Levodopa

INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa. 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 )

• INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJA inhaler
• For oral inhalation only
• DO NOT swallow INBRIJA capsules
• Only use INBRIJA capsules with the INBRIJA inhaler Inhale the contents of two INBRIJA capsules (84 mg) as needed for OFF symptoms, up to 5 times daily The maximum dose per OFF period is 84 mg, and the maximum recommended daily dosage of INBRIJA is 420 mg Important Administration Instructions INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJA inhaler
• INBRIJA capsules must not be swallowed as the intended effect will not be obtained
• INBRIJA capsules should be stored in their blister package and only removed immediately before use [see How Supplied/Storage and Handling ]
• Recommended Dosage INBRIJA should be taken when symptoms of an OFF period start to return
• The recommended dosage of INBRIJA is oral inhalation of the contents of two 42 mg capsules (84 mg) as needed, up to 5 times a day
• The maximum dose per OFF period is 84 mg, and the maximum daily dosage is 420 mg
• INBRIJA has been shown to be effective only in combination with carbidopa/levodopa [see Indications and Usage ]

INBRIJA (levodopa inhalation powder) consists of INBRIJA capsules and the INBRIJA inhaler. INBRIJA capsules contain 42 mg dry powder formulation of levodopa in a white capsule with two black color bands, and "A42" printed on one side. Inhalation powder: INBRIJA capsules contain 42 mg levodopa for use with the INBRIJA inhaler ( 3 )

• Safety and effectiveness
• In pediatric patients have not been established

Of the Parkinson's disease patients in Study 1 who took INBRIJA 84 mg, 49% (n=56) were 65 years of age and older and 51% (n=58) were under 65 years of age. Of these patients, the following age-related differences in adverse reactions were reported in patients 65 years of age and older vs. in patients under 65 years of age, respectively: cough 25% vs. 5%; upper respiratory tract infection 11% vs. 2%; nausea 7% vs. 3%; vomiting 4% vs. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Instructions for Administering INBRIJA It is important for patients to understand how to correctly administer INBRIJA
• It is recommended that patients be instructed in the proper administration of INBRIJA prior to use [see Dosage and Administration ]
• Patients should be counseled to take a dose of INBRIJA when the return of their Parkinson's symptoms (OFF periods) first occur [see Dosage and Administration ]
• Instruct patients to read the Instructions for Use before using INBRIJA. …

• INBRIJA is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or who have recently (within 2 weeks) taken a nonselective MAO inhibitor
• Hypertension can occur if these drugs are used concurrently [see Drug Interactions ]
• 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

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 ) 7.1 Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with INBRIJA is contraindicated [see Contraindications (4) ] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating INBRIJA. The use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatic hypotension. Monitor patients who are taking these drugs concurrently. …

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 ) 5.1 Falling Asleep During Activities of Daily Living and Somnolen …

The following serious adverse reactions are discussed below and elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.2) ] Hallucinations/Psychosis [see Warnings and Precautions (5.3) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.4) ] Dyskinesia [see Warnings and Precautions (5.5) ] Bronchospasm in Patients with Lung Disease [see Warnings and Precautions (5.6) ] Glaucoma [see Warnings and Precautions (5.7) ] The most common adverse reactions (incidence ≥ 5% and higher than placebo) were cough, nausea, upper respir …

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of INBRIJA in pregnant women. In animal studies, carbidopa/levodopa has been shown to be developmentally toxic (including teratogenic effects) [see Data ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. …

Based on the limited available information, the acute symptoms of carbidopa/levodopa overdosage can be expected to arise from dopaminergic overstimulation. Using more than one dose (84 mg) to treat the same OFF period may result in CNS disturbances, with an increasing risk for cardiovascular disturbance (e.g., hypotension, tachycardia) and increased risk for new or worsening psychiatric problems at higher doses. Reports of rhabdomyolysis and transient renal insufficiency suggest that levodopa overdosage may give rise to systemic complications. Monitor patients and provide supportive care. …

Store in a dry place between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). INBRIJA capsules should always be stored in the blister packaging and only removed immediately before use. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.