NABOTA® (JEUVEAU®) 100u

Glabellar Lines Administration: 0.1 mL (4 Units) by intramuscular injection into each of five sites, for a total dose of 20 Units.

NABOTA® (JEUVEAU®) 100u 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.

NABOTA® (JEUVEAU®) 100u 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.

• NABOTA® (JEUVEAU®) 100u 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.
• 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 NABOTA® (JEUVEAU®).
• NABOTA® (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.
• The potency units of JEUVEAU 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.
• In order to reduce the complication of eyelid ptosis, the following steps should be taken:
  1. Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
  2. Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
  3. Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
  4. Avoid injecting toxin closer than 1 centimeter above the central eyebrow.

Contraindications

• Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
• Infection at the injection site.

After-care

• Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking or breathing), or if any known symptom persists or worsens.
• 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.
• 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.
• Patients are advised to not perform any strenuous physical activities.
• Patients are also recommended to avoid exposure to extreme cold and hot temperatures.