Botox Cosmetic Prescribing Information
Postmarketing safety data from BOTOX Cosmetic and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, and particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia and spasticity. Advise patients or caregivers to seek immediate medical care if swallowing, speech or respiratory disorders occur.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX/BOTOX Cosmeticat the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines), or 100 Units (for severe primary axillary hyperhidrosis) have been reported.
No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX
for blepharospasm at the recommended dose (30 Units and below), strabismus, or chronic migraine at the labeled doses have been reported.Indications and Usage (1 INDICATIONS AND USAGE BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of: • moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity • moderate to severe lateral canthal lines associated with orbicularis oculi activity • moderate to severe forehead lines associated with frontalis muscle activity • moderate to severe platysma bands associated with platysma muscle activity BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of :
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Dosage and Administration (2.2 Recommended Dose The total recommended dose in adult patients by treatment area is shown in Table 1. BOTOX Cosmetic is administered by intramuscular injection.
The safety and effectiveness of dosing with BOTOX Cosmetic more frequentlythan every 3 months havenot been clinically evaluated.2.3 Preparation and Reconstitution Instructions BOTOX Cosmetic is supplied in single-dose 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 (see Table 2). 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.
*Preservative-free 0.9% Sodium Chloride Injection, USP Only 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. Administer BOTOX Cosmetic within 24 hours after reconstitution. During this time period, store reconstituted BOTOX Cosmetic in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze reconstituted BOTOX Cosmetic. BOTOX Cosmetic vials are for single-dose only. Discard any remaining solution. Reconstituted BOTOX Cosmetic is clear, colorless to slightly yellow solution, 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 use if the solution is cloudy or contains flakes or particles. 2.000000000000000e+00 4 Administration Draw properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe, and expel any air bubbles in the syringe barrel (see Table 3). Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle.
Glabellar Lines 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, take the following steps:
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic 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.Figure 1:
Lateral Canthal Lines Give injections with the needle bevel tip up and oriented away from the eye. Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 Units (0.6 mL) (12 Units per side). Administer the first injection (A) approximately 1.5-2.0 cm temporal to the lateral canthus and just temporal to the orbital rim. If the lines in the lateral canthal region are above and below the lateral canthus, inject per Figure 2. Alternatively, if the lines in the lateral canthal region are primarily below the lateral canthus, inject per Figure 3.
For simultaneous treatment with glabellar lines, the dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines (see Glabellar Lines Administration and Figure 1), with a total dose of 44 Units. Forehead Lines in Conjunction with Glabellar Lines Treat forehead lines in conjunction with glabellar lines (see Glabellar Lines Administration and Figure 1) to minimize the potential for brow ptosis. The recommended total dose for treatment of forehead lines (20 Units [0.5 mL]) in conjunction with glabellar lines (20 Units [0.5 mL]) is 40 Units (1 mL). When identifying the location of the appropriate injection sites in the frontalis muscle, assess the overall relationship between the size of the subject’s forehead, and the distribution of frontalis muscle activity. Locate the following horizontal treatment rows by light palpation of the forehead at rest and maximum eyebrow elevation:
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 5 sites in the frontalis muscle, for a total of 20 Units (0.5 mL). Place the 5 injections at the intersection of the horizontal treatment rows with the following vertical landmarks (see Figure 4):
Figure 4:
For simultaneous treatment with lateral canthal lines, the total dose is 64 Units, comprised of 20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines (see Lateral Canthal Lines Administration and Figures 2 and 3). Platysma Bands Using an appropriately sized sterile syringe, needle, and aseptic technique, inject 2 Units (0.05 mL) of reconstituted BOTOX Cosmetic into 4 sites in the upper segment of platysma muscle, below the jawline on each side. For each side, administer the 4 jawline injections to the upper platysma muscle approximately 1 to 2 cm inferior and parallel to the lower mandibular border. Ensure the anterior injection site is in line with the oral commissure, and the posterior injection is slightly anterior to the angle of the mandible. Administer the remaining 2 injections equidistant (approximately 1 to 2 cm apart) between the anterior and posterior injection points (see Figures 5 and 6). In addition, inject 1 Unit (0.025 mL) of reconstituted BOTOX Cosmetic into 5 sites along each vertical neck band, 1 to 2 vertical neck bands per side. For each vertical neck band identified, 1 to 2 per side, distribute 5 injections vertically approximately 1 to 2 cm apart (see Figures 5 and 6). Ensure the most superior injection site is approximately 1 to 2 cm inferior to the jawline injections. Depending on platysma band severity, the total dose may be 26 Units (1 band/side), 31 Units (1 band one side, 2 bands other side), or 36 Units (2 bands/side) (see Table 4 and Figures 5 and 6 below).
Administer all platysma muscle injections superficially and intramuscularly with the needle perpendicular to the surface of the skin. For vertical neck band injections, identify each band while the patient is contracting their platysma. Gently pinch the band to isolate the muscle from nearby anatomical structures during administration (see Table 4). To reduce injection-related complications, administer injection at least 1 cm inferior to the lower mandibular border. Do not inject into structures deep to the platysma muscle, particularly in the anterior region of the neck.
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- Glabellar Lines Administration: 0.1 mL (4 Units) into each of 5 sites, for a total dose of 20 Units ()2.000000000000000e+004Administration
Draw properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe, and expel any air bubbles in the syringe barrel (see Table 3). Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle.
Table 3: Amount of Reconstituted Toxin to Draw Per Treatment Area Treatment AreaAmount of Reconstituted Toxin to DrawGlabellar lines At least 0.5 mL Lateral canthal lines At least 0.6 mL Forehead lines and glabellar lines At least 1 mL Platysma bands - 1 band on each side: At least 0.65 mL
- 1 band on one side, 2 bands on the other side: At least 0.78 mL
- 2 bands on each side: At least 0.9 mL
Glabellar LinesAn 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, take the following steps:
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
- Place lateral corrugator injections 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.
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic
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.Figure 1:
Lateral CanthalLinesGive injections with the needle bevel tip up and oriented away from the eye. Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 Units (0.6 mL) (12 Units per side). Administer the first injection (A) approximately 1.5-2.0 cm temporal to the lateral canthus and just temporal to the orbital rim. If the lines in the lateral canthal region are above and below the lateral canthus, inject per Figure 2. Alternatively, if the lines in the lateral canthal region are primarily below the lateral canthus, inject per Figure 3.
For simultaneous treatment with glabellar lines, the dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines (see Glabellar Lines Administration and Figure 1), with a total dose of 44 Units.
Forehead Linesin Conjunction with Glabellar LinesTreat forehead lines in conjunction with glabellar lines (see Glabellar Lines Administration and Figure 1) to minimize the potential for brow ptosis. The recommended total dose for treatment of forehead lines (20 Units [0.5 mL]) in conjunction with glabellar lines (20 Units [0.5 mL]) is 40 Units (1 mL).
When identifying the location of the appropriate injection sites in the frontalis muscle, assess the overall relationship between the size of the subject’s forehead, and the distribution of frontalis muscle activity.
Locate the following horizontal treatment rows by light palpation of the forehead at rest and maximum eyebrow elevation:
- Superior Margin of Frontalis Activity: approximately 1 cm above the most superior forehead crease
- Lower Treatment Row: midway between the superior margin of frontalis activity and the eyebrow, at least 2 cm above the eyebrow
- Upper Treatment Row: midway between the superior margin of frontalis activity and lower treatment row
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 5 sites in the frontalis muscle, for a total of 20 Units (0.5 mL). Place the 5 injections at the intersection of the horizontal treatment rows with the following vertical landmarks (see Figure 4):
- On the lower treatment row at the midline of the face, and 0.5 – 1.5 cm medial to the palpated temporal fusion line (temporal crest); repeat for the other side.
- On the upper treatment row, midway between the lateral and medial sites on the lower treatment row; repeat for the other side.
