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.
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.
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-001720.2
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glabellar lines: pooled data from two multicenter, randomized,
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