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Approved Risk Evaluation and Mitigation Strategies (REMS)

Adasuve (loxapine)
NDA #022549
REMS last update: 01/27/2022



What is the purpose of the REMS?

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:

    1. Ensuring that Adasuve is dispensed only in certified healthcare settings that have:
      1. immediate access on site to supplies and healthcare professionals competent in the management of acute bronchospasm and access to emergency assistance for symptoms that require immediate attention. Healthcare settings must have a short-acting bronchodilator (e.g. albuterol), for the immediate treatment of bronchospasm; this shortacting bronchodialter can be delivered by inhaler (with spacer) or nebulizer.
      2. Processes and procedures to ensure that patients are screened for conditions for which Adasuve is contraindicated and monitored for signs of bronchospasms.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
01/27/2022 Modified to make the following changes:
  1. adding that a short-acting bronchodilator (e.g., albuterol) by inhaler, with spacer, is an acceptable option to treat bronchospasm caused by Adasuve
  2. removal of the requirement to ensure all relevant staff are trained and replaced with a requirement that the healthcare setting have processes and procedures to ensure the safe use of Adasuve
  3. removal of the every 15 minute monitoring requirement
  4. removal of the need for post-dose chest auscultation
  5. conversion of the REMS Document to the new standardized format
    6. In addition, the REMS goal was modified to reflect the above changes.
10/10/2017 Revised to change the application holder's name or address.
10/19/2016 Revised to change the application holder’s name or address
09/28/2016 Modified to:

  1. Change the goal of the Adasuve REMS.
  2. Change the prescriber and healthcare setting attestations, and requirements for certified healthcare settings.
  3. Update the REMS materials to reflect the supplies and personnel that a certified healthcare setting must now have available to manage acute bronchospasm.
  4. Remove the communication plan as an element of the REMS.
  5. update to reflect the change in ownership from Teva Pharmaceuticals to Alexza Pharmaceuticals, Inc.
  6. clarify your (Alexza Pharmaceuticals, Inc.) responsibilities in the implementation system.
12/09/2013 Modified to document the change in ownership/address from Alexza Pharmaceuticals to Teva Pharmaceuticals.
12/21/2012 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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