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Embryo-Fetal Toxocity

  • Exclude pregnancy before the initiation of treatment with Letairis. Females of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].
  • Because of the risk of embryo-fetal toxicity, females can only receive Letairis through a restricted program called the Letairis REMS program [see Warnings and Precautions (5.2)].

Approved Risk Evaluation and Mitigation Strategies (REMS)

Ambrisentan Shared System

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts


Additional Information

Updated January 2018