sponder Rates (% of Subjects Achieving ≥ 2-Grade Improvement from Baseline)
Trial JEUVEAU Placebo
Trial EV-001 N=246 N=84
67% 1%
Trial EV-002 N=246 N=78
71% 1%
16 HOW SUPPLIED/STORAGE AND HANDLING
JEUVEAU (prabotulinumtoxinA-xvfs) for injection is a vacuum-dried powder supplied in a single-dose vial in the following size:
100 Units (NDC 72301-595-10)
Storage
Unopened vials of JEUVEAU should be stored in a refrigerator between 2° to 8°C (36° to 46° F) in the original carton to protect from light.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking orbreathing), or if any known symptom persists or worsens [see Warnings and Precautions (5.1, 5.4)].
Inform patients that JEUVEAU injection may cause eye dryness. Advise patients to report symptoms of eye dryness (e.g., eye pain, eye
irritation, photosensitivity, or changes in vision) to their doctor [see Warnings and Precautions (5.9)].
Inform patients that if loss of strength, muscle weakness, blurred vision or drooping eyelids occur, they should avoid driving a car or
engaging in other potentially hazardous activities.
Manufactured by: Evolus Inc.
1027 Garden St., Santa Barbara, CA 93101
U.S. License Number 2070
at: Daewoong Pharmaceutical Co., Ltd.
12, Bongeunsa-ro 114-gil 12, Gangnam-gu,
Seoul, 135-715 Korea
©2019 Evolus. All rights reserved.
All Trademarks are the property of their respective owners.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761085s000lbl.pdf
