About Ranibizumab|Attributes

LUCENTIS was specifically designed for intravitreal administration for wet AMD¹

LUCENTIS molecule ^*

• As an antibody fragment, LUCENTIS is designed to be a small molecule with a molecular weight of
48 kD¹
• LUCENTIS has a short half-life with rapid intrinsic systemic elimination (half-life ~2 hours)^1,2
• Absence of the Fc portion on the antibody prevents binding to Fc receptors on the cells^2,3

LUCENTIS was manufactured and packaged for intravitreal use¹

LUCENTIS was formulated using the USP 789 guidelines to meet the specifications required by the FDA for intravitreal therapies^1,4
LUCENTIS is designed to form minimal aggregates (<1.5%)—this is due in part to removal of certain amino acids during the affinity maturation process⁵

Affinity maturation increases the binding affinity of LUCENTIS
(0.15 nM)³

LUCENTIS binds to multiple VEGF-A isoforms and cleavage products⁶
LUCENTIS has been engineered to specifically bind with high affinity to VEGF-A^1,2

INDICATION

LUCENTIS^® (ranibizumab injection) is indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)

IMPORTANT SAFETY INFORMATION

LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS.

WARNINGS AND PRECAUTIONS
Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering LUCENTIS. Patients should be monitored during the week following the injection to permit early treatment, should an infection occur.

Increases in intraocular pressure (IOP) have been noted within 60 minutes of intravitreal injection. IOP and perfusion of the optic nerve head should be monitored and managed appropriately.

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).

ADVERSE EVENTS
Serious adverse events related to the injection procedure occurring in <0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.

In neovascular (wet) age-related macular degeneration clinical trials, most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, vitreous detachment, and intraocular inflammation. Most common non-ocular side effects included nasopharyngitis, headache, arthralgia, and bronchitis.

In macular edema following retinal vein occlusion clinical trials, most common ocular side effects included conjunctival hemorrhage, eye pain, and maculopathy. Most common non-ocular side effects included nasopharyngitis, headache, influenza, and sinusitis.

For additional safety information, please see LUCENTIS full prescribing information

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