Juvmo (tavapadon) is filed as dopamine D1/D5 receptor partial agonist. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE JUVMO is indicated for the treatment of Parkinson’s disease (PD) in adults. JUVMO is a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease in adults. (1)
12.1 Mechanism of Action Tavapadon is a selective partial agonist at the dopamine D1 and D5 receptor subtypes (D1/D5).
5 WARNINGS AND PRECAUTIONS May cause hypotension/orthostatic hypotension. (5.1) May cause problems with impulse control or compulsive behaviors. Consider dose reductions or stopping JUVMO. (5.2) May cause hallucinations and psychotic-like behavior. The risk of hallucinations may be increased when co-administered with strong CYP3A inhibitors during the maintenance phase. (5.3) May cause dyskinesia or exacerbate pre-existing dyskinesia. (5.4) 5.1 Hypotension/Orthostatic Hypotension Patients with 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. For these reasons, patients with PD being treated with JUVMO should be monitored for signs and symptoms of hypotension/orthostatic hypotension especially during dose escalation, and should be informed of this risk. In Study 1 and Study 2 in patients with PD who were not taking levodopa [see Clinical Studies ( 14.1 )], orthostatic hypotension was reported in 5% of patients treated with JUVMO compared to 1% of patients who received placebo. Hypotension was reported in 4% of patients treated with JUVMO tablets compared to 1% on placebo. In Study 3 in patients taking JUVMO as adjunctive therapy to fixed dose levodopa [see Clinical Studies ( 14.2 )], orthostatic hypotension was reported in 8% of patients treated with JUVMO compared to 2% of patients on placebo. Hypotension was reported in 4% of patients treated with JUVMO compared to 0.4% on placebo. 5.2 Impulse Control/Compulsive Behaviors Patients may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and are generally used for the treatment of PD, including JUVMO. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. In Study 1 and Study 2, impulse control disorders were reported in 1% of patients treated with JUVMO compared to no patients on placebo. In Study 3, impulse control disorders were reported in 2% of patients treated with JUVMO compared to 1% of patients on placebo. 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 being treated with JUVMO. Consider reducing the dose or discontinuing JUVMO if a patient develops such urges. 5.3 Hallucinations and Psychotic-like Behavior Medications for the treatment of PD, including JUVMO, can have effects on thinking and behavior. This abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, symptoms of mania (e.g., insomnia, psychomotor agitation), disorientation, aggressive behavior, agitation, and delirium. In Study 1 and Study 2, hallucination was reported in 3% of patients treated with JUVMO compared to no patients on placebo. In Study 3, when added as an adjunct to a fixed dose of levodopa, hallucination was reported in 7% of patients treated with JUVMO compared to 1% of patients on placebo. Age appears to increase the risk of hallucinations in patients taking JUVMO. In Study 1 and Study 2, among patients 65 years of age and older, hallucination was reported in 4% of patients treated with JUVMO compared to no patients on placebo. In Study 3, among patients 65 years of age and older, hallucination was reported in 9% of patients treated with JUVMO compared to 1% of patients on placebo. The risk of hallucination may be increased when JUVMO is co-administered with strong CYP3A inhibitors during the maintenance phase [see Dosage and Administration ( 2.2 )]. 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. In addition, certain medications used to treat psychosis may exacerbate the symptoms of PD. Consider stopping JUVMO if hallucinations or psychotic-like behaviors occur. 5.4 Dyskinesia JUVMO may cause or exacerbate pre-existing dyskinesia. In Study 1 and Study 2, 0.6% of patients with PD treated with JUVMO reported dyskinesia compared with no patients on placebo. In Study 3, 10.0% of patients treated with JUVMO reported dyskinesia compared to 2% on placebo. Consider decreasing the dosage of JUVMO or other dopaminergic medications if dyskinesia occurs.
