OnabotulinumtoxinA

OnabotulinumtoxinA may be found in some form under the following brand names:

• Botox

• Botox Cosmetic

Before receiving onabotulinumtoxinA tell your doctor about all your medical conditions, including if you:

• have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome)
• have allergies to any botulinum toxin product
• had any side effect from any botulinum toxin product in the past
• have or have had a breathing problem, such as asthma or emphysema
• have or have had swallowing problems
• have or have had bleeding problems
• have plans to have surgery
• had surgery on your face
• have weakness of your forehead muscles, such as trouble raising your eyebrows
• have drooping eyelids
• have any other change in the way your face normally looks
• have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence. Symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever.
• have problems emptying your bladder on your own and are being treated for urinary incontinence

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products. 

Storage

Parenteral

2–8°C; do not use after expiration date marked on vial.1 5

Following reconstitution with 0.9% sodium chloride injection without preservatives, store at 2–8°C and use within 24 hours; do not freeze.1 5

• Inform patients with cervical dystonia of possibility of dysphagia (typically mild to moderate);1 9 14 57 69 rarely, severe dysphagia occurs, sometimes associated with aspiration, dyspnea, pneumonia, and need to reestablish an airway.1 5

• Importance of informing patients of possible systemic effects (e.g., weakness, shortness of breath, respiratory complications, swallowing difficulties) following local injection.371

• Advise patients and/or caregivers to seek immediate medical attention if unexpected muscle weakness, swallowing, speech, or respiratory disorders occur.1 5 371

• Advise previously sedentary patients to resume activity gradually following treatment.1 296 298

• Advise women who become pregnant while receiving the drug of the potential risks to the fetus and that abortion and fetal malformations have been observed in animals given the drug during gestation.1 5 296 298

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., neuromuscular disorders).

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

(oh nuh BOT yoo lin num TOKS in aye)

Axillary hyperhidrosis (Botox):

Treatment of severe primary axillary hyperhidrosis in adults not adequately managed with topical agents.

The safety and effectiveness for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive onabotulinumtoxinA for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (eg, hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.

Cervical dystonia (Botox): Treatment of cervical dystonia in patients ≥16 years to reduce the severity of abnormal head position and neck pain.

Chronic migraine (Botox): Prophylaxis of chronic migraine headaches (≥ 15 days/month with headache lasting ≥4 hours/day) in adults.

Glabellar lines (Botox Cosmetic): Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.

Lateral canthal lines (Botox Cosmetic): Temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adults.

Lower limb spasticity (Botox): Treatment of lower limb spasticity in adults to decrease the severity of increased muscle tone in ankle and toe flexors (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus).

Overactive bladder (Botox): Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults who have an inadequate response to or who are intolerant to an anticholinergic medication.

Strabismus and blepharospasm associated with dystonia (Botox): Treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders, in patients ≥12 years.

Upper limb spasticity (Botox): Treatment of upper limb spasticity in adults to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), finger flexors (flexor digitorum profundus and flexor digitorum sublimis), and thumb flexors (adductor pollicis and flexor pollicis longus).

Urinary incontinence due to detrusor overactivity (Botox): Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury [SCI], multiple sclerosis [MS]) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Canadian labeling: Additional use (not in US labeling): Dynamic equinus foot deformity in pediatric cerebral palsy patients; treatment of forehead lines in adults

Achalasia

American College of Gastroenterology (ACG) guidelines recommend botulinum toxin for patients with achalasia who are not candidates for pneumatic dilation or surgical myotomy, based on moderate-quality evidence. OnabotulinumtoxinA was the most frequently used product in controlled trials. Controlled trials demonstrate high rates of response (up to 75%) that may decrease over time, with repeat treatments possibly required at 6- to 24-month intervals.

Anal fissures

Evidence-based guidelines recommend botulinum toxin A intramuscular (IM) injection as an option for the treatment of anal fissures in adults who have not responded to preferred therapy. Healing rates do not appear to be affected by dose, formulation, or injection technique, although using an anterior injection location for posterior anal fissures may provide benefit over usual posterior administration. It is important to note that botulinum toxin A formulations are not interchangeable.

Sialorrhea (drooling) (adults)

The use of botulinum toxin A for decreasing or controlling sialorrhea has demonstrated benefit in randomized controlled trials and meta-analyses in patients with various neurological conditions. EFNS guidelines on the clinical management of ALS recommend botulinum toxin A in patients refractory to first-line therapy. An AAN report classifies botulinum toxin A as probably safe and effective in Parkinson-related sialorrhea. Additional study is needed to determine the expected duration of response, potential candidates, optimal dosing regimens, and standardization of injection procedures.