Figure 4:
For simultaneous treatment with lateral canthal lines, the total dose is 64 Units, comprised of 20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines (see Lateral Canthal Lines Administration and Figures 2 and 3).
PlatysmaBandsUsing an appropriately sized sterile syringe, needle, and aseptic technique, inject 2 Units (0.05 mL) of reconstituted BOTOX Cosmetic into 4 sites in the upper segment of platysma muscle, below the jawline on each side. For each side, administer the 4 jawline injections to the upper platysma muscle approximately 1 to 2 cm inferior and parallel to the lower mandibular border. Ensure the anterior injection site is in line with the oral commissure, and the posterior injection is slightly anterior to the angle of the mandible. Administer the remaining 2 injections equidistant (approximately 1 to 2 cm apart) between the anterior and posterior injection points (see Figures 5 and 6).In addition, inject 1 Unit (0.025 mL) of reconstituted BOTOX Cosmetic into 5 sites along each vertical neck band, 1 to 2 vertical neck bands per side. For each vertical neck band identified, 1 to 2 per side, distribute 5 injections vertically approximately 1 to 2 cm apart (see Figures 5 and 6). Ensure the most superior injection site is approximately 1 to 2 cm inferior to the jawline injections.Depending on platysma band severity, the total dose may be 26 Units (1 band/side), 31 Units (1 band one side, 2 bands other side), or 36 Units (2 bands/side) (see Table 4 and Figures 5 and 6 below).Figure5: Injection Sites for PlatysmaBand(2 Bands)
Figure6: Injection Sites for PlatysmaBand(1 Band)
Administer all platysma muscle injections superficially and intramuscularly with the needle perpendicular to the surface of the skin. For vertical neck band injections, identify each band while the patient is contracting their platysma. Gently pinch the band to isolate the muscle from nearby anatomical structures during administration (see Table 4).To reduce injection-related complications, administer injection at least 1 cm inferior to the lower mandibular border. Do not inject into structures deep to the platysma muscle, particularly in the anterior region of the neck.
Table 4: Dosing for Platysma Bands Platysma Bands PresentationJawline InjectionsNeck Band InjectionsTotal Number of Injection SitesTotal Dose1 band on each side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 10 sites and 10 Units) 18 sites 26 Units (0.65 mL) 1 band on one side,2 bands on the other side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 15 sites and 15 Units) 23 sites 31 Units (0.78 mL) 2 bands on each side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 20 sites and 20 Units) 28 sites 36 Units (0.9 mL) - 1 band on each side: At least 0.65 mL
- Lateral Canthal Lines Administration: 0.1 mL (4 Units) into each of 3 sites per side (6 total injection points), for a total of 24 Units ()2.000000000000000e+004Administration
Draw properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe, and expel any air bubbles in the syringe barrel (see Table 3). Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle.
Table 3: Amount of Reconstituted Toxin to Draw Per Treatment Area Treatment AreaAmount of Reconstituted Toxin to DrawGlabellar lines At least 0.5 mL Lateral canthal lines At least 0.6 mL Forehead lines and glabellar lines At least 1 mL Platysma bands - 1 band on each side: At least 0.65 mL
- 1 band on one side, 2 bands on the other side: At least 0.78 mL
- 2 bands on each side: At least 0.9 mL
Glabellar LinesAn 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, take the following steps:
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
- Place lateral corrugator injections 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.
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic
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.Figure 1:Lateral CanthalLinesGive injections with the needle bevel tip up and oriented away from the eye. Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 Units (0.6 mL) (12 Units per side). Administer the first injection (A) approximately 1.5-2.0 cm temporal to the lateral canthus and just temporal to the orbital rim. If the lines in the lateral canthal region are above and below the lateral canthus, inject per Figure 2. Alternatively, if the lines in the lateral canthal region are primarily below the lateral canthus, inject per Figure 3.
For simultaneous treatment with glabellar lines, the dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines (see Glabellar Lines Administration and Figure 1), with a total dose of 44 Units.
