Bronchospasm; Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Bronchospasm and Restricted Distribution Program/REMS

• 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) [see Warnings and Precautions (5.1, 5.2)].
• Prior to administering ADASUVE, screen patients regarding a current diagnosis, 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 [see Dosage and Administration (2.2, 2.4) and Contraindications (4)].
• Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS [see Warnings and Precautions (5.2)].

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.3)].