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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.

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

  1. 1. Data on File. D220801001. Newark, CA: Revance Therapeutics, Inc, 2022.
  2. 2. 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.
  3. 3. Data on File. D231201010. Newark, CA: Revance Therapeutics, Inc, 2023.
  4. 4. BOTOX® Cosmetic. Prescribing Information. Allergan Inc; 2023.
  5. 5. XEOMIN®. Prescribing Information. Merz Pharmaceuticals GmbH; 2021.
  6. 6. DYSPORT®. Prescribing Information. Ipsen Biopharmaceuticals, Inc.; 2023.
  7. 7. JEUVEAU®. Prescribing Information. Evolus, Inc; 2020.
  8. 8. DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2022.
  9. 9. Data on File. The Harris Poll Facial Injectables Landmark Survey Results. Newark, CA: Revance Therapeutics, Inc, 2018.
  10. 10. 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.
  11. 11. Pulkoski-Gross MJ, Fang C, Shai R, Too P. A cell-penetrating peptide binds directly to and enhances membrane binding of the core toxin of botulinum toxin type A (BoNTA). Poster presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA.
  12. 12. Solish N, Carruthers J, Kaufman J, Rubio R, Gross T, Gallagher C. Overview of DaxibotulinumtoxinA for Injection: a novel formulation of botulinum toxin type A. Drugs. 2021;81:2091-2101.
  13. 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.
  14. 14. Green JB, Mariwalla K, Coleman K, et al. A large, open-label, phase 3 safety study of daxibotulinumtoxinA for injection in glabellar lines: a focus on safety from the SAKURA 3 study. Dermatol Surg. 2021;47(1):42-46. doi:10.1097/DSS.0000000000002463.
  15. 15. Brown J, Stephenson J, Kooken K, Sparrow J. Impact of DaxibotulinumtoxinA for Injection on skin smoothness following treatment of glabellar lines. Poster presented at: Derm2023 NP/PA CME Conference; August 3-6, 2023; Las Vegas, NV.
  16. 16. Data on File. Gross. American Academy of Dermatology. Newark, CA: Revance Therapeutics, Inc, 2021.
  17. 17. Data on File. Sak_1_and_Sak_2_facial paresis-asymmetry. Newark, CA: Revance Therapeutics, Inc, 2018.
  18. 18. Data on File. D220801002. Newark, CA: Revance Therapeutics, Inc, 2021.

©2024 REVANCE AESTHETICS. DAXXIFY, Revance Therapeutics, and the Revance logo are registered trademarks of Revance Therapeutics, Inc. All other trademarks are the property of their respective owners.
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