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BOTOX Cosmetic onabotulinumtoxinA 100 [USP'U]/1 Injection, Powder, Lyophilized, For Solution, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Acetylcholine Release Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
DaxibotulinumtoxinA-lanm injection is used to temporarily smooth frown lines (wrinkles between the eyebrows) in adults 18 years of age and older. DaxibotulinumtoxinA-lanm injection is in a class of medications called neurotoxins. It blocks the nerve signals that cause uncontrollable tightening and movements of the muscle.
Read the full MedlinePlus article ↗- Botox (onabotulinumtoxinA) has a long list of medical uses that go well beyond cosmetics. It's FDA-approved to treat overactive bladder, prevent chronic migraines, reduce muscle st...
- I thought Botox was just for wrinkles — what else is it actually used for?
- The effects typically last several months — the exact duration depends on what you're being treated for. For most conditions, re-injection is done no sooner than every 3 months, an...
- How long do the effects of Botox last, and how often will I need injections?
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Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.5 mg
UNII ZIF514RVZR
A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
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0.9 mg
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $609.65 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0585 | $6.506 / J0585 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Botox 100 [USP'U] 00023-1145-01 | Allergan, | 1 vial | — | — | FDA listed | — |
| BOTOX Cosmetic 100 [USP'U]this 00023-9232-01 | Allergan, | 1 vial | — | — | FDA listed | — |
| Botox 100 [USP'U] 85766-0155-01 | Sportpharm | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00023-9232-01 You're viewing this | 1 VIAL, GLASS in 1 CARTON (0023-9232-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS | 2008-05-20 | Active |
| 00023-9232-02 | 1 VIAL, GLASS in 1 CARTON (0023-9232-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS | 2008-05-20 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00023-9232-01?
What is the difference between NDC 00023-9232-01 and NDC 00023-9232-02?
What NDC number is used to bill for this package of BOTOX Cosmetic onabotulinumtoxinA 100 [USP'U]/1 Injection, Powder, Lyophilized, For Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These 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. 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, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses. [see Warnings and Precautions ( 5.2 )] WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning.
The effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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.
The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms. ( 5.2 )
🎯 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 ( 1 ): 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
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Glabellar Lines Administration: 0.1 mL (4 Units) into each of 5 sites, for a total dose of 20 Units ( 2.4 ) 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 ( 2.4 ) 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 ( 2.4 ) 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) ( 2.4 ) BOTOX Cosmetic is administered by intramuscular injection ( 2.2 ) Follow dosage and administration recommendations.
Do not exceed the maximum recommended cumulative dose in a treatment session for any indication ( 2.1 , 2.2 ) See Preparation and Reconstitution Instructions for information on BOTOX Cosmetic reconstitution, storage, and preparation before injection ( 2.3 ) Figure 1: Figure 2 and 3 Figure 4: Figure 5: Injection Sites for Platysma Prominence (2 Bands) Figure 6: Injection Sites for Platysma Prominence (1 Band)
2.1Instructions for Safe Use 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 [see Warnings and Precautions ( 5.1 ) and Description ( 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 Dose The 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 Area Total Recommended Treatment Dose Glabellar 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 mL The safety and effectiveness of dosing with BOTOX Cosmetic more frequently than every 3 months have not been clinically evaluated.
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) Vial Amount of Diluent* Added Resulting Dose Units per 0.1 mL 50 Units 1.25 mL 4 Units 100 Units 2.5 mL…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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 For Injection: 50 Units or 100 Units vacuum-dried powder in a single-dose vial for reconstitution ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ( 4.1 , 5.4 ) Infection at the injection site ( 4.2 )
4.1Known Hypersensitivity to Botulinum Toxin BOTOX Cosmetic 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 ( 5.4 )] .
4.2Infection at the Injection Site(s) BOTOX Cosmetic is contraindicated in the presence of infection at the proposed injection site(s).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Potency Units of BOTOX Cosmetic cannot be compared to or converted into Units of any other preparations of botulinum toxin products ( 5.1 , 11 ) Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur ( 5.2 , 5.7 ) Potential serious adverse reactions after administration of BOTOX for unapproved uses ( 5.3 ) Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes.
Use caution when administering to patients with pre-existing cardiovascular disease. ( 5.5 ) Concomitant neuromuscular disorder may exacerbate clinical effects of treatment ( 5.6 ) Use with caution in patients with compromised respiratory function or dysphagia ( 5.7 )
5.1Lack of Equivalency B etween Botulinum Toxin Products The potency Units of BOTOX Cosmetic 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 [see Description ( 11 )] .
5.2Spread of Toxin Effect 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 Cosmetic at 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.
5.3Serious Adverse Reactions with Unapproved Use Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities.
There is insufficient information to identify factors associated with an increased risk for adverse reactions as…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions to BOTOX Cosmetic (onabotulinumtoxinA) for injection are discussed in greater detail in other sections of the labeling: Spread of Toxin Effects [see Warnings and Precautions ( 5.2 )] Hypersensitivity [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.4 )] Dysphagia and Breathing Difficulties [see Warnings and Precautions ( 5.7 )] The most common adverse reactions are ( 6.1 ): Glabellar Lines: eyelid ptosis (3%) Lateral Canthal Lines: eyelid edema (1%) Forehead Lines: headache (9%) and brow ptosis (2%) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. BOTOX and BOTOX Cosmetic contain the same active ingredient in the same formulation, but have different labeled Indications and Usage. Therefore, adverse events observed with the use of BOTOX also have the potential to be observed with the use of BOTOX Cosmetic.
In general, adverse reactions occur within the first week following injection of BOTOX Cosmetic and while in many cases are transient, may have a duration of several months or longer. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses (including e.g., syncope, hypotension), which may require appropriate medical therapy.
Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of nearby muscles may also occur due to spread of toxin [see Warnings and Precautions ( 5.2 )] . Glabellar Lines Table 5 lists selected adverse reactions reported by ≥1% of BOTOX Cosmetic treated subjects (N=405) aged 18 to 75 who were evaluated in the randomized, placebo-controlled clinical studies to assess the use of BOTOX Cosmetic in the improvement of the appearance of glabellar lines.
Table 5: Adverse Reactions Reported by ≥1% of BOTOX Cosmetic treated Subjects and More Frequent than in Placebo-treated Subjects in Double-blind, Placebo-controlled Clinical Studies of Treatment of Glabellar Lines Adverse Reactions by System Organ Class BOTOX Cosmetic (N=405) Placebo (N=130) General Disorders and Administration Site Conditions Facial pain 6 (1%) 0 (0%) Nervous System Disorders Facial paresis 5 (1%) 0 (0%) Eye Disorders Eyelid ptosis 13 (3%) 0 (0%) Musculoskeletal and Connective Tissue Disorders Muscular Weakness 6 (1%) 0 (0%) Lateral Canthal Lines Table 6 lists selected adverse reactions reported within 90 days following injection by ≥1% of BOTOX Cosmetic treated subjects (N=526) aged 18 to 75 who were evaluated in two randomized, double-blind, placebo-controlled clinical studies to assess the use of BOTOX Cosmetic in the improvement of the appearance of lateral canthal lines alone.
Table 6: Adverse Reaction Reported by ≥1% of BOTOX Cosmetic Treated Subjects and More Frequent than in Placebo-treated Subjects Within 90 Days, in Double-blind, Placebo-controlled Clinical Studies of Treatment of Lateral Canthal Lines Adverse Reactions by System Organ Class BOTOX Cosmetic 24 Units (N=526) Placebo (N=530) Eye disorders Eyelid edema 5 (1%) 0 (0%) Forehead Lines Table 7 lists selected adverse reactions reported by ≥1% of BOTOX Cosmetic treated subjects (N=665) aged 18 to 77 who were evaluated in two randomized, double-blind, placebo-controlled clinical studies to assess the use of BOTOX Cosmetic in the improvement of the appearance of forehead lines with glabellar lines.
Table 7: Adverse Reactions Reported by ≥1% of BOTOX Cosmetic treated Subjects More Frequently than in Placebo-treated Subjects, in D…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No formal drug interaction studies have been conducted with BOTOX Cosmetic (onabotulinumtoxinA) for injection. Patients receiving concomitant treatment of BOTOX Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of BOTOX Cosmetic may be potentiated ( 7 )
7.1Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission Co-administration of BOTOX Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.
