JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the

formulation [See Warnings and Precautions (5.4)].

4.2 Infection at the Injection Site(s)

JEUVEAU is contraindicated in the presence of infection at the proposed injection site(s).

5 WARNINGS AND PRECAUTIONS

5.1 Spread of Toxin Effect

Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond thesite of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia,

generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision andbreathing difficulties. 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 related to spread of toxin effects. In unapproved uses, including upperlimb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses

comparable to or lower than the maximum recommended total dose [see Use in Specific Populations (8.4)]. JEUVEAU is notapproved for the treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to

seek immediate medical care if swallowing, speech or respiratory difficulties occur.

5.2 Lack of Interchangeability between Botulinum Toxin Products

The potency units of JEUVEAU are specific to the preparation and assay method utilized. They are not interchangeable with otherpreparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into

units of any other botulinum toxin products assessed with any other specific assay method [see Description (11)]. 

5.3 Serious Adverse Reactions with Unapproved Use

Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated

with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, theadverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxinproducts to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant

disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with theunapproved uses of botulinum toxin products.

5.4 Hypersensitivity Reactions

Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products. These reactions include anaphylaxis,serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further injection of JEUVEAU should be discontinuedand appropriate medical therapy immediately instituted. The use of JEUVEAU in patients with a known hypersensitivity to any botulinum

neurotoxin or to any of the components in the formulation could lead to a life threatening allergic reaction [See Known Hypersensitivity to

Botulinum Toxin (4.1)].

5.5 Cardiovascular System