Question 3: Dopamine Receptor Biology and Tavapadon Mechanism of Action

INDICATION

Tavapadon is indicated for the treatment of Parkinson’s disease in adults.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Hypotension/Orthostatic Hypotension: Patients with Parkinson’s disease (PD) 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 being treated with 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 tavapadon. 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 tavapadon. Consider reducing the dose or discontinuing tavapadon if a patient develops such urges.

Hallucinations and Psychotic-like Behavior: Medications for the treatment of PD, including tavapadon, can have effects on thinking and behavior. Age appears to increase the risk of hallucinations in patients taking tavapadon. The risk of hallucination may be increased when tavapadon is co-administered with strong CYP3A inhibitors during the maintenance phase. Consider the risks and benefits prior to initiating treatment with tavapadon in patients with a major psychotic disorder because of the risk of exacerbating psychosis. Consider stopping tavapadon if hallucinations or psychotic-like behaviors occur.

Dyskinesia: Tavapadon may cause or exacerbate pre-existing dyskinesia. Consider decreasing the dosage of tavapadon or other dopaminergic medications if dyskinesia occurs.

Adverse Reactions 

The most common adverse reactions (≥5%) for tavapadon without concomitant levodopa were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety.

The most common adverse reactions (≥5%) for tavapadon with concomitant levodopa were nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension.

Drug Interactions 

Strong CYP3A inducers: Avoid use with tavapadon. Strong and moderate CYP3A inhibitors: avoid use with tavapadon during titration; tavapadon dosage modification is recommended during maintenance.

Moderate CYP3A inducers: Tavapadon dosage modification is recommended during titration and maintenance. Consult the full Prescribing Information for tavapadon for more information on drug interactions and recommended dosage modifications.

Dosage Forms and Strengths 

Tavapadon 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 or visit https://www.rxabbvie.com/pdf/juvmo_pi.pdf.

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