NABOTA® (JEUVEAU®) 200u

Suggested Initial Dosage: Inject 1.25-2.5 units (at each site in a 0.05-0.1 mL volume) into the medial and lateral orbicularis oculi of the upper lid and the lateral orbicularis oculi of the lower lid.

Typically, the initial impact of the injections is observed within 3 days, peaking at 1-2 weeks after the treatment. The effects of each treatment last roughly 3 months, after which the procedure can be repeated as needed. During subsequent treatments, the dosage may be doubled if the initial treatment's response is deemed insufficient (typically defined as an effect that doesn't exceed 2 months in duration).

NABOTA® (JEUVEAU®) 200u 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®) 200u 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®) 200u is supplied in a single-dose 100 Unit vial.
• Prior to intramuscular injection.
• Complete the reconstitution by adding 6 mL of 0.9 % nonpreserved saline solution into each of the 10 mL syringes and mix gently. This will result in three 10 mL syringes each containing 10 mL (~67 units in each), for a total of 200 units of reconstituted Clostridium Botulinum Toxin Type A.
• 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:

• Individuals with known hypersensitivity to any constituent of botulinum toxin product: Patients with myasthenia gravis or Eaton-Lambert syndrome; presence of infection at the proposed injection site(s). The recommended dosages and frequencies of administration of NABOTA should not be exceeded.
• Botulinum toxin for treatment of urinary incontinence due to neurogenic detrusor overactivity is also contraindicated in patients who have acute urinary tract infection and in patients with acute urinary retention who are not routinely performing clean intermittent self-catheterization (CIC).

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.
• As with any treatment with the potential to allow previously sedentary patients to resume activities, the sedentary patient should be cautioned to resume activity gradually following the administration of botulinum toxin product.
• Patients should also be advised of the potential for experiencing malaise lasting up to 6 weeks after injection.
• After bladder injections for urinary incontinence, patients should be instructed to contact their physician if they experience difficulties in voiding.