EDUCATIONAL PROGRAMS

Important Safety Information

Do not use INBRIJA if you take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last 2 weeks.

Important Safety Information

Do not use INBRIJA if you take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last 2 weeks.

Before using INBRIJA, tell your healthcare provider about all your medical conditions, including:

• asthma, chronic obstructive pulmonary disease (COPD), or any chronic lung disease
• daytime sleepiness from a sleep disorder or if you get drowsy/sleepy without warning or take a medicine that increases sleepiness such as sleep medicines, antidepressants, or antipsychotics
• dizziness, nausea, sweating, or fainting when standing from sitting/lying down
• history of abnormal movement (dyskinesia)
• mental health problems such as hallucinations or psychosis
• uncontrollable urges (for example, gambling, increased sexual urges, intense urges to spend money, or binge eating)
• glaucoma
• pregnancy or plans to become pregnant. It is not known if INBRIJA will harm an unborn baby.
• breastfeeding or plans to breastfeed. Levodopa (the medicine in INBRIJA) can pass into breastmilk and it is unknown if it can harm the baby.

Tell your healthcare provider if you take:

• MAO-B inhibitors
• dopamine D2 receptor antagonists (including phenothiazines, butyrophenones, risperidone, metoclopramide), or isoniazid
• iron salts or multivitamins that contain iron salts

Do not take more than 1 dose (2 capsules) for any OFF period. Do not take more than 5 doses (10 capsules) of INBRIJA in a day.

INBRIJA is for oral inhalation only. Do not swallow or open INBRIJA capsules.

Do not drive, operate machinery, or do other activities until you know how INBRIJA affects you. Sleepiness and falling asleep suddenly can happen as late as a year after treatment is started.

INBRIJA can cause serious side effects including the following. Tell your healthcare provider if you experience them:

• falling asleep during normal daily activities (such as driving, doing physical tasks, using hazardous machinery, talking, or eating) which can be without warning. If you become drowsy while using INBRIJA, do not drive or do activities where you need to be alert. Chances of falling asleep during normal activities increases if you take medicines that cause sleepiness.
• withdrawal-emergent hyperpyrexia and confusion (symptoms including fever, confusion, stiff muscles, and changes in breathing and heartbeat) if you suddenly lower or change your dose or stop using INBRIJA or carbidopa/levodopa medicines.
• low blood pressure with or without dizziness, fainting, nausea, and sweating. Get up slowly after sitting or lying down.
• hallucinations and other psychosis – INBRIJA may cause or worsen psychotic symptoms including hallucinations (seeing/hearing things that are not real); confusion, disorientation, or disorganized thinking; trouble sleeping; dreaming a lot; being overly suspicious or feeling people want to harm you; believing things that are not real, acting aggressive, and feeling agitated/restless.
• unusual uncontrollable urges such as gambling, binge eating, shopping, and sexual urges has occurred in some people using medicines like INBRIJA.
• uncontrolled, sudden body movements (dyskinesia) may be caused or worsened by INBRIJA. INBRIJA may need to be stopped or other Parkinson’s medicines may need to be changed.
• bronchospasm – people with asthma, COPD, or other lung diseases may wheeze or have difficulty breathing after inhaling INBRIJA. If you have these symptoms, stop taking INBRIJA and call your healthcare provider or go to the nearest hospital emergency room right away.
• increased eye pressure in patients with glaucoma. Your healthcare provider should monitor this.
• changes in certain lab values including liver tests

The most common side effects of INBRIJA include cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.

Please see the Patient Information Leaflet.