4 CONTRAINDICATIONS None. None. (4)
Nausea (≥5% (without levodopa)); Headache (≥5% (without levodopa)); Dizziness (≥5% (without levodopa)); Fatigue (≥5% (without levodopa)); Dysgeusia (≥5% (without levodopa)); Vomiting (≥5% (without levodopa)); Dry mouth (≥5% (without levodopa)); Anxiety (≥5% (without levodopa)); Dyskinesia (≥5% (with levodopa)); Hallucinations (≥5% (with levodopa)); Orthostatic hypotension (≥5% (with levodopa))
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypotension/Orthostatic Hypotension [see Warnings and Precautions ( 5.1 )] Impulse Control/Compulsive Behaviors [see Warnings and Precautions ( 5.2 )] Hallucinations and Psychotic-like Behavior [see Warnings and Precautions ( 5.3 )] Dyskinesia [see Warnings and Pr ec autions ( 5.4 )] Most common adverse reactions (≥ 5%) for JUVMO without concomitant levodopa were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety. (6.1) Most common adverse reactions (≥ 5%) for JUVMO with concomitant levodopa were nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because 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 clinical practice. The safety of JUVMO was evaluated in 1,279 patients with PD who received at least one dose of JUVMO. Of the patients with PD who received JUVMO, 870 were treated for at least 6 months and 630 were treated for at least 1 year. JUVMO without Concomitant L evodopa Study 1 evaluated fixed doses of once daily JUVMO 5 mg (n=177) and JUVMO 15 mg (n=177) compared to placebo (n=175). Study 2 evaluated doses of JUVMO 5 mg to 15 mg unless prevented by intolerance (n=151) compared to placebo (n=153) [see Clinical Studies ( 14.1 )]. In Study 1 and Study 2 combined (n=833 total patients), the most common adverse reactions that occurred in ≥ 5% of patients treated with JUVMO were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety. Adverse reactions led to discontinuation of JUVMO in 100 of 505 patients (20%). Of the 100 patients receiving JUVMO who discontinued because of an adverse reaction, 85 (85%) did so during the titration and/or adjustment phases. The most common adverse reactions leading to discontinuation in patients taking JUVMO were nausea, dizziness, headache, and vomiting. Table 4 presents the adverse reactions that occurred in ≥ 3% of patients treated with JUVMO and with a difference of ≥ 2% between the JUVMO and the placebo group in Study 1 and Study 2. Table 4: Adverse Reactions that Occurred in ≥ 3% of Patients with Parkinson’s Disease Treated with JUVMO and ≥ 2% Difference from Placebo in Study 1 and Study 2 (without Concomitant Levodopa) Adverse Reaction JUVMO Placebo ( N=505 ) % ( N=328 ) % Nausea 27 2 Headachea 17 5 Dizziness 14 4 Fatigueb 10 3 Dysgeusia 8 0 Vomiting 7 <1 Dry mouth 5 <1 Anxiety 5 2 Hypotension 4 1 Dyspepsia 4 1 Abnormal dreams 4 <1 Orthostatic hypotension 4 <1 Hallucinationc 3 0 Gastroesophageal reflux disease 3 <1 Constipation 3 1 a Headache includes multiple related terms b Fatigue includes asthenia c Hallucination includes multiple related terms JUVMO with Concomitant Levodopa Patients in Study 3 were on a fixed dose of levodopa and were titrated to JUVMO 15 mg once daily unless prevented by intolerance, resulting in maintenance doses between 5 mg and 15 mg (n=251), compared to placebo (n=254). The most common adverse reactions that occurred in ≥ 5% of patients treated with JUVMO were nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension. Adverse reactions led to discontinuation of JUVMO in 43 of 251 patients (17%). Of the 43 patients receiving JUVMO who discontinued because of an adverse reaction, 38 (88%) did so during the titration and adjustment phases. The most common adverse reactions leading to discontinuation included nausea, dyskinesia, visual hallucination, and dizziness. Table 5 summarizes the adverse reactions that occurred in ≥ 3% of patients who received JUVMO and with a difference of ≥ 2% between the JUVMO and the placebo groups in Study 3. Table 5: Adverse Reactions that Occurred in ≥ 3% of Patients with Parkinson’s Disease Treated with JUVMO and ≥ 2% Difference from Placebo in Study 3 (with Concomitant Levodopa) Adverse Reaction JUVMO Placebo ( N=251 ) % ( N=254 ) % Nausea 14 4 Dyskinesia 10 2 Dizziness 8 3 Headachea 7 3 Hallucinationb 7 1 Orthostatic hypotension 6 1 Hypotension 4 <1 Abdominal pain 3 <1 Asthenia 3 0 a Headache includes multiple related terms b Hallucination includes multiple related terms
