Jeuveau

Jeuveau is an FDA-registered drug product whose active ingredient is PRABOTULINUM TOXIN TYPE A. It is labelled by Evolus, Inc. taken by intramuscular and marketed as a human prescription drug product. Identifiers on file: NDC 72301-595, application BLA761085, label effective 20230428. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PRABOTULINUM TOXIN TYPE A are most often described in connection with: temporary improvement, appearance moderate, severe glabellar, lines associated, procerus muscle, activity adult, usage jeuveau, acetylcholine release. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 ) 2.1 Instructions 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 ) ]. 2.2 Preparation 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. 2.3 Administration 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 of the properly reconstituted JEUVEAU into a sterile syringe and expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle. Inject a dose of 0.1 mL (4 Units) intramuscularly into each of five sites: the inferomedial and superior middle of each corrugator, and one in the mid-line of the procerus muscle for a total dose of 20 Units (See Figure 1 ). Figure 1 Figure 1-2

4 CONTRAINDICATIONS • Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ( 4.1 ) • Infection at the injection site ( 4.2 ) 4.1 Known Hypersensitivity to Botulinum Toxin JEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [ See Warnings and Precautions ( 5.4 ) ]. 4.2 Infection at the Injection Site(s) JEUVEAU is contraindicated in the presence of infection at the proposed injection site(s).

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Spread of Toxin Effects [ see Warnings and Precautions ( 5.1 ) ] • Hypersensitivity [ see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.4 ) ] • Dysphagia and Breathing Difficulties [ See Warnings and Precautions ( 5.7 ) ] The most common adverse reactions are headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and increased white blood cell count (1%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Evolus at [1-877-386-5871] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In general, most adverse reactions occur within the first week following injection of JEUVEAU and while generally transient, may have a duration of several months or longer. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses, including syncope and hypotension, which may require appropriate medical therapy. Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of nearby muscles may also occur due to spread of toxin effect [ see Warnings and Precautions ( 5.1 ) ]. Glabellar Lines The adverse reactions below reflect exposure to JEUVEAU in the treatment of glabellar lines in placebo-controlled trials [ See Clinical Studies ( 14 ) ]. Table 2. Adverse Reactions Reported at Higher Frequency (≥1%) in the JEUVEAU Group Compared to the Placebo Group JEUVEAU EV-001, EV-002 N=492 n (%) PLACEBO EV-001, EV-002, N=162 n (%) Headache 57 (12%) 21 (13%) Eyelid Ptosis 8 (2%) 0 (0%) Upper Respiratory Tract Infection 13 (3%) 1 (1%) White blood cell count increase 6 (1%) 0 (0%) Two multi-center, open label, 1-year repeat dose safety trials, EV-004 [NCT02184988] and EV-006 [NCT02428608], were also conducted with JEUVEAU. Both trials evaluated repeat treatments of 20 units of JEUVEAU, up to a maximum total of 80 units, for the treatment of moderate to severe glabellar lines in adult subjects. Of the 922 subjects enrolled, the median number of treatments was three. The adverse events profile was similar to that reported in single dose trials. 6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to prabotulinumtoxinA-xvfs in the studies described below, with the incidence of antibodies in other studies, or to other products may be misleading. Treatment with botulinum toxins may result in the formation of antibodies that may reduce the effectiveness of subsequent treatments by inactivating biological activity of the toxin. Among 1,414 subjects treated with prabotulinumtoxinA-xvfs, 2 subjects were found to have pre-existing antibodies and 2 subjects had treatment-emergent antibodies.

What is Jeuveau used for?
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 …

Who makes Jeuveau?
Evolus, Inc. is the labeler of record for Jeuveau.

What form does Jeuveau come in?
administered by intramuscular. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Jeuveau prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Jeuveau been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.