me sleepiness or episodes offalling asleep during activities that require active participation (e.g., conversations, eating, etc.).
If treatment with INBRIJA continues, patients should be advised not to drive and to avoid otheractivities that might result in harm if the patients become somnolent. There is insufficientinformation to establish that dose reduction will eliminate episodes of falling asleep whileengaged in activities of daily living.
5.2 Withdrawal-Emergent Hyperpyrexia and Confusion
A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevatedtemperature, muscular rigidity, altered consciousness, and autonomic instability), with no otherobvious etiology, has been reported in association with rapid dose reduction, withdrawal of, orchanges in dopaminergic therapy.
5.3 Hallucinations/Psychosis
In placebo-controlled trials [see Clinical Studies (14)], hallucinations were reported in less than2% of patients treated with INBRIJA. Hallucinations may be responsive to reducing levodopatherapy. Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming.
Abnormal thinking and behavior may present with one or more symptoms, including paranoidideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressivebehavior, agitation, and delirium.
Because of the risk of exacerbating psychosis, patients with a major psychotic disorder shouldordinarily not be treated with INBRIJA. In addition, medications that antagonize the effects ofdopamine used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and maydecrease the effectiveness of INBRIJA [see Drug Interactions (7.2)]
5.4 Impulse Control/Compulsive Behaviors
Patients treated with INBRIJA can experience intense urges to gamble, increased sexual urges,intense urges to spend money, binge eating, and/or other intense urges, and the inability tocontrol these urges while taking one or more of the medications that increase centraldopaminergic tone. In some cases, although not all, these urges were reported to have stoppedwhen the dose was reduced or the medication was discontinued.
Because patients may not recognize these behaviors as abnormal, it is important for prescribersto specifically ask patients or their caregivers about the development of new or increasedgambling urges, sexual urges, uncontrolled spending or other urges while being treated withINBRIJA. Consider stopping the medication if a patient develops such urges while takingINBRIJA.
5.5 Dyskinesia
INBRIJA may cause or exacerbate dyskinesias. If troublesome dyskinesias occur, prescribersmay need to consider stopping treatment with INBRIJA and/or adjusting the patient’s dailymedications for the treatment of Parkinson’s disease. In Study 1, 4% patients treated withINBRIJA 84 mg reported dyskinesia, compared with 1% for patients on placebo [see AdverseReactions (6.1)].
5.6 Bronchospasm in Patients with Lung Disease
Because of the risk of bronchospasm, use of INBRIJA in patients with asthma, COPD, or otherchronic underlying lung disease is not recommended.
In a double-blind, placebo-controlled, crossover clinical study, 25 otherwise healthy subjectswith mild or moderate asthma on a stable regimen of asthma medication received placebo orINBRIJA 84 mg every 4 hours for a total of three doses.
Cough was the most frequent adversereaction, reporte |
