Latanoprost / netarsudil ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Rocklatan

Medically reviewed by Drugs.com. Last updated on Sep 14, 2023.

Latanoprost / netarsudil 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: There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies with latanoprost have revealed evidence of embryofetal lethality at doses 80 times higher than the recommended human ophthalmic dose (RHOD). Animal studies with IV natarsudil have revealed evidence of abortions, embryofetal lethality, and malformations (e.g., absent intermediate lung lobe, thoracogastroschisis, umbilical hernia) at doses at least 3 mg/kg/day. There are no controlled data using any of the drugs, alone or in combination, 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.

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Latanoprost / netarsudil ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects of this drug on the nursing infant are unknown.
-Some experts recommend using this drug with caution during lactation, especially if breastfeeding a newborn or preterm infant.
-Systemically circulating levels of this drug may be decreased by placing pressure over the tear duct in the corner of the eye over at least 1 minute; excess solution should be removed with tissues.

See references

Further information

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