Jeuveau Prabotulinum Toxin Type A 100 [USP'U]/1 Powder, 1 vial — NDC 72301-595-10 (Billing 72301-0595-10)

1 INDICATIONS AND USAGE JEUVEAU is 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. JEUVEAU is an acetylcholine release inhibitor and a 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 ( 1 )

2 DOSAGE AND ADMINISTRATION Glabellar Lines Administration: 0.1 mL (4 Units) by intramuscular injection into each of five sites, for a total dose of 20 Units ( 2.2 , 2.3 )

2.1Instructions for Safe Use The potency Units of JEUVEAU (prabotulinumtoxinA-xvfs) for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method [ see Warnings and Precautions ( 5.2 ) and Description ( 11 ) ]. Retreatment of JEUVEAU should be administered no more frequently than every three months.

Consideration of the cumulative dose is necessary when treating adult patients with JEUVEAU for glabellar lines if other botulinum toxin products are or have been used to treat other indications approved for those products. The safe and effective use of JEUVEAU depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. Physicians administering JEUVEAU must understand the relevant neuromuscular and/or orbital anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures [ see Warnings and Precautions ( 5.4 ) ].

2.2Preparation and Dilution Technique JEUVEAU is supplied in a single-dose 100 Unit vial. Prior to intramuscular injection, reconstitute each vacuum-dried vial of JEUVEAU with only sterile, preservative-free 0.9% Sodium Chloride Injection, USP to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL and a total treatment dose of 20 Units in 0.5 mL (see Table 1 ). Slowly inject the diluent into the vial.

Discard the vial if a vacuum does not pull the diluent into the vial. Dispose of any unused saline. Gently mix JEUVEAU with 0.9% Sodium Chloride Injection USP by rotating the vial.

JEUVEAU should be administered within 24 hours after reconstitution. During this time period, unused reconstituted JEUVEAU should be stored in a refrigerator between 2° to 8°C (36°F to 46°F) in the original carton to protect from light for up to 24 hours until time of use. Do not freeze reconstituted JEUVEAU.

JEUVEAU vials are for single-dose only. After reconstitution, JEUVEAU should be used for only one injection session and for only one patient. Discard any remaining solution after administration.

Table 1. Dilution Instructions for JEUVEAU Vials (100 Units) Diluent Preservative-free 0.9% Sodium Chloride Injection, USP Added to 100 Unit Vial Resulting Dose Units per 0.1 mL 2.5 mL 4 Units Reconstituted JEUVEAU should be clear, colorless, and free of particulate matter otherwise it should not be injected. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

2.3Administration Glabellar facial lines arise from the activity of the corrugator and orbicularis oculi muscles. These muscles move the brow medially and the procerus and depressor supercilii pull the brow inferiorly. This creates a frown or “furrowed brow”.

The location, size, and use of the muscles vary markedly among individuals. Lines induced by facial expression occur perpendicular to the direction of action of contracting facial muscles. An effective dose for facial lines is determined by gross observation of the patient’s ability to activate the superficial muscles injected.

In order to reduce the complication of eyelid ptosis the following steps should be taken: • Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. • Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge. • Ensure the injected volume/dose is accurate and where feasible kept to a minimum. • Avoid injecting JEUVEAU closer than 1 centimeter above the central eyebrow. Draw at least 0.5 mL… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS • For injection: 100 Units, vacuum-dried powder in a single-dose vial for reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP. For Injection: 100 Units vacuum-dried powder in a single-dose vial ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Advise patients to inform their doctor if they develop any unusual symptoms (including difficulty with swallowing, speaking, or breathing), 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.

520 Newport Center Drive, Suite 1200, Newport Beach, CA 92660 U.S. License Number 2070 at: Daewoong Pharmaceutical Co., Ltd. 12, Bongeunsa-ro 114-gil, Gangnam-gu, Seoul, 06170 Korea ©2023 Evolus.

All rights reserved. All Trademarks are the property of their respective owners. DWG-131 Rev.

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MEDICATION GUIDE JEUVEAU (pronounced Jū vō) (prabotulinumtoxinA-xvfs) for Injection What is the most important information I should know about JEUVEAU? JEUVEAU may cause serious side effects that can be life threatening. Call your healthcare provider or get medical help right away if you have any of these problems after treatment with JEUVEAU: • Problems swallowing, speaking, or breathing.

These problems can happen hours, days, or weeks after an injection of JEUVEAU if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with JEUVEAU. o People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with JEUVEAU. o Swallowing problems may last for several months.

People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving JEUVEAU have the highest risk of getting these problems. • Spread of toxin effects.

In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: o loss of strength and muscle weakness all over the body o blurred vision and drooping eyelids o trouble saying words clearly o trouble breathing o double vision o hoarseness or change or loss of voice o loss of bladder control o trouble swallowing These symptoms can happen hours, days, or weeks after you receive an injection of JEUVEAU.

These problems could make it unsafe for you to drive a car or do other dangerous activities. See “What should I avoid while receiving JEUVEAU?” What is JEUVEAU? JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).

It is not known if JEUVEAU is safe and effective for use in children. Do not receive JEUVEAU if you: • are allergic to JEUVEAU or any of the ingredients in JEUVEAU. See the end of the Medication Guide for a list of ingredients in JEUVEAU. • had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC ® ), onabotulinumtoxinA (BOTOX ® , BOTOX ® COSMETIC), abobotulinumtoxinA (DYSPORT ® ), or incobotulinumtoxinA (XEOMIN ® ). • have a skin infection at the planned injection site.

Before receiving JEUVEAU, tell your healthcare provider about all your medical conditions, including if you: • have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], Myasthenia gravis or Lambert-Easton syndrome). See “What is the most important information I should know about JEUVEAU?” • had any side effect from any botulinum toxin product in the past. • have or have had a breathing problem, such as asthma or emphysema. • have or have had swallowing problems. • have or have had bleeding problems. • have or have had heart problems. • have plans to have surgery. • have weakness of your forehead muscles, such as trouble raising your eyebrows. • have drooping eyelids. • have had surgery on your face. • have had dry eye with use of botulinum toxin products in the past. • are pregnant or plan to become pregnant.

It is not known if JEUVEAU can harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if JEUVEAU passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with JEUVEAU.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using JEUVEAU with certain other medicines may cause ser… [Excerpted — this section continues on DailyMed.]