NeuroBloc is recommended for intramuscular administration only. The safety of NeuroBloc outside the approved indication has not been established. This warning includes use in children and in any other indication besides cervical dystonia.
The risks, which can include death, may outweigh the potential benefits. Seroconversion As with many biological/biotechnology proteins used as therapeutic agents, repeated administration of NeuroBloc may be associated with development of antibodies to Botulinum Toxin Type B in some patients.
1). An investigation into the consequence of seroconversion showed that the presence of antibodies was not synonymous with a loss of clinical response, and did not have an impact on the overall safety profile. However, the clinical relevance of the presence of antibodies as determined by the mouse neutralisation / mouse protection assay is uncertain.
Caution should be used in patients with bleeding disorders or receiving anticoagulant therapy. 8). These include dysphagia and breathing difficulties. Pre-Existing neuromuscular disorders Patients treated with therapeutic doses may experience exaggerated muscle weakness.
3). There have been spontaneous reports of dysphagia, aspiration pneumonia and/or potentially fatal respiratory disease, after treatment with Botulinum Toxin Type A/B. Children (non approved use) and patients with underlying neuromuscular disorders including swallowing disorders are at increased risk of these adverse reactions.
In patients with neuromuscular disorders or history of dysphagia and aspiration, botulinum toxins should only be used in an experimental setting under strict medical supervision. Following NeuroBloc treatment, all patients and caregivers should be advised to seek medical attention for respiratory difficulties, choking or any new or worsening dysphagia.
Dysphagia has been reported following injection to sites other than the cervical musculature. Lack of interchangeability between botulinum toxin products The initial starting dose of 10,000 U (or 5000 U) is relevant only to NeuroBloc (Botulinum Toxin Type B).
These dose units are specific to NeuroBloc only and are not relevant to preparations of Botulinum Toxin Type A. The unit dose recommendations for Botulinum Toxin Type A are significantly lower than those for NeuroBloc and administration of Botulinum Toxin Type A at the unit dose recommended for NeuroBloc may result in systemic toxicity and life-threatening clinical sequelae.