WARNING: DISTANT SPREAD OF TOXIN EFFECT 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.
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
REFERENCES
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DaxibotulinumtoxinA for Injection has a prolonged duration of
response in the treatment of glabellar lines: pooled data from two
multicenter, randomized, double-blind, placebo-controlled, phase 3
studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol.
2020;82(4):838-845. doi:10.1016/j.jaad.2019.06.1313.
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Therapeutics, Inc; 2022.
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Results. Newark, CA: Revance Therapeutics, Inc, 2018.
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C. Overview of DaxibotulinumtoxinA for Injection: a novel
formulation of botulinum toxin type A. Drugs.
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- 13. Fabi SG, Cohen JL, Green LJ, et al. DaxibotulinumtoxinA for
Injection for the treatment of glabellar lines: efficacy results
from SAKURA 3, a large, open-label, phase 3 safety study. Dermatol Surg. 2020;47(1):48-54. doi:10.1097/DSS.0000000000002531t.
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phase 3 safety study of daxibotulinumtoxinA for injection in
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- 15. Brown J, Stephenson J, Kooken K, Sparrow J. Impact of
DaxibotulinumtoxinA for Injection on skin smoothness following
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CME Conference; August 3-6, 2023; Las Vegas, NV.
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CA: Revance Therapeutics, Inc, 2021.
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CA: Revance Therapeutics, Inc, 2018.
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