Risk Evaluation and Mitigation Strategies (REMS) Summary

Goal of the Adasuve (loxapine) Inhalation Powder REMS Program

The goal of the Adasuve REMS is to mitigate the risk of negative outcomes (respiratory distress or respiratory arrest) associated with Adasuve induced bronchospasm by: 

• Ensuring that Adasuve is dispensed only in certified healthcare settings that have immediate access on site to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services. Healthcare settings must have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm.
• Informing healthcare professionals about the serious risks associated with Adasuve, that Adasuve is contraindicated in patients with lung diseases and other conditions associated with bronchospasm, and how to monitor patients given Adasuve.

REMS Elements

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms