Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 ) ] The most common adverse reactions are headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and increased white blood cell count (1%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Evolus at [1-877-386-5871] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 drug cannot 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 a duration 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 nearby muscles may also occur due to spread of toxin effect [ see Warnings and Precautions ( 5.1 ) ].
Glabellar Lines The adverse reactions below reflect exposure to JEUVEAU in the treatment of glabellar lines in placebo-controlled trials [ See Clinical Studies ( 14 ) ].
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 57 (12%) 21 (13%) Eyelid Ptosis 8 (2%) 0 (0%) Upper Respiratory Tract Infection 13 (3%) 1 (1%) White blood cell count increase 6 (1%) 0 (0%) Two multi-center, open label, 1-year repeat dose safety trials, EV-004 [NCT02184988] and EV-006 [NCT02428608], were also conducted with JEUVEAU.
Both trials evaluated repeat treatments of 20 units of JEUVEAU, up to a maximum total of 80 units, for the treatment of moderate to severe glabellar lines in adult subjects.
5 WARNINGS AND PRECAUTIONS • Potency Units of JEUVEAU are not interchangeable with other preparations of botulinum toxin products ( 5.2 , 11 ) • Spread of toxin effects;
swallowing and breathing difficulties can lead to death.
Seek immediate medical attention if respiratory, speech, or swallowing difficulties occur ( 5.2 , 5.7 ) • Potential serious adverse reactions after JEUVEAU injections for unapproved uses ( 5.3 ) • Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes.
Use caution when administering to patients with pre-existing cardiovascular disease ( 5.5 ) • Concomitant neuromuscular disorder may exacerbate clinical effects of treatment ( 5.6 ) • Use with caution in patients with compromised respiratory function or dysphagia ( 5.7 ) 5.1 Spread of Toxin Effect Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site 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, and breathing difficulties.
Like all medications, Jeuveau can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: