For patients when an OAB* medication fails†
Six months between treatments‡
and no daily OAB pills1
That’s the freedom
of BOTOX®
- *Overactive bladder.
- †Patients who had an inadequate response to or were intolerant of 1 anticholinergic.
- ‡Patients should be considered for reinjection when the effect of the previous
injection has diminished but no sooner than 12 weeks from the prior injection. - §At week 12 in clinical trials.
Most plans require only 1 OAB
medication* failure before
moving to BOTOX®2
*Anticholinergic.
Resources
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GoIndications
Adult Bladder Dysfunction:
Adult Bladder Dysfunction:
Overactive Bladder
BOTOX® for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
BOTOX® for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Detrusor Overactivity Associated With a Neurologic
Condition
BOTOX® is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
BOTOX® is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED
WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that 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 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 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.
Postmarketing reports indicate that 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 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 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.
CONTRAINDICATIONS
BOTOX® is contraindicated in the presence of infection at the proposed injection site(s) and in patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation.
BOTOX® is contraindicated in the presence of infection at the proposed injection site(s) and in patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation.
BOTOX® is contraindicated for
intradetrusor injection in patients with a urinary tract infection, or in patients
with urinary retention, or post-void residual (PVR) urine volume > 200 mL who are
not routinely performing clean intermittent self-catheterization (CIC).
WARNINGS AND
PRECAUTIONS
Spread of Toxin Effect
See Boxed Warning.
Spread of Toxin Effect
See Boxed Warning.
Lack of Interchangeability Between Botulinum Toxin
Products
The potency Units of BOTOX® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX® cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.
The potency Units of BOTOX® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX® cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.
Serious 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 preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
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 preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX® should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently, the causal agent cannot be reliably determined.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX® should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently, the causal agent cannot be reliably determined.
Increased Risk of Clinically Significant Effects With
Preexisting Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis (ALS), or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with known or unrecognized neuromuscular disorders or neuromuscular junction disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from therapeutic doses of BOTOX® (see Warnings and Precautions).
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis (ALS), or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with known or unrecognized neuromuscular disorders or neuromuscular junction disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from therapeutic doses of BOTOX® (see Warnings and Precautions).
Dysphagia and Breathing
Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Pulmonary Effects of BOTOX® in Patients With Compromised Respiratory Status
Treated for Detrusor Overactivity Associated With a Neurologic
Condition
Patients with compromised respiratory status treated with BOTOX® for detrusor overactivity associated with a neurologic condition should be monitored closely.
Patients with compromised respiratory status treated with BOTOX® for detrusor overactivity associated with a neurologic condition should be monitored closely.
Autonomic Dysreflexia in Patients Treated for Detrusor
Overactivity Associated With a Neurologic Condition
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% vs 0.4%, respectively).
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% vs 0.4%, respectively).
Urinary Tract Infections in Patients With Overactive
Bladder
BOTOX® increases the incidence of urinary tract infection. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.
BOTOX® increases the incidence of urinary tract infection. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.
Urinary Retention in Adults Treated for Bladder
Dysfunction
Due to the risk of urinary retention, treat only patients who are willing and able to initiate catheterization posttreatment, if required, for urinary retention.
Due to the risk of urinary retention, treat only patients who are willing and able to initiate catheterization posttreatment, if required, for urinary retention.
In patients who are not catheterizing, post-void residual (PVR)
urine volume should be assessed within 2 weeks posttreatment and periodically as
medically appropriate up to 12 weeks, particularly in patients with multiple
sclerosis or diabetes mellitus. Depending on patient symptoms, institute
catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls
below 200 mL. Instruct patients to contact their physician if they experience
difficulty in voiding as catheterization may be required.
Overactive Bladder
In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX® 100 Units, as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.
In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX® 100 Units, as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.
Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than
nondiabetics. In clinical trials, 12.3% of patients (10/81) with diabetes developed
urinary retention following treatment with BOTOX® 100 Units
vs 0% of patients (0/69) treated with placebo. In patients without diabetes, 6.3% of
patients (33/526) developed urinary retention following treatment with BOTOX® 100 Units vs 0.6% of patients (3/516) treated with placebo.
Adult Detrusor Overactivity Associated With a Neurologic
Condition
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX® 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX® 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
Among patients not using CIC at baseline, those with multiple
sclerosis were more likely to require CIC postinjection than those with spinal cord
injury.
Human Albumin and Transmission of Viral
Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
ADVERSE REACTIONS
Adverse reactions to BOTOX® for injection are discussed in greater detail in the following sections: Boxed Warning, Contraindications, and Warnings and Precautions.
Adverse reactions to BOTOX® for injection are discussed in greater detail in the following sections: Boxed Warning, Contraindications, and Warnings and Precautions.
Overactive Bladder
The most frequently reported adverse reactions for overactive bladder occurring within 12 weeks of injection include urinary tract infection (BOTOX® 18%, placebo 6%); dysuria (BOTOX® 9%, placebo 7%); urinary retention (BOTOX® 6%, placebo 0%); bacteriuria (BOTOX® 4%, placebo 2%); and residual urine volume (BOTOX® 3%, placebo 0%).
