LUCENTIS

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

LUCENTIS is indicated for the treatment of patients with:

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Single-dose prefilled syringe designed to provide 0.05 mL for intravitreal injection. Colorless to pale yellow 10 mg/mL solution (LUCENTIS 0.5 mg) Colorless to pale yellow 6 mg/mL solution (LUCENTIS 0.3 mg)

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis and Retinal Detachments [see Warnings and Precautions (5.1) ] Increases in Intraocular Pressure [see Warnings and Precautions (5.2) ] Thromboembolic Events [see Warnings and Precautions (5.3) ] Fatal Events in patients with DME and DR at baseline [see Warnings and Precautions (5.4) ]

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

Drug interaction studies have not been conducted with LUCENTIS. LUCENTIS intravitreal injection has been used adjunctively with PDT. Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when LUCENTIS was administered 7 days (± 2 days) after PDT.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

More concentrated doses as high as 2 mg ranibizumab in 0.05 mL have been administered to patients. No additional unexpected adverse reactions were seen.

11 DESCRIPTION

DESCRIPTION SECTION

LUCENTIS ® (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. LUCENTIS is a sterile, colorless to pale yellow solution in a single-dose prefilled syringe. LUCENTIS is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL LUCENTIS (0.5 mg dose prefilled syringe) or 6 mg/mL LUCENTIS (0.3 mg dose prefilled syringe) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

Unless otherwise noted, visual acuity was measured at a distance of 4 meters.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Each LUCENTIS 0.5 mg carton (NDC 50242-080-03) contains a single-dose, prefilled syringe designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution. The prefilled syringe has a non-retractable plunger stopper and a syringe cap consisting of a tamper-evident rigid seal with a rubber tip cap including a Luer lock adapter. The prefilled syringe has a plunger rod and a CLEAR finger grip. Each prefilled syringe is sterile and is packed in a sealed tray. Each LUCENTIS 0.3 mg carton (NDC 50242-082-03) contains a single-dose, prefilled syringe designed to deliver 0.05 mL of 6 mg/mL ranibizumab solution. The prefilled syringe has a non-retractable plunger stopper and a syringe cap consisting of a tamper-evident rigid seal with a rubber tip cap including a Luer lock adapter. The prefilled syringe has a plunger rod and an ORANGE finger grip. Each prefilled syringe is sterile and is packed in a sealed tray. EACH CARTON IS FOR SINGLE-EYE USE ONLY.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise patients that in the days following LUCENTIS administration, patients are at risk of developing endophthalmitis and retinal vasculitis with or without occlusion. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise the patient to seek immediate care from an ophthalmologist [see Warnings and Precautions (5.1 , 5.5) ] .

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

LUCENTIS ® (ranibizumab injection) Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 LUCENTIS ® is a registered trademark of Genentech, Inc. © 2024 Genentech, Inc. Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL - 0.5 mg Syringe Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50242-080-03 LUCENTIS ® RANIBIZUMAB INJECTION 0.5 mg DOSE PREFILLED SYRINGE STERILE. SINGLE-DOSE. INDICATED FOR Neovascular (wet) age-related macular degeneration (wAMD) Macular edema following retinal vein occlusion (RVO) Myopic choroidal neovascularization (mCNV) 0.5 mg wAMD | RVO | mCNV For intravitreal injection only. Rx only KEEP REFRIGERATED. DO NOT FREEZE. PROTECT FROM LIGHT. Genentech 11013083

PRINCIPAL DISPLAY PANEL - 0.3 mg Syringe Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50242-082-03 LUCENTIS ® RANIBIZUMAB INJECTION 0.3 mg DOSE PREFILLED SYRINGE STERILE. SINGLE-DOSE. INDICATED FOR Diabetic macular edema (DME) Diabetic retinopathy (DR) 0.3 mg DME | DR For intravitreal injection only. Rx only KEEP REFRIGERATED. DO NOT FREEZE. PROTECT FROM LIGHT. Genentech 11013082