There are various botulinum toxin formulations available worldwide. In this article, we will look at Prosigne and how it compares to other botulinum toxins.
What is Prosigne?
Botulinum toxin products are used for both therapeutic and cosmetic purposes. Prosigne is a botulinum toxin type A product made by a company called Lanzhou Biological Products Institute in China. Globally, botulinum toxin A is marketed under brand names such as Botox which is made by the US pharmaceutical giant Allergan, Dysport which is made by the French pharmaceutical company Ipsen in collaboration with Galderma, Xeomin which is made by Merz in Germany, Neuronox which is made by Medy-Tox Inc. in South Korea, and Jeuveau which is made by Evolus Inc. which has its headquarters in the US. Botulinum toxin type B is available under the brand name Myobloc, made by US WorldMeds, LLC.
List of Prosigne Substitutes
As mentioned, botulinum toxins are available under various brand names around the world, such as Botox, Botox Vista (Japan), Botulax (Thailand), Botulift (Brazil), botulinum A toxin (various countries), Botulismus-Antitoxin, Disport (Georgia), Dyslor (Uruguay), Dysport 300 and Dysport 500 (Bulgaria, Israel), Dysport 300 E and Dysport 500 E (Austria, Hungary, Switzerland), Dysport 300 and Dysport 500 Einheiten (Germany), Lantox (Colombia), Lanzox (Indonesia), Magnion 50, 100 and 200 (Colombia), Meditoxin (South Korea), Nabota (Thailand), Neuronox (Georgia), 100 u x 1's and Neuronox (Ranbaxy, Reage (Chile), Vistabel (Europe), Xeomeen (Mexico), Xeomin 50 E and 100 E (Switzerland, Austria, Germany), and Zentox (Thailand).
What is Prosigne used to treat?
Some of the uses of Prosigne include:
Blepharospasm (abnormal eyelid movements).
Hemifacial spasm (involuntary twitching of one half of the face).
Spasmodic torticollis or cervical dystonia (painful involuntary contraction of neck muscles).
Dynamic equinus foot deformity (a foot disorder common in children with cerebral palsy) .
Focal hyperhidrosis of axilla (excessive sweating in the armpits).
Urinary incontinence (urine leakage) due to overactivity of bladder muscles in patients with spinal cord injury or multiple sclerosis.
Strabismus (crossed eyes) in children.
Focal spasticity (muscle stiffening) after stroke.
Spasmodic dysphonia (a voice disorder).
Movement disorders like oromandibular dystonia.
Chronic migraine prevention.
Temporary improvement in fine lines and wrinkles of the upper face, including glabellar lines (frown lines between the eyebrows), crow's feet lines, and horizontal forehead lines.
Other Important Information on Prosigne Botulinum Toxin Injections
Patients treated with Prosigne receive doses based on the indication. The injections are performed in treatment cycles and total dosing should not exceed a set limit. Some dosing recommendations are listed below.
The dose should not exceed 100 units every 12 weeks for blepharospasm.
200 units cumulative dose in 2 months for hemifacial spasm.
Maximum 25 units single dose for strabismus.
Maximum dose of 6 units/kg for spasmodic torticollis (cervical dystonia) every 2 months.
A dose of 4 units/kg up to 200 units at a single treatment for pediatric cerebral palsy, repeated no more frequently than every two months.
The dose for upper facial lines is individualized and is usually 4 units at each of the 5 sites for glabellar lines for a total dose of 20 units and repeated no more frequently than every three months. For crow's feet lines, 2-6 units per injection site are recommended for a total dose of 6-18 units bilaterally. For forehead lines, the recommendation is 2-6 units per injection site for a total dose of 8-24 units at 4 sites.
For focal spasticity or focal dystonia in adults, the dose should be individualized.
For hyperhidrosis of the axilla, 50 units of Prosigne are injected into each axilla at multiple injection sites.
For chronic migraine, the dose is 155-195 units in 7 areas of the head and neck muscles, with retreatment every 12 weeks.
For neurogenic detrusor overactivity (overactive bladder), the dose is 200 units with prophylactic antibiotics given 1-3 days before the treatment, on the day of the treatment, and 1-3 days post-treatment.
Prosigne Side Effects
Most adverse events occur within one week of an injection of botulinum toxin type A. They are usually short lived but can last for several months. The most common side effects are localized pain at the injection site, tenderness, redness, bruising, and swelling. While weakness of the injected muscle(s) is expected, sometimes the botulinum toxin can spread to adjacent muscles and cause adverse effects.
Very rarely, there can be difficulty swallowing, pneumonia, or severe allergic reactions (anaphylaxis) after treatment with botulinum toxin, potentially leading to death. There can also be rare adverse events of cardiovascular system, including arrhythmia (abnormal heart rhythm) and myocardial infarction (heart attack), which may lead to fatal outcomes. The risk is higher in patients with pre-existing cardiovascular risk factors. It is unclear if or how botulinum toxin causes these events.
Other adverse events reported after injection of botulinum toxin include skin rashes, such as urticaria, erythema multiforme, and psoriasiform eruptions, pruritus (itching), and allergic reaction.
Side Effects of Prosigne for Cervical Dystonia
Double-blind randomized clinical trials and open-label studies have shown that the most common adverse reactions after botulinum toxin injections for cervical dystonia are difficulty swallowing, difficulty breathing, upper respiratory infection, neck pain, and headache. Other side effects include increased cough, flu like syndrome, back pain, rhinitis, dizziness, hypertonia, injection site soreness, asthenia (lack of energy), dry mouth, speech disorder, fever, nausea, and drowsiness. Rarely, stiffness, numbness, double vision, and eyelid drooping have been reported.
