ILEVRO

What it is

ILEVRO is nepafenac eye drops suspension containing 3 mg/mL (0.3%) nepafenac. It is a light yellow to yellow, uniform suspension for multiple-dose topical ophthalmic use.

Approved indications

ILEVRO is indicated for: — Prevention and treatment of postoperative pain and inflammation associated with cataract surgery — Reduction in risk of postoperative macular oedema associated with cataract surgery in patients with non-proliferative diabetic retinopathy

Dosing overview

For the prevention and treatment of pain and inflammation, the dose is one drop of ILEVRO in the conjunctival sac of the affected eye(s) once daily, beginning one day prior to cataract surgery and continued on the day of surgery, with an additional drop administered 30 to 120 minutes prior to surgery. The effectiveness of ILEVRO was demonstrated for up to 14 days of the postoperative period. For reduction in the risk of postoperative macular oedema associated with cataract surgery in patients with non-proliferative diabetic retinopathy, the dose is one drop of ILEVRO in the conjunctival sac of the affected eye(s) once daily beginning one day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician, with an additional drop administered 30 to 120 minutes prior to surgery.

Key safety warnings

Use of topical NSAIDs may result in keratitis, and in some susceptible patients, continued use may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation, which may be sight threatening. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases such as 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, and topical NSAIDs should be used with caution in these patients. Ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery, and ILEVRO should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time. Topical NSAIDs may slow or delay healing, topical corticosteroids are also known to slow or delay healing, and concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Patients should be instructed to avoid sunlight during treatment with ILEVRO.

Contraindications

ILEVRO is contraindicated in patients with hypersensitivity to the active substance nepafenac or to any of the excipients, hypersensitivity to other NSAIDs, and patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs. Soft contact lenses should not be used with ILEVRO because the benzalkonium chloride preservative may be absorbed by these lenses.

Regulatory history

ILEVRO was first approved on 4 November 2015. The TGA approved the registration of ILEVRO (nepafenac 0.3% eye drops) for the prevention and treatment of postoperative pain and inflammation associated with cataract surgery following resolution of minor quality deficiencies. ARTG 230200 (ILEVRO nepafenac 0.3% eye drops, suspension, bottle) was first listed on 2015-11-04, and ARTG 309880 (ILEVRO nepafenac 0.3% eye drops, suspension, oval bottle) was first listed on 2019-08-30.