"BOXED WARNING(WHAT IS THIS?): Jeuveau (prabotulinumtoxinA-xvfs); Evolus; For the improvement of glabellar lines, Approved February 2019
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent 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 of spasticity or any conditions other than glabellar lines. [See Warnings and Precautions (5.1)]
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use JEUVEAU� safely and effectively. See full prescribing information 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 COMPLETE BOXED WARNING.
The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent 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 of spasticity or any conditions other than glabellar lines. [See Warnings and Precautions (5.1)]
INDICATIONS AND USAGE
JEUVEAU is an acetylcholine release inhibitor and a neuromuscular blocking agent 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 (1)
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 (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
For Injection: 100 Units vacuum-dried powder in a single- dose vial (3)
CONTRAINDICATIONS
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Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ( 4.1)
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Infection at the injection site ( 4.2)
WARNINGS AND PRECAUTIONS
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Potency Units of JEUVEAU are not interchangeable with other preparations of botulinum toxin products ( 5.2, 11)
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Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur ( 5.2, 5.7)
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Potential serious adverse reactions after JEUVEAU injections for unapproved uses ( 5.3)
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Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease. ( 5.5)
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Concomitant neuromuscular disorder may exacerbate clinical effects of treatment ( 5.6)
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Use with caution in patients with compromised respiratory function or dysphagia ( 5.7)
ADVERSE REACTIONS
The most common adverse reactions are (6.1):
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Headache (12%)
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Eyelid Ptosis (2%)
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Upper Respiratory Tract Infection (3%)
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Increase White Blood Cell count (1%)
To report SUSPECTED ADVERSE REACTIONS, contact Evolus at [1-877-386-5871] or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Patients receiving concomitant treatment of JEUVEAU and aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents), or muscle relaxants, should be observed closely because the effect of JEUVEAU may be potentiated (7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2019"
