Nabota Warnings

The term "unit" upon which dosing is based, is a specific measurement of toxin activity that is unique to Daewoong's formulation of botulinum toxin type A. Therefore, the "unit" used to describe NABOTA activity are different from those used to describe that of other botulinum toxin preparations and the units representing NABOTA activity are not interchangeable with other products.
NABOTA should only be given by physicians with the appropriate qualifications and experience in the treatment of patients and the use of required equipment. The relevant anatomy, and any alterations to the anatomy due to prior surgical procedures, must be understood prior to administering NABOTA and injection into vulnerable anatomic structures must be avoided.
Distant Spread of Toxin Effect: Post-marketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms that are consistent with the mechanism of action of botulinum toxin have been reported hours to weeks after injection, and may include muscular weakness, ptosis, diplopia, blurred vision, facial weakness, swallowing and speech disorders, constipation, aspiration pneumonia, difficulty breathing and respiratory depression. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in patients who have underlying conditions and comorbidities that would predispose them to these symptoms including adults treated for spasticity and other conditions and are treated with high doses. Swallowing and breathing difficulties can be life threatening and death has been reported, although a definitive casual association to botulinum toxin product has not been established.