Side Effects of Prosigne for Primary Axillary Hyperhidrosis
When Prosigne botulinum toxin is used for excessive armpit sweating, the most commonly reported adverse events are injection site pain and bruising, non-armpit sweating, infection, throat inflammation, flu like syndrome, headache, fever, neck pain or back pain, itching, and anxiety.
Side Effects of Prosigne for Blepharospasm and Hemifacial Spasm
The most frequently reported side effects after botulinum toxin type A injections for blepharospasm are eyelid drooping, superficial punctate keratitis (an eye disorder), and dry eyes. Other adverse events include eye irritation, tearing, lagophthalmos (inability to close the eyelids completely), photophobia (light sensitivity), ectropion (eyelid turned outward), keratitis (inflammation of the cornea), double vision, entropion (eyelid turned inward), skin rash, and swelling of the eyelid skin.
Side Effects of Prosigne for Strabismus
Adverse effects of botulinum toxin injection treatment of strabismus (crossed eyes) includes ptosis (eyelid drooping), eye muscle paralysis, double vision, and other eye problems.
Immunogenicity
The body can form neutralizing antibodies to botulinum toxin type A. This can reduce the clinical efficacy of the treatment because the antibodies inactivate the toxin. Some patients can become non-responsive to treatments with botulinum toxin type A due to immunogenicity (formation of antibodies). How fast neutralizing antibodies form and what affects their formation has not been well studied. However, some studies indicate that botulinum toxin type A injections at higher doses or more frequent intervals can lead to a higher incidence of antibody formation. Therefore, to reduce the potential for antibody formation, the lowest effective dose should be given at the longest possible intervals between the treatments.
Interactions with Prosigne Injection
Simultaneous administration of botulinum toxin type A and other agents that affect neuromuscular transmission (such as aminoglycosides and curare-like compounds) can lead to augmentation of the toxin's effect and should therefore be performed with caution.
The effect of administering two botulinum toxin type together or within months of each other is not known. However, if a repeat botulinum toxin injection is given before the effects of a previous one have gone away, it can lead to excessive neuromuscular weakness.
When not to use Prosigne injection?
It is not recommended to treat patients with botulinum toxin if they have a history of hypersensitivity or allergy to these products. The treatment is also not recommended in patients with neuromuscular conditions such as myasthenia gravis (Eaton-Lambert syndrome) or ALS. The injections should not be performed if there is active infection or inflammation at the injection site.
Prosigne Botulinum Toxin Type for Underactive Bladder
Treatment of patients with underactive bladder with BTX-A (Prosigne from Lanzhou Biological Products, Lanzhou, China) was found to increase the maximum flow rate, decrease the maximum urethral pressure, decrease the detrusor leak point pressure, and decrease post-voiding residual urine volume, although the latter increased 3 months after the treatment. Out of the 35 patients in a prospective randomized double blind study, roughly 57% were reliant on clean intermittent catheterization (CIC) before the BTX-A injection, but one month after the injection approximately 75% of patients could partly void and 25% could void without CIC. There was a slight decrease in hydronephrosis in 3 patients and complete resolution of hydronephrosis in 2 patients from the 8 patients who showed hydronephrosis before the treatment. The patients were followed for 3-6 months. The patients benefited for 2-3 months without any serious adverse events reported, indicating efficacy and safety of botulinum toxin for underactive bladder.
Comparison of Botox and Prosigne Botulinum Toxin Injection for Chronic Migraine
Intramuscular botulinum toxin injections were performed every 12 weeks for treatment of chronic migraine by blocking peripheral nerves in the head region. Systematic review found one placebo controlled study that evaluated single administration of BTX for unilateral facial nerve blockade in 40 patients with chronic migraine. One group of patients received 25 IU of Botox, another group received 25 IU of Prosigne, another received 33.3 IU of Prosigne, and the control group received saline. The dose was placed at 10 sites in various regions of the head. Pain control and adverse effects were evaluated pre-treatment and 4, 8, and 12 weeks post treatment. On follow up, the results showed that 25 IU of Botox group and 33.3 IU of Prosigne group had a 7-day interval between migraine headaches and a 70% reduction in frequency and intensity over a period of 12 weeks. The 25 IU dose of Prosigne resulted in 8 weeks of migraine pain control.
Comparison Between Dysport and Prosigne in the Treatment of Cervical Dystonia
A study compared two formulations of botulinum neurotoxin type A sold in Brazil - Lanzhou BTX type A (Prosigne) and abobotulinumtoxin A (Dysport) - for the treatment of patients with cervical dystonia. This was a randomized double blind trial in which one group of fourteen patients received Dysport and the other group of twenty patients received Prosigne. Each patient received 5 injections of the botulinum neurotoxins over a period of 13 months. A 3 U of Dysport for 1 U of Prosigne dose equivalence was used. The patients were evaluated before and after the first and fifth treatment sessions for functional improvement on the basis of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The first treatment session reduced the average TWSTRS value by 12.78 points in the Dysport group and 9.98 points in the Prosigne group. After the last treatment session, the researchers assessed improvement and found a reduction in TWSTRS values of 11.87 points for Dysport and 11.35 points for Prosigne. Conclusions: The data showed similar efficacy and safety profiles for both Dysport and Prosigne in the treatment of cervical dystonia.
