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Dosing|Treatment Recommendations

Initial Monthly Dosing with LUCENTIS

4 initial monthly doses are proven to result in early improvement

  • To achieve results comparable with those seen in MARINA and ANCHOR, monthly dosing of LUCENTIS is recommended1
  • Some clinical trial patients who experienced a >15-letter gain with 4 initial monthly doses maintained or continued to demonstrate a significant improvement in visual acuity through year 2 with consistent dosing
Persistent Monthly Dosing with LUCENTIS

If patients gain letters after 4 monthly injections, they may still be improving—consistent dosing should be considered; if patients lose letters after 4 monthly injections, consistent dosing should be considered1

  • Some clinical trial patients who experienced an initial loss of <15 letters also maintained vision or demonstrated a gain by year 1
  • There were a small number of clinical trial patients who experienced a loss of >15 letters over the course of treatment
Monthly Dosing with LUCENTIS

Persistent, continuous monitoring is critical to determining the appropriate treatment schedule to optimize outcomes1

  • Monthly dosing of LUCENTIS is recommended to achieve similar results to those seen in pivotal clinical studies through year 2
  • Monitor regularly to prevent the risk of progressive vision loss

Patients vary in their treatment time to response and can experience periods of gain and loss within the course of treatment.2

If monthly dosing is not feasible, less frequent dosing may be considered after 4 initial monthly doses; however, quarterly dosing has been shown to result in some loss of benefit1

  • The PIER trial demonstrated vision improvement (up to 5 letters) during initial monthly dosing, and VA returned to baseline with subsequent mandated quarterly dosing1

PIER: Phase IIIb, multicenter (45 sites), randomized, double-masked, sham-controlled study in 184 patients with choroidal neovascularization (CNV) lesions with or without a classic component.
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INDICATION

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration.

IMPORTANT SAFETY INFORMATION

LUCENTIS is contraindicated in patients with ocular or periocular infections.

Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis and retinal detachment. 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 (<4%) of arterial thromboembolic events (ATEs) observed in LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of inhibitors of VEGF.

Serious adverse events related to the injection procedure occurring in <0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract. Other serious ocular events occurring in <2% of patients included intraocular inflammation with or without hypersensitivity and increased IOP.

In clinical trials, most common ocular side effects included conjunctival hemorrhage, eye pain, and vitreous floaters. Most common nonocular side effects included nasopharyngitis, headache, respiratory and urinary tract infections.

LUCENTIS is for prescription use only.

Individual results with LUCENTIS may vary.

Please see LUCENTIS full Prescribing Information