Botulinum toxin type B interacts in the following cases:
Co-administration of botulinum toxin type B and aminoglycosides or agents interfering with neuromuscular transmission (e.g. curare-like compounds) should be considered with caution.
Animal reproduction studies are insufficient with respect to effects on pregnancy and embryonal/foetal development. The potential risk for humans is unknown. Botulinum toxin type B should not be used during pregnancy unless the clinical condition of the woman requires treatment with botulinum toxin type B.
It is unknown whether botulinum toxin type B is excreted in human breast milk. The excretion of botulinum toxin type B in milk has not been studied in animals. A decision must be made on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with botulinum toxin type B taking into account the benefit of breast-feeding to the child and the benefit of botulinum toxin type B therapy to the woman.
No fertility studies have been performed and it is not known whether botulinum Toxin type B can affect reproduction capacity.
No studies on the effects on the ability to drive and use machines have been performed. Botulinum toxin type B may impair the ability to drive or operate machinery in case of adverse reactions such as muscle weakness and eye disorders (blurred vision, eyelid ptosis).
The most commonly reported adverse reactions associated with botulinum toxin type B treatment were dry mouth, dysphagia, dyspepsia, and injection site pain.
Adverse reactions related to spread of toxin distant from the site of administration have been reported: exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases.
Adverse reactions seen in all clinical studies are listed below according to MedDRA system organ class and in decreasing frequency which is defined as follows: Very Common (>1/10); Common (>1/100 to <1/10); Uncommon (>1/1000 to <1/100).
| System Organ Class | Very Common | Common |
|---|---|---|
| Nervous system disorders | dry mouth, headache | torticollis (worsening from baseline), taste perversion |
| Eye disorders | blurred vision | |
| Respiratory thoracic and mediastinal disorders | dysphonia | |
| Gastrointestinal disorders | dysphagia | dyspepsia |
| Musculoskeletal connective tissue and bone disorders | myasthenia | |
| General disorders and administration site conditions | injection site pain | neck pain influenza like illness |
In common with Botulinum Toxin Type A, electrophysiological jitter, which is not associated with clinical weakness or other electrophysiological abnormalities, may be experienced in some distant muscles.
Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases).
The following effects have also been reported during post marketing use: abnormal accommodation, dry eye, ptosis, vomiting, constipation, flu-like symptoms, asthenia, angioedema, rash, urticaria and pruritus.
The available reports indicate that the product has been used in the paediatric population. Case reports are more likely to be serious in children (40%) compared to those in adults and older people (12%), possibly as a result of using an inappropriately high dosage for the child.
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