Loading…
ILEVRO is a brand name for Nepafenac, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening.
3% and should be monitored closely for corneal health. There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drug substances.
Topical NSAIDs, including ILEVRO, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical corticosteroids may increase the potential for healing complications.
The safety of ILEVRO for pre-treatment more than one day before cataract surgery, the total treatment duration greater than two weeks, or treatment with dosing frequency more than once daily, has not been assessed in humans. Hematologic With some NSAIDs, including ILEVRO, the potential exists for increased bleeding time due to interference with thrombocyte aggregation.
There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ILEVRO be used with caution in patients with known bleeding tendencies or who are receiving medications which may prolong bleeding time.
Ophthalmologic Use of topical NSAIDs, including ILEVRO, may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation.
These events may be sight-threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of ILEVRO and should be closely monitored for corneal health. , dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight- threatening.
Topical NSAIDs should be used with caution in these patients. Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions. Post-marketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nepafenac in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Contact lens wear is not recommended during the postoperative period following cataract surgery; therefore, contact lenses should not be worn during treatment with ILEVRO. In addition, ILEVRO contains benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses.
ILEVRO may cause temporary blurred vision or other visual disturbances that can affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until vision clears before driving or using machinery.
Sexual Function/Reproduction There are no data on the effect of ILEVRO on human fertility.
Special Populations Pregnant Women:
No adequate and well-controlled studies have been conducted in pregnant women. Studies in animals with nepafenac have shown reproductive toxicity. The potential risk for humans is unknown. The inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development, therefore, the use of ILEVRO during pregnancy is not recommended.
Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 260 and 2400 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 80 and 680 times human plasma exposure for rabbits, respectively.
In rats, maternally toxic doses ≥ 10 mg/kg were associated with dystocia, increased postimplantation loss, reduced fetal weights and growth, and reduced fetal survival. Nepafenac has been shown to cross the placental barrier in rats.
ILEVRO Product Monograph Page 6 of 33 Nursing Mothers:
It is unknown whether nepafenac is excreted in human milk. Animal studies have shown excretion of nepafenac in the milk of pregnant rats. Caution should be exercised when ILEVRO is administered to a nursing woman.
Pediatric Use:
The safety and effectiveness of ILEVRO in pediatric patients have not been established. Its use is not recommended in these patients until further data become available.
Geriatric Use:
No overall differences in safety and effectiveness have been observed between elderly and younger patients. 8%) patients exposed to ILEVRO experienced 205 adverse events. 2%) patients. 1%) patient. No serious adverse drug reactions related to ILEVRO were reported in these studies.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared […]