Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 WARNINGS AND PRECAUTIONS Increased bleeding time due to interference with thrombocyte aggregation ( 5.1 ) Delayed healing ( 5.2 ) Corneal effects including keratitis ( 5.3 ) 5.1 Increased Bleeding Time With some NSAIDs including ILEVRO ® 0.3%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation.
There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery.
It is recommended that ILEVRO ® 0.3% be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
5.2 Delayed Healing Topical NSAIDs including ILEVRO ® 0.3%, may slow or delay healing.
Topical corticosteroids are also known to slow or delay healing.
Like all medications, Ilevro can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: