LEGAL GUIDELINES ON BOTULINUM TOXIN (BOTOX)
BOTOX 50, 100 or 200 ALLERGAN UNITS, powder for injectable solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
Type A botulinum toxin (Clostridium botulinum), 50, 100 or 200 ALLERGAN UNITS per vial. One unit corresponds to the lethal dose 50 (LD50) of the reconstituted product, injected intraperitoneally into mice.
Units of botulinum toxin are not interchangeable from one product to another.
Excipients: human albumin, sodium chloride
Powder for injectable solution.
CLINICAL DATA – THERAPEUTIC INDICATIONS
Treatment of idiopathic overactive bladder syndrome associated with the following symptoms:
- 3 episodes of urinary incontinence over the course of 3 days
- urinary frequency defined by a number of urinations ≥ 8 per day and not adequately responding to anticholinergics (after 3 months of treatment) or intolerant to anticholinergic treatment and not responding to well-managed physical therapy.
Treatment of neurogenic detrusor overactivity leading to urinary incontinence not controlled by anticholinergic treatment among:
- patients with spinal cord injuries
- patients suffering from multiple sclerosis using self-catheterisation as a method of urination.
Adults and children over 12 years of age
- Ocular motricity problems: strabismus, recent oculomotor paralysis, recent thyrotoxic myopathy
- Hemifacial spasm
- Spasmodic torticollis
- Severe axillary hyperhidrosis which is resistant to local treatment and brings serious psychological and social consequences.
Adults and children 2 years and over
Local symptomatic treatment of spasticity (muscular hyperactivity) of upper and/or lower limbs.
DOSAGE AND METHOD OF ADMINISTRATION
BOTOX must be administered as part of an overall, multidisciplinary treatment, by specialist doctors who already have considerable experience in the use of the toxin in these circumstances and a range of technical equipment.
The recommended doses of BOTOX are not interchangeable with those for other preparations of botulinum toxin. They are indicated in ALLERGAN UNITS (see section 4.4) and are different to other preparations of botulinum toxin.
If different types of BOTOX are used in one injection procedure, special attention must be paid to using the right amount of solvent by reconstructing the number of units by 0.1 ml measured. The quantity of solvent varies for BOTOX 50 ALLERGAN UNITS, BOTOX 100 ALLERGAN UNITS and BOTOX 200 ALLERGAN UNITS. Each syringe will be labelled accordingly.
If there is a history of neurogenic damage to the face, it is recommended to reduce the dosage during
the first injection session (see section Special warning and precautions for use).
Initial treatment must begin with the weakest dosage recommended for the procedure. Elderly patients with significant medical history and concomitant treatments must be treated with care.
The tolerance and effectiveness of BOTOX in the treatment of ocular motricity problems, blepharospasm, hemifacial spasm or cervical dystonia has not been established among children (younger than 12). No data is available.
The tolerance and effectiveness of BOTOX in the treatment of spasticity has not been established in children below the age of 2 years. No data is available.
The safety and effectiveness of BOTOX in the treatment of bladder dysfunctions has not been established in children and adolescents (below the age of 18). No data is available.
The tolerance and effectiveness of BOTOX in the treatment of primary axillary hyperhidrosis has not been established among children younger than 12.
Minimum period between 2 injection sessions:
The presence of antibodies against type A botulinum toxin can reduce the effectiveness of treatment with BOTOX. Consequently, as a precaution, a minimum period between 2 injection sessions must be respected:
- Guidelines for severe axillary hyperhidrosis which is resistant to local treatment: 4 months.
- For local symptomatic treatment of spasticity (muscular hyperactivity) of upper and/or lower limbs in adults and children over the age of 2: 3 months.
- For other guidelines for adults and children over 12 years of age: 2 months and 10 weeks for the treatment of spasmodic torticollis.
- For overactive bladder syndrome in adults: when the benefits of the previous injection diminish (in general, 6 months), whilst respecting the minimum interval of 3 months.
- For neurogenic detrusor overactivity in adults: when the benefits of the previous injection diminish (in general, 9 months), whilst respecting the minimum interval of 3 months.
Intramuscularly or intradermally following the guidelines. Refer to the specific recommendations described below.
Generally, the optimum dose and the number of injection sites per muscle are not set out in all the indications. In this case, the dosing schedules must be established individually by the practitioner. The optimum doses must always be established by titration and must not exceed the maximum recommended dose.
After disinfecting the skin, the diluted BOTOX dose is injected using a sterile needle which is suitable for the muscle to be injected.
Electromyographic guidance can increase the precision of the injection: the electrical activity recorded by the point of the injection needle is used as a guide to position it in the targeted muscle.
This guidance is essential in the treatment of strabismus.
With children, botulinum toxin injections must be administered by specialist doctors who have extensive experience in providing this treatment to children. This medical treatment must be included as part of an overall multidisciplinary treatment (involving a neurologist, paediatrician, specialist of physical medicine and rehabilitation, orthopaedic surgeon, etc.)
For adult patients suffering from overactive bladder syndrome, this medical treatment of injection in the detrusor muscle must be included within an overall multidisciplinary treatment, involving a urologist and obstetrician-gynaecologist doctor specifically trained in the use of botulinum toxin in these circumstances under the supervision of a urologist. Botulinum toxin injections must be carried out using a cystoscope, either flexible or rigid, avoiding the trigone.
For adult patients suffering from neurogenic detrusor overactivity, this medical treatment of injection into the detrusor muscle must be included within an overall multidisciplinary treatment, involving a urologist and a Doctor of Physical Medicine and rehabilitation specifically trained in the use of botulinum toxin in these circumstances under the supervision of a urologist. Botulinum toxin injections must be carried out using a cystoscope, either flexible or rigid, avoiding the trigone.
For instructions on the reconstitution, manipulation and elimination of BOTOX, see section 6.6.
After reconstitution, BOTOX should be used for only one injection session and for only one patient.