Loxapine (inhaled)
Package labels
Loading package label images…
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.
ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest, particularly in patients with lung diseases ( 4 , 5.1 ) ADASUVE is available only through a restricted program called the ADASUVE REMS ( 5.2 ) 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.
Certified healthcare settings must have a short-acting bronchodilator available for the immediate treatment of bronchospasm ( 5.1 , 5.2 ) 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 ( 5.3 ) 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 (5.1 , 5.2) ] . 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 (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…
Handling and access
REMS
RequiredStated in the label quoted on this page.
- Restricted distribution (ETASU)
- Healthcare setting certification
- Medication Guide
Dosing in kidney impairment
Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Associated features can include elevated serum creatine phosphokinase (CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration, and renal failure.
Preparation and administration
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 When the ADASUVE inhaler is removed from the pouch, the indicator light is off (see Figure 2 ).
Figure 2. ADASUVE Inhaler with Indicator Light 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. 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 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 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 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. Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Loxapine (inhaled)
Label text (3 paragraphs)
7 DRUG INTERACTIONS
7.1 CNS Depressants ADASUVE is a central nervous system (CNS) depressant. The concurrent use of ADASUVE with other CNS depressants (e.g., alcohol, opioid analgesics, benzodiazepines, tricyclic antidepressants, general anesthetics, phenothiazines, sedative/hypnotics, muscle relaxants, and/or illicit CNS depressants) can increase the risk of respiratory depression, hypotension, profound sedation, and syncope. Therefore, consider reducing the dose of CNS depressants if used concomitantly with ADASUVE.
7.2 Anticholinergic Drugs ADASUVE has anticholinergic activity. The concomitant use of ADASUVE and other anticholinergic drugs can increase the risk of anticholinergic adverse reactions including exacerbation of glaucoma and urinary retention.
Contraindications
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.
Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung disease associated with bronchospasm ( 4 ) Acute respiratory signs/symptoms (e.g., wheezing) ( 4 ) Current use of medications to treat airways disease, such as asthma or COPD ( 4 ) History of bronchospasm following ADASUVE treatment ( 4 ) Known hypersensitivity to loxapine or amoxapine ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
DLikelihood score D: Possible rare cause of clinically apparent liver injury.
Loxapine is a conventional antipsychotic used in the therapy of schizophrenia. Loxapine therapy is commonly associated with minor serum aminotransferase elevations and in very rare instances has been linked to clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including ADASUVE, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ).
The available data from published case reports and pharmacovigilance cases with loxapine, the active ingredient in ADASUVE, in pregnant women are insufficient 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 (see Clinical Considerations ) .
In animal reproduction studies, increased embryofetal toxicity and death in rat fetuses and offspring were observed when pregnant rats were orally administered loxapine, during the period of organogenesis, at doses approximately less than or equal to the maximum recommended human dose (MRHD) based on mg/m 2 body surface area (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including ADASUVE, during the third trimester of pregnancy. These symptoms have varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.
Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Animal Data Pregnant rats were administered oral doses of 1, 4, and 12 mg/kg/day loxapine (~1, 4, and 12 times the MRHD of 10 mg/day based on mg/m 2 body surface area, respectively)…
Breastfeeding (LactMed)
Because no information is available on the use of loxapine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.