Approved Risk Evaluation and Mitigation Strategies (REMS)

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Adasuve (loxapine)
NDA #22549
REMS last update: 12/09/2013

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

To be able to dispense Adasuve
  • Designate an authorized representative to carry out the certification process on behalf of the healthcare setting.
  • Have the authorized representative review the educational materials for dispensers, including: Education Program.
  • Ensure the healthcare setting is able to provide immediate access on-site to a metered-dose inhaled and nebulized form of a short-acting beta-agonist bronchodilator.
  • Ensure the healthcare setting has personnel and equipment on-site to provide advanced airway management, including intubation and mechanical ventilation.
  • Train all relevant staff involved in the dispensing of Adasuve on safe use conditions using the Education Program.
  • Establish processes and procedures to verify that safe use conditions have been met.
  • Enroll in the REMS by completing and submitting the Healthcare Facility Enrollment Form.
Before dispensing Adasuve
  • Verify that patients have been screened 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 disease such as asthma or COPD; and examine patients (including chest auscultation) for respiratory abnormalities.
  • Dispense no more than 1 dose within a 24-hour period and not through an outpatient pharmacy.
After Adasuve is administered
  • Assess patient’s vital signs and chest auscultation for symptoms and signs of bronchospasm for at least every 15 minutes for a minimum of one hour.
Ongoing
  • Re-enroll in the Adasuve REMS program every 3 years.
  • Do not distribute, transfer, loan, or sell product.
  • Maintain records of relevant staff training and the healthcare settings’ compliance with established processes and procedures.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

Wholesalers that distribute Adasuve

To be able to distribute Adasuve
  • Designate an authorized representative to carry out the certification process on behalf of the wholesaler.
  • Establish processes and procedures to verify that Adasuve is distributed only to certified healthcare settings.
  • Have the authorized representative review the educational materials for distributors, including: program materials.
  • Enroll in the REMS by completing and submitting the Wholesaler/Distributor Enrollment Form.
Ongoing, as needed
  • Re-enroll in the Adasuve REMS program every 3 years.
  • Cooperate with audits carried out by the sponsor 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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