2 DOSAGE AND ADMINISTRATION JUVMO is taken orally once daily, with or without food. (2.1) See Table 1 for the recommended titration schedule. (2.1) Recommended maintenance dosage is 5 mg orally once daily. The dosage may be increased to a maximum of 15 mg once daily based on tolerability and clinical response. (2.1) 2.1 Dosing Recommendations Administer JUVMO orally once daily with or without food. The recommended dosage and titration are included in Table 1. The JUVMO titration pack is recommended for patients initiating therapy with JUVMO to provide doses consistent with the recommended titration schedule to reach the 5 mg maintenance dosage [ see How Supplied/Storage and Handling ( 16.1 ) ]. Table 1: Recommended Dosage Titration Regimen * Treatment Days JUVMO Dosage Days 1 to 4 0.25 mg once daily Days 5 to 8 0.5 mg once daily Days 9 to 12 0.75 mg once daily Days 13 to 16 1 mg once daily Days 17 to 20 1.5 mg once daily Days 21 to 24 2.25 mg once daily Days 25 to 40 3 mg once daily Maintenance Dosage Day 41 and thereafter 5 mg once daily Maximum Dosage If needed, based on tolerability and clinical response, the maintenance dose may be increased in increments of 5 mg approximately every 15 days to the maximum recommended daily dosage. 15 mg once daily * Dose and titration should be guided by tolerability and clinical response. If required, longer intervals between dose adjustment can be used. 2. 2 Dosage Modifications for CYP3A Inhibitors Strong or Moderate CYP3A Inhibitors [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.1 )] JUVMO Titration Avoid concomitant use of strong or moderate CYP3A inhibitors during titration of JUVMO. JUVMO Maintenance when Initiating Strong or Moderate CYP3A Inhibitors Follow the JUVMO dosage modifications in Table 2 when initiating a strong or moderate CYP3A inhibitor for patients already on JUVMO maintenance. Table 2: Dosage Modifications When Initiating a CYP3A Inhibitor in Patients Already on JUVMO Maintenance Current JUVMO Maintenance Dosage Recommended JUVMO Modification for Maintenance Dosage When Initiating a Strong CYP3A Inhibitor When Initiating a Moderate CYP3A Inhibitor 5 mg once daily 5 mg every 7 days 5 mg every 3 days 10 mg once daily 10 mg every 7 days 10 mg every 3 days 15 mg once daily 15 mg every 7 days 15 mg every 3 days Discontinuing CYP3A Inhibitors Upon discontinuation of the strong or moderate CYP3A inhibitor, resume the JUVMO maintenance dosage that was used prior to the initiation of the CYP3A inhibitor. Monitor patients for clinical response and tolerability. 2.3 Dosage Modifications for CYP3A Inducers Strong CYP3A Inducers [see Drug Interactions ( 7.1 ) ] Avoid concomitant use of strong CYP3A inducers during titration and maintenance of JUVMO. Moderate CYP3A Inducers [see Drug Interactions ( 7.1 )] Initiating JUVMO Titration and Maintenance when on Long-Term Moderate CYP3A Inducers Follow the JUVMO dosage modifications in Table 3 when initiating JUVMO titration and maintenance in patients who are already on long-term moderate CYP3A inducers. Table 3: Dosage Modifications for Patients Already on Moderate CYP3A Inducers Titration Regimen ( r equires two JUVMO titration packs)* Treatment Days JUVMO Dosage Days 1 to 4 0.25 mg twice daily Days 5 to 8 0.5 mg twice daily Days 9 to 12 0.75 mg twice daily Days 13 to 16 1 mg twice daily Days 17 to 20 1.5 mg twice daily Days 21 to 24 2.25 mg twice daily Days 25 to 40 3 mg twice daily Maintenance Dosage Day 41 and thereafter 5 mg twice daily Maximum Dosage If needed, based on clinical response and tolerability, the maintenance dosage may be increased to 5 mg three times a day. If further escalation is needed, the dose may be increased by 5 mg every 15 days, administered in divided doses (either twice a day or three times a day), to the maximum recommended daily dosage. 45 mg daily(15 mg three times daily) * Use one JUVMO titration pack for the morning dose and the second JUVMO titration pack for the evening dose. JUVMO Maintenance when Initiating Moderate CYP3A Inducers For patients who are already on JUVMO maintenance dosage and start to take moderate CYP3A inducers, modifications to JUVMO dosing are provided below: Days 1 to 7 of concomitant use: continue the current maintenance dosage of JUVMO (5 mg, 10 mg, or 15 mg once daily). Day 8 and thereafter during concomitant use: increase the frequency of the maintenance dosage of JUVMO to twice daily. If needed, based on clinical response and tolerability, the maintenance dosage can be increased to three times daily. Discontinuing CYP3A Inducers Upon discontinuation of moderate CYP3A inducers, gradually reduce the JUVMO dosage to once daily. Monitor patients for clinical response and tolerability. 2.4 Missed Dose If a dose of JUVMO is missed, take it as soon as remembered on the same day, but do not double the dose. Do not take a missed dose on the following day. Skip the missed dose and resume the regular dosing schedule.
