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DAXXIFY™ (daxibotulinumtoxinA-lanm) injection is approved for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults.Read More
DaxibotulinumtoxinA for Injection was approved for the treatment of moderate to severe frown lines (glabellar lines) in adults. Revance is also evaluating DaxibotulinumtoxinA for Injection for additional use in aesthetic medicine including the full upper face, forehead lines and crow’s feet and in therapeutic indications, including cervical dystonia and upper limb spasticity.
1 – RHA® DIRECTIONS FOR USE. NEWARK, CA: REVANCE THERAPEUTICS, INC, 2020.
2 – RHA® REDENSITY™ DIRECTIONS FOR USE. NEWARK, CA: REVANCE THERAPEUTICS, INC, 2021.
3 – JUVÉDERM VOLLURE XC INSTRUCTIONS FOR USE, MARCH 2017.
4 – RESTYLANE INSTRUCTIONS FOR USE, APRIL 2016.
5 – RESTYLANE REFYNE INSTRUCTIONS FOR USE, DECEMBER 2016.
6 – RESTYLANE DEFYNE INSTRUCTIONS FOR USE, DECEMBER 2016.
7 – JUVÉDERM VOLUMA INSTRUCTIONS FOR USE, SEPTEMBER 2016.
8 – RESTYLANE LYFT WITH LIDOCAINE INSTRUCTIONS FOR USE, NOVEMBER 2018.
9 – MONHEIT G ET AL. DERMATOL SURG. PUBLISHED ONLINE MARCH 24, 2020. DOI:10.1097/DSS.0000000000002391
10 – KAUFMAN-JANETTE J ET AL. J COSMET DERMATOL. PUBLISHED ONLINE AUGUST 24, 2019. DOI:10.1111/JOCD.13100.
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 glabellar lines.
IMPORTANT SAFETY INFORMATION
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.
The most commonly observed adverse reactions (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).
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.