Additional Information

Description

BOTOX® (onabotulinumtoxinA) is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. Each vial of BOTOX (onabotulinumtoxinA) for injection contains 200 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride.

BOTOX® (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the following: 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; 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; 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; prophylaxis of headaches in adult patients with chronic migraine (=15 days per month with headache lasting 4 hours a day or longer).

It is also used in the treatment of spasticity in patients 2 years of age and older; treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain; treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients; treatment of blepharospasm associated with dystonia in patients 12 years of age and older; treatment of strabismus in patients 12 years of age and older. Safety and effectiveness of BOTOX®   have not been established for: prophylaxis of episodic migraine (14 headache days or fewer per month); treatment of upper or lower limb spasticity in pediatric patients; treatment of hyperhidrosis in body areas other than axillary.

Follow indication-specific dosage and administration recommendations; Do not exceed a total dose of 400 units administered in a 3-month interval.  BOTOX® (onabotulinumtoxinA) is contraindicated for use in patients with hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation; infection at the proposed injection site; intradetrusor injections: urinary tract infection or urinary retention. 

Prescribing information for product information, medication guide, warnings, and precautions: https://www.rxabbvie.com/pdf/botox_pi.pdf