Adasuve

ADASUVE- loxapine aerosol, powder
Alexza Pharmaceuticals, Inc.

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 equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation) [see Warnings and Precautions (5.1, 5.2)]. 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 [see Dosage and Administration (2.2, 2.4) and Contraindications (4)].

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 (5.2)].

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 (5.3)].

1 INDICATIONS AND USAGE

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

“Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior), leading clinicians to the use of rapidly absorbed antipsychotic medications to achieve immediate control of the agitation [see Clinical Studies (14)].

The efficacy of ADASUVE was established in one study of acute agitation in patients with schizophrenia and one study of acute agitation in patients with bipolar I disorder [see Clinical Studies (14)].

Limitations of Use:

As part of the ADASUVE REMS Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility [see Warnings and Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

ADASUVE must be administered only by a healthcare professional. ADASUVE is administered by oral inhalation only. The recommended dose for acute agitation is 10 mg administered by oral inhalation, using a single-use inhaler. Administer only a single dose within a 24-hour period [see Warnings and Precautions (5.1)].

2.2 Required Examination Prior to Dosing

Prior to administering ADASUVE, screen all patients for a history of asthma, COPD, or other pulmonary disease, and examine patients (including chest auscultation) for respiratory signs (e.g. wheezing) [see Warnings and Precautions (5.1)].

2.3 Important Administration Instructions

Read all of these instructions prior to administering ADASUVE.

Step 1. Open the Pouch

When ready to use, tear open the foil pouch and remove the inhaler from the package (see Figure 1).

Figure 1. Tearing the pouch

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When the ADASUVE inhaler is removed from the pouch, the indicator light is off (see Figure 2).

Figure 2. ADASUVE Inhaler with Indicator Light


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(click image for full-size original)

Step 2. Pull Tab

Firmly pull the plastic tab from the rear of the inhaler (see Figure 3). 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.

Figure 3.

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Step 3. 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.

Step 4. Instruct the Patient to Exhale

Instruct the patient to hold the inhaler away from the mouth and breathe out fully to empty the lungs (see Figure 4).

Figure 4. Exhale

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Step 5. 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 (see Figure 5). Check that the green light turns off indicating that the dose has been delivered.

Figure 5. Inhale

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Step 6. 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 (see Figure 6).

Figure 6. Hold Breath 
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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.

2.4 Monitoring to Assess Safety

Monitor the patient for signs and symptoms of bronchospasm after ADASUVE administration. Perform a physical examination, including chest auscultation, at least every 15 minutes for at least one hour after ADASUVE administration [see Warnings and Precautions (5.1)].

3 DOSAGE FORMS AND STRENGTHS

ADASUVE is an inhalation powder supplied in a single-use, disposable inhaler containing 10 mg of loxapine base.

4 CONTRAINDICATIONS

ADASUVE is contraindicated in patients with the following:

  • Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm [see Warnings and Precautions (5.1)]
  • Acute respiratory symptoms or signs (e.g., wheezing) [see Warnings and Precautions (5.1)]
  • Current use of medications to treat airways disease, such as asthma or COPD [see Warnings and Precautions (5.1)]
  • History of bronchospasm following ADASUVE treatment [see Warnings and Precautions (5.1)]
  • Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred with oral loxapine and amoxapine.

5 WARNINGS AND PRECAUTIONS

5.1 Bronchospasm

ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest [see Adverse Reactions (6.1)]. 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) [see Boxed Warning and Warnings and Precautions (5.2)].

Prior to administering ADASUVE, screen patients regarding a current diagnosis or history of asthma, COPD, and other lung disease associated with bronchospasm, acute respiratory symptoms or signs, current use of medications to treat airways disease, such as asthma or COPD; and examine patients (including chest auscultation) for respiratory abnormalities (e.g., wheezing) [See Dosage and Administration (2.2) and Contraindications (4)]. Monitor patients for symptoms and signs of bronchospasm (i.e., vital signs and chest auscultation) at least every 15 minutes for a minimum of one hour following treatment with ADASUVE [see Dosage and Administration (2.4)]. ADASUVE can cause sedation, which can mask the symptoms of bronchospasm.

Because clinical trials in patients with asthma or COPD demonstrated that the degree of bronchospasm, as indicated by changes in forced expiratory volume in 1 second (FEV1), was greater following a second dose of ADASUVE, limit ADASUVE use to a single dose within a 24 hour period.

Advise all patients of the risk of bronchospasm. Advise them to inform the healthcare professional if they develop any breathing problems such as wheezing, shortness of breath, chest tightness, or cough following treatment with ADASUVE.

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