See Supplemental Patient Information
- Potency units of the formulation are specific to the preparation and utilized assay method; formulation is not interchangeable with other preparations of botulinum toxin products and cannot be compared to or converted into units of any other botulinum toxin products assessed using any other specific assay method
- Toxin effects are observed beyond the site of local injection
- Asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties have occurred [US Black Box Warning]
- Life threatening swallowing and breathing difficulties has occurred; even deaths have been reported. Children treated for spasticity are at higher risk. Symptoms have also occurred in those adults having history of underlying conditions predisposing them to these symptoms [US Black Box Warning]
- In unapproved uses including spasticity in children, and in approved indications, symptoms consistent with spread of toxin effect have occurred at doses comparable to or lower than doses used to treat cervical dystonia [US Black Box Warning]
- Dysphagia and breathing difficulties in treatment of cervical dystonia have occurred; patients with pre-existing swallowing or breathing diffculties are more susceptible. Weakening of muscles in the area of injection involved in breathing or swallowing has occurred. Additional respiratory muscles are involved on occurring of distant effects
- Deaths have occurred due to complication of severe dysphagia. Persistent dysphagia for several weeks requires use of a feeding tube to maintain adequate nutrition and hydration. Aspiration due to severe dysphagia is a particular risk when treating patients in whom swallowing or respiratory function is already compromised
- Treatment of cervical dystonia with botulinum toxins weakens neck muscles that serve as accessory muscles of ventilation. Critical loss of breathing capacity have occurred in patients with respiratory disorders who are dependent upon accessory muscles
- Serious breathing difficulties including respiratory failure have been reported on post marketing surveillance in cervical dystonia patients
- Patients with smaller neck muscle mass and patients requiring bilateral injections into the sternocleidomastoid muscle are susceptible to greater risk for dysphagia
- Immediately provide medical attention on developing problems with swallowing, speech or respiratory disorders
- Injecting drug into the levator scapulae is associated with an increased risk of URTI and dysphagia
- Closely monitor patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders. Patients with neuromuscular disorders are at increased risk of clinically significant effects including severe dysphagia and respiratory compromise
- Closely monitor patients with compromised respiratory status for upper limb spasticity
- Theoretical and extremely remote risk for transmission of Creutzfeldt-Jakob disease exists
- Safety of abobotulinum toxin A for the treatment of hyperhidrosis have not been established
Cautions: Use cautiously in
- Inflamed skin at site of application
- Atrophy at site of application
- Dysphagia
- Small neck muscle mass (on use for cervical dystonia)
- Pulmonary impairment
- Neuromuscular disease
- Facial nerve disorder
- Lambert-Eaton syndrome
- Myasthenia gravis
- Amyotrophic lateral sclerosis
- Motor neuropathy
- Ptosis
- Deep dermal scarring
- Dermatochalasis
- Thick sebaceous skin
- Diabetes mellitus
Supplemental Patient Information
- Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking, or breathing), or if worsening of existing symptoms
- Advise patients to avoid driving a car or engaging in other potentially hazardous activities
Pregnancy Category:C
Breastfeeding: Safety Unknown; unknown whether this drug is excreted in human milk. Manufacturer advises to use this drug during pregnancy only if the potential benefit justifies the potential risk to the fetus.
