Avacincaptad pegol ophthalmic Pregnancy and Breastfeeding Warnings
Brand names: Izervay
Medically reviewed by Drugs.com. Last updated on Nov 8, 2023.
Avacincaptad pegol ophthalmic Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not assigned.
Risk summary: Inadequate data available on use of this drug in pregnant women to inform a drug-related risk.
In animal studies, intravenous administration of this drug to pregnant rats and rabbits during the period of organogenesis revealed no evidence of adverse effects to the fetus or pregnant female at 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. There are no controlled data in human pregnancy.
In pregnant rats, short thoracolumbar supernumerary ribs (a non-adverse skeletal variation), was observed at all doses. The clinical relevance of this finding is unknown.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Avacincaptad pegol ophthalmic Breastfeeding Warnings
This drug should be used during breastfeeding only if the benefit to mother outweighs the risk to the infant.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown.
In humans, plasma concentrations of this drug are predicted to be approximately 7,000-fold lower than vitreal concentrations. Consider the dose and route of administration when making decisions about breast feeding.
See also
References for pregnancy information
- (2023) "Product Information. Izervay (avacincaptad pegol ophthalmic)." IVERIC Bio, Inc.
References for breastfeeding information
- (2023) "Product Information. Izervay (avacincaptad pegol ophthalmic)." IVERIC Bio, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.