INDICATIONS AND USAGE
ADASUVE® (loxapine) inhalation powder, for oral inhalation use, 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: As part of the ADASUVE Risk Evaluation
and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, 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. 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 (eg, albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm. 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.
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.
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.
- 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 (eg, wheezing)
- Current use of medications to treat airways disease, such as asthma or COPD
- History of bronchospasm following ADASUVE treatment
- Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred
with oral loxapine and amoxapine
- ADASUVE must be administered only by a healthcare professional
- Prior to administration, all patients must be screened for a history of pulmonary
disease and examined (including chest auscultation) for respiratory abnormalities
(eg, wheezing)
- Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation
using the single-use inhaler
- After ADASUVE administration, patients must be monitored for signs and symptoms
of bronchospasm at least every 15 minutes for at least 1 hour
- ADASUVE can cause sedation, which can mask the symptoms of bronchospasm
- Antipsychotic drugs can cause a potentially fatal symptom complex called Neuroleptic
Malignant Syndrome (NMS), manifested by hyperpyrexia, muscle rigidity, altered mental
state, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac
dysrhythmia. Associated features can include escalated serum creatine phosphokinase
(CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration,
and renal failure. If NMS occurs, immediately discontinue antipsychotic drugs and
other drugs that may contribute to the underlying disorder, monitor and treat symptoms,
and treat any concomitant serious medical problems
- ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution
in patients with known cardiovascular disease, cerebrovascular disease, or conditions
that would predispose patients to hypotension. In the presence of severe hypotension
requiring vasopressor therapy, epinephrine should not be used
- ADASUVE may increase the risk of falls, which could cause fractures or other injuries.
Patients taking antipsychotics with certain health conditions or those on long-term therapy
should be evaluated by their healthcare professional for the potential risk of falls
- Use ADASUVE with caution in patients with a history of seizures or with conditions
that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures
have occurred in patients treated with oral loxapine, and can also occur in epileptic
patients
- Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking,
and motor skills
- The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants
- Treatment with antipsychotic drugs caused an increased incidence of stroke and transient
ischemic attack in elderly patients with dementia-related psychosis; ADASUVE is
not approved for the treatment of patients with dementia-related psychosis
- Use of ADASUVE may exacerbate glaucoma or cause urinary retention
- The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical
studies in patients with agitation treated with ADASUVE were dysgeusia, sedation,
and throat irritation
- Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester
of pregnancy are at risk of extrapyramidal and/or
withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus
- Nursing mothers: Discontinue drug or nursing, taking into account the importance
of the drug to the mother
- The safety and effectiveness of ADASUVE in pediatric patients have not been established