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.
INDICATION
DAXXIFY® (daxibotulinumtoxinA-Ianm) 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.
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 other 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 (≥1%) were headache (6%), eyelid ptosis (2%) and
facial paresis (1%).
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.
DAXI-00389.4
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