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, on-site resources to manage bronchospasm and/or respiratory distress.

In addition, the REMS Program will inform healthcare professionals about:

  • The risk of bronchospasm after ADASUVE administration
  • Appropriate patient selection
  • Monitoring patients after ADASUVE administration
  • Management of bronchospasm, if it occurs

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 equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation).

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 (eg, 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

Steps for Safe Use of ADASUVE
Screen Image Icon for table Screen Row-Image of Checksheet or list-

screen

Ask if patient is taking medication to treat asthma or COPD and/or check medical records

Ask if patient has a current diagnosis or history of asthma, COPD, or other lung disease and/or check medical records

Examine patients (including chest auscultation) for respiratory signs (eg, wheezing)

Do not use in patients with acute respiratory signs or symptoms; with a current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm; or with current use of medications to treat airways disease, such as asthma or COPD

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counsel

Counsel patient/caregiver on potential for bronchospasm that may occur after dosing and the need for them to report symptoms immediately

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monitor

Monitor patient every 15 minutes for at least 1 hour after treatment for signs and symptoms of bronchospasm including chest auscultation

Ask patient every 15 minutes about any difficulty breathing

Image Manage Icon for table Manage Row-Image of Lungs-Subtext If bronchospam occurs

If bronchospasm occurs

manage

Treat bronchospasm with an inhaled short-acting beta-agonist bronchodilator (eg, albuterol)

If medically necessary, provide additional therapy for bronchospasm per asthma guidelines, including intubation and mechanical ventilation as needed

These risks do not constitute a complete list of all the risks associated with ADASUVE. Please see the Full Prescribing Information, including Boxed Warning, for more information regarding the risks associated with ADASUVE.