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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.
*At least 50% of patients in SAKURA 1 and SAKURA 2 had none or mild frown lines for 24 weeks (6 months) and 23.9 weeks (6 months) or longer, respectively, per both investigator's and patient's assessments. 5% of patients in SAKURA 1 and 3% of patients in SAKURA 2 had none or mild frown lines at 9 months per investigator’s assessment. In SAKURA 1, SAKURA 2, and SAKURA 3 OLS Treatments 1 and 2, 7.5%, 5.4%, 17.4%, and 11.6% of patients, respectively, had not returned to baseline severity at 9 months per both investigator’s and patient’s assessments. Conventional neuromodulator treatments last 3-4 months.2,4,9 †Based on in vitro data.12 ‡Per pooled data from SAKURA 1 and SAKURA 2.1,3 §Based on patient diary data from SAKURA 1 and SAKURA 2. || Preservative-free. ¶Per pooled data from SAKURA 1 and SAKURA 2.74% achieved a ≥2-grade improvement at week 4 per both investigator’s and patient’s assessments.1,3
REFERENCES
1. DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2022. 2. 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. 2021;47(1):48-54. 3. 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. 4. 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. 5. BOTOX® Cosmetic. Prescribing Information. Allergan Inc; 2021. 6. XEOMIN®. Prescribing Information. Merz Pharmaceuticals GmbH; 2021. 7. DYSPORT®. Prescribing Information. Ipsen Biopharm Ltd; 2020. 8. JEUVEAU®. Prescribing Information. Evolus, Inc; 2019. 9. Data on File. Protocols 1620301-303. Post Hoc Analysis. Newark, CA: Revance Therapeutics, Inc, 2021. 10. Data on File. The Harris Poll Facial Injectables Landmark Survey Results. Newark, CA: Revance Therapeutics, Inc, 2018. 11. Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical experiences with CPP-based self-assembling peptide systems in topical drug development. Methods Mol Biol. 2011;683:553-572. 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. 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. 14. Data on File. D220801001. Newark, CA: Revance Therapeutics, Inc, 2022. 15. Data on File. Sak_1_and_Sak_2_facial paresis-asymmetry. Newark, CA: Revance Therapeutics, Inc, 2019. 16. Data on File. D220801002. Newark, CA: Revance Therapeutics, Inc, 2021.
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.
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.
*At least 50% of patients in SAKURA 1 and SAKURA 2 had none or mild frown lines for 24 weeks (6 months) and 23.9 weeks (6 months) or longer, respectively, per both investigator's and patient's assessments. 5% of patients in SAKURA 1 and 3% of patients in SAKURA 2 had none or mild frown lines at 9 months per investigator’s assessment. In SAKURA 1, SAKURA 2, and SAKURA 3 OLS Treatments 1 and 2, 7.5%, 5.4%, 17.4%, and 11.6% of patients, respectively, had not returned to baseline severity at 9 months per both investigator’s and patient’s assessments. Conventional neuromodulator treatments last 3-4 months.2,4,9 †Based on in vitro data.12 ‡Per pooled data from SAKURA 1 and SAKURA 2.1,3 §Based on patient diary data from SAKURA 1 and SAKURA 2. || Preservative-free. ¶Per pooled data from SAKURA 1 and SAKURA 2.74% achieved a ≥2-grade improvement at week 4 per both investigator’s and patient’s assessments.1,3
REFERENCES
1. DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2022. 2. 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. 2021;47(1):48-54. 3. 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. 4. 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. 5. BOTOX® Cosmetic. Prescribing Information. Allergan Inc; 2021. 6. XEOMIN®. Prescribing Information. Merz Pharmaceuticals GmbH; 2021. 7. DYSPORT®. Prescribing Information. Ipsen Biopharm Ltd; 2020. 8. JEUVEAU®. Prescribing Information. Evolus, Inc; 2019. 9. Data on File. Protocols 1620301-303. Post Hoc Analysis. Newark, CA: Revance Therapeutics, Inc, 2021. 10. Data on File. The Harris Poll Facial Injectables Landmark Survey Results. Newark, CA: Revance Therapeutics, Inc, 2018. 11. Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical experiences with CPP-based self-assembling peptide systems in topical drug development. Methods Mol Biol. 2011;683:553-572. 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. 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. 14. Data on File. D220801001. Newark, CA: Revance Therapeutics, Inc, 2022. 15. Data on File. Sak_1_and_Sak_2_facial paresis-asymmetry. Newark, CA: Revance Therapeutics, Inc, 2019. 16. Data on File. D220801002. Newark, CA: Revance Therapeutics, Inc, 2021.
DAXXIFY® Reconstitution Instructions 
