Warnings and Precautions
Endophthalmitis and Retinal Detachments
Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering LUCENTIS. In addition, patients should be monitored during the week following the injection to permit early treatment should an infection occur [see Dosage and Administration (2.3, 2.4) and Patient Counseling Information].
Increases in Intraocular Pressure
Increases in intraocular pressure have been noted within 60 minutes of intravitreal injection with LUCENTIS. Therefore, intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed appropriately [See Dosage and Administration].
Although there was a low rate (<4%) of arterial thromboembolic events observed in the LUCENTIS clinical trials, there is a theoretical risk of arterial thromboembolic events following intravitreal use of inhibitors of VEGF [see Adverse Reactions].
Use in Specific Populations
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 should be given to a pregnant woman only if clearly needed
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 is administered to a nursing woman.
The safety and effectiveness of LUCENTIS in pediatric patients has not been established.
In the controlled clinical studies, approximately 94% (822/879) of the patients randomized to treatment with LUCENTIS were ≥65 years of age and approximately 68% (601/879) were ≥75 years of age. No notable difference in treatment effect was seen with increasing age in any of the studies. Age did not have a significant effect on systemic exposure in a population pharmacokinetic analysis 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. Sixty‑eight percent of patients (136 of 200) in a population pharmacokinetic analysis had renal impairment (46.5% mild, 20% moderate, and 1.5% severe). Reduction in ranibizumab clearance is minimal in patients with renal impairment and 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 dysfuntion.