7.2Anticholinergic Drugs Use of anticholinergic drugs after administration of BOTOX Cosmetic may potentiate systemic anticholinergic effects.
7.3Other Botulinum Neurotoxin Products The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
7.4Muscle Relaxants Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX Cosmetic.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary 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 [see Data]. 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. Data Animal Data 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
0.5Units/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
0.25Units/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.
8. 2 Lactation Risk Summary There are no data on the presence of BOTOX Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BOTOX Cosmetic and any potential adverse effects on the breastfed infant from BOTOX Cosmetic or from the underlying maternal conditions.
8.4Pediatric Use The safety and effectiveness of BOTOX Cosmetic have not been established in pediatric patients.
8.5Geriatric Use Glabellar Lines In the two initial glabellar lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older [see Clinical Studies ( 14 )] . Lateral Canthal Lines In the two lateral canthal lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older. Forehead Lines In the two forehead lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older.
Platysma Bands In the two platysma bands clinical studies of BOTOX Cosmetic, 3.6% of subjects (13 subjects) treated with BOTOX Cosmetic were 65 years or older. Although the responder rates appeared to be higher for subjects yo…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary 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 [see Data]. 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. Data Animal Data 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
0.5Units/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
0.25Units/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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of BOTOX Cosmetic have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Glabellar Lines In the two initial glabellar lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older [see Clinical Studies ( 14 )] . Lateral Canthal Lines In the two lateral canthal lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older. Forehead Lines In the two forehead lines clinical studies of BOTOX Cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older.
Platysma Bands In the two platysma bands clinical studies of BOTOX Cosmetic, 3.6% of subjects (13 subjects) treated with BOTOX Cosmetic were 65 years or older. Although the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older, clinical studies of BOTOX Cosmetic did not include sufficient numbers of subjects 65 years or older to determine whether they respond differently from younger subjects.
🆘 Overdosage ▾
10 OVERDOSAGE Excessive doses of BOTOX Cosmetic (onabotulinumtoxinA) for injection may be expected to produce neuromuscular weakness with a variety of symptoms. Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur or overdose be suspected, consider patients for further medical evaluation and immediately institute appropriate medical therapy, which may include hospitalization.
The patient should be medically supervised for several weeks for signs and symptoms of systemic muscular weakness which could be local, or distant from the site of injection [see Boxed Warning and Warnings and Precautions ( 5.2 , 5.7 )] . If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspiration pneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place.
Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care. In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration.
In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100. More information can be obtained at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5232a8.htm.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action BOTOX Cosmetic blocks neuromuscular transmission by binding to acceptor sites on motor nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a pre-synaptic protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX Cosmetic produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX Cosmetic.
12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted with BOTOX Cosmetic (onabotulinumtoxinA) for injection.
12.3Pharmacokinetics Using currently available analytical technology, it is not possible to detect BOTOX Cosmetic in the peripheral blood following intramuscular injection at the recommended doses. 12. 6 Immunogenicity Since BOTOX Cosmetic is a therapeutic protein, there is a potential for immunogenicity.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to BOTOX Cosmetic in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
In three Lateral Canthal Line trials, 916 subjects (517 subjects at 24 Units and 399 subjects at 44 Units) treated with BOTOX Cosmetic had specimens analyzed for antibody formation. Among the 916 BOTOX Cosmetic treated subjects, 14 subjects (1.5%) developed binding antibodies and no subjects (0%) developed the presence of neutralizing antibodies. The data reflect the subjects whose test results were considered positive or negative for neutralizing activity to BOTOX Cosmetic in a mouse protection assay.
The critical factors for neutralizing antibody formation have not been well characterized. The results from some studies suggest that botulinum toxin injections at more frequent intervals or at higher doses may lead to greater incidence of antibody formation. The potential for antibody formation may be minimized by injecting with the lowest effective dose given at the longest feasible intervals between injections.
🧬 Mechanism of Action ▾
12.1Mechanism of Action BOTOX Cosmetic blocks neuromuscular transmission by binding to acceptor sites on motor nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a pre-synaptic protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX Cosmetic produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX Cosmetic.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING BOTOX Cosmetic (onabotulinumtoxinA) for injection is a vacuum-dried powder supplied in a single-dose vial in the following sizes: 50 Units: NDC 0023-3919-50 100 Units: NDC 0023-9232-01 BOTOX Cosmetic cartons have features to alert users if contents may have been compromised. Each BOTOX Cosmetic vial label and carton labeling also contain the U.S. License number 1889 [see Dosage and Administration ( 2.1 )] .
