8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

The two clinical trials of JEUVEAU included 68 subjects age 65 and greater. Although no differences in safety or efficacy were observedbetween older and younger subjects. Clinical studies of JEUVEAU did not include sufficient numbers of subjects aged 65 and over to

determine whether they respond differently from younger subjects.

10 OVERDOSAGE

There is no information regarding overdose from clinical studies of JEUVEAU. Excessive doses of JEUVEAU (prabotulinumtoxinA-xvfs)Injection may be expected to produce neuromuscular weakness with a variety of symptoms.

Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur, oroverdose be suspected, these patients should be considered for further medical eva luation and appropriate medical therapy immediately

instituted, which may include hospitalization. The person should be medically supervised for several weeks for signs and symptoms ofsystemic muscular weakness which could be local, or distant from the site of injection [see Boxed Warning and Warnings and Precautions

(5.1)].

If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspirationpneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until

recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to othergeneral supportive care.

In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) inAtlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin

administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Departmentto process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1­

770-488-7100. More information can be obtained at http://www.cdc.gov/ncidod/srp/drugs/formulary.html#1a.

11 DESCRIPTION

PrabotulinumtoxinA-xvfs is an acetylcholine release inhibitor and a neuromuscular blocking agent. PrabotulinumtoxinA-xvfs is supplied as asterile, vacuum-dried powder in a single-dose vial intended for intramuscular use after reconstitution. PrabotulinumtoxinA-xvfs is a 900 kDa

botulinum toxin type A, produced from fermentation of Clostridium botulinum.

The primary release procedure for JEUVEAU uses an animal based potency assay to determine the potency relative to a reference standard.

The assay is specific to Evolus Inc. product, JEUVEAU. One Unit of JEUVEAU corresponds to the calculated median intraperitoneal lethaldose (LD50) in mice. Due to specific details of this assay Units of biological activity of JEUVEAU cannot be converted into Units of any other