Xeomin® — Important Safety Information (ISI)

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

What Is Xeomin?

Xeomin® (incobotulinumtoxinA) 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. Unlike Botox and Jeuveau, Xeomin contains only the active neurotoxin component without complexing proteins, sometimes referred to as a “naked” neurotoxin formulation.

Boxed Warning — Spread of Toxin Effects

WARNING: DISTANT SPREAD OF TOXIN EFFECT. The effects of Xeomin and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. Swallowing and breathing difficulties can be life-threatening and there have been reports of death. Immediate medical attention is required if swallowing, speech, or respiratory disorders occur after injection.

Contraindications

• Known hypersensitivity to incobotulinumtoxinA or any component of the formulation
• Infection at the proposed injection site

Warnings and Precautions

• Spread of Toxin Effect: See Boxed Warning. All patients should be monitored after injection.
• Lack of Interchangeability: Xeomin units are not interchangeable with other botulinum toxin products. Do not attempt to convert units between products.
• 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.
• Dysphagia and Breathing Difficulties: Dysphagia is a commonly reported adverse event following injection of botulinum toxins in the treatment of cervical dystonia. This risk is relevant even at doses used for cosmetic indications in susceptible patients.

Most Common Adverse Reactions

The most common adverse reactions in glabellar line treatment include:

• Headache
• Eyelid ptosis
• Nasopharyngitis
• Injection site bruising and swelling
• Dry mouth

Drug Interactions

Co-administration with aminoglycosides or other agents interfering with neuromuscular transmission should only be performed with caution. The concomitant use of Xeomin and other botulinum toxin products is not recommended.

Pregnancy and Lactation

There are no adequate and well-controlled studies of Xeomin in pregnant or nursing women. Based on animal data, Xeomin may cause fetal harm. Use during pregnancy is not recommended. Effects on breastfed infants are unknown. The clinical benefits of treatment should be weighed against potential risk.

Full Prescribing Information

This ISI is a summary. Full prescribing information is available in the Xeomin package insert and at merz.com. Discuss any questions with Dr. Ashar before your treatment.