Nabota Special Precautions

General: The safe and effective use of botulinum toxin product depends upon proper storage of the product, selection of the correct dose and proper reconstitution and administration techniques.
The relevant anatomy and any alterations to the anatomy due to prior surgical procedures, must be understood prior to administering botulinum toxin product and care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received botulinum toxin product injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Some patients had preexisting dysphagia or significant debility. Pneumothorax associated with injection procedure has been reported following the administration of botulinum toxin product near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.
An understanding of standard electromyographic techniques is also required for treatment of strabismus and may be useful for the treatment of cervical dystonia and hemifacial spasm and for the treatment of focal spasticity associated with stroke or pediatric cerebral palsy.
Caution should be used when botulinum toxin product is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Caution should also be exercised when botulinum toxin product is utilized for treatment of patients with amyotrophic lateral sclerosis or disorders that produce peripheral neuromuscular dysfunction.
No cases of systemic toxicity have been reported following accidental injection or oral ingestion of botulinum toxin product. Signs of overdose are not apparent immediately post-injection. Should accidental or oral ingestion occur, the patient should be medically supervised for several days on an office or outpatient basis for signs or symptoms of systemic weakness or muscle paralysis.
Anaphylactic reactions to botulinum toxin type A have not been reported so far, but as with all biological products, necessary precautions should be taken, adrenaline (epinephrine) and other anaphylactic measures should be available.
NABOTA contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
Blepharospasm: Reduced blinking following the use of botulinum toxin product injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defects and corneal ulceration, especially in patients with VII^th nerve disorders. Careful testing of corneal sensation in eyes previously operated upon, avoidance of injection into the lower lid area to avoid ectropion and vigorous treatment of any epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses or closures of the eye by patching or other means.
Because of the anticholinergic activity of botulinum toxin, caution should be exercised when treating patients at risk for angle-closure glaucoma, including patients with anatomically narrow angles. Acute angle glaucoma has been reported very rarely following periorbital injections of botulinum toxin.
Strabismus: During the administration of botulinum toxin product for the treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred from needle penetrations into the orbit. It is recommended that appropriate instruments to decompress the orbit be accessible. Ocular (globe) penetrations by needles have also occurred. An ophthalmoscope to diagnose this condition should be available.
Cervical Dystonia: The most frequently reported severe adverse event associated with the use of botulinum toxin type A in patients with cervical dystonia is dysphagia, with dyspnea also being reported on occasion. On rare occasions, the dysphagia has been severe enough to warrant the insertion of a gastric feeding tube. Dysphagia may persist for 2-3 weeks after injection, but infrequently has been reported to last 5 months post-injection. There have also been at least 2 reported incidents where subsequent to the finding of dysphagia, patients developed aspiration pneumonia and died. Limiting the dose injected into the sternocleidomastoid muscle to <100 units may decrease the occurrence of dysphagia. Patients with smaller neck muscle mass or patients who require bilateral injections into the sternocleidomastoid muscle, have been reported to be at greater risk of dysphagia. Dysphagia may be attributable to distribution of the pharmacological effect of botulinum toxin product resulting from spread of the toxin in the vicinity of the injection site.
Cerebral Palsy and Focal Spasticity in Adults: Botulinum toxin product is a treatment of focal spasticity that has been studied in association with usual standard of care regimens. Botulinum toxin product is not likely to be effective in improving range of motion at a joint affected by a fixed contracture.
Hyperhidrosis: Patients should be evaluated for potential causes of secondary hyperhidrosis (eg, hyperthyroidism, pheochromocytoma) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Chronic Migraine: Refer to preceding Precautions, including specific information for Cervical Dystonia, Blepharospasm and Strabismus, due to similar injection sites.
Neurogenic Detrusor Overactivity: Appropriate medical caution should be exercised for performing a cystoscopy.
In these patients, autonomic dysreflexia associated with the procedure could occur, which may require prompt medical therapy.
Due to the risk of urinary retention, only who are willing and/or able to initiate catheterization post-treatment, if required, should be considered for treatment.
In patient who are not catheterizing, post-void residual urine volume should be assessed within 2 weeks post-treatment and periodically as medically appropriate up to 12 weeks. Patients should be instructed to contact their physician if they experience difficulties in voiding as catheterization may be required.
Information for Patients: As with any treatment with the potential to allow previously sedentary patients to resume activities, the sedentary patient should be cautioned to resume activity gradually following the administration of botulinum toxin product. Patients should also be advised of the potential for experiencing malaise lasting up to 6 weeks after injection.
After bladder injections for urinary incontinence, patients should be instructed to contact their physician if they experience difficulties in voiding.
Effects on the Ability to Drive or Operate Machinery: There are no known sedative effects of botulinum toxin. Its effects on the neuromuscular junction with consequent effects on muscle activity need to be taken into consideration together with an appraisal of the underlying disease when advising patients on their suitability to drive or operate machinery.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: The safety and effectiveness of botulinum toxin in the treatment of blepharospasm, hemifacial spasm and associated focal dystonias, spasmodic torticollis or upper facial lines (forehead, crow's feet and glabellar lines) in children <12 years have not been demonstrated.
Safety and effectiveness in children and adolescents below the age of 20 years were not investigated for improvement of glabellar lines.
The safety and efficacy of upper limb spasticity have not been established in children and adolescents under the age of 18 years.