Rx Item-JEUVEAU prabotulinum toxin type a powder Inj 100U SDV by Evolus Pharma

Glabellar Lines
Jeuveau (prabotulinumtoxinA) is a proprietary 900 kDa purified botulinum toxin type A formulation for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines. JEUVEAU (prabotulinumtoxinA-xvfs) for injection is a vacuum-dried powder supplied in a single-dose vial in the following size:

100 Units (NDC 72301-595-10)

Storage

Unopened vials of JEUVEAU should be stored in a refrigerator between 2� to 8�C (36� to 46� F) in the original carton to protect from light. 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. (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 headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), increase white blood cell count (1%) (6.1).

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

Closely observe patients receiving concomitant treatment of JEUVEAU and aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents), or muscle relaxants, because JEUVEAU�s effect may be potentiated. (7)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 7/2019

Rx Item-JEUVEAU prabotulinum toxin type
RX72301-595-10

Rx Item-JEUVEAU prabotulinum toxin type
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