PrabotulinumtoxinA-xvfs

(Jeuveau®)

PrabotulinumtoxinA-xvfs

Drug updated on 12/11/2024

Dosage FormInjection (intramuscular; 100 units/vial)
Drug ClassAcetylcholine release inhibitors and neuromuscular blocking agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Specific Population Types: The majority of participants in the studies were female, aged 18 to 65 years, and were treated in outpatient settings such as private offices or day clinics. No additional subgroup-specific findings regarding effectiveness were reported in the studies, suggesting that the results may primarily apply to this demographic without noted distinctions based on other characteristics.
  • Safety Profile Summary: OnabotulinumtoxinA-20 U and AbobotulinumtoxinA-50 U showed a higher incidence of major adverse events (AEs) compared to placebo, with OnabotulinumtoxinA-20 U reporting a Peto odds ratio of 3.62 (95% confidence interval (CI) 1.50 to 8.74) and AbobotulinumtoxinA-50 U a Peto odds ratio of 3.36 (95% CI 0.88 to 12.87); however, there was no difference in overall AEs for OnabotulinumtoxinA-20 U (relative risk (RR) 1.14, 95% CI 0.89 to 1.45). IncobotulinumtoxinA-20 U and DaxibotulinumtoxinA-40 U did not report major AEs, but DaxibotulinumtoxinA-40 U was associated with a significant increase in any AEs (RR 2.23, 95% CI 1.46 to 3.40).

Product Monograph / Prescribing Information

Document TitleYearSource
Jeuveau (prabotulinumtoxinA-xvfs) Prescribing Information.2023Evolus Inc., Newport Beach, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Botulinum toxin type A for facial wrinkles2021The Cochrane Database of Systematic Reviews