Approved Risk Evaluation and Mitigation Strategies (REMS)

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Adasuve (loxapine)
NDA #022549
REMS last update: 10/10/2017



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 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.
  2. 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.

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

Healthcare settings that dispense Adasuve must

To become certified to dispense
  • Have necessary supplies and personnel to manage acute bronchospasm and ready access to emergency response services on-site.
  • Have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for immediate treatment of bronchospasm on site.
  • Train all relevant staff involved in the prescribing, dispensing, administration, and monitoring on the REMS program requirements using the Healthcare Provider Brochure, Steps for Safe Use of Adasuve, Order Set/Protocol Template and Adasuve Education Program.
    | Education Program | | Healthcare Provider Brochure | | Steps for Safe Use | | Order Set/Protocol Template |
  • Designate an authorized representative to carry out the certification process on behalf of the healthcare setting.
  • Have the authorized representative enroll in the REMS Program by completing the Healthcare Facility Enrollment Information and Form.
    | Healthcare Facility Enrollment Information and Form |
Before dispensing
  • Dispense no more than one dose in a 24-hour period.
Before administering
  • Assess the patient’s medical history for a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD) or other lung disease associated with bronchospasm, acute respiratory signs/symptoms (e.g. wheezing), and current use of medications to treat airways diseases such as asthma or COPD.
  • Assess the patient for respiratory abnormalities by examination (including chest auscultation).
After administering; at least every 15 minutes for a minimum of one hour
  • Assess the patient’s symptoms and signs of bronchospasm by examining vital signs and chest auscultation.
To maintain certification to dispense, if the healthcare setting designates a new authorized representative
  • Designate an authorized representative to carry out the certification process on behalf of the healthcare setting.
  • Have the authorized representative enroll in the REMS Program by completing the Healthcare Facility Enrollment Information and Form.
    | Healthcare Facility Enrollment Information and Form |
To maintain certification to dispense, within three years from the date of initial certification, every three years thereafter.
At all times
  • Report any adverse events of bronchospasm that require emergency response services, in addition to any fatalities that occur following treatment to the sponsor or FDA.
  • Do not distribute, transfer, loan, or sell Adasuve.
  • Maintain records of training and all processes and procedures are in place and are being followed.
  • Comply with audits carried out by the sponsor, FDA, or third-party to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Adasuve REMS, see the DailyMed link(s).
Material Name Material Name Link
Education Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Education_Program.pdf
Healthcare Facility Enrollment Information and Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Healthcare_Facility_Enrollment_Information_and_Form.pdf
Healthcare Provider Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Healthcare_Provider_Brochure.pdf
Order Set/Protocol Template (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Order_Set_Protocol_Template.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_REMS_Website_Screenshots.pdf
Steps for Safe Use (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Adasuve_2017_10_10_Steps_for_Safe_Use.pdf

What updates have been made to the REMS?

Date Summary of change
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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