7 D RUG INTERACTIONS Avoid concomitant use of strong or moderate CYP3A inhibitors during titration and strong CYP3A inducers during titration and maintenance of JUVMO. (2.2, 7.1) Recommended JUVMO dosage modifications during maintenance dosing: Strong and moderate CYP3A inhibitors: Decrease dosing frequency. (2.2, 7.1) Strong CYP3A inducers: Concomitant use is not recommended. (2.3, 7.1) Moderate CYP3A inducers (long-term): Increase dosing frequency. (2.3, 7.1) CYP3A substrates: If JUVMO is used concomitantly with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, consider a dosage modification of such substrates when initiating or discontinuing JUVMO. (7.2) CYP2C8 substrates: If JUVMO is used concomitantly with sensitive CYP2C8 substrates or CYP2C8 substrates where minimal concentration changes may increase the risk of adverse reactions, consider a dosage reduction of such substrates. (7.2) BCRP Substrates: If JUVMO is used concomitantly with BCRP substrates, consider a reduction in dosage of BCRP substrates as clinically appropriate. (7.2) 7.1 Effect of Other Drugs on JUVMO Table 6 describes drug interactions where concomitant use of another drug affects the use of JUVMO. Table 6: Drug Interactions: Concomitant Use of Other Drugs that Affect the Use of JUVMO Strong and Moderate CYP3A Inhibitors Prevention or Management If JUVMO is used with a strong or moderate CYP3A inhibitor during JUVMO maintenance, reduce JUVMO dosage frequency [see Dosage and Administration ( 2.2 )]. Mechanism and Clinical Effect(s) Tavapadon is CYP3A substrate. Concomitant use of strong and moderate CYP3A inhibitors increase the exposure of tavapadon, which may increase the risk of adverse reactions [see Clinical Pharmacology ( 12.3 )]. Concomitant use of strong CYP3A inhibitors may increase the risk of hallucinations [see Warnings and Precautions ( 5.3 ), Clinical Pharmacology ( 12.3 )]. Strong and Moderate CYP3A Inducers Prevention or Management Concomitant use of JUVMO with a strong CYP3A inducer is not recommended [see Dosage and Administration ( 2.3 )]. If JUVMO is used in a patient already on a long-term moderate CYP3A inducer, increase JUVMO dosage frequency [see Dosage and Administration ( 2. 3 )]. Mechanism and Clinical Effect(s) Tavapadon is CYP3A substrate. Concomitant use of strong or moderate CYP3A inducer decreases the exposure of tavapadon which may result in reduced JUVMO efficacy [see Clinical Pharmacology ( 12.3 )]. 7.2 Effect of JUVMO on Other Drugs Table 7 describes drug interactions where JUVMO affects concomitant use of another drug. Table 7: Drug Interactions: JUVMO Affecting Other Drugs with Concomitant Use CYP3A Substrates Prevention or Management Consider a dose modification of sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, as clinically appropriate, when initiating or discontinuing JUVMO. Mechanism and Clinical Effect(s) JUVMO is an inducer of CYP3A [see Clinical Pharmacology ( 12.3 )]. Concomitant use of JUVMO may decrease the concentrations of CYP3A substrates. CYP2C8 Substrates Prevention or Management Consider a dosage reduction of sensitive CYP2C8 substrates or CYP2C8 substrates where minimal concentration changes may increase the risk of severe adverse reactions, as clinically appropriate, when concomitantly used with JUVMO. Mechanism and Clinical Effect(s) JUVMO is an inhibitor of CYP2C8 [see Clinical Pharmacology ( 12.3 )]. Concomitant use of JUVMO may increase the plasma concentrations of CYP2C8 substrates. BCRP Substrates Prevention or Management Consider a dosage reduction of BCRP substrates, as clinically appropriate, when concomitantly used with JUVMO. Mechanism and Clinical Effect(s) JUVMO is an inhibitor of efflux transporter BCRP [see Clinical Pharmacology ( 12.3 )]. Concomitant use of JUVMO may increase the exposure of BCRP substrates.
