Features of INBRIJA^® for On-demand Use 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.

FEATURES OF INBRIJA FOR ON-DEMAND USE
A Discussion With:
Peter A. LeWitt, MD | Fernando Pagan, 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

1 dose of INBRIJA (84mg) is administered in two 42-mg capsules. No more than 1 dose can be administered per period of symptom return, and patients may take up to a maximum of 5 doses per day as needed.

What are some of the features of INBRIJA that will make it well suited for on-demand use in your patients? Start with you, Fernando.

[Dr. Pagan talking to camera]

FERNANDO PAGAN, MD
Professor and Vice Chairman,
Department of Neurology at MedStar Georgetown University Hospital

So some of the features, I think, that make INBRIJA very well suited for on-demand use is, number one, its unique delivery system. So through an inhaler, it has an onset of action in 10 minutes, so a patient can decide when to use it, depending on when those return of symptoms begin. And I think that was a very important part of the clinical studies, that patients were able to use it up to five times a day, and most patients used it on average about twice a day when they felt those symptoms start to come on, so at the beginning of an OFF period. So I think that makes it very well suited, so a patient can decide when to use it when they start to see those symptoms come back on. And the unique delivery system, as we talked about, we are bypassing the gastrointestinal system. So, oftentimes, one of the most common things that have been done in the past is to use extra medications and sometimes that doesn't work when you’re taking it orally. So the gastrointestinal system, bypassing it can be very beneficial to bypass the gastrointestinal problems that we often see in some of our Parkinson's patients.

[Chart showing UPDRS Part III Motor Score change at 12 weeks Post Dose for INBRIJA and Placebo is shown alongside window of Dr. Pagan speaking]

[Dr. LeWitt talking to camera]

Yes, Salima, when you use this with your patients, what kinds of things enter into your discussions in terms of features that you would perhaps use as your encouragement to give a try of a therapy like this?

[Dr. Brillman talking to camera]

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

Something I find helpful when talking to patients about INBRIJA is pointing out that this is levodopa, a drug that is familiar to them. The delivery system is different, but the medication is the same.

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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.

03/2021 INB10299

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06/21 INB10407