1
INDICATIONS AND USAGE
BOTOX is an acetylcholine releaseinhibitor 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 5years 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 (15days 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 12years of age and older (1.7)
Treatment of strabismus in patients12 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)
1.1
Adult
Bladder Dysfunction
Overactive Bladder
BOTOXfor 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
BOTOXis indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
1.2
Pediatric
Detrusor
Overactivity associated with a Neurologic Condition
BOTOX is indicated for the 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.
3
Chronic
Migraine
BOTOXis indicated for the prophylaxis of headaches in adult patients with chronic migraine (15 days per month with headache lasting 4 hours a day or longer).
Limitations of Use
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies.
1.
4
Spasticity
BOTOX is indicated for the treatment of spasticity in patients 2 years of age and older.
Limitations of Use
BOTOX has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture.
1.
5
Cervical Dystonia
BOTOX is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
1.
6
Primary Axillary Hyperhidrosis
BOTOX is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
Limitations of Use
The safety and effectiveness of BOTOX for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Safety and effectiveness of BOTOX have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.
1
.
7
Blepharospasm and Strabismus
BOTOX is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and older.