Applies to prabotulinumtoxinA: intramuscular powder for injection.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in Jeuveau can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these side effects (up to several hours or several weeks after an injection):

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

• trouble breathing, talking, or swallowing;

• loss of bladder control;

• hoarse voice, drooping eyelids;

• vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light); or

• chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats.

Common side effects may include:

• headache;

• drooping eyelids;

• increased white blood cell counts; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to prabotulinumtoxinA: intramuscular powder for injection.

General

The most common adverse reaction reported have included headache, eyelid ptosis, upper respiratory tract infection, and increases in white blood cell count.^[Ref]

Nervous system

Very common (10% or more): Headache (12%)

Hematologic

Common (1% to 10%): Increased white blood cell count

Immunologic

Comparison of the incidence of antibodies to this botulinum may be misleading as the detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. The observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Treatment with botulinum toxins may result in the formation of antibodies that may reduce the effectiveness of subsequent treatments by inactivating biological activity of the toxin. Of the 1414 subjects treated with this drug, 2 subjects were found to have preexisting antibodies and 2 subjects had treatment-emergent antibodies.

Very rare (less than 0.01%): Treatment emergent botulinum antibodies

Ocular

Common (1% to 10%): Eyelid ptosis

Respiratory

Common (1% to 10%): Upper respiratory infection