Indications
(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 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 are:
Glabellar lines (≥1%) were headache (6%), eyelid ptosis (2%) and facial
paresis (1%).
Cervical Dystonia (≥5%): headache (9%), injection site pain (8%),
injection site erythema (6%), 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.