Tardive dyskinesia

Evidence from small, noncontrolled trials suggests some benefit with botulinum toxin A for treatment of localized tardive dyskinesia (eg, orofacial, head and neck, cervical). Evaluation of data is limited because several studies do not specify what botulinum toxin type A product was used. Use of onabotulinumtoxinA has been evaluated primarily in case reports demonstrating benefit in most patients. AAN clinical practice guidelines find the data inadequate to support or refute the use of botulinum toxin type A for treatment of tardive dyskinesia.

Additional Off-Label Uses

Dynamic muscle contracture in pediatric cerebral palsy patients; Oromandibular dystonia; Spasmodic dysphonia (laryngeal dystonia) and other dystonias (ie, writer's cramp, focal task-specific dystonias)

There are no dosage adjustments provided in the manufacturer’s labeling.

Store unopened vials under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 36 months or until the expiration date on the vial. After reconstitution, store in refrigerator at 2°C to 8°C (36°F to 46°F) and use within 24 hours (does not contain a preservative).

Botox 100-unit vial: The following stability information has also been reported: May be stored at room temperature for up to 5 days (Cohen 2007).

Adverse effects usually occur in 1 week and may last up to several months. Frequency not always defined.

>10%:

Bladder dysfunction:

Genitourinary: Urinary tract infection (18% to 49%), urinary retention (6% to 17%)

Cervical dystonia:

Central nervous system: Headache (11%)

Gastrointestinal: Dysphagia (19%)

Neuromuscular & skeletal: Neck pain (11%)

Respiratory: Upper respiratory tract infection (12%)

Other indications (blepharospasm, glabellar lines, lateral canthal lines, primary axillary hyperhidrosis, strabismus):

Ophthalmic: Blepharoptosis (blepharospasm: 21%; strabismus: 1% to 38%; glabellar lines: 3%), vertical deviation of eyes (strabismus 17%)

1% to 10%:

Bladder dysfunction:

Central nervous system: Myasthenia (4%), abnormal gait (3%), falling (3%)

Gastrointestinal: Constipation (4%)

Genitourinary: Dysuria (4% to 9%), bacteriuria (4%), hematuria (4%), increased post-void residual urine volume (not requiring catheterization: 3%)

Neuromuscular & skeletal: Muscle spasm (2%)

Cervical dystonia:

Central nervous system: Dizziness (2% to 10%), hypertonia (2% to 10%), numbness (2% to 10%), speech disturbance (2% to 10%), drowsiness

Gastrointestinal: Nausea (2% to 10%), xerostomia (2% to 10%)

Immunologic: Antibody development (1%)

Local: Injection site reaction: Soreness (2% to 10%)

Neuromuscular & skeletal: Back pain (2% to 10%), stiffness (2% to 10%), weakness (2% to 10%)

Ophthalmic: Blepharoptosis (2% to 10%), diplopia (2% to 10%)

Respiratory: Cough (2% to 10%), dyspnea (2% to 10%), flu-like symptoms (2% to 10%), rhinitis (2% to 10%)

Miscellaneous: Fever (2% to 10%)

Chronic migraines:

Cardiovascular: Hypertension (2%)

Central nervous system: Headache (5%), exacerbation of migraine headache (4%), facial paresis (2%)

Local: Pain at injection site (3%)

Neuromuscular & skeletal: Neck pain (9%), myasthenia (4%), stiffness (4%), musculoskeletal pain (3%), myalgia (3%), muscle spasm (2%)

Ophthalmic: Blepharoptosis (4%)

Respiratory: Bronchitis (3%)

Lower limb spasticity:

Local: Pain at injection site (2%)

Neuromuscular & skeletal: Arthralgia (3%), back pain (3%), myalgia (2%)

Respiratory: Upper respiratory tract infection (2%)

Upper limb spasticity:

Central nervous system: Fatigue (2% to 3%)

Gastrointestinal: Nausea (2% to 3%)

Neuromuscular & skeletal: Limb pain (5% to 9%), myasthenia (2% to 4%)

Respiratory: Bronchitis (2% to 3%)

Other indications (blepharospasm, glabellar lines, lateral canthal lines, primary axillary hyperhidrosis, reduction of glabellar lines, strabismus):

