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]
