The safety of ONGENTYS was evaluated in 265 patients with Parkinson’s disease (PD) in two 14-15 week placebo- and active-controlled (Study 1) or placebo-controlled (Study 2) studies. Use with caution in Parkinson’s patients with suspected or diagnosed dopamine dysregulation syndrome.īecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Re-evaluate the patient’s current therapy(ies) for Parkinson’s disease and consider stopping ONGENTYS if a patient develops such urges while taking ONGENTYS. In Study 1 and Study 2, impulse control disorders occurred in 1% of patients treated with ONGENTYS 50 mg, and in no patient who received placebo. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with ONGENTYS. In some cases, these urges were reported to have stopped when the dose was reduced, or the medication was discontinued. Patients treated with ONGENTYS can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more dopaminergic therapies that increase central dopaminergic tone. If a decision is made to continue ONGENTYS, patients should be advised not to drive and to avoid other potentially dangerous activities.ĥ.6 Impulse Control / Compulsive Disorders If a patient develops daytime sleepiness or episodes of falling asleep during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), consider discontinuing ONGENTYS or adjusting other dopaminergic or sedating medications. Patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event.īefore initiating treatment with ONGENTYS, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with dopaminergic therapy, such as concomitant sedating medications or the presence of a sleep disorder. Patients treated with dopaminergic medications and medications that increase levodopa exposure, including ONGENTYS, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. 7 Hepatic Impairment 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 information are not listed.ĥ.2 Falling Asleep During Activities of Daily Living and Somnolence FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dosing and Administration Information 2.2 Dosage Recommendations for Patients with Hepatic Impairment 2.3 D iscontinuation and Missed Dose 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Cardiovascular Effects with Concomitant Use of Drugs Metabol ized by Catechol-O-Methyltransferase (COMT) 5.2 Falling Asleep During Activities of Daily Living and Somnolence 5.3 Hypotension/Syncope 5.4 Dyskinesia 5.5 Hallucinations and Psychosis 5.6 Impulse Control / Compulsive Disorders 5.7 Withdrawal- E mergent Hyperpyrexia and Confusion 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 7 DRUG INTERACTIONS 7.1 Non-Selective Monoamine Oxidase (MAO) Inhibitors 7.2 Effect of ONGENTYS on Other Drugs 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6
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