Central nervous system: Facial pain (1%), facial paresis (1%), anxiety, dizziness, headache, pain

Dermatologic: Diaphoresis (nonaxillary), pruritus, skin rash

Gastrointestinal: Nausea

Immunologic: Antibody development (2%)

Infection: Infection

Local: Injection site reaction: Hemorrhage, pain, soreness

Neuromuscular & skeletal: Weakness (1%), back pain, neck pain

Ophthalmic: Dry eye syndrome (6%), eyelid edema (1%), diplopia, ectropion, entropion, eye irritation (includes dry eye, lagophthalmos, photophobia), keratitis, lacrimation, superficial punctate keratitis

Respiratory: Flu-like symptoms, pharyngitis

Miscellaneous: Fever

<1% (Limited to important or life-threatening): Any indication: Acute angle-closure glaucoma, alopecia, amyotrophy, anaphylaxis, anorexia, antibody development (neutralizing), aspiration pneumonia, asthma, brachial plexopathy, cardiac arrhythmia, corneal perforation, corneal ulceration, denervation, erythema, erythema multiforme, exacerbation of myasthenia gravis, eye infection, focal facial paralysis, hypersensitivity reaction, hypoacusis, lagophthalmos, madarosis, myalgia, myocardial infarction, peripheral neuropathy, pneumonia, psoriasiform eruption, radiculopathy, reduced blinking, respiratory depression, respiratory failure, retrobulbar hemorrhage, seizure, serum sickness, syncope, urinary incontinence

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Serious and/or immediate hypersensitivity reactions (eg, anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea) have occurred. If a reaction occurs, discontinue and institute immediate treatment.

• Antibody formation: Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy.

• Autonomic dysreflexia: Has been observed with therapy in patients with detrusor overactivity associated with a neurologic condition; acts as stimuli to trigger an exaggerated sympathetic and parasympathetic response. Clinical presentation often includes headache, a marked increase in blood pressure, and diaphoresis; prompt treatment may be required in patients presenting with severe symptoms (eg, hypertensive crisis).

• Cardiovascular events: Arrhythmia and MI (some fatal) have been reported following administration. Some of these patients had risk factors including preexisting cardiovascular disease. The exact relationship to onabotulinumtoxinA has not been established.

• Dysphagia: Common when used for cervical dystonia and may persist anywhere from 2 weeks up to 5 months after administration. In severe cases (some fatal), patients may require alternative feeding methods (eg, feeding tube). Risk factors include smaller neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae. Risk of aspiration resulting from severe dysphagia is increased in patients when swallowing is already compromised. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia.

• Hematologic: Use with caution in patients with bleeding disorders and/or receiving anticoagulation therapy.

• Respiratory effects: Bronchitis and upper respiratory infection have been reported more frequently in patients treated for upper or lower limb spasticity.

• Systemic toxicity: [US Boxed Warning]: Distant spread of botulinum toxin beyond the site of injection has been reported; dysphagia and breathing difficulties have occurred and may be life threatening; other symptoms reported include blurred vision, diplopia, dysarthria, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence, which may develop within hours or weeks following injection. The risk is likely greatest in children treated for the unapproved use of spasticity, but symptoms can also occur in adults treated for spasticity and other conditions. Systemic effects have occurred following use in approved and unapproved uses, including doses comparable to or lower than doses used to treat cervical dystonia and upper limb spasticity. Immediate medical attention required if respiratory disorders, speech, or swallowing difficulties appear.

• Urinary retention: An increased incidence of urinary retention and need for catheterization has been observed in patients receiving therapy for bladder dysfunction (overactive bladder or detrusor overactivity associated with a neurologic condition); due to the risk of urinary retention, treatment should only be used in patients able and willing to initiate post-treatment catheterization, if required. Patients with diabetes had an increased incidence of urinary retention. Patients experiencing difficulty in voiding should be instructed to consult their health care provider.

• UTI: Therapy in patients with overactive bladder increases the incidence of UTIs; clinical trials for overactive bladder excluded patients with >2 UTIs in the previous 6 months and those taking chronic antibiotics for prophylaxis of recurrent UTIs. Consider risks versus benefits when contemplating use in these patients or patients experiencing recurrent UTIs during treatment. Patients with diabetes had an increased incidence of UTI.

Disease-related concerns:

• Episodic migraines: Safety and efficacy have not been established in patients with 14 or fewer headaches per month.

