EYLEA HD- aflibercept injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Regeneron Pharmaceuticals, Inc

Laluan pentadbiran:

INTRAVITREAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

EYLEA HD is indicated for the treatment of: EYLEA HD is contraindicated in patients with ocular or periocular infections. EYLEA HD is contraindicated in patients with active intraocular inflammation. EYLEA HD is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in EYLEA HD. 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 HD 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 exposure (based on AUC for free aflibercept) was approximately 0.9 -fold of the population pharmacokinetic estimated exposure in humans after an intravitreal dose of 8 mg (see Data) . Animal reproduction studies are not always predictive of human response, and it is not known whether EYLEA HD 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 HD may pose a risk to human embryofetal development. EYLEA HD 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 0.9-fold of the population pharmacokinetic estimated systemic exposure (AUC) in humans after an intravitreal dose of 8 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 HD is not recommended during breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EYLEA HD and any potential adverse effects on the breastfed child from EYLEA HD. Contraception Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment, and for at least 4 months after the last intravitreal injection of EYLEA HD. Infertility There are no data regarding the effects of EYLEA HD on human fertility. Aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose 91 times higher (based on AUC of free aflibercept) than the corresponding systemic level estimated based on population pharmacokinetic analysis in humans following an intravitreal dose of 8 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 HD in pediatric patients have not been established. In PULSAR, approximately 90% (604/673) of the patients in the HDq12 and HDq16 groups were 65 years of age or older and approximately 51% (343/673) were 75 years of age or older. In PHOTON, approximately 44% (214/491) of the patients in the HDq12 and HDq16 groups were 65 years of age or older and approximately 10% (50/491) were 75 years of age or older.

Ringkasan produk:

EYLEA HD (aflibercept) is a clear to slightly opalescent, colorless to pale yellow solution supplied in the following presentations [see Dosage and Administration (2.5) and (2.6)]. Each vial is for single eye use only. Discard unused portion. Refrigerate EYLEA HD 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.

Status kebenaran:

Biologic Licensing Application

Ciri produk

EYLEA HD- AFLIBERCEPT INJECTION, SOLUTION
REGENERON PHARMACEUTICALS, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EYLEA HD SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EYLEA HD.
EYLEA HD (AFLIBERCEPT) INJECTION, FOR INTRAVITREAL USE
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Warnings and Precautions (5.1)
12/2023
INDICATIONS AND USAGE
EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor
indicated for the treatment of patients
with:
Neovascular (Wet) Age-Related Macular Degeneration (nAMD) (1.1)
Diabetic Macular Edema (DME) (1.2)
Diabetic Retinopathy (DR) (1.3)
DOSAGE AND ADMINISTRATION
NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION (NAMD)
The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL
solution) administered by
intravitreal injection every 4 weeks (approximately every 28 days +/-
7 days) for the first three
doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via
intravitreal injection once every 8 to
16 weeks, +/- 1 week. (2.2)
DIABETIC MACULAR EDEMA (DME)
The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL
solution) administered by
intravitreal injection every 4 weeks (approximately every 28 days +/-
7 days) for the first three
doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via
intravitreal injection once every 8 to
16 weeks, +/- 1 week. (2.3)
DIABETIC RETINOPATHY (DR)
The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL
solution) administered by
intravitreal injection every 4 weeks (approximately every 28 days +/-
7 days) for the first three
doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via
intravitreal injection once every 8 to
12 weeks, +/- 1 week. (2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 8 mg (0.07 mL of 114.3 mg/mL solution) in a single-dose
vial (3)
CONTRAINDICATIONS
Ocular or periocular infection (4.1)
Active intraocular inflammation (4.2)
Hypersensitivity (4.3)
WARNINGS AND PRECAUTIONS
Endophthalmitis, retinal detachm