HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useINBRIJA 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 ofOFF episodes in patients with Parkinson’s disease treated withcarbidopa/levodopa (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. DO NOT swallow INBRIJA capsules. Only useINBRIJA capsules with the INBRIJA inhaler (2.1)
Inhale the contents of two INBRIJA capsules (84 mg) as needed for OFFsymptoms, up to 5 times daily (2.2)
The maximum dose per OFF period is 84 mg, and the maximumrecommended daily dosage of INBRIJA is 420 mg (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: INBRIJA capsules contain 42 mg levodopa for use withthe INBRIJA inhaler (3)
CONTRAINDICATIONS
INBRIJA is contraindicated in patients currently taking a nonselectivemonoamine 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 riskof withdrawal-emergent hyperpyrexia and confusion (5.2)
Hallucinations/ exacerbation of psychosis may occur. Patients with amajor psychotic disorder should not be treated with INBRIJA (5.3, 7.2)
Impulse Control Disorders: consider dose reduction or stoppingINBRIJA (5.4)
May cause or exacerbate dyskinesia: adjustment of levodopa therapymay be considered, including stopping INBRIJA (5.5)
Not recommended in patients with asthma, COPD, or other chronicunderlying lung disease (5.6)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5% and higher thanplacebo) were cough, nausea, upper respiratory tract infection, and sputumdiscolored (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AcordaTherapeutics, Inc. at 1-800-367-5109 or FDA at 1-800-FDA-1088 orwww.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 theeffectiveness 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 FDAapprovedpatient labeling.
Revised: 12/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Recommended Dosage
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Falling Asleep During Activities of Daily Living and
Somnolence
5.2 Withdrawal-Emergent Hyperpyrexia and Confusion
5.3 Hallucinations/Psychosis
5.4 Impulse Control/Compulsive Behaviors
5.5 Dyskinesia
5.6 Bronchospasm in Patients with Lung Disease
5.7 Glaucoma
5.8 Laboratory Test Abnormalities
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase (MAO) Inhibitors
7.2 Dopamine D2 Receptor Antagonists and Isoniazid
7.3 Iron Salts
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pedia |
