What is the PS-Ambrisentan Risk Evaluation and Mitigation Strategy (REMS)?

The PS-Ambrisentan Risk Evaluation and Mitigation Strategy (REMS) Program

A Risk Evaluation and Mitigation Strategy is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

The PS-Ambrisentan REMS is a safety program that manages the risk of serious birth defects when taking ambrisentan. The PS-Ambrisentan REMS is required by the Food and Drug Administration (FDA).

  • Only prescribers and pharmacies certified by the PS-Ambrisentan REMS can prescribe and dispense ambrisentan to patients
  • Patients must be enrolled in the PS-Ambrisentan REMS and follow all the safety rules in the REMS in order to receive ambrisentan.