Name: Juvmo (tavapadon) in Parkinson's disease: Special populations
Published: 2026-09-27T21:44:59-04:00

Pregnancy

“There are no adequate data on the developmental risk associated with the use of JUVMO in pregnant women. In animal studies, administration of tavapadon during organogenesis (rats and rabbits) did not result in adverse developmental effects at exposures greater than those used clinically (see Data). Following administration of tavapadon throughout pregnancy and lactation (rats), there were adverse effects on postnatal growth at exposures 7 times those used clinically (see Data).” (opens the prescribing information at this quote)

Lactation

“There are no data on the presence of tavapadon in human milk, the effects of tavapadon on the breastfed infant, or the effects of tavapadon on milk production. Tavapadon was present in the milk when administered to lactating rats.” (opens the prescribing information at this quote)

Pediatric use

“Safety and effectiveness in pediatric patients have not been established.” (opens the prescribing information at this quote)

Geriatric use and risk of hallucinations

“Of the 1,279 patients who received JUVMO in clinical studies, 691 (54%) were ≥ 65 years of age and 166 (13%) were ≥ 75 years of age. Patients aged 65 years and older who are treated with JUVMO are at an increased risk of hallucinations [see Warnings and Precautions (5.3)].” (opens the prescribing information at this quote)

Renal and hepatic impairment, age, sex, body weight, and race

“No clinically significant differences in pharmacokinetics of tavapadon were observed based on age (21 years to 79 years), sex, body weight (56 kg to 119 kg), race, severe renal impairment not requiring dialysis (eGFR < 30 mL/min estimated by CKD-EPI equation), mild hepatic impairment (Child-Pugh Class A), or moderate hepatic impairment (Child-Pugh Class B).” (opens the prescribing information at this quote)
“The effects of renal impairment in patients with eGFR < 15 mL/min or on dialysis and severe hepatic impairment (Child-Pugh Class C) on tavapadon pharmacokinetics have not been studied.” (opens the prescribing information at this quote)

Dedicated hepatic impairment study

“The primary purpose of the study is to assess the effect of hepatic impairment on the PK of tavapadon following administration of a single oral dose in participants with mild and moderate hepatic impairment relative to age, body weight, and sex-matched participants with normal hepatic function.” (opens the source at this quote in a new tab)

Dedicated renal impairment study

“The primary purpose is to assess the effect of renal impairment on the PK of tavapadon following administration of a single oral dose in participants with severe renal impairment relative to age, body weight, and sex-matched participants with normal renal function.” (opens the source at this quote in a new tab)