Patients that may benefit from INBRIJA^® 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.

PATIENTS THAT MAY BENEFIT FROM INBRIJA
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 would you add as to what kinds of patients might benefit from using INBRIJA as-needed based on your clinical experience today with a drug that's been out there for a couple of years?

[Dr. Pagan talking to camera]

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

One of the things that I think about in my clinical experience is there's a lot of variability in OFF periods. So there's a lot of different patient types in my clinical experience that can benefit. There are some patients who unpredictably wear off, and it could be because of protein intake. So if they were off unpredictably, when they see the return of symptoms, they can use INBRIJA. There's other patients who have a delayed onset of the medications that they're taking for their maintenance therapy, so that's also an OFF period. So, again, when they see return of those symptoms, they can use that as well. So there is a lot of variability of what different patients are going to be experiencing. So a delayed onset or it could be a missed dose effect. There could be early wearing off. And so you really have to take a look, and when you see that patients are having variable OFF periods and you've tried to decrease their off time with multiple medications, I think we have to think of these as-needed therapies, as we stated before.

[Dr. LeWitt talking to camera]

Very good, I can just add personal experience with a patient who typically in the middle of afternoon would wear off in the benefits of medication, something that my friend and late colleague, Eldad Melamed, described as the siesta stomach. And so this patient, although taking medication quite regularly by mouth, is always ready with the INBRIJA in mid-afternoon to use it when feeling the delay, as you've described, in onset of effect, or just the premature wearing down of previous effect, knowing that somewhere between 2:00 p.m. and 4:00 p.m. this siesta stomach syndrome seems to affect him in a big way.

Capsules should be stored in their blister package and only removed immediately prior to use

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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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MERZ THERAPEUTICS and the stylized MERZ THERAPEUTICS logo are trademarks of Merz Therapeutics, LLC. © 2024 Merz Therapeutics, Inc. All rights reserved. 01/24 PD13395

03/2021 INB10300

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06/21 INB10407