Discussing INBRIJA^® with Patients Transcript

[Purple and gold sail and INBRIJA logo appear]

PRACTICAL CONSIDERATIONS
for Treating Parkinson's Disease Symptoms When They Return:
Expert Perspectives
INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa
Selected Important Safety Information

• INBRIJA is contraindicated in patients taking or who have recently taken (within 2 weeks) nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine) due to risk of hypertension. Discontinue use of nonselective MAO inhibitors at least 2 weeks prior to initiating INBRIJA.

See additional Important Safety Information later in this video.

INBRIJA Levodopa inhalation powder is indicated for intermittent treatment of off episodes in patients with Parkinson's disease treated with carbidopa levodopa. INBRIJA is contraindicated in patients who are taking or who have recently taken, within two weeks, nonselective monoamine oxidase MAO inhibitors, for example, phenelzine and tranylcypromine due to risk of hypertension. Discontinue use of nonselective MAO inhibitors at least two weeks prior to initiating INBRIJA.

DISCUSSING INBRIJA WITH PATIENTS
A Discussion With:
Peter A. LeWitt, MD | Salima Brillman, MD

[Dr. LeWitt talking to camera]

PETER A. LEWITT, MD
Director, Parkinson's Disease and Movement Disorders Program at Henry Ford Hospital
Professor of Neurology at Wayne State University School of Medicine

I'd like to get some insights from the both of you as to how we discuss with patients phase of initiation. You've chosen the patient for probably needing it. How do we communicate that need? What kinds of tips have you come up from experience to guide the patient to getting started with this therapy? What to expect? What hurdles are ahead for getting therapy started with them? Let's start with you, Salima. Tell me a little bit about your experience so far.

[Dr. Brillman talking to camera]

SALIMA BRILLMAN, MD
Parkinson's Disease and Movement Disorders Center of Silicon Valley

The first thing is education. I think it's really important that the patient understands their OFF periods and understand what their particular return of symptoms is for them. If they can identify it, then we're in the game. It's important for them to understand what their symptoms are and particularly when they occur. I always ask them to use INBRIJA at the onset of when they're starting to have the return of symptoms. In my experience, they will have the most success when they utilize it at the onset. Then I give them tips about how to utilize the inhaler. I share with them helpful hints that the company has given us for educating patients on the inhalation technique. I explain that cough is one of the most common adverse events that can happen. It makes sense to have a cough because you're inhaling a powder. Some of the tips for administration include sitting up straight, utilizing the inhaler in front of them, taking a breath so that they can hear the whirling from the inhaler, and not feeling like they need to inhale the entire capsule in one breath. They can also utilize a sip of liquid in between inhalations. I have found it really useful to use the demonstration video provided by Acorda as part of my training patients on how to use INBRIJA, especially during telemedicine visits. There are also nurse educators that are available to reinforce our training with patients. These resources are useful to educate patients.

https://www.inbrija.com/helpful-hints.pdf

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Helpful Hints for Administration and Addressing Cough
This is a new experience; it may take some practice

Tips for Administration

• Stand or sit up straight and look straight ahead while breathing in; hold the inhaler level
• Breathe in slowly and gently, just enough to hear or feel the capsule whirl; there is no need to breathe in strongly
• Hold breath for a few seconds
• Patients may take more than 1 breath per capsule

Addressing Cough

• Inhalation of INBRIJA can lead to coughing or sensation of choking at the time of administration
• For some patients, sipping liquid before and after inhaling the medication helps
• Patients should try not to cough; if they cough out the medicine, it will reduce the amount they receive
• If cough occurs, patients should breath in again with the same capsule

Please see Full Prescribing Information, including Instructions for Use, provided.

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Indication
INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease (PD) treated with carbidopa/levodopa.

