Omlonti Pregnancy Warnings
Safety has not been established in women during pregnancy.
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Animal studies have revealed evidence of teratogenicity. There is no controlled data on human pregnancy.
In animal reproduction studies, this drug was not teratogenic in rats at doses 2452 times the maximum recommended human ocular dose (MRHOD) when administered subcutaneously, but in pregnant rabbits during organogenesis it produced fetal skeletal anomalies including thoracic misaligned centrum and hemivertebra, fused sternebra and absent rib at 24 times MRHOD.
Additional fetal skeletal anomalies, such as absent thoracic arch, fused rib, and misaligned and misshapen cervical vertebrae occur at doses 256 times and 3,696 times MRHOD, respectively.
No Observed Adverse Effect Level [NOAEL] in rat and rabbit was 1 mg/kg/day and 0.8 mg/kg/day, respectively.
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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.
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