Healthcare Setting

Only healthcare settings certified in the ADASUVE REMS may dispense ADASUVE.

To become certified to dispense:

1

Site Requirements

Have immediate access to supplies and personnel competent in the management of acute bronchospasm including: a short-acting bronchodilator (e.g., albuterol), delivered by inhaler (with spacer) or nebulizer, and access to emergency assistance for symptoms that require immediate medical attention.
2

Designate an Authorized Representative

Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the ADASUVE REMS on behalf of the healthcare setting.
3

Review the Healthcare Setting Guide

Have the authorized representative review the Education Program for Healthcare Settings
4

Complete the Healthcare Setting Enrollment Form

Have the authorized representative enroll in the Adasuve REMS by completing the Healthcare Setting Enrollment Form and submitting it to the Adasuve REMS.
5

Establish Processes and Procedures

Establish processes and procedures to:
  • assess the patient for respiratory abnormalities before administration by medical history, medication history, and chest auscultation,
  • monitor the patient for a minimum of 1 hour after administration for bronchospasm,
  • provide that no more than a single dose of ADASUVE is administered within a 24-hour period, and
  • provide that ADASUVE is not dispensed outside of the certified healthcare setting.