Important Safety Information

• INBRIJA is contraindicated in patients taking or who have recently taken (within 2 weeks) nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine) due to risk of hypertension. Discontinue use of nonselective MAO inhibitors at least 2 weeks prior to initiating INBRIJA.
• Patients treated with levodopa, the active ingredient in INBRIJA, have reported falling asleep during activities of daily living, including operation of motor vehicles, which sometimes resulted in accidents. Many patients reported somnolence but some reported no warning signs (sleep attack). This may occur more than a year after initiating treatment. Reassess patients for drowsiness/sleepiness including occurrence during specific activities. Advise patients of potential for drowsiness and ask about factors that may increase this risk (e.g., sedating medications, sleep disorders).
  • Consider discontinuing INBRIJA in patients who report significant daytime sleepiness or falling asleep during activities that require active participation. If continuing INBRIJA, advise patients not to drive and to avoid activities that may result in harm. There is insufficient information that dose reduction will eliminate episodes of falling asleep during activities of daily living.
• Neuroleptic malignant syndrome-like symptoms (e.g., elevated temperature, muscular rigidity, altered consciousness, autonomic instability) have been reported with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy.
• Hallucinations (with or without confusion, insomnia, and excessive dreaming) may occur and may respond to reducing levodopa therapy. Abnormal thinking and behavior may present with paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium.
• INBRIJA should ordinarily not be used in patients with major psychotic disorder due to risk of exacerbating psychosis. Dopamine antagonists used to treat psychosis may exacerbate symptoms of PD and decrease INBRIJA efficacy.
• Patients on medications that increase central dopaminergic tone such as INBRIJA can experience intense urges to gamble or spend money, increased sexual urges, binge eating and/or other intense urges, and inability to control them. In some cases, these urges stopped with dose reduction or medication discontinuation. Since some patients may not recognize these behaviors as abnormal, ask patients or their caregivers about development of new or increased urges and consider stopping INBRIJA if this occurs.
• INBRIJA may cause or exacerbate dyskinesias. If troublesome dyskinesias occur, consider stopping INBRIJA or adjusting other PD medications.
• INBRIJA is not recommended in patients with asthma, COPD, or other chronic underlying lung disease because of the risk of bronchospasm.
• Monitor patients with glaucoma for increased intraocular pressure.
• Abnormalities in laboratory tests may include elevations of liver function tests (e.g., alkaline phosphatase, AST, ALT, lactic dehydrogenase, bilirubin) blood urea nitrogen, hemolytic anemia, and positive direct antibody test. Increased levels of catecholamines and their metabolites in plasma and urine may result in false-positive results suggesting pheochromocytoma.
• The most common adverse reactions (≥ 5% and > placebo) were cough (15% vs 2%), upper respiratory tract infection (6% vs 3%), nausea (5% vs 3%), and sputum discolored (5% vs 0%).
• Use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatic hypotension. Monitor patients taking these drugs concurrently.
• Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce levodopa efficacy; monitor for worsening symptoms.
• Iron salts or multivitamins with iron salts may reduce levodopa bioavailability
• INBRIJA should be used during pregnancy/nursing only if potential benefit justifies potential risk. There are no adequate data on INBRIJA in pregnant women or breastfed infants. Animal data shows carbidopa/levodopa is developmentally toxic (including teratogenicity). Levodopa may affect milk production, interfering with lactation. Levodopa has been detected in human milk.
• Safety and effectiveness in pediatric patients have not been established.
• Geriatric patients (n=56) experienced more of the following adverse reactions than patients <65 (n=58): cough (25% vs 5%), upper respiratory tract infection (11% vs 2%), nausea (7% vs 3%), vomiting (4% vs 2%), pain in extremities (4% vs 0%), and discolored nasal discharge (4% vs 0%).

Please see the Full Prescribing Information at www.INBRIJAFullPI.com

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ACORDA THERAPEUTICS, the stylized ACORDA THERAPEUTICS logo, INBRIJA and the INBRIJA logo are all trademarks of Acorda Therapeutics, Inc.© 2021 Acorda Therapeutics, Inc. All rights reserved.

06/2021 INB10418

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06/21 INB10407