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Latanoprostene bunod ophthalmic Pregnancy and Breastfeeding Warnings

Latanoprostene bunod ophthalmic is also known as: Vyzulta

Medically reviewed on Dec 28, 2017

Latanoprostene bunod ophthalmic Pregnancy Warnings

Animal studies have not been reported. Animal studies with the IV formulation have been conducted and resulted in teratogenicity, fetal harm, and malformations. There are no controlled data in human pregnancy.

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.

The manufacturer makes no recommendation regarding use 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.

See references

Latanoprostene bunod ophthalmic Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.

See references

References for pregnancy information

  1. "Product Information. Vyzulta (latanoprostene bunod ophthalmic)." Bausch and Lomb, Rochester, NY.

References for breastfeeding information

  1. "Product Information. Vyzulta (latanoprostene bunod ophthalmic)." Bausch and Lomb, Rochester, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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