BTXA™ is eligible to patients from children to elderly. However, patients should consult their doctors before they receive the injection.
BTXA™ is contraindicated in individuals with anaphylactic constitution and known hypersensitivity to this preparation, pregnancy, breast milk feeding, motor neuron disease, neuromuscular joint disease, and medications of aminoglycosides, d-penicillamine, quinine and wafarin/heparin. If there are serious immediate hypersensitivity reactions such as anaphylaxis, urticaria, edema, and dyspnea occur, stop further BTXA™ injection and receive appropriate medical therapy at once.
There is no systemic side effect in all patients who received BTXA™ injection, even the ones who received it repeatedly in long-term. Some local side effects might occur in small amount of patients. The most common one are edema of eyelid, droopy of eyelid, lacrimation, algophthalmos and weakness of muscle. Occasionally, dyspbea or syphagia may occur in individuals after injection. However, the side effect is mild, temporary and will disappear spontaneously within a few weeks. The percentage of occurrence is alike the other similar products.
BTXA™ is applied non-surgically by an ultra-fine needle of syringe to inject into muscle. Pain is minimized because of the ultra-fine needle and the small dose of BTXA™. The treatment time depends on the site of injection and the number of injection sites. The treatment usually takes around 15 minutes.
The time of onset varies individually and depends on the site of injection. In general, the effects of BTXA™ could be observed and become noticeable a few days or to a week after injection.
The effect of BTXA™ will last for up to 3 to 6 months or more and it also depends on individual response. To carry on the effect, second injection is required after fading of the previous effect.
In order to minimize the potential of neutralizing antibody formation, it is suggested injecting the lowest effective dose as less frequent as possible. In this way, the response to BTXA™ could be maintained satisfactorily.
BTXA™ is produced by the GMP licensed manufacturer with more than 70 years of experience in biological product research and production. The product is manufactured under strict quality control system in which routine inspections and surveillance were performed by the local authorities as well as authorities in export countries to assure the products' quality is up to satisfactory standard and safety level.
Since BTXA™ was officially launched into market in 1997, BTXA™ has been used safely for over 15 years which developed with millions of case were treated. A more than five years’ continuous safety monitoring on BTXA™ application was carried out and respective Periodic Safety Update Report (PSUR) was issued in Jan 2009. Nowadays, around 30 countries have approved applications of BTXA™. Its quality is then recognized as well as its efficacy and safety in clinical uses.
Gelatin was chosen in the BTXA™ formulation as stabilizer because of the concern of potential viral contamination (e.g. HIVs and Hepatitis) in botulinum toxin by the human serum albumin of which other brands were employed. Gelatin indeed is a commonly used stabilizer in lyophilized biological products. It is good at keeping the product's stability. The origin of the gelatin used in BTXA™ was extracted from bovine skin and it is sourced from BSE (Bovine Spongiform Encephalopathy)-Free regions with certifications verified. Strict quality control tests are done before the gelatin is put into BTXA™ production to ensure the product quality maintained at high level.
50 Units provides flexibility for treatment operation. Doctors would be able to consume the whole vial at a single operation without further concern of storage, potency lost, and possible contamination when it is opened for long.
BTXA™ has been employed for registration in most of the countries. Alternative brand names like Prosigne in Brazil, Redux in Peru, Lantox in Russia and Colombia, Lanzox in Indonesia are employed as well.
Cold chain is used for any BTXA™ shipments. Storage condition is closely monitored for the whole shipment process. Quality is thus guaranteed.