LUCENTIS Indications and Important Safety Information
INDICATIONS
LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with:
- Neovascular (wet) age-related macular degeneration (wAMD)
- Macular edema following retinal vein occlusion (RVO)
- Diabetic macular edema (DME)
IMPORTANT SAFETY INFORMATION
LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS.
Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.
Increases in intraocular pressure have been noted both pre-injection and post-injection with LUCENTIS.
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
In the LUCENTIS Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, headache, influenza, sinusitis, cough, and nausea.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
For additional safety information, please see LUCENTIS full Prescribing Information.