ABOUT INBRIJA™

Dosing and Administration

Demonstrated Usability

99.8%
of 629 patients in 2 clinical trials demonstrated the ability to self‑administer INBRIJA while in an OFF period after instruction1

INBRIJA Dosing and Administration

INBRIJA can help bridge the gaps when PD symptoms start to return for patients on CD/LD therapy.

Dosing

  • One dose (84 mg) = two 42 mg capsules
  • No more than 1 dose per OFF period
  • May be taken as needed up to a maximum of 5x per day when symptoms start to return
    • Average number of doses in clinical trials: ~2 per day1,19

Important Administration Instructions

  • For oral inhalation only; INBRIJA capsules must not be swallowed as intended effect would not be obtained
  • INBRIJA capsules are only for use with the INBRIJA inhaler
  • Patients must continue their scheduled CD/LD regimen
  • Capsules should be stored in their blister package and only removed immediately before use

View Demonstration Video

View this demonstration that instructs patients on the correct use of INBRIJA.

Please see
Instructions For Use

INBRIJA Administration

PREPARE THE DOSE
  • Insert 1st capsule into inhaler
  • Click once to puncture capsule
TAKE THE DOSE
  • Exhale completely before inhaling INBRIJA
  • Inhale INBRIJA with a deep, comfortable breath until lungs feel full
  • Hear and feel the capsule whirl inside the inhaler
  • Wait 5 seconds and exhale
  • Remove 1st capsule and insert 2nd capsule, repeating previous steps
  • One dose (84 mg) = two 42 mg capsules; no more than 1 dose per OFF period
DISPOSE AND STORE
  • Discard used capsules and store inhaler for future use

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.