal Effects [see Warnings and Precautions (5.3) ] 6.2 Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation.
These reactions occurred in approximately 5% to 10% of patients.
Other ocular adverse reactions occurring at an incidence of approximately 1% to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, and vitreous detachment.
Some of these reactions may be the consequence of the cataract surgical procedure.
6.3 Non-Ocular Adverse Reactions Non-ocular adverse reactions reported at an incidence of 1% to 4% included headache, hypertension, nausea/vomiting, and sinusitis.
Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC at 1-833-4HARROW or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Serious and Otherwise Important Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of labeling.
Increased Bleeding Time [see Warnings and Precautions (5.1) ] Delayed Healing [see Warnings and Precautions (5.2) ] Corneal Effects [see Warnings and Precautions (5.3) ] 6.2 Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation.
These reactions occurred in approximately 5% to 10% of patients.
Other ocular adverse reactions occurring at an incidence of approximately 1% to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, and vitreous detachment.
Some of these reactions may be the consequence of the cataract surgical procedure.
6.3 Non-Ocular Adverse Reactions Non-ocular adverse reactions reported at an incidence of 1% to 4% included headache, hypertension, nausea/vomiting, and sinusitis.