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Botulotoxin off label use

Botulinum toxin type A (Botox) is used for a number of indications in neurology, physiotherapy, urology, surgery and cosmetics. This drug also has a high safety profile and in the Czech Republic has been applied for decades. For example in the most important area, neurology, we use this drug in patients with spasticity after a stroke, patients with cervical dystonia, blepharospasm, facial hemispasm, another focal dystonias, and also for over 20 years in children with cerebral palsy.

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Botulinum toxin indications are not yet exhausted and we anticipate further indication extension. Since this drug relaxes muscles and acts against the pain we expect its expansion mainly in back pain patients – that means patients with back pain, pain in muscles, tendons, with painful spasms (contractions) and so on. For pain botulinum toxin is officially used in patients with chronic migraine where the common painkillers have failed. Currently, one of the botulinum toxin mechanisms helps against the pain in patients with spastic limbs. When the physician considers that botulinum toxin could help and the disease is not included in the formal list of diseases that are allowed to be treated with botulinum toxin, the physician might treat the patient in an “off label use” procedure. Such drug application is possible only under specific conditions: the physician must indicate this therapy, there is no other efficient medication available, the patient must agree with this therapy and the application must be reported to the competent authority ((SÚKL = Státní ústav pro kontrolu léčiv = State Institute for Drug Control).) “off label use” application is not covered by health insurance – that means the patient pays for this kind of treatment himself.

Generally, botulinum toxin application takes place approximately once in three months or less frequently, we use very thin needles and approximately 25 to 400 units of Botox is applied. The number of units is dependent on the indication, application area, patient weight and other circumstances. Botulinum toxin application must take place individually and always after thorough examination and consultation.

Before the first application the physician examines the patient and his/her case history and if botulinum toxin is medically indicated, the physician notifies the patient about the drug – how this therapy works and what the possible side effects are. The consultation mentioned above often takes up one separate appointment with the physician. Subsequently, if the patient agrees with the therapy, he/she will sign the “informed consent” document and the botulinum toxin will be applied. A clinical visit with botulinum toxin application lasts approximately 30 minutes or longer. The effect of botulinum toxin occurs within seven days and the check visit is performed approximately one month after injection/s. At that time we expect the maximum effect of botulinum toxin. If the therapy is effective it might be repeated once every three months or less frequently. The number of applications in the future is not limited.

The important information that it is useful or necessary to know about this treatment is mentioned further.

What to expect after the application of botulinum toxin

The effect of botulinum toxin should appear on average seven days after injection. The maximum effect is expected approximately within one month after injection. The medication effect’s duration is about three months but each patient might respond individually to the treatment. It means that the botulinum toxin effect might appear from three to ten days after injection, the drug’s effect duration might be half a year for some individuals and for another just two months. It also depends on the number of units that are administered. The more units that are applied the stronger the effect expected. Conversely, if the patient has a cold (flu or other acute illness) at the time of application the botulinum toxin might completely fail and there is even the possibility of future ineffectiveness. If botulinum toxin is properly indicated the majority of patients respond to this therapy very well. Patients satisfied with this treatment come repeatedly for application and that takes place approximately from two to four times per year. If the first application does not work it is strongly advised to try one more treatment session. The reason might be that the physician is initially careful with the number of units and tend to administer the lowest dose. The second application might be already successful. Given the medication bring about a clear benefit to the patient long-term treatment could be indicated.

Who administers botulinum toxin

The physician who administers botulinum toxin is required to have long-term experience with this drug. It is a highly specific drug that needs a special approach and knowledge of the application schemas and the side effects. The physician who administers botulinum toxin at our department has worked with this medication for more than 10 years in various indications.

Informed consent

The patient will have signed an “informed consent” document before the first application of botulinum toxin. It is not a mandatory issue within the health care system in the Czech Republic, however, at our department it is assurance that you have been properly educated about this medication and any important information hasn’t been omitted. Informed consent contains basic information on botulinum toxin treatment and is also focused on its side effects. The original of the informed consent remains in our medical documentation and a copy is for the patient. more >>>

Side effects of botulinum toxin

It is known that each medicament might have side effects (adverse events). The physician who administers the drug to the patient must be sure that this drug has a greater benefit (positive impact / importance) than its possible side effects. Side effects are listed in the leaflet which is mandatory for each distributed drug in the Czech Republic. For Botox you can download this information from the website of the SÚKL (Státní ústav pro kontrolu léčiv = State Institute for Drug Control) database (information is in Czech) or here in our web under the link SPC – botulinum toxin (information is in Czech). Simultaneously we have the side effects of botulinum toxin listed in our (Information in English) Informed Consent here

How I can get the application of botulinum toxin

Make an appointment with us for consultation. If you are unsure we will try to advise you whether to try application or not. Given that this matter is very specific and indications are in “off label use” process rather rare (the physician should be careful), we advise you to send your question by e-mail. This e-mail conversation is free.

How are the botulinum toxin applications covered

Currently, the application of botulinum toxin “off label use” is not covered by health insurance and is fully paid by the patient. Application of a standard dose of botulinum toxin costs approximately 6800 CZK. At present the prices are subsidized. Any further information is available via e-mail or telephone call.