Acoltremon ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Tryptyr

Medically reviewed by Drugs.com. Last updated on Jul 15, 2025.

Acoltremon ophthalmic Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Malformative risk with the use of this drug in pregnant women is unlikely as systemic exposure to this drug from ocular administration is negligible.

Animal studies have failed to reveal evidence of embryofetal toxicity. After daily IV injections in pregnant rats and rabbits during organogenesis, no maternal or embryofetal toxicity was observed at 806-fold (rats) and 2151-fold (rabbits) the maximum recommended human ocular dose of this drug on a mg/m2 basis. 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.

See references

Acoltremon ophthalmic Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-Systemic exposure to this drug after topical ocular administration is low.
-The effects in the nursing infant are unknown; due to the lack of clinical data during lactation, the risk to a nursing infant cannot be determined.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.

See references

Further information

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