HIGHLIGHTS OF PRESCRIBING
INFORMATION
These highlights do not include all theinformation needed to use JEUVEAUsafelyand effectively.
See full prescribinginformation for JEUVEAU.
JEUVEAU(prabotulinumtoxinA-xvfs) for injection, for intramuscular use
Initial U.S. Approval: 2019
WARNING: DISTANT SPREAD OF TOXIN
EFFECT
See full prescribing information for completeboxed warning
The effects of all botulinum toxin products,including JEUVEAU, may spread from thearea of injection to produce symptomsconsistent with botulinum toxin effects.
These symptoms have been reported hoursto weeks after injection. Swallowing andbreathing difficulties can be life threateningand there have been reports of death.
JEUVEAU is not approved for the treatment ofspasticity or any conditions other thanglabellar lines. [See Warnings andPrecautions]
INDICATIONS AND USAGE
JEUVEAU is an acetylcholine release inhibitorand a neuromuscular blocking agent indicated forthe temporary improvement in the appearance ofmoderate to severe glabellar lines associated
with corrugator and/or procerus muscle activity inadult patients
DOSAGE AND ADMINISTRATION
Glabellar Lines Administration: 0.1 mL (4 Units)by intramuscular injection into each of five sites,for a total dose of 20 Units
DOSAGE FORMS AND STRENGTHS
For Injection: 100 Units vacuum-dried powder in
a single- dose vial (3)
-CONTRAINDICATIONS
• Hypersensitivity to any botulinum toxinpreparation or to any of the components in theformulation
• Infection at the injection site
WARNINGS AND PRECAUTIONS
•Potency Units of JEUVEAU are notinterchangeable with other preparations ofbotulinum toxin products
• Spread of toxin effects; swallowing andbreathing difficulties can lead to death. Seekimmediate medical attention if respiratory,speech or swallowing difficulties occur (5.2, 5.7)
• Potential serious adverse reactions afterJEUVEAU injections for unapproved uses
• Adverse event reports have been receivedinvolving the cardiovascular system, some withfatal outcomes. Use caution when administeringto patients with pre-existing cardiovascular
disease.
• Concomitant neuromuscular disorder mayexacerbate clinical effects of treatment
• Use with caution in patients with compromisedrespiratory function or dysphagia
ADVERSE REACTIONS
The most common adverse reactions are:
• Headache (9.3%)
• Eyelid Ptosis (2%)
• Upper Respiratory Tract Infection (3%)
• Increase White Blood Cell count (1%)
To report SUSPECTED ADVERSE
REACTIONS, contact Evolus at [1-877-3865871] or FDA at 1-800-FDA-1088or www.fda.gov/medwatch.
DRUG INTERACTIONS
Patients receiving concomitant treatment of JEUVEAU and aminoglycosides or other agentsinterfering with neuromuscular transmission (e.g.curare-like agents), or muscle relaxants, should
be observed closely because the effect ofJEUVEAU may be potentiated
See 17 for PATIENT COUNSELING
INFORMATION and Medication Guide.
Revised: 02/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: [DISTANT SPREAD OF TOXIN EFFECT]
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Instructio
