2.2 Preparation and Dilution Technique

2.3 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Known Hypersensitivity to Botulinum Toxin

4.2 Infection at the Injection Site(s)

5 WARNINGS AND PRECAUTIONS

5.1 Spread of Toxin Effect

5.2 Lack of Interchangeability between Botulinum Toxin Products

5.3 Serious Adverse Reactions with Unapproved Use

5.4 Hypersensitivity Reactions

5.5 Cardiovascular System

5.6 Increased Risk of Clinically Significant Effects with Pre-Existing

Neuromuscular Disorders

5.7 Dysphagia and Breathing Difficulties

6 ADVERSE REACTIONS

FULL PRESCRIBING INFORMATION

6.1 Clinical Trials Experience

6.2 Immunogenicity

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are notlisted. 

WARNING: DISTANT SPREAD OF TOXIN EFFECT

The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptomsconsistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and

breathing difficulties can be life threatening and there have been reports of death. JEUVEAU is not approved for the treatment ofspasticity or any conditions other than glabellar lines. [See Warnings and Precautions (5.1)]

1 INDICATIONS AND USAGE

JEUVEAU is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugatorand/or procerus muscle activity in adult patients.

2 DOSAGE AND ADMINISTRATION

2.1 Instructions for Safe Use

The potency Units of JEUVEAU (prabotulinumtoxinA-xvfs) for injection are specific to the preparation and assay method utilized. They arenot interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be

compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method [see Warningsand Precautions (5.2) and Description (11)].

Retreatment of JEUVEAU should be administered no more frequently than every three months. Consideration of the cumulative dose isnecessary when treating adult patients with JEUVEAU for Glabellar Lines if other botulinum toxin products are or have been used to treat

other indications approved for those products.

The safe and effective use of JEUVEAU depends upon proper storage of the product, selection of the correct dose, and proper reconstitutionand administration techniques. Physicians administering JEUVEAU must understand the relevant neuromuscular and/or orbital anatomy of

the area involved and any alterations to the anatomy due to prior surgical procedures [see Warnings and Precautions (5.4)].

2.2 Preparation and Dilution Technique