• Neuromuscular disease: Use with caution in patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis, Lambert-Eaton syndrome). Risk of adverse events including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise may be increased.

• Ocular diseases: Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration when treating blepharospasm. Retrobulbar hemorrhages may occur from needle penetration into orbit when treating strabismus; spatial disorientation, double vision, or past-pointing may occur if one or more extraocular muscles are paralyzed. Covering the affected eye may help. Careful testing of corneal sensation, avoidance of lower lid injections, and treatment of epithelial defects are necessary. Use caution in patients with angle closure glaucoma.

• Respiratory disease: Use extreme caution in patients with preexisting respiratory disease; treatment with botulinum toxin may weaken accessory muscles that are necessary for these patients to maintain adequate ventilation. Serious breathing difficulties, including respiratory failure, have been reported. Risk of aspiration resulting from severe dysphagia is increased in patients with decreased respiratory function.

Concurrent drug therapy issues:

• Neuromuscular transmission: Use with extreme caution in patients receiving other agents that may interfere with neuromuscular transmission (eg, aminoglycosides, neuromuscular-blocking agents)

Dosage form specific issues:

• Albumin: Product may contain albumin; albumin carries an extremely remote risk for transmission of viral diseases, Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD). No cases of transmission of viral diseases, CJD, or vCJD have been identified for licensed albumin or albumin contained in other licensed products.

• Product interchangeability: Botulinum products (abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) are not interchangeable; potency units are specific to each preparation and cannot be compared or converted to any other botulinum product.

Other warnings/precautions:

• Bladder dysfunction: Appropriate use: Rule out acute UTI prior to treatment; appropriate prophylactic antimicrobial therapy is required prior to, during, and following treatment. Discontinue antiplatelet therapy at least 3 days prior to administration.

• Hazardous tasks: May impair ability to drive and/or operate machinery due to the intended effects of treatment; if loss of strength, muscle weakness, or impaired vision occurs, patients should avoid driving or engaging in other hazardous activities.

• Injection site: Use with caution if there is inflammation or excessive weakness or atrophy at the proposed injection site(s); use is contraindicated if infection is present. Serious events (including fatalities) have been observed with direct injection into the esophagus, stomach, salivary glands, and oro-lingual-pharyngeal region. Use caution when administering in close proximity to the lungs (especially the apices); pneumothorax has been reported following administration near the thorax.

• Primary axillary hyperhidrosis: Appropriate use: Evaluate for secondary causes prior to treatment (eg, hyperthyroidism). Safety and efficacy for treatment of hyperhidrosis in other areas of the body have not been established.

• Temporary reduction in glabellar lines: Appropriate use: Do not use more frequently than every 3 months (Canadian labeling states not to use more frequently than every 2 months). Patients with marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart were excluded from clinical trials. Use with caution in patients with surgical alterations to the facial anatomy. Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration. Spatial disorientation, double vision, or past pointing may occur if one or more extraocular muscles are paralyzed.

• Unapproved use: Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, including fatalities, have been reported in patients who have received injections for unapproved uses. In these cases, the reactions were not necessarily related to distant spread of toxin, but may have resulted from administration to the site of injection and/or adjacent structures; several patients had preexisting dysphagia or other significant disabilities.

• Upper or lower limb spasticity: Appropriate use: Safety and effectiveness of other upper or lower limb muscle groups have not been established. Treatment has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture.

Applies to onabotulinumtoxinA: injectable powder for injection

Gastrointestinal

Common (1% to 10%): Constipation, nausea
Uncommon (0.1% to 1%): Dysphagia, oral dryness
Postmarketing reports: Abdominal pain, anorexia[Ref]

Nervous system

Common (1% to 10%): Headache, worsening migraine, facial paresis
Uncommon (0.1% to 1%): Vertigo
Frequency not reported: VII nerve disorder, new or recurrent seizures
Postmarketing reports: Brachial plexopathy
Nervous system side effects have included fatigue (2 to 3%), dizziness (2 to 10%), fever (2 to 10%), drowsiness (2 to 10%), and numbness (2 to 10%).[Ref]

Respiratory

Common (1% to 10%): Bronchitis, cough, rhinitis, dyspnea, pharyngitis[Ref]

Musculoskeletal

Common (1% to 10%): Pain in extremity, muscle weakness, asthenia, back pain, hypertonia, stiffness, fall, gait disturbance, muscle spasm, neck pain, musculoskeletal stiffness, myalgia
Uncommon (0.1% to 1%): Jaw pain
Postmarketing reports: Denervation/muscle atrophy[Ref]

