LUCENTIS- ranibizumab injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

RANIBIZUMAB (UNII: ZL1R02VT79) (RANIBIZUMAB - UNII:ZL1R02VT79)

Disponibil de la:

Genentech, Inc.

INN (nume internaţional):

RANIBIZUMAB

Compoziție:

RANIBIZUMAB 10 mg in 1 mL

Calea de administrare:

INTRAVITREAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

LUCENTIS is indicated for the treatment of patients with:           LUCENTIS is contraindicated in patients with ocular or periocular infections. LUCENTIS is contraindicated in patients with known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. Hypersensitivity reactions may manifest as severe intraocular inflammation. Risk Summary There are no adequate and well-controlled studies of LUCENTIS administration in pregnant women. Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [Cmax ]) after a single eye treatment at the recommended clinical dose. No skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [see Animal Data] . Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab [see Clinical Pharmacology (12.1)] , treatment with LUCENTIS may pose a risk to human embryofetal development. LUCENTIS should be given to a pregnant woman only if clearly needed. Data Animal Data An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. Pregnant animals received intravitreal injections of ranibizumab every 14 days starting on Day 20 of gestation, until Day 62 at doses of 0, 0.125, and 1 mg/eye. Skeletal abnormalities including incomplete and/or irregular ossification of bones in the skull, vertebral column, and hindlimbs and shortened supernumerary ribs were seen at a low incidence in fetuses from animals treated with 1 mg/eye of ranibizumab. The 1 mg/eye dose resulted in trough serum ranibizumab levels up to 13 times higher than predicted Cmax levels with single eye treatment in humans. No skeletal abnormalities were seen at the lower dose of 0.125 mg/eye, a dose which resulted in trough exposures equivalent to single eye treatment in humans. No effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity was observed. Risk Summary There are no data available on the presence of ranibizumab in human milk, the effects of ranibizumab on the breastfed infant or the effects of ranibizumab on milk production/excretion. 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 developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LUCENTIS and any potential adverse effects on the breastfed child from ranibizumab. Infertility No studies on the effects of ranibizumab on fertility have been conducted and it is not known whether ranibizumab can affect reproduction capacity. Based on the anti-VEGF mechanism of action for ranibizumab, treatment with LUCENTIS may pose a risk to reproductive capacity. The safety and effectiveness of LUCENTIS in pediatric patients have not been established. In the clinical studies, approximately 76% (2449 of 3227) of patients randomized to treatment with LUCENTIS were ≥ 65 years of age and approximately 51% (1644 of 3227) were ≥ 75 years of age [see Clinical Studies (14)]. 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.

Rezumat produs:

EACH CARTON IS FOR SINGLE-EYE USE ONLY. LUCENTIS should be refrigerated at 2º-8ºC (36º-46ºF). DO NOT FREEZE. Do not use beyond the date stamped on the label. Protect LUCENTIS prefilled syringes from light and store in the original carton until time of use. Do not open LUCENTIS prefilled syringe sealed tray until time of use.

Statutul autorizaţiei:

Biologic Licensing Application

Caracteristicilor produsului

LUCENTIS- RANIBIZUMAB INJECTION, SOLUTION
GENENTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LUCENTIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LUCENTIS.
LUCENTIS (RANIBIZUMAB INJECTION) FOR INTRAVITREAL INJECTION
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Dosage and Administration, General Dosing Information (2.1)
8/2023
Dosage and Administration, Preparation for Administration (2.6)
8/2023
Dosage and Administration, Administration (2.7)
8/2023
Warnings and Precautions, Retinal Vasculitis with or without Occlusion
(5.5)
2/2024
INDICATIONS AND USAGE
LUCENTIS, a vascular endothelial growth factor (VEGF) inhibitor, is
indicated for the treatment of patients
with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD) (1.1)
Macular Edema Following Retinal Vein Occlusion (RVO) (1.2)
Diabetic Macular Edema (DME) (1.3)
Diabetic Retinopathy (DR) (1.4)
Myopic Choroidal Neovascularization (mCNV) (1.5)
DOSAGE AND ADMINISTRATION
For ophthalmic intravitreal injection only (2.1)
Neovascular (Wet) Age-Related Macular Degeneration (AMD) (2.2):
LUCENTIS 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be
administered by intravitreal
injection once a month (approximately 28 days).
-
-
Macular Edema Following Retinal Vein Occlusion (RVO) (2.3):
LUCENTIS 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be
administered by intravitreal
injection once a month (approximately 28 days).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) (2.4):
LUCENTIS 0.3 mg (0.05 mL of 6 mg/mL solution) is recommended to be
administered by intravitreal
injection once a month (approximately 28 days).
Myopic Choroidal Neovascularization (mCNV) (2.5):
LUCENTIS 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be
initially administered by
intravitreal injection once a month (approximately 28 days) for up to
three months. Patients may be
retreated if needed.
DOSAGE FORMS AND STRENGTHS
Single-dose prefilled syringe designed t