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ISI IMPORTANT SAFETY INFORMATION ISI
 IMPORTANT SAFETY INFORMATION
ADASUVE® (loxapine) inhalation powder, for oral inhalation use, 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… Read More Important Safety Information>
ADVERSE REACTIONS

Clinical trials adverse reactions in patients with agitation associated with schizophrenia or bipolar I disorder

Adverse reactions* in 3 short-term placebo-controlled trials1

Airway adverse reactions in the 3 trials in acute agitation

  • Patients with clinically significant acute or chronic pulmonary disease (eg, clinically apparent asthma, bronchitis, emphysema) were excluded from the trials2,3
  • Bronchospasm (includes reports of wheezing, shortness of breath, and cough) occurred in 2 patients in the ADASUVE group (n=259) and 0 patients in the placebo group (n=263)1
  • ADASUVE can cause sedation, which can mask the symptoms of bronchospasm
  • In patients treated with ADASUVE without a history of pulmonary disease, 1 of 524 (0.19%) had significant bronchospasm requiring rescue treatment with a usual dose of albuterol bronchodilator and oxygen4

Extrapyramidal symptoms1

  • One patient (0.4%) with agitation who received ADASUVE experienced extrapyramidal symptoms (EPS) vs 0% with placebo

In a QTc study in healthy adult subjects, ADASUVE did not prolong the QTc interval1

  • In healthy subjects, the effect of ADASUVE on the QTc prolongation was evaluated in a randomized, double-blinded, positive- (moxifloxacin 400 mg) and placebo-controlled parallel study
Pulmonary Safety Studies

In healthy subjects and subjects with asthma or COPD

Healthy subjects1

  • In this crossover study, 30 subjects (26 evaluable) received 2 doses of either ADASUVE or placebo 8 hours apart, and 2 doses of the alternate treatment at least 4 days later
  • No volunteers in this trial developed airway related adverse reactions (cough, wheezing, chest tightness, or dyspnea)

Subjects with asthma1

  • 52 subjects with mild-moderate persistent asthma (with FEV1 ≥60% of predicted) were randomized to treatment with 2 doses of ADASUVE 10 mg or placebo. The second dose was to be administered 10 hours after the first dose
  • In the ADASUVE group, 9/26 (35%) subjects (vs 1/26 [4%] for placebo) did not receive a second dose of study medication because they had a ≥20% decrease in FEV1 or they developed respiratory symptoms after the first dose

Subjects with COPD1

  • 53 subjects (52 evaluable) with mild to severe COPD (with FEV1 ≥40% of predicted) were randomized to treatment with 2 doses of ADASUVE 10 mg or placebo. The second dose was to be administered 10 hours after the first dose
  • In the ADASUVE group, 7/25 (28%) subjects (vs 1/27 [4%] for placebo) did not receive a second dose of study medication because they had a ≥20% decrease in FEV1 or they developed respiratory symptoms after the first dose
Defined as bronchospasm, chest discomfort, cough, dyspnea, throat tightness, and/or wheezing.
Albuterol via metered dose inhaler or nebulizer.
  • Administer only a single 10 mg dose of ADASUVE within a 24-hour period by
    oral inhalation using the single-use inhaler
  • ADASUVE is contraindicated in patients with a current diagnosis or history of asthma, COPD, or other pulmonary disease associated with bronchospasm
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.
For more information on the ADASUVE REMS Program, please call 855-755-0492 or visit adasuverems.com

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 (e.g., 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
  • 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
REFERENCES
  1. ADASUVE [package insert]. Mountain View, CA: Alexza Pharmaceuticals, Inc.; September 2016.
  2. Data on file. Clinical Study Report 004-301. Alexza Pharmaceuticals.
  3. Data on file. Clinical Study Report 004-302. Alexza Pharmaceuticals.
  4. Data on file. Integrated Summary of Safety. Alexza Pharmaceuticals.
ALEXZA ©2016 ALEXZA® Pharmaceuticals.
All rights reserved. September 2016  ADA-50003All rights reserved.
|
Alexza ©2016 ALEXZA® Pharmaceuticals.
All rights reserved. September 2016  ADA-50003
ISI IMPORTANT SAFETY INFORMATION
EXPAND

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 (e.g., 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
  • 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
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