The most frequently reported adverse reactions for overactive bladder occurring within 12 weeks of injection include urinary tract infection (BOTOX® 18%, placebo 6%); dysuria (BOTOX® 9%, placebo 7%); urinary retention (BOTOX® 6%, placebo 0%); bacteriuria (BOTOX® 4%, placebo 2%); and residual urine volume (BOTOX® 3%, placebo 0%).
A higher incidence of urinary tract infection was observed in
patients with diabetes mellitus treated with BOTOX® 100
Units and placebo than nondiabetics.
The incidence of UTI increased in patients who experienced a
maximum post-void residual (PVR) urine volume ≥ 200 mL following BOTOX® injection compared to those with a maximum PVR < 200 mL
following BOTOX® injection, 44% vs 23%, respectively.
Adult Detrusor Overactivity Associated With a Neurologic
Condition
The most frequently reported adverse reactions within 12 weeks of BOTOX® injection for detrusor overactivity associated with a neurologic condition include urinary tract infection (BOTOX® 24%, placebo 17%); urinary retention (BOTOX® 17%, placebo 3%); and hematuria (BOTOX® 4%, placebo 3%).
The most frequently reported adverse reactions within 12 weeks of BOTOX® injection for detrusor overactivity associated with a neurologic condition include urinary tract infection (BOTOX® 24%, placebo 17%); urinary retention (BOTOX® 17%, placebo 3%); and hematuria (BOTOX® 4%, placebo 3%).
The following adverse event rates were reported at any time
following initial injection and prior to reinjection or study exit (median duration
of 44 weeks of exposure): urinary tract infections (49%), urinary retention (17%),
constipation (4%), muscular weakness (4%), dysuria (4%), fall (3%), gait disturbance
(3%), and muscle spasm (2%).
Postmarketing Experience
Adverse reactions that have been identified during postapproval use of BOTOX® are discussed in greater detail in Postmarketing Experience (Section 6.3 of the Prescribing Information).
Adverse reactions that have been identified during postapproval use of BOTOX® are discussed in greater detail in Postmarketing Experience (Section 6.3 of the Prescribing Information).
There have been spontaneous reports of death, sometimes
associated with dysphagia, pneumonia, and/or other significant debility or
anaphylaxis, after treatment with botulinum toxin. There have also been reports of
adverse events involving the cardiovascular system, including arrhythmia and
myocardial infarction, some with fatal outcomes. Some of these patients had risk
factors, including cardiovascular disease. The exact relationship of these events to
the botulinum toxin injection has not been established.
DRUG
INTERACTIONS
Co-administration of BOTOX® and other agents interfering with neuromuscular transmission (eg, aminoglycosides, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® may potentiate systemic anticholinergic effects. 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. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX®.
Co-administration of BOTOX® and other agents interfering with neuromuscular transmission (eg, aminoglycosides, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® may potentiate systemic anticholinergic effects. 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. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX®.
References: 1. BOTOX® Prescribing
Information, July 2021.
2. Data on file,
Allergan.
3. Cubanski J, Damico A, Neuman T, Jacobson G. Sources of supplemental coverage among Medicare beneficiaries in 2016. Kaiser Family Foundation. November 28, 2018. Accessed May 13, 2021. https://www.kff.org/medicare/issue-brief/sources-of-supplemental-coverage-among-medicare-beneficiaries-in-2016/.
4. Data on file, National Association for Continence, January 2020; NAFC’s 2nd Annual Survey—Talking to Your Doctor.
5. Hashim H, Beusterien K, Bridges JF, Amos K, Cardozo L. Patient preferences for treating refractory overactive bladder in the UK. Int Urol Nephrol. 2015;47(10):1619-1627.
6. Sievert KD, Chapple C, Herschorn S, et al. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014;68(10):1246-1256.
7. Nitti VW, Dmochowski R, Herschorn S, et al; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo-controlled trial. J Urol. 2013;189(6):2186-2193.
8. Chapple C, Sievert KD, MacDiarmid S, et al. OnabotulinumtoxinA 100U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomized, double-blind, placebo-controlled trial. Eur Urol. 2013;64(2):249-256.
9. Patrick DL, Khalaf KM, Dmochowski R, Kowalski JW, Globe DR. Psychometric performance of the incontinence quality-of-life questionnaire among patients with overactive bladder and urinary incontinence. Clin Ther. 2013;35(6):836-845.
10. Everaert K, Gruenenfelder J, Schulte-Baukloh H, et al. Impact of onabotulinumtoxinA on quality of life and practical aspects of daily living: a pooled analysis of two randomized controlled trials. Int J Urol. 2015;22(12):1131-1137.
11. Nitti VW, Ginsberg D, Sievert KD, et al. Durable efficacy and safety of long-term onabotulinumtoxinA treatment in patients with overactive bladder syndrome: final results of a 3.5-year study. J Urol. 2016;196(3):791-800.
12. Kennelly M, Chapple CR, Hale D, Sand P, Khullar V. Expert consensus guidance on appropriate management of incomplete voiding of the bladder post-onabotulinumtoxinA injection in patients with idiopathic overactive bladder. EMJ Urol. 2020;8(suppl 1):2-12.
+
Important Safety Information
IMPORTANT SAFETY INFORMATION,
INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that 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 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
Postmarketing reports indicate that 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 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