ADASUVE® REMS Program
ADASUVE is a drug-device combination product that delivers an aerosol of the antipsychotic agent loxapine in a single oral inhalation. ADASUVE has been approved by the US Food and Drug Administration (FDA) for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for ADASUVE to ensure that the benefits of treatment outweigh the risks of bronchospasm.
The purpose of the ADASUVE REMS Program is to mitigate the risk of bronchospasm that has the potential to lead to respiratory distress and respiratory arrest.
In order to mitigate the risk, the ADASUVE REMS Program requires that ADASUVE is only administered in enrolled healthcare facilities with immediate access on site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency
In addition, the REMS Program will inform healthcare professionals about:
Important Safety Information About ADASUVE
Risk of Bronchospasm
ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest.
Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services. Facilities must have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm.
ADASUVE is contraindicated in patients with a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung disease associated with bronchospasm because they are at increased risk of bronchospasm.
ADASUVE is also contraindicated in patients with acute respiratory signs/symptoms (e.g., wheezing) or who are currently taking medications to treat airways disease, such as asthma or COPD.
ADASUVE is contraindicated in patients with a history of bronchospasm following ADASUVE treatment.
Prior to administering ADASUVE, screen patients regarding a current diagnosis or history or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.
The Use of ADASUVE Should Be Accompanied by a 4-step Process of: Screening, Counseling, Monitoring, and Management
These risks do not constitute a complete list of all the risks associated with ADASUVE. Please see the Prescribing Information, including Boxed Warning, for more information regarding the risks associated with ADASUVE.
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