"HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use INBRIJA safely and effectively. See full prescribing information for INBRIJA.
INBRIJA� (levodopa inhalation powder), for oral inhalation use
Initial U.S. Approval: 1970
INDICATIONS AND USAGE
INBRIJA is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa ( 1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. DO NOT swallow INBRIJA capsules. Only use INBRIJA capsules with the INBRIJA inhaler ( 2.1)
Inhale the contents of two INBRIJA capsules (84 mg) as needed for OFF symptoms, up to 5 times daily ( 2.2)
The maximum dose per OFF period is 84 mg, and the maximum recommended daily dosage of INBRIJA is 420 mg ( 2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: INBRIJA capsules contain 42 mg levodopa for use with the INBRIJA inhaler ( 3)
CONTRAINDICATIONS
INBRIJA is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor or who have recently (within 2 weeks) taken a nonselective MAO inhibitor ( 4, 7.1)
WARNINGS AND PRECAUTIONS
May cause falling asleep during activities of daily living ( 5.1)
Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion ( 5.2)
Hallucinations/ exacerbation of psychosis may occur. Patients with a major psychotic disorder should not be treated with INBRIJA ( 5.3, 7.2)
Impulse Control Disorders: consider dose reduction or stopping INBRIJA ( 5.4)
May cause or exacerbate dyskinesia: adjustment of levodopa therapy may be considered, including stopping INBRIJA ( 5.5)
Not recommended in patients with asthma, COPD, or other chronic underlying lung disease ( 5.6)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5% and higher than placebo) were cough, nausea, upper respiratory tract infection, and sputum discolored ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Acorda Therapeutics, Inc. at 1-800-367-5109 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Monitor patients on MAO-B inhibitors for orthostatic hypotension ( 7.1)
Dopamine D2 antagonists, isoniazid, and iron salts: May reduce the effectiveness of INBRIJA ( 7.2, 7.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm ( 8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2018"
