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Included as part of the PRECAUTIONS section.

Endophthalmitis and Retinal Detachments

Intravitreal injections, including those with LUCENTIS (ranibizumab injection) , have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering LUCENTIS (ranibizumab injection) . In addition, patients should be monitored during the week following the injection to permit early treatment should an infection occur [see DOSAGE AND ADMINISTRATION and PATIENT INFORMATION].

Increases in Intraocular Pressure

Increases in intraocular pressure have been noted within 60 minutes of intravitreal injection with LUCENTIS (ranibizumab injection) . Therefore, intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed appropriately [see DOSAGE AND ADMINISTRATION].

Thromboembolic Events

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS (ranibizumab injection) 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).

Neovascular (Wet) Age-Related Macular Degeneration

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 (ranibizumab injection) compared with 1.1% (5 out of 441) in patients from the control arms [see Clinical Studies]. 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 (ranibizumab injection) -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 (ranibizumab injection) 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 (ranibizumab injection) compared to 1.1% (5 out of 435) inpatients in the control arms (odds ratio 2.2 (95% confidence interval (0.8-7.1))).

Macular Edema Following Retinal Vein Occlusion

The ATE rate in the two controlled RVO studies during the first six months was 0.8% in both the LUCENTIS (ranibizumab injection) 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 (ranibizumab injection) and 2 out of 260 in the control arms) [see Clinical Studies]. The stroke rate was 0.2% (I out of 525) in the combined group of LUCENTIS (ranibizumab injection) -treated patients compared to 0.4% (1 out of 260) in the control arms.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity or mutagenicity data are available for ranibizumab injection in animals or humans.

No studies on the effects of ranibizumab on fertility have been conducted.

Use In Specific Populations

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with ranibizumab. It is also not known whether ranibizumab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. LUCENTIS (ranibizumab injection) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether ranibizumab is excreted in human milk. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when LUCENTIS (ranibizumab injection) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of LUCENTIS (ranibizumab injection) in pediatric patients has not been established.

Geriatric Use

In the clinical studies, approximately 82% (1146/1406) of the patients randomized to treatment with LUCENTIS (ranibizumab injection) were ≥ 65 years of age and approximately 55% (772/1406) were ≥ 75 years of age. No notable differences in efficacy or safety were seen with increasing age in these studies. Age did not have a significant effect on systemic exposure in population pharmacokinetic analyses after correcting for creatinine clearance.

Patients with Renal Impairment

No formal studies have been conducted to examine the pharmacokinetics of ranibizumab in patients with renal impairment. In population pharmacokinetic analyses of patients, 54% (389/725) had renal impairment (39% mild, 12% moderate, and 2% severe). The reduction in ranibizumab clearance in patients with renal impairment is considered clinically insignificant. Dose adjustment is not expected to be needed for patients with renal impairment.

Patients with Hepatic Dysfunction

No formal studies have been conducted to examine the pharmacokinetics of ranibizumab in patients with hepatic impairment. Dose adjustment is not expected to be needed for patients with hepatic dysfunction.

Last reviewed on RxList: 7/21/2010
This monograph has been modified to include the generic and brand name in many instances.