Forehead Linesin Conjunction with Glabellar LinesTreat forehead lines in conjunction with glabellar lines (see Glabellar Lines Administration and Figure 1) to minimize the potential for brow ptosis. The recommended total dose for treatment of forehead lines (20 Units [0.5 mL]) in conjunction with glabellar lines (20 Units [0.5 mL]) is 40 Units (1 mL).
When identifying the location of the appropriate injection sites in the frontalis muscle, assess the overall relationship between the size of the subject’s forehead, and the distribution of frontalis muscle activity.
Locate the following horizontal treatment rows by light palpation of the forehead at rest and maximum eyebrow elevation:
- Superior Margin of Frontalis Activity: approximately 1 cm above the most superior forehead crease
- Lower Treatment Row: midway between the superior margin of frontalis activity and the eyebrow, at least 2 cm above the eyebrow
- Upper Treatment Row: midway between the superior margin of frontalis activity and lower treatment row
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 5 sites in the frontalis muscle, for a total of 20 Units (0.5 mL). Place the 5 injections at the intersection of the horizontal treatment rows with the following vertical landmarks (see Figure 4):
- On the lower treatment row at the midline of the face, and 0.5 – 1.5 cm medial to the palpated temporal fusion line (temporal crest); repeat for the other side.
- On the upper treatment row, midway between the lateral and medial sites on the lower treatment row; repeat for the other side.
Figure 4:For simultaneous treatment with lateral canthal lines, the total dose is 64 Units, comprised of 20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines (see Lateral Canthal Lines Administration and Figures 2 and 3).
PlatysmaBandsUsing an appropriately sized sterile syringe, needle, and aseptic technique, inject 2 Units (0.05 mL) of reconstituted BOTOX Cosmetic into 4 sites in the upper segment of platysma muscle, below the jawline on each side. For each side, administer the 4 jawline injections to the upper platysma muscle approximately 1 to 2 cm inferior and parallel to the lower mandibular border. Ensure the anterior injection site is in line with the oral commissure, and the posterior injection is slightly anterior to the angle of the mandible. Administer the remaining 2 injections equidistant (approximately 1 to 2 cm apart) between the anterior and posterior injection points (see Figures 5 and 6).In addition, inject 1 Unit (0.025 mL) of reconstituted BOTOX Cosmetic into 5 sites along each vertical neck band, 1 to 2 vertical neck bands per side. For each vertical neck band identified, 1 to 2 per side, distribute 5 injections vertically approximately 1 to 2 cm apart (see Figures 5 and 6). Ensure the most superior injection site is approximately 1 to 2 cm inferior to the jawline injections.Depending on platysma band severity, the total dose may be 26 Units (1 band/side), 31 Units (1 band one side, 2 bands other side), or 36 Units (2 bands/side) (see Table 4 and Figures 5 and 6 below).Figure5: Injection Sites for PlatysmaBand(2 Bands)Figure6: Injection Sites for PlatysmaBand(1 Band)Administer all platysma muscle injections superficially and intramuscularly with the needle perpendicular to the surface of the skin. For vertical neck band injections, identify each band while the patient is contracting their platysma. Gently pinch the band to isolate the muscle from nearby anatomical structures during administration (see Table 4).To reduce injection-related complications, administer injection at least 1 cm inferior to the lower mandibular border. Do not inject into structures deep to the platysma muscle, particularly in the anterior region of the neck.
Table 4: Dosing for Platysma Bands Platysma Bands PresentationJawline InjectionsNeck Band InjectionsTotal Number of Injection SitesTotal Dose1 band on each side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 10 sites and 10 Units) 18 sites 26 Units (0.65 mL) 1 band on one side,2 bands on the other side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 15 sites and 15 Units) 23 sites 31 Units (0.78 mL) 2 bands on each side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 20 sites and 20 Units) 28 sites 36 Units (0.9 mL) - 1 band on each side: At least 0.65 mL
- Forehead Lines Administration: 0.1 mL (4 Units) into each of 5 forehead line sites (20 Units) with 0.1 mL (4 Units) into each of 5 glabellar line sites (20 Units), for a recommended total of 40 Units ()2.000000000000000e+004Administration
Draw properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe, and expel any air bubbles in the syringe barrel (see Table 3). Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle.