Do not use the product and contact AbbVie for additional information at 1-800-678-1605 if the labeling is not as described above. Storage Store unopened vials of BOTOX Cosmetic in a refrigerator 2°C to 8°C (36ºF to 46ºF). Do not use after the expiration date on the vial.
Store reconstituted BOTOX Cosmetic in a refrigerator 2°C to 8°C (36ºF to 46ºF) and administer within 24 hours [see Dosage and Administration ( 2.3 )] .
📋 Description ▾
11 DESCRIPTION BOTOX Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
The primary release procedure for BOTOX Cosmetic uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to AbbVie’s products BOTOX and BOTOX Cosmetic. One Unit of BOTOX Cosmetic corresponds to the calculated median intraperitoneal lethal dose (LD 50 ) in mice.
Due to specific details of this assay such as the vehicle, dilution scheme and laboratory protocols, Units of biological activity of BOTOX Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX Cosmetic is approximately 20 Units/nanogram of neurotoxin complex. Each vial of BOTOX Cosmetic contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; or 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Provide a copy of the Medication Guide and review the contents with the patient. Swallowing, Speaking or Breathing Difficulties, or Other Unusual Symptoms Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking, or breathing), or if any existing symptom worsens [see Boxed Warning and Warnings and Precautions ( 5.2 , 5.7 )] .
Ability to Operate Machinery or Vehicles Advise patients that if loss of strength, muscle weakness, blurred vision, or drooping eyelids occur, avoid driving a car or engaging in other potentially hazardous activities. Ophthalmic Adverse Reactions Inform patients that BOTOX Cosmetic 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.
Manufactured by: AbbVie Inc. 1 N Waukegan Rd. North Chicago, IL 60064 U.S.
License number 1889 © 2024 AbbVie. All rights reserved. BOTOX and its design are trademarks of Allergan, Inc., an AbbVie company.
V4.1USPI3919 Logo Description automatically generated
💬 Medication Guide ▾
MEDICATION GUIDE BOTOX ® BOTOX ® Cosmetic (Boe-tox) (onabotulinumtoxinA) for i njection , for intramuscular, intradetrusor, or intradermal use What is the most important information I should know about BOTOX and BOTOX Cosmetic? BOTOX and BOTOX Cosmetic may cause serious side effects that can be life threatening, including: Problems breathing or swallowing Spread of toxin effects These problems can happen hours, days, to weeks after an injection of BOTOX or BOTOX Cosmetic. Call your doctor or get medical help right away if you have any of these problems after treatment with BOTOX or BOTOX Cosmetic: Problems swallowing, speaking, or breathing.
These problems can happen hours, days, to weeks after an injection of BOTOX or BOTOX Cosmetic usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with BOTOX or BOTOX Cosmetic . People with certain breathing problems may need to use muscles in their neck to help them breathe.
These people may be at greater risk for serious breathing problems with BOTOX or BOTOX Cosmetic . Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water.
If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving BOTOX or BOTOX Cosmetic have the highest risk of getting these problems. Spread of toxin effects.
In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body double vision, blurred vision and drooping eyelids hoarseness or change or loss of voice (dysphonia) trouble saying words clearly (dysarthria) loss of bladder control trouble breathing trouble swallowing These symptoms can happen hours, days, to weeks after you receive an injection of BOTOX or BOTOX Cosmetic .
These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while receiving BOTOX or BOTOX Cosmetic ?" There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when BOTOX Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, forehead lines, or vertical bands connecting the jaw and neck.
What are BOTOX and BOTOX Cosmetic? BOTOX is a prescription medicine that is injected into muscles and used: to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency) and urinating often (frequency) in adults when another type of medicine (anticholinergic) does not work well enough or cannot be taken. to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken. to treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken. to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day. to treat increased muscle stiffness in people 2 years of age and older with spasticity. to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults. to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older.
BOTOX is also injected into the skin to trea…