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
- Effects of injection may spread from therapeutic area of site of application to produce symptoms consistent with botulinum toxin effects. Asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties symptoms have occurred hours to weeks after injection [US Black Box Warning]
- Life threatening swallowing and breathing difficulties have occurred; even deaths have been reported [US Black Box Warning]
- 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 indications, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses [US Black Box Warning]
- Dysphagia and breathing difficulties in treatment of cervical dystonia have occurred. Patients with pre-existing swallowing or breathing difficulties are more prone to these complications. Weakening of muscles in the area of injection involved in breathing or swallowing have occurred
- Persistent dysphagia for several months 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
- Patients having history of respiratory disorders are prone to critical loss in breathing capacity
- Serious breathing difficulties including respiratory failure have occurred 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
- Provide immediate medical attention to patients treated with botulinum toxin on occurrence of problems with swallowing, speech or respiratory disorders
- 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
- Theoretical and extremely remote risk for transmission of Creutzfeldt-Jakob disease exists
- Initiate treatment of botulinum toxin naïve patients at lower doses
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
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; literature unavailable on the medical use of botulin A (botulinum toxin) during breastfeeding. One infant was safely breastfed during maternal botulism and no botulinum toxin was detected in the mother's milk or infant. As the doses used medically are far lower than those that cause botulism, amounts ingested by the infant, if any, are expected to be insignificant and not cause any adverse effects in breastfed infants. No special precautions required. This information is based on based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 January 2011). Manufacturer advises caution.