Table 3: Amount of Reconstituted Toxin to Draw Per Treatment Area Treatment AreaAmount of Reconstituted Toxin to DrawGlabellar lines At least 0.5 mL Lateral canthal lines At least 0.6 mL Forehead lines and glabellar lines At least 1 mL Platysma bands - 1 band on each side: At least 0.65 mL
- 1 band on one side, 2 bands on the other side: At least 0.78 mL
- 2 bands on each side: At least 0.9 mL
Glabellar LinesAn 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, take the following steps:
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
- Place lateral corrugator injections 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.
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic
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.Figure 1:Lateral CanthalLinesGive injections with the needle bevel tip up and oriented away from the eye. Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 Units (0.6 mL) (12 Units per side). Administer the first injection (A) approximately 1.5-2.0 cm temporal to the lateral canthus and just temporal to the orbital rim. If the lines in the lateral canthal region are above and below the lateral canthus, inject per Figure 2. Alternatively, if the lines in the lateral canthal region are primarily below the lateral canthus, inject per Figure 3.
For simultaneous treatment with glabellar lines, the dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines (see Glabellar Lines Administration and Figure 1), with a total dose of 44 Units.
Forehead Linesin Conjunction with Glabellar LinesTreat forehead lines in conjunction with glabellar lines (see Glabellar Lines Administration and Figure 1) to minimize the potential for brow ptosis. The recommended total dose for treatment of forehead lines (20 Units [0.5 mL]) in conjunction with glabellar lines (20 Units [0.5 mL]) is 40 Units (1 mL).
When identifying the location of the appropriate injection sites in the frontalis muscle, assess the overall relationship between the size of the subject’s forehead, and the distribution of frontalis muscle activity.
Locate the following horizontal treatment rows by light palpation of the forehead at rest and maximum eyebrow elevation:
- Superior Margin of Frontalis Activity: approximately 1 cm above the most superior forehead crease
- Lower Treatment Row: midway between the superior margin of frontalis activity and the eyebrow, at least 2 cm above the eyebrow
- Upper Treatment Row: midway between the superior margin of frontalis activity and lower treatment row
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 5 sites in the frontalis muscle, for a total of 20 Units (0.5 mL). Place the 5 injections at the intersection of the horizontal treatment rows with the following vertical landmarks (see Figure 4):
- On the lower treatment row at the midline of the face, and 0.5 – 1.5 cm medial to the palpated temporal fusion line (temporal crest); repeat for the other side.
- On the upper treatment row, midway between the lateral and medial sites on the lower treatment row; repeat for the other side.
Figure 4:For simultaneous treatment with lateral canthal lines, the total dose is 64 Units, comprised of 20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines (see Lateral Canthal Lines Administration and Figures 2 and 3).
