U.S. FDA Approves Alexza's ADASUVE® (loxapine) Inhalation Powder For The Acute Treatment Of Agitation Associated With Schizophrenia Or Bipolar I Disorder In Adults

ADASUVE Partial Prescribing Information (U.S.) Please click here for Full Prescribing Information, including Boxed WARNINGS, or visit www.adasuve.com .

INDICATIONS AND USAGE

ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.  Efficacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.    Limitations of Use: ADASUVE must be administered only in an enrolled healthcare facility.

IMPORTANT SAFETY INFORMATION

WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.

Bronchospasm:

• ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest
• ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
• 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)

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

CONTRAINDICATIONS:

ADASUVE is contraindicated in patients with the following:

• 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)
• Current use of medications to treat airways disease, such as asthma or COPD
• History of bronchospasm following ADASUVE treatment
• Known hypersensitivity to loxapine and amoxapine

WARNINGS AND PRECAUTIONS:

• Neuroleptic Malignant Syndrome : May develop in patients treated with antipsychotic drugs. Discontinue treatment
• Hypotension and Syncope : Use with caution in patients with known cardiovascular or cerebrovascular disease
• Seizure : Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold
• Potential for Cognitive and Motor Impairment : Use caution when driving or operating machinery
• Cerebrovascular Adverse Reactions : Increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis treated with antipsychotic drugs

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 2% and greater than placebo) in clinical studies in patients with agitation treated with ADASUVE were dysgeusia, sedation, throat irritation

ADASUVE will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS.  ADASUVE should only be administered in a healthcare facility enrolled in the ADASUVE REMS program that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation).  In addition to product labeling, Alexza developed the ADASUVE REMS with the purpose of mitigating the risk of bronchospasm.  The ADASUVE REMS includes a communication plan and an "elements to assure safe use" of the product, including provisions designed to ensure that ADASUVE will only be dispensed in healthcare settings that are enrolled in the ADASUVE REMS program.

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