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Lifitegrast ophthalmic Pregnancy and Breastfeeding Warnings

Lifitegrast ophthalmic is also known as: Xiidra

Medically reviewed on August 9, 2018

Lifitegrast ophthalmic Pregnancy Warnings

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.

Animal studies have failed to reveal evidence of teratogenicity at IV injection doses at clinically relevant systemic exposures. Preimplantation loss, minor skeletal abnormalities, and/or omphalocele was observed in animal models when given this drug during organogenesis as an IV injection at doses of at least 3 mg/kg/day. 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

Lifitegrast ophthalmic Breastfeeding Warnings

Systemic exposure is low when administered via the ocular route. There are no data on the effects of this drug on milk production.

Benefit should outweigh risk.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Xiidra (lifitegrast ophthalmic)." Shire US Inc, Florence, KY.

References for breastfeeding information

  1. "Product Information. Xiidra (lifitegrast ophthalmic)." Shire US Inc, Florence, KY.

Further information

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

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