EYLEA- aflibercept injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

aflibercept (UNII: 15C2VL427D) (aflibercept - UNII:15C2VL427D)

थमां उपलब्ध:

Regeneron Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

aflibercept

रचना:

aflibercept 40 mg in 1 mL

प्रशासन का मार्ग:

INTRAVITREAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

EYLEA is indicated for the treatment of: EYLEA is contraindicated in patients with ocular or periocular infections. EYLEA is contraindicated in patients with active intraocular inflammation. EYLEA is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in EYLEA. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation. Risk Summary Adequate and well-controlled studies with EYLEA have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. A fetal No Observed Adverse Effect Level (NOAEL) was not identified. At the lowest dose shown to produce adverse embryofetal effects, systemic exposures (based on AUC for free aflibercept) were approximately 6 times higher than AUC values observed in humans after a single intravitreal 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 EYLEA can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for aflibercept [see Clinical Pharmacology (12.1)], treatment with EYLEA may pose a risk to human embryofetal development. EYLEA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In two embryofetal development studies, aflibercept produced adverse embryofetal effects when administered every three days during organogenesis to pregnant rabbits at intravenous doses ≥3 mg per kg, or every six days during organogenesis at subcutaneous doses ≥0.1 mg per kg. Adverse embryofetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete ossification). The maternal No Observed Adverse Effect Level (NOAEL) in these studies was 3 mg per kg. Aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal NOAEL was not identified. At the lowest dose shown to produce adverse embryofetal effects in rabbits (0.1 mg per kg), systemic exposure (AUC) of free aflibercept was approximately 6 times higher than systemic exposure (AUC) observed in adult patients after a single intravitreal dose of 2 mg. Risk Summary There is no information regarding the presence of aflibercept in human milk, the effects of the drug on the breastfed infant, or the effects of the drug 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, EYLEA is not recommended during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EYLEA and any potential adverse effects on the breastfed child from EYLEA. Contraception Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment, and for at least 3 months after the last intravitreal injection of EYLEA. Infertility There are no data regarding the effects of EYLEA on human fertility. Aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose approximately 1500 times higher than the systemic level observed in adult patients with an intravitreal dose of 2 mg. A No Observed Adverse Effect Level (NOAEL) was not identified. These findings were reversible within 20 weeks after cessation of treatment [see Nonclinical Toxicology (13.1)]. The safety and effectiveness of EYLEA have been demonstrated in two clinical studies of pre-term infants with ROP. These two studies randomized pre-term infants between initial treatment with EYLEA or laser. Efficacy of each treatment is supported by the demonstration of a clinical course which was better than would have been expected without treatment [see Dosage and Administration (2.9), Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14.6)] . In the clinical studies, approximately 76% (2049/2701) of patients randomized to treatment with EYLEA were ≥65 years of age and approximately 46% (1250/2701) were ≥75 years of age. No significant differences in efficacy or safety were seen with increasing age in these studies.

उत्पाद समीक्षा:

Each pre-filled syringe or vial is a clear, colorless to pale yellow solution and is for single eye use only. EYLEA is supplied in the following presentations [see Dosage and Administration (2.1), (2.2), (2.3), (2.4) and (2.9)]. Discard unused portion. Refrigerate EYLEA at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use beyond the date stamped on the carton and container label. Store in the original carton until time of use to protect from light. Do not open sealed blister tray until time of use.

प्राधिकरण का दर्जा:

Biologic Licensing Application

उत्पाद विशेषताएं

EYLEA- AFLIBERCEPT INJECTION, SOLUTION
REGENERON PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EYLEA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EYLEA.
EYLEA (AFLIBERCEPT) INJECTION, FOR INTRAVITREAL USE
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Indications and Usage (1.5)
2/2023
Dosage and Administration (2)
2/2023
Warnings and Precautions (5.1)
12/2023
Warnings and Precautions (5.3)
2/2023
INDICATIONS AND USAGE
EYLEA is a vascular endothelial growth factor (VEGF) inhibitor
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)
Retinopathy of Prematurity (ROP) (1.5)
DOSAGE AND ADMINISTRATION
NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION (AMD)
The recommended dose for EYLEA is 2 mg (0.05 mL of 40 mg/mL solution)
administered by
intravitreal injection every 4 weeks (approximately every 28 days,
monthly) for the first 3 months,
followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal
injection once every 8 weeks (2
months). (2.5)
Although EYLEA may be dosed as frequently as 2 mg every 4 weeks
(approximately every 25 days,
monthly), additional efficacy was not demonstrated in most patients
when EYLEA was dosed every 4
weeks compared to every 8 weeks. Some patients may need every 4 week
(monthly) dosing after
the first 12 weeks (3 months). (2.5)
Although not as effective as the recommended every 8 week dosing
regimen, patients may also be
treated with one dose every 12 weeks after one year of effective
therapy. Patients should be
assessed regularly. (2.5)
MACULAR EDEMA FOLLOWING RETINAL VEIN OCCLUSION (RVO)
The recommended dose for EYLEA is 2 mg (0.05 mL of 40 mg/mL solution)
administered by
intravitreal injection once every 4 weeks (approximately every 25
days, monthly). (2.6)
DIABETIC MACULAR EDEMA (DME) AND DIAB