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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.
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.
INDICATIONDAXXIFY™ (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.
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.
REFERENCES
- DAXXIFY™. Prescribing Information. Revance Therapeutics, Inc.; 2022.
- 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. doi:10.1097/DSS.0000000000002531.
- Bertucci V, Solish N, Kaufman-Janette J, et al. [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.
- Carruthers JD, Fagien S, Joseph JH, et al. [DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: results from each of two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2)]. Plast Reconstr Surg. 2020;145(1):45-58.
- BOTOX® Cosmetic. Prescribing Information. Allergan, Inc; 2020.
- Xeomin®. Prescribing Information. Merz Pharmaceuticals GmbH; 2020.
- Dysport®. Prescribing Information. Ipsen Biopharmaceuticals, Ltd; 2020.
- Jeuveau®. Prescribing Information. Evolus, Inc; 2020.
- Data on File. Protocols 1620301-303. Post Hoc Analysis. Newark, CA: Revance Therapeutics, Inc, 2021.
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