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Drug Interactions Advise patients and/or caregivers to inform their healthcare provider of all the medicines the patient is taking, including over-the-counter medicines, dietary supplements, and herbal products (e.g., St. John’s Wort), and if there is a change (e.g., discontinuing) in their medication [see Dosage and Administration ( 2.2 , 2.3 ), Drug Interactions ( 7.1 , 7.2 )]. Instruct patients who are initiating JUVMO when concomitantly taking a moderate CYP3A inducer how to properly administer the titration packs. Hypotension /Orthostatic Hypotension Advise patients that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, falling, fainting, or blackouts, and sometimes sweating. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time. Instruct patients to rise slowly after sitting or lying down while using JUVMO [see Warnings and Precautions ( 5.1 )]. Impulse Control/Compulsive Behaviors Advise patients and their caregivers that patients may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, binge or compulsive eating, and/or other intense urges and the inability to control these urges while taking JUVMO alone or with one or more medication(s) for the treatment of Parkinson’s disease. Advise patients that they should report any of these adverse reactions to their healthcare provider [see Warnings and Precautions ( 5.2 )]. Hallucinations/Psych otic Behavior Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations) and other symptoms of psychosis while taking JUVMO. Advise patients that they should report any of these adverse reactions to their healthcare provider [see Warnings and Precautions ( 5.3 )]. Dyskinesia Inform patients that JUVMO may cause or exacerbate pre-existing dyskinesias [see Warnings and Precautions ( 5.4 )]. Marketed by: AbbVie Inc.North Chicago, IL 60064 U.S.A. JUVMO and its design are trademarks of Cerevel Therapeutics, LLC, an AbbVie company. ©2026 AbbVie. All rights reserved. 20095842
According to its FDA label, Juvmo (tavapadon) is approved for: 1 INDICATIONS AND USAGE JUVMO is indicated for the treatment of Parkinson’s disease (PD) in adults. JUVMO is a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease in adults. (1) For medical advice, please talk to your prescriber or pharmacist.
Juvmo (tavapadon) belongs to the dopamine D1/D5 receptor partial agonist class of medications.
The FDA label lists Juvmo (tavapadon) as: 3 DOSAGE FORMS AND STRENGTHS Tablets supplied as: 0.25 mg: Round, orange, film-coated, with “NRS” debossed on one side and “025” on the other side 1 mg: Rectangle, orange, film-coated, with “NRS” debossed on one side and “1” on the other side 5 mg: Diamond, purple, film-coated, with “NRS” debossed on one side and “5” on the other side 10 mg: Oval, purple, film-coated, with “NRS” debossed on one side and “10” on the other side 15 mg: Rectangle, purple, film-coated, with “NRS” debossed on one side and “15” on the other side Tablets: 0.25 mg, 1 mg, 5 mg, 10 mg, and 15 mg (3); oral route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Juvmo. Availability changes as patents expire.
Our ingest of the FDA label for Juvmo (tavapadon) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Juvmo (tavapadon) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Juvmo (tavapadon) as 2026-09-25.
The FDA label lists AbbVie Inc. as a labeler/manufacturer of Juvmo (tavapadon). Multiple firms may market generics of the same molecule.
The FDA label states: "16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]." Follow the packaging insert for the authoritative guidance.
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