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Nuceiva®

(Botulinum Toxin Type A)

NUCEIVA is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.1

NUCEIVA should only be administered by healthcare practitioners with appropriate qualifications and expertise in the treatment of glabellar lines and the use of required equipment.

Learn More

Licensed in 35 Countries2-6

Neuromodulator
‍Treatment

Acts in 2 days1

At day 2, the percentages of responders in each of the Nuceiva®, Botox® and placebo groups were 54.2%, 57.0%, and 12.2%, respectively. The test of superiority of Nuceiva® vs placebo was highly statistically significant: the absolute difference in the percentages of responders was 41.9% (P < 0.001).

Lasts up to 4 months1

Nuceiva® injections significantly reduced the severity of glabellar lines by 1 point or greater at maximum frown for up to 139 days, as measured by the investigator assessment of glabellar line severity at maximum frown.

High patient satisfaction 94.5%7

Percentage of patients with a positive response (improved/much improved) on the Global Aesthetic Improvement Scale (GAIS) by patient assessment (PA) by visit (Per Protocol population) ET, early termination. The percentages of responders in each of the Nuceiva®, Botox® and placebo groups were 94.5%, 93.4%, and 8.3%, respectively. Most randomised patients (527/540, 97.6%) qualified for inclusion in the PP population. The test of superiority of Nuceiva® vs placebo was highly statistically significant: the absolute difference in the percentages of responders was 85.0% (P < 0.001).

Injecting Nuceiva

Please first refer to the Nuceiva Summary of Product Characteristics for administration contraindications, precautions, warnings and instructions. NUCEIVA should only be administered by healthcare practitioners with appropriate qualifications and expertise in the treatment of glabellar lines and the use of required equipment.

See The Results

Day 0 & Day 30
Day 2
Day 30
Day 120
Day 0 & Day 30
Day 2
Day 30
Day 120
Soo Youn
Soo Youn
Soo Youn
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Soo Youn
Soo Youn
Soo Youn
Soo Youn
Soo Youn
Soo Youn
David
David
David
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David
David
David
David
David
David
Arielle
Arielle
Arielle
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Arielle
Arielle
Arielle
Arielle
Arielle
Arielle
Sarah
Sarah
Sarah
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Sarah
Sarah
Sarah
Sarah
Sarah
Sarah
Tajah
Tajah
Tajah
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Tajah
Tajah
Tajah
Tajah
Tajah
Tajah
Lisa
Lisa
Lisa
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Lisa
Lisa
Lisa
Lisa
Lisa
Lisa
Tia
Tia
Tia
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Tia
Tia
Tia
Tia
Tia
Tia
Shai
Shai
Shai
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Shai
Shai
Shai
Shai
Shai
Shai
Tugba
Tugba
Tugba
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Tugba
Tugba
Tugba
Tugba
Tugba
Tugba
Josephine
Josephine
Josephine
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Josephine
Josephine
Josephine
Josephine
Josephine
Josephine
Soo Youn
Soo Youn
David
David
Arielle
Arielle
Sarah
Sarah
Tajah
Tajah
Lisa
Lisa
Tia
Tia
Shai
Shai
Tugba
Tugba
Josephine
Josephine
At maximum frown. Actual patient. For illustration only. Individual results may vary.

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

Soo Youn
Soo Youn
David
David
Arielle
Arielle
Sarah
Sarah
Tajah
Tajah
Lisa
Lisa
Tia
Tia
Shai
Shai
Tugba
Tugba
Josephine
Josephine
At maximum frown. Actual patient. For illustration only. Individual results may vary.

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 54% of Nuceiva patients had a >1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

In a study, just over 94% of Nuceiva patients expressed a positive response (improved or much improved) at 30 days after treatment.3

In a study, 58% of Nuceiva patients had a >1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (secondary endpoint). Results based on a 1-grade improvement may not be considered clinically meaningful.2

References

1.
Nuceiva SmPC
2.
FDA. Jeuveau Drugs@FDA: FDA Approved Drug Products. Last Reviewed 2022.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process  (Accessed: 11/2023)
3.
European Commission. Granting Marketing Authorisation of Nuceiva in the European Union. 27 September 2019
4.
HRES Gov Canada. Product Monograph Nuceiva. Last reviewed 2018.
https://pdf.hres.ca/dpd_pm/00046932.PDF (Accessed: 11/2023)
5.
Australian Government Therapeutic Goods Administration. Nuceiva Approval Letter. 13 January 2023
6.
Swiss Approval Letter
7.
Rzany, Berthold-Josef, et al. 2021 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthetic Surgery Journal. 2019 doi.org/10.1093/asj/sjz110
8.
Beer KR, et al. Dermatol Surg. 2019;45(11):1381-1393

Adverse events should be reported

Reporting forms and information can be found at yellowcard.mhra.gov.uk/ or search MHRA yellow card in the Google Play or Apple App Store.

Adverse events should also be reported to Evolus International Ltd.

Please contact Evolus Europe Medical Information by medicalinformation@evolus.com or calling 08000541302.

Evolus clinical trial details can be found here. For any additional information, please email medicalinformation@evolus.com

Evolus is unable to provide advice on personal medical matters. Please consult your healthcare professional for specific, health-related advice and support.Links to the electronic medicines compendium (emc) website to access the Patient Information Leaflets (PIL) and Summary of Product Characteristics (SmPC) for our medicine in the United Kingdom is also available here.

NUCEIVA PRESCRIBING INFORMATION

Legal category: POM. List price: 50 unit vial - £75.50

REPORTING OF SIDE EFFECTS FOR THE UNITED KINGDOM

Adverse events should be reported.Reporting forms and information can be found at yellowcard.mhra.gov.uk/ or search MHRA yellow card in the Google Play or Apple App Store.

Adverse events should also be reported to Evolus International Ltd.

Please contact Evolus Europe Medical Information by medicalinformation@evolus.com or calling 08000541302.

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