Adasuve

Adasuve is a prescription medication used to treat acute agitation adults with schizophrenia or bipolar disorder. Adasuve is a type of medication known as a typical antipsychotic. Adasuve blocks the effects of a chemical in your brain, which leads to mental and physical relaxation.

Adasuve comes in an inhalation and is usually taken once a day.

Common side effects of Adasuve include bad taste in the mouth, sleepiness, and sore throat. Do not drive or operate heavy machinery until you know how Adasuve affects you.

Adasuve is a prescription medication is used to treat acute agitation in adults with schizophrenia or bipolar disorder.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• other medications you are taking
• previous history of response to antipsychotic drugs

The recommended dose of Adasuve (loxapine) for acute agitation is 10 mg administered by oral inhalation.

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). 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).

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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Adasuve is not approved for the treatment of patients with dementia-related psychosis.

Adasuve may cause serious side effects, including:

Tell your healthcare provider right away if you have any of these symptoms of bronchospasm after taking Adasuve. Your healthcare provider should check you for breathing problems before and after you take Adasuve.

• Tardive dyskinesia (TD). TD is one of a group of side effects that includes restlessness, sudden and painful muscle stiffness, and tremors and slowing down of all body muscles. These side effects may develop over months, years, and even after a decade of use of Adasuve.
• Increased risk of death in elderly patients with dementia-related psychosis.
  • Medicines like Adasuve can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
  • Adasuve is not approved for the treatment of patients with dementia-related psychosis.
• Narrowing of the airways (bronchospasm) that can cause you to have problems breathing or to stop breathing.
  • People who have asthma or other airway or lung problems, such as chronic obstructive pulmonary disease (COPD), have a higher risk of bronchospasm when taking Adasuve. Symptoms of bronchospasm may include:
    • wheezing
    • coughing
    • chest tightness
    • shortness of breath
• Neuroleptic malignant syndrome (NMS), a rare but serious condition that may cause death. Symptoms of NMS may include:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in pulse, heart rate, and blood pressure

Tell your healthcare provider right away if you have any of these symptoms of NMS after taking Adasuve.

• low blood pressure (hypotension), lightheadedness, or fainting
• seizures (convulsions)
• severe sleepiness and difficulty with potentially dangerous activities such as driving
• worsening of glaucoma
• difficulty urinating
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Adasuve affects you.
• Do not drink alcohol while taking Adasuve. It can increase your chances of getting serious side effects.
• Do not take Adasuve if you are allergic to it, medications similar to loxapine, or to any of the inactive ingredients.

Do not take Adasuve if you:

• have or have had asthma, chronic obstructive pulmonary disease (COPD), or other airway or lung problems that can cause bronchospasm
• are having problems with wheezing, coughing, chest tightness, or shortness of breath
• are taking medicines to treat asthma or COPD
• have taken Adasuve before and had bronchospasm
• are allergic to loxapine or amoxapine

The most common side effects of Adasuve include:

• bad, bitter, or metallic taste in your mouth (dysgeusia)
• sleepiness (especially when used with other drugs that cause sleepiness)
• sore throat

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Adasuve. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Adasuve and other medicines may affect each other causing side effects. Adasuve may affect the way other medicines work, and other medicines may affect the way Adasuve works.

Especially tell your healthcare provider if you take:

• alcohol
• opioid analgesics
• benzodiazepines
• tricyclic antidepressants
• general anesthetics
• phenothiazines
• sedative/hypnotics
• muscle relaxants
• illicit CNS depressants

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Adasuve will harm your unborn baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Adasuve passes into your breast milk. You and your healthcare provider should decide if you will take Adasuve if you are breastfeeding.

Do not drink alcohol while taking loxapine. It can increase your chances of getting serious side effects.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with loxapine. Contact you doctor if you experience signs of TD.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how loxapine affects you.