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 clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Spread of Toxin Effect [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Cardiovascular System Adverse Reactions [see Warnings and Precautions (5.5) ] Increased Neuromuscular Compromise in Patients with Pre-Existing Neuromuscular Disorders [see Warnings and Precautions (5.6) ] Dysphagia and Breathing Difficulties [see Warnings and Precautions (5.7) ] Ophthalmic Adverse Reactions in Patients Treated for Glabellar Lines [see Warnings and Precautions (5.9) ] The most commonly observed adverse reactions are: Glabellar Lines (≥1%): headache (6%), eyelid ptosis (2%), and facial paresis (1%).
( 6.1 ) Cervical Dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Revance Therapeutics, Inc.
at 1-877-373-8669 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, 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 practice.
The most common side effects from treatment with DAXXIFY usually occur within one to two weeks after injection and, while generally transient, may have a duration of several weeks or months.
Glabellar Lines In the two randomized, placebo-controlled, Phase 3 clinical trials that assess the use of DAXXIFY for the temporary improvement in the appearance of moderate to severe glabellar lines, GL-1 and GL-2, 406 subjects received a single-dose treatment of 40 Units DAXXIFY, and 203 subjects received placebo.
The most frequent adverse reactions are presented in Table
TABLE 3: Most Common Adverse Reactions ≥1% and More Frequent than Placebo in Pooled Double- Blind, Placebo-Controlled Trials for Glabellar Lines Adverse Reaction DAXXIFY N=406 n (%) Placebo N=203 n (%) Headache 26 (6%) 4 (2%) Eyelid ptosis 9 (2%) 0 (0%) Facial paresis Facial paresis, including facial asymmetry.
5 (1%) 0 (0%) Injection site reactions were reported in 6% of subjects treated with DAXXIFY and in 6% of subjects treated with placebo (these reactions included injection site pain, injection site erythema, injection site oedema, injection site bruising, injection site hematoma, injection site papule, and injection site pruritus).
5 WARNINGS AND PRECAUTIONS The potency units of DAXXIFY are not interchangeable with other preparations of other 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.
( 5.1 ) Adverse event reports have been received involving the cardiovascular system with botulinum toxin products, some with fatal outcomes.
Use caution when administering to patients with pre-existing cardiovascular disease.
Like all medications, Daxxify 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: