Loxapine

What it is used for

ADASUVE is a prescription medicine that is inhaled through your mouth and is used to treat acute agitation in adults with schizophrenia or bipolar I disorder. It is not known if ADASUVE is safe and effective in children.

The most important thing to know

ADASUVE is available only through the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program. The healthcare setting must be certified in the ADASUVE REMS Program before you can be given ADASUVE. ADASUVE may cause serious side effects, including:

• 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: 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.
  • wheezing
  • coughing
  • chest tightness
  • shortness of breath
• 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.

Side effects, and when to stop

ADASUVE can cause serious side effects, including:

• neuroleptic malignant syndrome (NMS). NMS is a rare but serious condition that may cause death. Symptoms of NMS may include: Tell your healthcare provider right away if you have any of these symptoms of NMS after taking ADASUVE.
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in pulse, heart rate, and blood pressure
• 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

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.

General information about the safe and effective use of ADASUVE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about ADASUVE. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about ADASUVE that is written for health professionals. For more information, go to www.ADASUVE.com or call 1-800-284-0062.

Who should not take it

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

What to say before you start

Before you take ADASUVE, tell your healthcare provider if you:

• have high or low blood pressure
• have or have had heart problems or stroke
• have or have had seizures (convulsions)
• drink alcohol or use street drugs
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if ADASUVE will harm your unborn baby. Talk to your healthcare provider about the risks to you and your unborn or newborn baby if you take ADASUVE during pregnancy.
  • If you become pregnant while receiving ADASUVE, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
• are breastfeeding or plan to breastfeed. It is not known if ADASUVE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ADASUVE.

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.

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. How should I take ADASUVE?

• Your healthcare provider will show you how to take ADASUVE right before you take it.
• Take ADASUVE exactly as your healthcare provider shows you to take it.
• ADASUVE is for oral inhalation only.

What to avoid

• 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.