Jeuveau® — Important Safety Information (ISI)

Read this information carefully before receiving Jeuveau treatment. Discuss any questions or concerns with your provider.

What Is Jeuveau?

Jeuveau® (prabotulinumtoxinA-xvfs) is an FDA-approved botulinum toxin type A product used to temporarily improve the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) in adults. Manufactured by Evolus, Jeuveau was developed specifically for aesthetic use. Its units of activity are unique to the product and cannot be compared to or converted into the units of any other botulinum toxin.

Boxed Warning — Spread of Toxin Effects

WARNING: DISTANT SPREAD OF TOXIN EFFECT. The effects of Jeuveau and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include muscle weakness, double or blurred vision, drooping eyelids, and difficulty with swallowing, speech, or breathing. Swallowing and breathing difficulties can be life-threatening and there have been reports of death. Symptoms can occur hours to weeks after injection. Immediate medical attention is required if swallowing, speech, or respiratory disorders occur after treatment.

Contraindications

Jeuveau should not be used in patients with any of the following:

• Known hypersensitivity to any botulinum toxin preparation or to any component of the formulation
• Infection at the proposed injection site

Warnings and Precautions

• Spread of Toxin Effect: See the Boxed Warning above. All patients should be monitored after injection for signs of distant spread.
• Lack of Interchangeability: Jeuveau units are not interchangeable with other botulinum toxin products. Doses cannot be converted between products. Jeuveau is not approved for any condition other than glabellar lines.
• Hypersensitivity Reactions: Serious or immediate hypersensitivity reactions have been reported with botulinum toxin products. If such a reaction occurs, treatment should be stopped and appropriate medical care given immediately.
• Pre-existing Neuromuscular Disorders: Use with caution in patients with peripheral motor neuropathic diseases or neuromuscular junction disorders such as myasthenia gravis or Lambert-Eaton syndrome, who may be at increased risk of serious side effects.
• Dysphagia and Breathing Difficulties: Swallowing and breathing difficulties can occur following injection of botulinum toxins and can be life-threatening, including in patients treated for cosmetic indications who have underlying susceptibility.

Most Common Adverse Reactions

The most common adverse reactions reported in glabellar line treatment include:

• Headache
• Eyelid drooping (ptosis)
• Upper respiratory tract infection
• Increased white blood cell count
• Injection site reactions, including pain and bruising
• Eye dryness

Drug Interactions

Co-administration with aminoglycoside antibiotics or other agents that interfere with neuromuscular transmission (such as curare-like compounds or muscle relaxants) should be performed only with caution, as these may potentiate the effect of Jeuveau. The concomitant use of Jeuveau and other botulinum toxin products is not recommended, and cumulative dosing should be considered if other botulinum toxin products have been used.

Pregnancy and Lactation

The available data on Jeuveau use in pregnant women are insufficient to identify a drug-associated risk, and it should be used during pregnancy only if clearly needed. There are no data on the presence of Jeuveau in human milk, its effects on a breastfed infant, or its effects on milk production. The clinical benefits of treatment should be weighed against the potential risks with your provider.

Full Prescribing Information

This ISI is a summary and does not include all of the information needed to use Jeuveau safely. Full prescribing information, including the Boxed Warning, is available in the Jeuveau package insert and at jeuveau.com. Discuss any questions with our medical team before your treatment.