INDICATION
DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an acetylcholine release
inhibitor and neuromuscular blocking agent indicated for the temporary
improvement in the appearance of moderate to severe glabellar lines associated
with corrugator and/or procerus muscle activity in adult patients and for the
treatment of cervical dystonia in adults.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY® and all botulinum toxin products may spread from the area
of injection to produce symptoms consistent with botulinum toxin effects. 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. DAXXIFY®
is not approved for the treatment of spasticity or any conditions other than cervical
dystonia and glabellar lines.
IMPORTANT SAFETY INFORMATION
Contraindications
DAXXIFY® contraindications include hypersensitivity to any botulinum toxin
preparation or any of the components in the formulation and infection at the
injection site(s).
Warnings and Precautions
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
The potency units of DAXXIFY® are not interchangeable with preparations of
other botulinum toxin products. Recommended dose and frequency of
administration should not be exceeded. Patients should seek immediate medical
attention if respiratory, speech or swallowing difficulties occur. Use caution
when administering to patients with pre-existing cardiovascular disease.
Concomitant neuromuscular disorders may exacerbate clinical effects of
treatment.
Adverse Reactions
The most commonly observed adverse reactions are:
Glabellar lines (≥1%): headache (6%), eyelid ptosis (2%) and facial paresis (1%).
Cervical dystonia (≥5%): headache (9%), injection site pain (8%), injection site
erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%).
Drug Interactions
Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic
agents or any other agents interfering with neuromuscular transmission or
muscle relaxants should only be performed with caution as the effect of
DAXXIFY® may be potentiated. The effect of administering different botulinum
neurotoxins during course of treatment with DAXXIFY® is unknown.
Use in Specific Populations
DAXXIFY® is not recommended for use in children or pregnant women.
Please see DAXXIFY® full Prescribing Information, including Boxed Warning and Medication Guide.
To report side effects associated with DAXXIFY®, please visit
safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch
DAXI-004726