PlatysmaBandsUsing an appropriately sized sterile syringe, needle, and aseptic technique, inject 2 Units (0.05 mL) of reconstituted BOTOX Cosmetic into 4 sites in the upper segment of platysma muscle, below the jawline on each side. For each side, administer the 4 jawline injections to the upper platysma muscle approximately 1 to 2 cm inferior and parallel to the lower mandibular border. Ensure the anterior injection site is in line with the oral commissure, and the posterior injection is slightly anterior to the angle of the mandible. Administer the remaining 2 injections equidistant (approximately 1 to 2 cm apart) between the anterior and posterior injection points (see Figures 5 and 6).In addition, inject 1 Unit (0.025 mL) of reconstituted BOTOX Cosmetic into 5 sites along each vertical neck band, 1 to 2 vertical neck bands per side. For each vertical neck band identified, 1 to 2 per side, distribute 5 injections vertically approximately 1 to 2 cm apart (see Figures 5 and 6). Ensure the most superior injection site is approximately 1 to 2 cm inferior to the jawline injections.Depending on platysma band severity, the total dose may be 26 Units (1 band/side), 31 Units (1 band one side, 2 bands other side), or 36 Units (2 bands/side) (see Table 4 and Figures 5 and 6 below).Figure5: Injection Sites for PlatysmaBand(2 Bands)Figure6: Injection Sites for PlatysmaBand(1 Band)Administer all platysma muscle injections superficially and intramuscularly with the needle perpendicular to the surface of the skin. For vertical neck band injections, identify each band while the patient is contracting their platysma. Gently pinch the band to isolate the muscle from nearby anatomical structures during administration (see Table 4).To reduce injection-related complications, administer injection at least 1 cm inferior to the lower mandibular border. Do not inject into structures deep to the platysma muscle, particularly in the anterior region of the neck.
Table 4: Dosing for Platysma Bands Platysma Bands PresentationJawline InjectionsNeck Band InjectionsTotal Number of Injection SitesTotal Dose1 band on each side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 10 sites and 10 Units) 18 sites 26 Units (0.65 mL) 1 band on one side,2 bands on the other side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 15 sites and 15 Units) 23 sites 31 Units (0.78 mL) 2 bands on each side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 20 sites and 20 Units) 28 sites 36 Units (0.9 mL) - 1 band on each side: At least 0.65 mL
- Platysma Bands Administration: 0.05 mL (2 Units) into each of 4 sites in the upper segment of the platysma muscles, below the jawline on each side and 0.025 mL (1 Unit) into 5 sites on each vertical neck band per side (1 to 2 bands per side) for a total of 26 Units, 31 Units, or 36 Units (18, 23, or 28 injection sites, respectively) ()2.000000000000000e+004Administration
Draw properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe, and expel any air bubbles in the syringe barrel (see Table 3). Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle.
Table 3: Amount of Reconstituted Toxin to Draw Per Treatment Area Treatment AreaAmount of Reconstituted Toxin to DrawGlabellar lines At least 0.5 mL Lateral canthal lines At least 0.6 mL Forehead lines and glabellar lines At least 1 mL Platysma bands - 1 band on each side: At least 0.65 mL
- 1 band on one side, 2 bands on the other side: At least 0.78 mL
- 2 bands on each side: At least 0.9 mL
Glabellar LinesAn 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, take the following steps:
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
- Place lateral corrugator injections 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.
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic
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.Figure 1:Lateral CanthalLinesGive injections with the needle bevel tip up and oriented away from the eye. Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 Units (0.6 mL) (12 Units per side). Administer the first injection (A) approximately 1.5-2.0 cm temporal to the lateral canthus and just temporal to the orbital rim. If the lines in the lateral canthal region are above and below the lateral canthus, inject per Figure 2. Alternatively, if the lines in the lateral canthal region are primarily below the lateral canthus, inject per Figure 3.
For simultaneous treatment with glabellar lines, the dose is 24 Units for lateral canthal lines and 20 Units for glabellar lines (see Glabellar Lines Administration and Figure 1), with a total dose of 44 Units.
Forehead Linesin Conjunction with Glabellar LinesTreat forehead lines in conjunction with glabellar lines (see Glabellar Lines Administration and Figure 1) to minimize the potential for brow ptosis. The recommended total dose for treatment of forehead lines (20 Units [0.5 mL]) in conjunction with glabellar lines (20 Units [0.5 mL]) is 40 Units (1 mL).
When identifying the location of the appropriate injection sites in the frontalis muscle, assess the overall relationship between the size of the subject’s forehead, and the distribution of frontalis muscle activity.
