inability to substantially lessen glabellar lines even by physically spreading them apart). Do not exceed the recommended dosage andfrequency of administration of JEUVEAU.

5.9 Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin Products

Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reducedblinking, and corneal disorders, may occur with use of botulinum toxins, including JEUVEAU. If symptoms of dry eye (e.g., eye irritation,

photophobia, or visual changes) persist, consider referring patient to an ophthalmologist [see Warnings and Precautions 5.1].

5.10 Human Albumin and Transmission of Viral Diseases

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, itcarries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk

for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be consideredextremely remote. No cases of transmission of viral diseases or CJD or vCJD have ever been identified for licensed albumin or albumin

contained in other licensed products.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Spread of Toxin Effects [see Warnings and Precautions (5.1)]

•  Hypersensitivity [see Contraindications (4.1) and Warnings and Precautions (5.4)]

• Dysphagia and Breathing Difficulties [See Warnings and Precautions (5.7)] 

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drugcannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In general, most adverse reactions occur within the first week following injection of JEUVEAU and while generally transient, may have aduration of several months or longer. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may

be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses, including syncope and hypotension,which may require appropriate medical therapy.

Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of nearbymuscles may also occur due to spread of toxin [see Warnings and Precautions (5.1)].

Glabellar Lines The adverse reactions below reflect exposure to JEUVEAU with glabellar lines in placebo-controlled studies [See Clinical Studies (14)].

Table 2. Adverse Reactions Reported at Higher Frequency (≥1%) in the JEUVEAU Group Compared to the Placebo Group

JEUVEAU

EV-001, EV-002

N=492

n (%)

PLACEBO

EV-001, EV-002,

N=162

n (%)

Headache

Eyelid Ptosis

Upper Respiratory Tract Infection

White blood cell count increase

57 (12%)

8 (2%)

13 (3%)

6 (1%)

21 (13%)

0 (0%)

1 (1%)

0 (0%)