Optanep Adverse Reactions

Summary of the safety profile: In clinical studies involving 1300 patients using nepafenac 3 mg/mL eye drops, 3 side effects (eye pain, punctate keratitis, hypersensitivity) have been observed in 3 patients (0.2%). One patient (0.1%) discontinued due to an adverse reaction (hypersensitivity), while no placebo-treated patients in these same studies discontinued due to an adverse reaction.
Observed adverse reactions with the use of Nepafenac 1 mg/mL eye drops, suspension and may also be observed with the use of Nepafenac 3 mg/mL eye drops, suspension. In clinical studies involving 2314 patients receiving Nepafenac 1 mg/mL eye drops, the most common adverse reactions were punctate keratitis, foreign body sensation, and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.
The following adverse reactions are evaluated according to the treatment and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post-marketing reports.
Immune system disorders: Rare: Hypersensitivity.
Nervous system disorders: Rare: Dizziness, headache.
Eye disorders: Uncommon: keratitis, punctuate keratitis, corneal epithelium defect, foreign body sensation in the eye, eyelid margin crusting.
Rare: Iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, watering of eyes, allergic conjunctivitis, increased lacrimation, conjunctival hyperemia.
Not known: impaired healing (cornea), corneal opacity, corneal scar, reduced visual acuity, eye irritation, eye swelling, ulcerative keratitis, corneal thinning, blurred vision.
Vascular disorders: Not known: Increase in blood pressure.
Gastrointestinal disorders: Rare: Nausea.
Not known: Vomiting.
Skin and subcutaneous tissue disorders: Rare: Cutis laxa (as a result of thickening, skin shows sagging in the form of folds) allergic dermatitis.
Not Known: Increase in blood pressure.
Description of selected adverse effects: Patients with evidence of corneal epithelial breakdown should immediately discontinue the use of Nepafenac and should be monitored closely for corneal health.
From post-marketing experience with Nepafenac 1 mg/mL eye drops, cases reporting corneal epithelium defect/disorder have been identified. Severity of these cases varies from non-serious effects on the epithelial integrity of the corneal epithelium to more serious events where surgical interventions and/or medical therapy are required to regain clear vision.
Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight-threatening.
Pediatric population: The safety and efficacy of Nepafenac in children and adolescents have not been established.