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IMPORTANT SAFETY INFORMATION
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, particularly in patients with lung diseases. Administer ADASUVE only in a certified healthcare setting that has immediate access on site to supplies and healthcare professionals competent in the management of acute bronchospasm and access to emergency assistance for symptoms that require immediate medical attention… Read More Important Safety Information>

INDICATIONS AND USAGE

ADASUVE® is an atypical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Limitations of Use: ADASUVE must be administered only in a certified healthcare setting.

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, particularly in patients with lung diseases. Administer ADASUVE only in a certified healthcare setting that has immediate access on site to supplies and healthcare professionals competent in the management of acute bronchospasm and access to emergency assistance for symptoms that require immediate medical attention [see Warnings and Precautions]. Certified healthcare settings must have a short-acting bronchodilator (e.g. albuterol) available for the immediate treatment of bronchospasm; this short-acting bronchodilator can be delivered by inhaler (with spacer) or nebulizer. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and assess (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE [see Dosage and Administration and Contraindications].

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].

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].

PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS.

  • 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, assess the patient for respiratory abnormalities (by medical history, medication history, and chest auscultation)
  • 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 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: Neonates exposed to antipsychotic drugs, including ADASUVE, during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms after delivery. There is insufficient data on loxapine to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother associated with untreated schizophrenia or bipolar I disorder, and with exposure to antipsychotics, including ADASUVE, during pregnancy
  • Lactation: There is no available information on the presence of loxapine in human milk although likely since loxapine has been found in animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ADASUVE and any potential adverse effects on the breastfed child from ADASUVE or from the underlying maternal condition
  • The safety and effectiveness of ADASUVE in pediatric patients have not been established
Alexza ©2022 Alexza Pharmaceuticals, Inc. All rights reserved.
ADA-50105.  January 2022.
|
Galen ©2022 Alexza Pharmaceuticals, Inc. All rights reserved.
ADA-50105. January 2022.
      IMPORTANT SAFETY INFORMATION
EXPAND

INDICATIONS AND USAGE

ADASUVE® is an atypical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Limitations of Use: ADASUVE must be administered only in a certified healthcare setting.

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, particularly in patients with lung diseases. Administer ADASUVE only in a certified healthcare setting that has immediate access on site to supplies and healthcare professionals competent in the management of acute bronchospasm and access to emergency assistance for symptoms that require immediate medical attention [see Warnings and Precautions]. Certified healthcare settings must have a short-acting bronchodilator (e.g. albuterol) available for the immediate treatment of bronchospasm; this short-acting bronchodilator can be delivered by inhaler (with spacer) or nebulizer. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and assess (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE [see Dosage and Administration and Contraindications].

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].

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].

PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNINGS.

  • 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, assess the patient for respiratory abnormalities (by medical history, medication history, and chest auscultation)
  • 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 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: Neonates exposed to antipsychotic drugs, including ADASUVE, during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms after delivery. There is insufficient data on loxapine to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother associated with untreated schizophrenia or bipolar I disorder, and with exposure to antipsychotics, including ADASUVE, during pregnancy
  • Lactation: There is no available information on the presence of loxapine in human milk although likely since loxapine has been found in animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ADASUVE and any potential adverse effects on the breastfed child from ADASUVE or from the underlying maternal condition
  • The safety and effectiveness of ADASUVE in pediatric patients have not been established
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