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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>

Instructions for using ADASUVE

Read all of the instructions prior to administering ADASUVE to a patient1

  • Open the pouch

    Open the Pouch

    When ready to use, tear open the foil pouch and remove the inhaler from the package. When the ADASUVE inhaler is removed from the pouch, the indicator light is off.

  • Pull tab

    Pull tab

    Firmly pull the plastic tab from the rear of the inhaler. Check that the green light turns on. This indicates that the inhaler is ready for use. Use the inhaler within 15 minutes after removing the tab to prevent automatic deactivation of the inhaler. The green light will turn off, indicating that the inhaler is not usable. Discard the inhaler after one use.

  • Explain Procedures to the Patient

    Explain Procedures to the Patient

    Explain the administration procedures to the patient prior to use, and advise the patient that it is important to follow the instructions. Inform the patient that the inhaler may produce a flash of light and a clicking sound, and it may become warm during use. These are normal.

  • Instruct the Patient to Exhale

    Instruct the Patient to Exhale

    Instruct the patient to hold the inhaler away from the mouth and breathe out fully to empty the lungs.

  • Instruct the Patient to Inhale

    Instruct the Patient to Inhale

    Instruct the patient to put the mouthpiece of the inhaler between the lips, close the lips, and inhale through the mouthpiece with a steady deep breath. Check that the green light turns off indicating that the dose has been delivered.

  • Instruct the Patient to Hold Breath

    Instruct the
    Patient to Hold Breath

    Instruct the patient to remove the mouthpiece from the mouth and hold the breath for as long as possible, up to 10 seconds.

IMPORTANT
If the green light remains on after the patient inhales, the dose of ADASUVE has NOT been delivered. Instruct the patient to repeat Step 4, Step 5, and Step 6 up to 2 additional times. If the green light still does not turn off, discard the inhaler and use a new one.
FOR ORAL INHALATION ONLY
  • ADASUVE must be administered by a healthcare professional in a REMS-enrolled healthcare facility. Administer only a single dose within a 24-hour period1
  • Prior to administration, all patients must be screened for a history of pulmonary disease and examined (including chest auscultation) for respiratory abnormalities (eg, wheezing)
DOSING

Handheld, single-use inhaler provides single-breath activation and rapid drug delivery1

Administer only a single
10 mg dose
of ADASUVE
within any 24-hour period1

Removal of a pull-tab renders
the device ready for use1

Delivers an aerosol of pure loxapine that is quickly absorbed through the lungs and into the bloodstream1

Learn about the
ADASUVE REMS Program

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
REFERENCE
  1. ADASUVE [package insert]. Mountain View, CA: Alexza Pharmaceuticals, Inc.; September 2016.
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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