Locate the following horizontal treatment rows by light palpation of the forehead at rest and maximum eyebrow elevation:
- Superior Margin of Frontalis Activity: approximately 1 cm above the most superior forehead crease
- Lower Treatment Row: midway between the superior margin of frontalis activity and the eyebrow, at least 2 cm above the eyebrow
- Upper Treatment Row: midway between the superior margin of frontalis activity and lower treatment row
Inject 4 Units (0.1 mL) of reconstituted BOTOX Cosmetic into 5 sites in the frontalis muscle, for a total of 20 Units (0.5 mL). Place the 5 injections at the intersection of the horizontal treatment rows with the following vertical landmarks (see Figure 4):
- On the lower treatment row at the midline of the face, and 0.5 – 1.5 cm medial to the palpated temporal fusion line (temporal crest); repeat for the other side.
- On the upper treatment row, midway between the lateral and medial sites on the lower treatment row; repeat for the other side.
Figure 4:For simultaneous treatment with lateral canthal lines, the total dose is 64 Units, comprised of 20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines (see Lateral Canthal Lines Administration and Figures 2 and 3).
PlatysmaBandsUsing an appropriately sized sterile syringe, needle, and aseptic technique, inject 2 Units (0.05 mL) of reconstituted BOTOX Cosmetic into 4 sites in the upper segment of platysma muscle, below the jawline on each side. For each side, administer the 4 jawline injections to the upper platysma muscle approximately 1 to 2 cm inferior and parallel to the lower mandibular border. Ensure the anterior injection site is in line with the oral commissure, and the posterior injection is slightly anterior to the angle of the mandible. Administer the remaining 2 injections equidistant (approximately 1 to 2 cm apart) between the anterior and posterior injection points (see Figures 5 and 6).In addition, inject 1 Unit (0.025 mL) of reconstituted BOTOX Cosmetic into 5 sites along each vertical neck band, 1 to 2 vertical neck bands per side. For each vertical neck band identified, 1 to 2 per side, distribute 5 injections vertically approximately 1 to 2 cm apart (see Figures 5 and 6). Ensure the most superior injection site is approximately 1 to 2 cm inferior to the jawline injections.Depending on platysma band severity, the total dose may be 26 Units (1 band/side), 31 Units (1 band one side, 2 bands other side), or 36 Units (2 bands/side) (see Table 4 and Figures 5 and 6 below).Figure5: Injection Sites for PlatysmaBand(2 Bands)Figure6: Injection Sites for PlatysmaBand(1 Band)Administer all platysma muscle injections superficially and intramuscularly with the needle perpendicular to the surface of the skin. For vertical neck band injections, identify each band while the patient is contracting their platysma. Gently pinch the band to isolate the muscle from nearby anatomical structures during administration (see Table 4).To reduce injection-related complications, administer injection at least 1 cm inferior to the lower mandibular border. Do not inject into structures deep to the platysma muscle, particularly in the anterior region of the neck.
Table 4: Dosing for Platysma Bands Platysma Bands PresentationJawline InjectionsNeck Band InjectionsTotal Number of Injection SitesTotal Dose1 band on each side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 10 sites and 10 Units) 18 sites 26 Units (0.65 mL) 1 band on one side,2 bands on the other side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 15 sites and 15 Units) 23 sites 31 Units (0.78 mL) 2 bands on each side2 Units (0.05 mL) into 4 sites per side (total of 8 sites and 16 Units) 1 Unit (0.025 mL) into 5 sites per band (total of 20 sites and 20 Units) 28 sites 36 Units (0.9 mL) - 1 band on each side: At least 0.65 mL
- BOTOX Cosmetic is administered by intramuscular injection ()2.2Recommended DoseThe total recommended dose in adult patients by treatment area is shown in Table 1. BOTOX Cosmetic is administered by intramuscular injection.
