The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for ADASUVE to ensure that the benefits of treatment outweigh the risks of bronchospasm.
The purpose of the ADASUVE REMS is to mitigate the risk of bronchospasm that has the potential to lead to respiratory distress and respiratory arrest.
Healthcare Setting
Only healthcare settings certified in the ADASUVE REMS may dispense ADASUVE.