disease. Use caution when administering to patients with pre-existing cardiovascular disease.

5.6 Increased Risk of Clinically Significant Effects with Pre-Existing Neuromuscular Disorders

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myastheniagravis or Lambert-Eaton syndrome) were excluded from the clinical studies of JEUVEAU. Patients with neuromuscular disorders may be at

increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severedysphagia and respiratory compromise from typical doses of JEUVEAU.

5.7 Dysphagia and Breathing Difficulties

Treatment with botulinum toxin products, including JEUVEAU, can result in swallowing or breathing difficulties. Patients with preexistingswallowing or breathing difficulties may be more susceptible to these complications. In most cases, this has been a consequence of

weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing[see Warnings and Precautions (5.1)].

Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for severalmonths, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a

particular risk when treating patients in whom swallowing or respiratory function is already compromised.

Treatment with botulinum toxins, including JEUVEAU, may weaken neck muscles that serve as accessory muscles of ventilation. This mayresult in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory

muscles. There have been postmarketing reports from other botulinum toxin products of serious breathing difficulties, including respiratoryfailure.

Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscle for the treatment ofcervical dystonia have been reported to be at greater risk for dysphagia. Injections into the levator scapulae for the treatment cervical

dystonia may be associated with an increased risk of upper respiratory infection and dysphagia. JEUVEAU is not approved for the treatmentcervical dystonia.

Patients treated with botulinum toxin products, including JEUVEAU, may require immediate medical attention should they develop problemswith swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin [see

Warnings and Precautions (5.1)].

5.8 Pre-existing Conditions at the Injection Site

Caution should be used when JEUVEAU treatment is used in the presence of inflammation at the proposed injection site(s) or whenexcessive weakness or atrophy is present in the target muscle(s).