INBRIJA™<small>(levodopa inhalation powder)</small>

INBRIJA (levodopa inhalation powder) is a prescription medicine used for the return of Parkinson’s symptoms (known as OFF episodes) in people treated with carbidopa-levodopa medicines. INBRIJA does not replace regular carbidopa-levodopa medicines.

Selected Important Safety Information

INBRIJA is not to be used if patients take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last 2 weeks.

Please see Additional Important Safety Information below.

Parkinson’s disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. It causes a range of symptoms including impaired movement, muscle stiffness and tremors. As Parkinson’s progresses, people with Parkinson’s experience OFF periods, which are characterized by the return of Parkinson’s symptoms. This return can occur despite the individual’s current baseline Parkinson’s therapies.

Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s. Nearly 40% of the 1 million people with Parkinson’s in the U.S. experience OFF periods.

Acorda is pleased to have been able to contribute this additional treatment option.

For more information download the Inbrija Fact Sheet, Off Period Fact Sheet or visit www.INBRIJA.com

Additional Important Safety Information

Before using INBRIJA, patients should tell their healthcare provider about all their medical conditions, including:

  • asthma, chronic obstructive pulmonary disease (COPD), or any chronic lung disease
  • daytime sleepiness from a sleep disorder or if they get drowsy/sleepy without warning or take a medicine that increases sleepiness such as sleep medicines, antidepressants, or antipsychotics
  • feel dizzy, nausea, sweaty, or faint when standing from sitting/lying down
  • history of abnormal movement (dyskinesia)
  • mental health problem 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.

Patients should tell their healthcare provider if they take:

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

No more than 1 dose (2 capsules) should be taken for any OFF period. No more than 5 doses (10 capsules) of INBRIJA should be taken in a day.

INBRIJA is for oral inhalation only. INBRIJA capsules are not to be swallowed or opened.

Patients are not to drive, operate machinery, or do other activities until they know how INBRIJA affects them. 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. Patients should tell their healthcare provider if they 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 patients become drowsy while using INBRIJA, they should not drive or do activities where they need to be alert. Chances of falling asleep during normal activities increases if patients take medicines that cause sleepiness.
  • withdrawal-emergent hyperpyrexia and confusion (symptoms including fever, confusion, stiff muscles, and changes in breathing and heartbeat) in patients who suddenly lower or change their dose or stop using INBRIJA or carbidopa/levodopa medicines.
  • low blood pressure with or without dizziness, fainting, nausea, and sweating. Patients should 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 them; 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 patients have these symptoms, they should stop taking INBRIJA and call their healthcare provider or go to the nearest hospital emergency room right away.
  • increased eye pressure in patients with glaucoma. Healthcare providers 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.

INBRIJA is a trademark of Acorda Therapeutics, Inc.

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