Table 1: Total Recommended Treatment Dose Treatment AreaTotal Recommended Treatment DoseGlabellar lines 20 Units in 0.5 mL Lateral canthal lines 24 Units in 0.6 mL Forehead lines and glabellar lines 40 Units in 1 mL Platysma bands One band on each side: 26 Units in 0.65 mL
1 band on one side, 2 bands on the other side: 31 Units in 0.78 mL
Two bands on each side: 36 Units in 0.9 mLThe safety and effectiveness of dosing with BOTOX Cosmetic
more frequentlythan every 3 months havenot been clinically evaluated. - Follow dosage and administration recommendations. Do not exceed the maximum recommended cumulative dose in a treatment session for any indication (,2.1Instructions forSafeUse
The potency Units of BOTOX Cosmetic (onabotulinumtoxinA) for injection are specific to the preparation and assay method utilized. BOTOX Cosmetic is not equivalent to 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
[seeWarnings and Precautions (5.1) andDescription (11)].Follow indication specific dosage and administration recommendations. Do not exceed the maximum recommended cumulative dose in a treatment session for any indication.
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 structural anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures and disease.
Do not use BOTOX Cosmetic and contact AbbVie (1-800-678-1605) if:
- The tamper evident features on the carton appear to be broken or compromised, or
- The U.S. License number 1889 is not present on the vial label and carton labeling[see How Supplied/Storage and Handling (16)]
)2.2Recommended DoseThe total recommended dose in adult patients by treatment area is shown in Table 1. BOTOX Cosmetic is administered by intramuscular injection.Table 1: Total Recommended Treatment Dose Treatment AreaTotal Recommended Treatment DoseGlabellar lines 20 Units in 0.5 mL Lateral canthal lines 24 Units in 0.6 mL Forehead lines and glabellar lines 40 Units in 1 mL Platysma bands One band on each side: 26 Units in 0.65 mL
1 band on one side, 2 bands on the other side: 31 Units in 0.78 mL
Two bands on each side: 36 Units in 0.9 mLThe safety and effectiveness of dosing with BOTOX Cosmetic
more frequentlythan every 3 months havenot been clinically evaluated. - The tamper evident features on the carton appear to be broken or compromised, or
- See Preparation and Reconstitution Instructions for information on BOTOX Cosmetic reconstitution, storage, and preparation before injection ()2.3Preparation and Reconstitution Instructions
BOTOX Cosmetic is supplied in single-dose 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 (see Table 2). 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.
Table 2: Dilution Instructions for BOTOX Cosmetic Vials (50 Units and 100 Units) VialAmount of Diluent* AddedResulting Dose Units per 0.1 mL50 Units 1.25 mL 4 Units 100 Units 2.5 mL 4 Units *Preservative-free 0.9% Sodium Chloride Injection, USP Only
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. Administer BOTOX Cosmetic within 24 hours after reconstitution. During this time period, store reconstituted BOTOX Cosmetic in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze reconstituted BOTOX Cosmetic. BOTOX Cosmetic vials are for single-dose only. Discard any remaining solution.
Reconstituted BOTOX Cosmetic is clear, colorless to slightly yellow solution, 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 use if the solution is cloudy or contains flakes or particles.
- For injection: 50 Units, vacuum-dried powder in a single-dose vial for reconstitution
- For injection: 100 Units, vacuum-dried powder in a single-dose vial for reconstitution
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX Cosmetic in pregnant women.
In animal studies, administrations of BOTOX Cosmetic during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity
The background risk of major birth defects and miscarriage for the indicated populations 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 miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
When BOTOX Cosmetic (4, 8, or 16 Units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. The no-effect dose for developmental toxicity in these studies (4 Units/kg) is approximately 4 times the average high human dose for glabellar lines, lateral canthal lines, and forehead lines of 64 Units on a body weight basis (Units/kg).
When BOTOX Cosmetic was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 Units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 Units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits. These doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. The developmental no-effect doses in these studies of 1 Unit/kg in rats is approximately equal the average high human dose of 64 Units based on Units/kg, and the developmental no-effect dose of 0.25 Units/kg in rabbits is less than the average high human dose based on Units/kg.
When pregnant rats received single intramuscular injections (1, 4, or 16 Units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. The developmental no-effect level for a single maternal dose in rats (16 Units/kg) is approximately 16 times the average high human dose of 64 Units based on Units/kg.