April 7, 2020: A Letter from Our CEO

Dear Doctor,

I am the founder and CEO of Acorda Therapeutics, and a board-certified internist. I started Acorda to contribute to patient care, and my associates and I never take that privilege for granted.

I know these are challenging times for you, your practice, and your patients. Notwithstanding the hardships imposed by social distancing and the disruption of virtually every normal routine, your patients still need care, information, and support. I want to let you know what we have been doing to continue to provide support related to INBRIJA for your patients and you:

  • Our field sales and medical teams are connecting digitally or by phone into physicians’ offices to provide educational materials and support, such as virtual speaker programs and responses to questions.
  • We have engaged a team of nurse educators to connect with every new INBRIJA patient to review with them the appropriate use of INBRIJA. This is in addition to our customer support team, which continues to be available to help patients negotiate reimbursement and answer other questions regarding INBRIJA. You and your patients may access them at 1-888-887-3447.
  • If you want to submit a prescription and don’t have access to your office fax, please call Prescription Support Services at 1-888-887-3447 for assistance.
  • We also offer commercially insured patients a free trial of one carton of INBRIJA. If you wish to start an eligible patient on this free trial, you may download the form here.
  • We recently enhanced our patient training materials with “Helpful Hints” and an updated video. You and your patients can find these here.

In addition to providing support from our field team, Acorda’s Chief Medical Officer, Burkhard Blank, and I would also be pleased to have you contact us directly any time you would like to bring something to our attention personally, or if you have ideas about how we can better serve you, your practice, and the community. We may be reached at the email addresses and numbers below.

Sincerely,

Ron Cohen, M.D.

President and CEO
Phone: 914-326-5101
Email: rcohen@acorda.com

Burkhard Blank, M.D.

Chief Medical Officer
Phone: 914-326-5490
Email: bblank@acorda.com

INBRIJA® Indication

Intermittent treatment of OFF episodes in patients with PD treated with CD/LD.

Important Safety Information

  • Contraindication: nonselective MAOIs (e.g., phenelzine, tranylcypromine) due to hypertension risk. Discontinue their use at least 2 weeks prior to initiating INBRIJA.
  • Not recommended in patients with asthma/COPD/other chronic lung disease due to bronchospasm risk.
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Indication

INBRIJA is indicated for 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 may 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.