Dosage & Administration
Glabellar Lines Administration: 0.1 mL (4 Units) by intramuscular injection into each of five sites, for a total dose of 20 Units (
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.
Diluent Preservative-free 0.9% Sodium Chloride Injection, USPAdded 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.
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:
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).
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Jeuveau Prescribing Information
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.
Glabellar Lines Administration: 0.1 mL (4 Units) by intramuscular injection into each of five sites, for a total dose of 20 Units (
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.
Diluent Preservative-free 0.9% Sodium Chloride Injection, USPAdded 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.
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).
• For injection: 100 Units, vacuum-dried powder in a single-dose vial for reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP.
The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. An embryofetal developmental study conducted with JEUVEAU in pregnant rats revealed no treatment-related effects to the developing fetus when JEUVEAU was administered intramuscularly during organogenesis at doses up to 12 times the maximum recommended human dose (MRHD) (
In an embryofetal developmental study, intramuscular doses up to 4 Unit/kg JEUVEAU were administered to pregnant rats once daily during organogenesis (gestation days 6 to 16). No maternal or embryofetal toxicities were observed at doses up to 4 Unit/kg (12 times the MRHD of 20 Units, based on Unit/kg comparison).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
• Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ()4.1 Known Hypersensitivity to Botulinum ToxinJEUVEAU 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].• Infection at the injection site ()4.2 Infection at the Injection Site(s)JEUVEAU is contraindicated in the presence of infection at the proposed injection site(s).