BOTOX Cosmetic (onabotulinum toxin A) For Injection 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 ≤ 65 years of age.

Instructions for Use

The potency Units of BOTOX Cosmetic (onabotulinum toxin A) 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 BOTOX Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method [see DESCRIPTION].

Using a 30-33 gauge needle, inject a dose of 0.1 mL (4 Units) intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units (see Figure 1). Typically the initial doses of reconstituted BOTOX Cosmetic induce chemical denervation of the injected muscles one to two days after injection, increasing in intensity during the first week.

The duration of effect of BOTOX Cosmetic for glabellar lines is approximately 3-4 months. The safety and effectiveness of more frequent dosing with BOTOX Cosmetic has not been clinically evaluated and is not recommended.

Figure 1

In treating adult patients for one or more indications with BOTOX and BOTOX Cosmetic, the maximum cumulative dose should generally not exceed 360 Units, in a 3 month interval.

The safe and effective use of BOTOX Cosmetic depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. Physicians administering BOTOX Cosmetic 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].

Preparation and Dilution Technique

BOTOX Cosmetic is supplied in single-use 50 Units and 100 Units per vial. Prior to intramuscular injection, reconstitute each vacuum-dried vial of BOTOX Cosmetic with sterile, preservative-free 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size needle and syringe 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). Then slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX Cosmetic with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX Cosmetic should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTOX Cosmetic should be stored in a refrigerator (2° to 8°C). BOTOX Cosmetic vials are for single-use only. Discard any remaining solution.

Table 1: Dilution Instructions for BOTOX Cosmetic Vials (100 Units and 50 Units)

Reconstituted BOTOX Cosmetic should be clear, colorless, and free of particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and whenever the solution and the container permit. Do not freeze reconstituted BOTOX Cosmetic.

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 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.
• Do not inject toxin closer than 1 cm above the central eyebrow.

Draw at least 0.5 mL of the properly reconstituted toxin into the sterile syringe, preferably a tuberculin 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 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units (see Figure 1).

Dosage Forms And Strengths

• For injection: 50 Units, vacuum-dried powder in a single use vial for reconstitution
• For injection: 100 Units, vacuum-dried powder in a single use vial for reconstitution

Storage And Handling

BOTOX Cosmetic is supplied in a single-use vial in the following sizes:

50 Units: NDC 0023-3919-50
100 Units: NDC 0023-9232-01

Vials of BOTOX Cosmetic have a holographic film on the vial label that contains the name “Allergan” within horizontal lines of rainbow color. In order to see the hologram, rotate the vial back and forth between your fingers under a desk lamp or fluorescent light source. (Note: the holographic film on the label is absent in the date/lot area.) If you do not see the lines of rainbow color or the name “Allergan,” do not use the product and contact Allergan for additional information at 1-800-890-4345 from 7:00 AM to 3:00 PM Pacific Time.

Storage

Unopened vials of BOTOX Cosmetic should be stored in a refrigerator (2° to 8°C). Do not use after the expiration date on the vial.

Manufactured by: Allergan Pharmaceuticals Ireland a subsidiary of: Allergan, Inc., 2525 Dupont Dr. Irvine, CA 92612. Revised: 11/2012

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.