Approved Risk Evaluation and Mitigation Strategies (REMS)

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Adasuve (loxapine)
NDA #022549
REMS last update: 10/19/2016

View the Adasuve Prescribing Information and Medication Guide at DailyMed.
View Adasuve's Regulatory Information at Drugs@FDA

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.
  • 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.
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.
To maintain certification to dispense, within three years from the date of initial certification, every three years thereafter.
  • Have the authorized representative enroll in the REMS Program by completing the Healthcare Facility Enrollment Information and Form.
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:


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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