HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BOTOX
®
safely and effectively. See full prescribing information for BOTOX.
BOTOX
®
(onabotulinumtoxinA) for injection, for intramuscular,
intradetrusor, or intradermal use
Initial U.S. Approval: 1989
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INDICATIONS AND USAGE
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BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent
indicated for:
Treatment of overactive bladder (OAB) with symptoms of urge urinary
incontinence, urgency, and frequency, in adults who have an inadequate response
to or are intolerant of an anticholinergic medication (1.1)
Treatment of urinary incontinence due to detrusor overactivity associated with a
neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in
adults who have an inadequate response to or are intolerant of an anticholinergic
medication (1.1)
Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years
of age and older who have an inadequate response to or are intolerant of
anticholinergic medication. (1.2)
Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per
month with headache lasting 4 hours a day or longer) (1.3)
Treatment of spasticity in patients 2 years of age and older (1.4)
Treatment of cervical dystonia in adult patients, to reduce the severity of
abnormal head position and neck pain (1.5)
Treatment of severe axillary hyperhidrosis that is inadequately managed by
topical agents in adult patients (1.6)
Treatment of blepharospasm associated with dystonia in patients 12 years of age
and older (1.7)
Treatment of strabismus in patients 12 years of age and older (1.7)
Limitations of Use
Safety and effectiveness of BOTOX have not been established for:
Prophylaxis of episodic migraine (14 headache days or fewer per month) (1.3)
Treatment of hyperhidrosis in body areas other than axillary (1.6)
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DOSAGE AND ADMINISTRATION
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Follow indication-specific dosage and administration recommendations. In a 3
month interval, do not exceed a total dose of:
Adults: 400 Units
Pediatrics: the lesser of 10 Units/kg or 340 Units (2.1)
See Preparation and Dilution Technique for instructions on BOTOX
reconstitution, storage, and preparation before injection (2.2)
Overactive Bladder: Recommended total dose 100 Units, as 0.5 mL (5 Units)
injections across 20 sites into the detrusor (2.3)
Adult Detrusor Overactivity associated with a Neurologic Condition:
Recommended total dose 200 Units, as 1 mL (~6.7 Units) injections across 30
sites into the detrusor (2.3)
Pediatric Detrusor Overactivity associated with a Neurologic Condition: 0.5 mL
injections across 20 sites into the detrusor (2.4)
Greater than or equal to 34 kg: Recommended total dose is 200 Units
Less than 34 kg: Recommended total dose is 6 Units/kg
Chronic Migraine: Recommended total dose 155 Units, as 0.1 mL (5 Units)
injections per each site divided across 7 head/neck muscles (2.5)
Adult Upper Limb Spasticity: Recommended total dose up to 400 Units divided
among affected muscles (2.6)
Adult Lower Limb Spasticity: Recommended total dose 300 Units to 400 Units
divided across ankle and toe muscles (2.6)
Pediatric Upper Limb Spasticity: Recommended total dose 3 Units/kg to 6
Units/kg (maximum 200 Units) divided among affected muscles (2.7)
Pediatric Lower Limb Spasticity: Recommended total dose 4 Units/kg to 8
Units/kg (maximum 300 Units) divided among affected muscles (2.7)
Cervical Dystonia: Base dosing on the patient’s head and neck position,
localization of pain, muscle hypertrophy, patient response, and adverse event
history; use lower initial dose in botulinum toxin naïve patients (2.8)
Axillary Hyperhidrosis: 50 Units per axilla (2.9)
Blepharospasm: 1.25 Units-2.5 Units into each of 3 sites per affected eye (2.10)
Strabismus: The dose is based on prism diopter correction or previous response
to treatment with BOTOX (2.11)
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DOSAGE FORMS AND STRENGTHS
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For Injection: 100 Units or 200 Units vacuum-dried powder in a single-dose vial
(3)
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CONTRAINDICATIONS
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Hypersensitivity to any botulinum toxin preparation or to any of the
components in the formulation (4, 5.4, 6)
Infection at the proposed injection site (4)
Intradetrusor Injections: Urinary tract infection or urinary retention (4)
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WARNINGS AND PRECAUTIONS
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Spread of toxin effects; swallowing and breathing difficulties can lead to death.
Seek immediate medical attention if respiratory, speech or swallowing
difficulties occur (5.1, 5.6)
Potency Units of BOTOX are not interchangeable with other preparations of
botulinum toxin products (5.2, 11)
Potential serious adverse reactions after BOTOX injections for unapproved
uses (5.3)
Concomitant neuromuscular disorder may exacerbate clinical effects of
treatment (5.5)
Use with caution in patients with compromised respiratory function (5.6, 5.7,
5.10)
Corneal exposure and ulceration due to reduced blinking may occur with
BOTOX treatment of blepharospasm (5.8)
Retrobulbar hemorrhages and compromised retinal circulation may occur with
BOTOX treatment of strabismus (5.9)
Bronchitis and upper respiratory tract infections in patients treated for spasticity
(5.10)
Urinary tract infections in patients treated for OAB (5.12)
Urinary retention: Post-void residual urine volume should be monitored in
patients treated for OAB or adult detrusor overactivity associated with a
neurologic condition who do not catheterize routinely, particularly patients with
multiple sclerosis or diabetes mellitus. (5.13)
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ADVERSE REACTIONS
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The most common adverse reactions (≥5% and >placebo, if applicable) are (6.1):
OAB: urinary tract infection, dysuria, urinary retention
Adult Detrusor Overactivity associated with a neurologic condition: urinary
tract infection, urinary retention
Pediatric Detrusor Overactivity associated with a neurologic condition: urinary
tract infection, leukocyturia, bacteriuria
Chronic Migraine: neck pain, headache
Adult Spasticity: pain in extremity
Pediatric Spasticity: upper respiratory tract infection
Cervical Dystonia: dysphagia, upper respiratory infection, neck pain, headache,
increased cough, flu syndrome, back pain, rhinitis
Axillary Hyperhidrosis: injection site pain and hemorrhage, non-axillary
sweating, pharyngitis, flu syndrome
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at
1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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DRUG INTERACTIONS
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Patients receiving concomitant treatment of BOTOX 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 may be potentiated (7.1, 7.4)
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USE IN SPECIFIC POPULATIONS
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Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 11/2023
WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete boxed warning.
The effects of BOTOX 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. (5.1)