Role of as-needed therapies transcript
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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.
ROLE OF AS-NEEDED THERAPIES
A Discussion With:
Peter A. LeWitt, MD | Fernando Pagan, MD | Salima Brillman, MD
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[Dr. LeWitt talking to camera]
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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
(DR. LEWITT)
And I'm going to turn to Fernando to discuss the role for therapies used as-needed in Parkinson's disease.
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[Dr. Pagan talking to camera]
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FERNANDO PAGAN, MD
Professor and Vice Chairman,
Department of Neurology at MedStar Georgetown University Hospital
(DR. PAGAN)
So, Dr. LeWitt, I think one of the interesting things that we've seen a shift in paradigm of how we're approaching Parkinson's is that we've usually used maintenance therapies to treat the motor symptoms of Parkinson's. Again, levodopa is the main maintenance therapy that we have to treat the motor symptoms of Parkinson's, and along the way, when we start to see more OFF periods reemerge, we tend to use a lot of adjunctive therapies and when we see the return of symptoms we do have as-needed therapies. And INBRIJA is an excellent example of this as-needed therapy to use when you see the return of symptoms.
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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.
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WHY SHOULD A PHYSICIAN USE A THERAPY LIKE INBRIJA versus adjusting the patient’s baseline medications?
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[Dr. Brillman talking to camera]
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SALIMA BRILLMAN, MD
Parkinson's Disease and Movement Disorders Center of Silicon Valley
(DR. BRILLMAN)
They're not mutually exclusive, of course, and one can do both. In terms of the utilization of INBRIJA and adjusting the baseline medications, we have to remember that people can have partial ONs, they can have failed ONs, that no matter how one adjusts their oral medications, they still may have failure of ONs. So these kinds of OFF periods can be benefited by the utilization of INBRIJA.
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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.
02/2021 INB9263
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View the referenced video
06/21 INB10407