tric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing informationare not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson’sdisease treated with carbidopa/levodopa.
2 DOSAGE AND ADMINISTRATION
INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJAinhaler.
2.1 Important Administration Instructions
INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJAinhaler. 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 immediatelybefore use [see How Supplied/Storage and Handling (16.2)].
2.2 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 themaximum daily dosage is 420 mg. INBRIJA has been shown to be effective only in combinationwith carbidopa/levodopa [see Indications and Usage (1)].
3 DOSAGE FORMS AND STRENGTHS
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 withtwo black color bands, and “A42” printed on one side.
4 CONTRAINDICATIONS
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 (7.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Falling Asleep During Activities of Daily Living and Somnolence
Patients treated with levodopa, the active ingredient in INBRIJA, have reported falling asleepwhile engaged in activities of daily living, including the operation of motor vehicles, whichsometimes resulted in accidents. Although many of these patients reported somnolence, somereported no warning signs (sleep attack) and believed that they were alert immediately prior tothe event. Some of these events have been reported more than 1 year after the initiation oftreatment.
Prescribers should reassess patients for drowsiness or sleepiness. Prescribers should also beaware that patients may not acknowledge drowsiness or sleepiness until directly questionedabout drowsiness or sleepiness during specific activities.
Before initiating treatment with INBRIJA, advise patients about the potential to developdrowsiness and ask about factors that may increase the risk for somnolence with INBRIJA suchas the concomitant use of sedating medications and the presence of sleep disorders.
Considerdiscontinuing INBRIJA in patients who report significant dayti |
