moderate to severe glabellar lines in adult subjects. Of the 922 subjects enrolled the median number of treatments was three. The adverseevents profile was similar to that reported in single dose trials.

6.2 Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on thesensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay

may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications,and underlying disease. For these reasons, comparison of the incidence of antibodies to prabotulinumtoxinA-xvfs in the studies described

below with the incidence of antibodies in other studies or to other products may be misleading.

Treatment with botulinum toxins may result in the formation of antibodies that may reduce the effectiveness of subsequent treatments by

inactivating biological activity of the toxin. Among 1,414 subjects treated with prabotulinumtoxinA-xvfs, 2 subjects were found to have preexistingantibodies and 2 subjects had treatment-emergent antibodies.

7 DRUG INTERACTIONS

No formal drug interaction studies have been conducted with JEUVEAU (prabotulinumtoxinA-xvfs) for injection. However, the potential forcertain drugs to potentiate the effects of JEUVEAU warrant consideration given the potential risks involved and should be used with caution.

• Aminoglycosides or other agents interfering with neuromuscular transmission

• Anticholinergic drugs

• Botulinum neurotoxin products

• Muscle relaxant

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmentaloutcomes. An embryofetal developmental study conducted with JEUVEAU in pregnant rats revealed no treatment-related effects to the

developing fetus when JEUVEAU was administered intramuscularly during organogenesis at doses up to 12 times the maximumrecommended human dose (MRHD) (see Data). 

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a

background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth

defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Animal Data

In an embryofetal developmental study, intramuscular doses up to 4 unit/kg JEUVEAU were administered to pregnant rats once daily duringorganogenesis (gestation days 6 to 16). No maternal or embryofetal toxicities were observed at doses up to 4 unit/kg (12 times the MRHD of

20 units, based on unit/kg comparison).

8.2 Lactation

There is no information regarding the presence of prabotulinumtoxinA in human or animal milk, its effects on the breastfed infant or on milkproduction.