Dysport® — Important Safety Information (ISI)

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

What Is Dysport?

Dysport® (abobotulinumtoxinA) 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 less than 65 years of age. Manufactured by Ipsen, Dysport is a distinct formulation with its own dosing, and 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 Dysport 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

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

• Known hypersensitivity to any botulinum toxin product or to any component of the formulation
• Allergy to cow’s milk protein. Dysport may contain trace amounts of cow’s milk protein, so patients with this allergy should not be treated
• 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.
• Serious Hypersensitivity Reactions: Serious reactions, including anaphylaxis, serum sickness, hives, soft tissue swelling, and shortness of breath, have been reported. If a serious reaction occurs, treatment should be stopped and appropriate medical care given immediately.
• Lack of Interchangeability: Dysport units are not interchangeable with other botulinum toxin products. Doses cannot be converted 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, 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:

• Nasopharyngitis (common cold symptoms)
• Headache
• Injection site reactions, including pain, bruising, and swelling
• Upper respiratory tract infection
• Eyelid swelling and eyelid drooping (ptosis)
• Sinus inflammation (sinusitis)
• Nausea

Drug Interactions

Co-administration with aminoglycoside antibiotics or other agents that interfere with neuromuscular transmission (such as curare-like compounds) should be performed only with caution, as these may potentiate the effect of Dysport. The concomitant use of Dysport and other botulinum toxin products is not recommended.

Pregnancy and Lactation

There are no adequate and well-controlled studies of Dysport in pregnant women, and it should be used during pregnancy only if the potential benefit justifies the potential risk. It is not known whether Dysport is present in human milk or what effect it may have on a breastfed infant. 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 Dysport safely. Full prescribing information, including the Boxed Warning, is available in the Dysport package insert and at dysport.com. Discuss any questions with our medical team before your treatment.