IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Hypotension/Orthostatic Hypotension: Patients with Parkinson's disease may have an impaired capacity to respond to an orthostatic challenge. In clinical studies and clinical experience, dopaminergic medications appear to impair the systemic regulation of blood pressure, resulting in hypotension and/or orthostatic hypotension, especially during dose escalation. Patients with PD treated with JUVMO (tavapadon) should be monitored for signs and symptoms of hypotension/orthostatic hypotension, especially during dose escalation, and should be informed of this risk.
Impulse Control/Compulsive Behaviors: Patients may experience intense urges while on JUVMO. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while on JUVMO. Consider reducing the dose or discontinuing JUVMO if a patient develops such urges.
Hallucinations and Psychotic-like Behavior: Medications for the treatment of PD, including JUVMO, can have effects on thinking and behavior. Age appears to increase the risk of hallucinations in patients taking JUVMO. The risk of hallucination may be increased when JUVMO is co-administered with strong CYP3A inhibitors during the maintenance phase. Consider the risks and benefits prior to initiating treatment with JUVMO in patients with a major psychotic disorder because of the risk of exacerbating psychosis. Consider stopping JUVMO if hallucinations or psychotic-like behaviors occur.
Dyskinesia: JUVMO may cause or exacerbate pre-existing dyskinesia. Consider decreasing the dosage of JUVMO or other dopaminergic medications if dyskinesia occurs.
Adverse Reactions
The most common adverse reactions (≥5%) for JUVMO without levodopa were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety.
The most common adverse reactions (≥5%) for JUVMO with levodopa were nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension.
Drug Interactions
Strong CYP3A Inducers: Avoid use with JUVMO. Strong and moderate CYP3A inhibitors: avoid use with JUVMO during titration; JUVMO dosage modification is recommended during maintenance. Moderate CYP3A Inducers: JUVMO dosage modification is recommended during titration and maintenance. Consult the full Prescribing Information for JUVMO for more information on drug interactions and recommended dosage modifications.
Dosage Forms and Strengths
JUVMO is available as 5 mg, 10 mg, and 15 mg tablets, as well as 0.25 mg and 1 mg tablets contained in a Titration Pack.
Please see full Prescribing Information.
INDICATION
JUVMO is indicated for the treatment of Parkinson’s disease in adults.
US-TAV-260171
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