IZERVAY- avacincaptad pegol injection

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

AVACINCAPTAD PEGOL SODIUM (UNII: K86ENL12I5) (AVACINCAPTAD PEGOL - UNII:TT0V5JLG5B)

Disponibbli minn:

Astellas Pharma US, Inc.

Rotta amministrattiva:

INTRAVITREAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

IZERVAY™ is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). IZERVAY is contraindicated in patients with ocular or periocular infections. IZERVAY is contraindicated in patients with active intraocular inflammation. Risk Summary There are no adequate and well-controlled studies of IZERVAY administration in pregnant women. The use of IZERVAY may be considered following an assessment of the risks and benefits. Administration of avacincaptad pegol to pregnant rats and rabbits throughout the period of organogenesis resulted in no evidence of adverse effects to the fetus or pregnant female at intravenous (IV) doses 5.1 times and 3.2 times the human exposure (based on AUC) at the maximum recommended human dose (MRHD) of 2 mg once monthly, respectively (see Data) . In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15%-20%, respectively. Data Animal Data An embryo fetal developmental toxicity study was conducted with pregnant rats. Pregnant rats received daily intravenous (IV) injections of avacincaptad pegol from day 6 to day 17 of gestation at 0.1, 0.4, 1.2 mg/kg/day. No maternal or embryofetal adverse effects were observed at any dose evaluated. An increase in the incidence of a non-adverse skeletal variation, described as short thoracolumbar (ossification site without distal cartilage) supernumerary ribs, was observed at all doses evaluated. The clinical relevance of this finding is unknown. Plasma exposures at the high dose were 5.1 times the MRHD, based on Area Under the Curve (AUC). An embryo fetal developmental toxicity study was conducted with pregnant rabbits. Pregnant rabbits received daily IV injections of avacincaptad pegol from day 7 to day 19 of gestation at 0.12, 0.4, 1.2 mg/kg/day. No maternal or embryofetal adverse effects were observed at any dose evaluated. Plasma exposure in pregnant rabbits at the highest dose of 1.2 mg/kg/day was 3.2 times the human exposure at the MRHD, based on AUC. Risk Summary There is no information regarding the presence of avacincaptad pegol in human milk, the effects of the drug on the breastfed infant, or the effects of avacincaptad pegol on milk production. Many drugs are transferred in human milk with the potential for absorption and adverse reactions in the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for IZERVAY, and any potential adverse effects on the breastfed infant from IZERVAY. Safety and effectiveness of IZERVAY in pediatric patients have not been established. Of the total number of patients who received IZERVAY in the two clinical trials, 90% (263/292) were ≥65 years and 61% (178/292) were ≥75 years of age. No significant differences in efficacy or safety of avacincaptad pegol were seen with increasing age in these studies. No dose adjustment is required in patients 65 years and above.

Sommarju tal-prodott:

IZERVAY (avacincaptad pegol intravitreal solution) is supplied as a sterile, clear to slightly opalescent, colorless to slightly yellowish 20 mg/mL solution in a single-dose glass vial. Each glass vial contains an overfill amount to allow administration of a single 0.1 mL dose of solution containing 2 mg of avacincaptad pegol (oligonucleotide basis). Each IZERVAY carton (NDC 82829-002-01) contains one glass vial, one sterile 5-micron transfer filter needle (19-gauge x 1½ inch, 1.1 mm x 40 mm), and one sterile 1 mL Luer lock syringe. Store IZERVAY in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Keep the vial in the original carton to protect from light. Prior to use, the unopened glass vial of IZERVAY may be kept at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours. Ensure that the injection is given immediately after preparation of the dose.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

IZERVAY- AVACINCAPTAD PEGOL INJECTION
ASTELLAS PHARMA US, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IZERVAY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IZERVAY.
IZERVAY (AVACINCAPTAD PEGOL INTRAVITREAL SOLUTION)
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
IZERVAY is a complement inhibitor indicated for the treatment of
geographic atrophy (GA) secondary to
age-related macular degeneration (AMD) (1).
DOSAGE AND ADMINISTRATION
The recommended dose for IZERVAY is 2 mg (0.1 mL of 20 mg/mL solution)
administered by intravitreal
injection to each affected eye once monthly (approximately 28 ± 7
days) for up to 12 months (2.2).
DOSAGE FORMS AND STRENGTHS
Intravitreal solution: 20 mg/mL in a single-dose vial (3).
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
The most common adverse reactions were conjunctival hemorrhage (13%),
increased IOP (9%), blurred
vision (8%) and neovascular age-related macular degeneration (7%)
(6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTELLAS PHARMA US,
INC. AT 1-800-707-
4479 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Recommended Dosage
2.3 Preparation for Administration
2.4 Injection Procedure
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Ocular or Periocular Infections
4.2 Active Intraocular Inflammation
5 WARNINGS AND PRECAUTIONS
5.1 Endophthalmitis and Retinal Detachments
5.2 Neovascular AMD
5.3 Increase in Intraocular Pressure
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
™
Ocular or periocular infections (4.1).
Active intraocular inflammation (4.2).
Endophthalmitis and Retinal Detachments (5.1).
Neovascular AMD (5.2)
Increase in Intraocular Pressur