LUCENTIS® (ranibizumab injection) 0.5 mg prefilled syringe
The Efficacy and Safety of LUCENTIS is prefilled.
LUCENTIS 0.5 mg is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).
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IMPORTANT SAFETY INFORMATION
LUCENTIS is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. Hypersensitivity reactions may manifest as severe intraocular inflammation.
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).
Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with LUCENTIS compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded.
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, anemia, nausea, and cough.
For additional safety information, please see LUCENTIS full prescribing information.