Terms & Conditions

BY USING THIS SITE YOU ACKNOWLEDGE THAT GENENTECH USA, INC. IS PROVIDING THE MATERIAL FOR INFORMATIONAL PURPOSES ONLY AND THAT NEITHER GENENTECH USA, INC. NOR THEIR LICENSORS ARE PROVIDING THE MATERIALS TO YOU FOR THE PURPOSES OF GIVING YOU MEDICAL ADVICE. YOU SHOULD NOT RELY ON THE MATERIALS IN DECIDING ON A TREATMENT PLAN, DRUG USAGE, OR ANY OTHER MEDICAL ADVICE REGARDING THE MATERIALS, AND GENENTECH USA, INC., AND THEIR LICENSORS STRONGLY URGE THAT YOU CONSULT WITH A PHYSICIAN IN CONNECTION WITH ANY AND ALL TREATMENT OPTIONS THAT MAY BE AVAILABLE TO YOU.

This site could contain technical inaccuracies and/or typographical errors. Genentech USA, Inc. may make improvements and/or changes in the materials contained on the site at any time.

IN NO EVENT SHALL GENENTECH USA, INC., ITS PARENT COMPANY OR EITHER OF THEIR LICENSORS BE LIABLE FOR ANY DIRECT, SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS RELATED TO THE USE OF OUR WEBSITES, WHETHER IN AN ACTION OF CONTRACT, BREACH OF WARRANTY, NEGLIGENCE, OR OTHER TORTIOUS ACTION ARISING OUT OF OR IN CONNECTION WITH THE USE OF THE MATERIALS CONTAINED ON THIS SITE.

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 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 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).

The ATE rate in the three controlled neovascular AMD studies during the first year was 1.9% (17 out of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 1.1% (5 out of 441) in patients from the control arms. In the second year of studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 out of 721) in the combined group of LUCENTIS-treated patients compared with 2.9% (10 out of 344) in patients from the control arms.

In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2 and a study of LUCENTIS used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 out of 484) in patients treated with 0.5 mg LUCENTIS compared to 1.1% (5 out of 435) in patients in the control arms (odds ratio 2.2 (95% confidence interval (0.8-7.1))).

The ATE rate in the two controlled RVO studies during the first six months was 0.8% in both the LUCENTIS and control arms of the studies (4 out of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS and 2 out of 260 in the control arms). The stroke rate was 0.2% (1 out of 525) in the combined group of LUCENTIS-treated patients compared to 0.4% (1 out of 260) in the control arms.

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 the LUCENTIS Phase III clinical trials, most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, vitreous detachment, maculopathy, and intraocular inflammation. Most common non-ocular side effects included headache, arthralgia, influenza, nasopharyngitis, sinusitis, and bronchitis.

As with all therapeutic proteins, there is the potential for an immune response in patients treated with LUCENTIS. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time.

For additional safety information, please see LUCENTIS full prescribing information.