Cardiovascular

Common (1% to 10%): Hypertension
Frequency not reported: Arrhythmia, myocardial infarction (sometimes fatal)[Ref]

Local

Common (1% to 10%): Injection site pain[Ref]

Immunologic

Common (1% to 10%): Flu syndrome, infection
Frequency not reported: Immunogenicity (formation of neutralizing antibodies to botulinum toxin type A which may reduce the effectiveness of therapy)[Ref]

Ocular

Common (1% to 10%): Eyelid ptosis
Uncommon (0.1% to 1%): Dry eye, eyelid edema, eye infection, diplopia
Very rare (less than 0.01%): Corneal perforation
Frequency not reported: Superficial punctate keratitis, irritation, tearing, lagophthalmos, photophobia, ectropion, keratitis, diplopia, local swelling of the eyelid skin lasting for several days following eyelid injection, reduced blinking (from the injection of the orbicularis muscle which may lead to serious corneal exposure), persistent epithelial defect
Postmarketing reports: Visual disturbance[Ref]

Other

Common (1% to 10%): Fatigue, dizziness, hypertonia, asthenia, speech disorder, fever, stiffness, numbness, non-axillary sweating, sweating
Very rare (less than 0.01%): Brachial plexopathy
Frequency not reported: Focal facial paralysis, syncope, exacerbation of myasthenia gravis
Postmarketing reports: Hypoacusis, hypoesthesia, malaise, paresthesia, peripheral neuropathy, radiculopathy, tinnitus[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Frequency not reported: Diffuse skin rash
Postmarketing reports: Alopecia (including madarosis), erythema multiforme, dermatitis psoriasiform, psoriasiform eruption[Ref]

General

Adverse reactions usually occur within the first week following injection of this drug and while generally 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.[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (26% in patients without diabetes and 31% in patients with diabetes), urinary retention (24%)
Common (1% to 10%): Dysuria, hematuria, bacteriuria, residual urine volume

Hematologic

Common (1% to 10%): Hemorrhage[Ref]

Psychiatric

Common (1% to 10%): Anxiety[Ref]

Some side effects of onabotulinumtoxinA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

OnabotulinumtoxinA (Botox(R)):
GENERAL COMMENTS:
-Patients should not have an acute urinary tract infection prior to treatment. Prophylactic antibiotics (except aminoglycosides) should be administered 1 to 3 days pretreatment, on the treatment day, and 1 to 3 days posttreatment.
-Patients should discontinue antiplatelet therapy at least 3 days before the injection procedure. Patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.
-Appropriate caution should be exercised when performing a cystoscopy.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

OVERACTIVE BLADDER (OAB):
100 units per treatment

OAB COMMENTS:
-An intravesical instillation of diluted local anesthetic with or without sedation may be used prior to injection, per local site practice. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.
-Reconstituted drug is injected into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve adequate visualization for the injections, but over-distension should be avoided.
-The injection needle should be filled (primed) with approximately 1 mL of reconstituted drug prior to the start of injections (depending on the needle length) to remove any air.
-After the injections are given, patients should demonstrate their ability to void prior to leaving the clinic. The patient should be observed for at least 30 minutes post-injection and until a spontaneous void has occurred.
-Patients should be considered for reinjection when the clinical effect of the previous injection has diminished (median time until patients qualified for the second treatment about 24 weeks, but no sooner than 12 weeks from the prior bladder injection.

DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION:
200 units per treatment

DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION COMMENTS:
-An intravesical instillation of diluted local anesthetic with or without sedation, or general anesthesia may be used prior to injection. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.

Uses:
-OVERACTIVE BLADDER (OAB): 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 OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION: Treatment of urinary incontinence due to detrusor over activity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

US BOXED WARNINGS:
Distant Spread of Toxin Effect:
-The effects of 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 potentially fatal. 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 with an underlying condition that would predispose them to these symptoms. Spread of effects have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses.

Safety and efficacy have not been established in patients under 18 years of age for the prophylaxis of headaches in chronic migraine, treatment of OAB, detrusor overactivity associated with a neurologic condition, upper limb spasticity, and axillary hyperhidrosis; in patients under 16 years of age for treatment of cervical dystonia; and in patients under 12 years of age for treatment of blepharospasm and strabismus.

Consult WARNINGS section for additional precautions.