Lucentis™ (ranibizumab injection)

• Full Prescribing Information
• Healthcare Provider Letters

  3 letters

  SAILOR with AMD - Jan 2007 Important Drug Notification: Intraocular Inflammatory Reactions After Intravitreal Injection - Dec 2008 Safety Risk with Intravitreal Use of VEGF - Aug 2006
• Material Safety Data Sheet

Indication

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 within 60 minutes of intravitreal injection.

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 ofVEGF 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 nonocular side effects included nasopharyngitis, headache, influenza, sinusitis, cough, and nausea.

For additional safety information, please see LUCENTIS full prescribing information at www.lucentis.com.