How to use

The valued members of our association can access our detailed step-by-step online "How to effectively use β0ToxinA®" manual, rich in vital information on correct procedures that will minimize the risk of side effects.

"How to effectively use β0ToxinA®" − Step-by-step manual

1 CONTRAINDICATIONS β0ToxinA® should not be used in the presence of infection at the proposed site of injection and in individuals with anaphylactic tendency and known hypersensitivity to any of its ingredients. It should not be administered to pregnant or breast-feeding women and children below 12 years of age as trials on these groups are still few. It is also contraindicated in patients suffering from eyebrow hyperplasia and neurological disorders such as ALS, myasthenia gravis, or Eaton-Lambert syndrome, as they may suffer severe side effects. It is ineffective in patients with serious muscle fibre contracture The injection should be postponed in patients who have a fever or acute infectious diseases. The utmost care should be taken with patients with blood, heart, liver, or lung diseases, or active tuberculosis; and those who have experienced problems with injections, who have muscle, swallowing, or breathing problems, or have had surgery or injury in the head.

2 Pre-treatment Schedule the appointment early enough to allow time for the patient to fill out forms (a consent and disclaimer form) and consult with you or a member of your staff. Often patients, especially first-time ones, have questions and doubts, and need some time and talk to ease away their anxiety. Always take the time to learn enough about your patient's medical history, any allergies, problems, or conditions that would lead to potential complications. Make sure you know all the medications they are taking. You may also want to ask about their expectations of the outcome of the treatment. Remember to do this even with return patients, as changes and improvements following further treatments may be less dramatic than after the first injection. Remember that your patient has the right to know what is going to happen at any time, so explain exactly and step by step what you are going to do in a calm and reassuring tone. No anesthesia is required, although you may choose to numb the area about to be injected with an ice pack for just a minute or two before the injection to help minimize the pain associated with the injection. The use of an ice pack can also help reduce some of the potential bruising and swelling.

Alternatively, an anaesthetic cream may be applied. Explain that the whole procedure will take an average of 15 minutes, and never longer than half an hour, and that the discomfort associated with the injection is minimal and brief, resembling a pin prick.

3 Administration β0ToxinA® is a prescription-only treatment and should be administered carefully by a qualified medical practitioner or authorized cosmetic specialist skilled and familiar with it. Furthermore, a thorough knowledge of muscular anatomy of the forehead and periorbital regions is mandatory, just like proficiency at electromyographic amplifier technique.

3.1 Reconstitution To reconstitute, β0ToxinA® should be diluted with sterile preservative-free physiological saline or β0ToxinA® Instant according to the dilution table below. The solid white product then dissolves into a transparent colourless to yellowish solution. One unit (U) of β0ToxinA® corresponds to 1 LD50 of (rodent) intraperitoneally-injected Botulinum Toxin Type A.

U / 0.1 ml Volume of
solvent (ml)
10.0 1.0
5.0 2.0
2.5 4.0
1.25 8.0

Shake the vial very gently (to avoid possible loss of potency) after adding sterile physiological saline or β0ToxinA® Instant until completely dissolved, making sure that the reconstituted solution is clear and no particles are present in it before injecting it into the patient.

3.2 Dosage The FDA recommends that the lowest effective dose should be used. Therefore especially patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dose. Subsequent dosing should be optimized according to the patient's individual response. Keep in mind that the injecting volume into each muscle should not exceed 0.1 ml. In case of unsatisfactory response, a supplementary injection may be given. In case of relapse, the dose can be repeated or increased even at irregular intervals, but the maximum dose for each muscle should not exceed 5 U/injection. Up to 100 U can be evenly distributed in the chosen points.

NEW! 3.3 Pre-injection procedure We advise physicians to treat botulinum injections like other, especially injectable, medications (ex. antibiotics) where it is safe to do a quick allergy testing. After examining the patient and making sure no contraindications exist, but before the treatment itself, inject a tiny amount of preparation subcutaneaously into the arm and wait a few minutes looking for possible local swelling and reddening. If no such reactions occur, the patient is not allergic to botulinum toxin nor to any excipients and you can safely administer it, knowing that he/she will not react adversely.

3.4 Proper Injecting Technique Carefully consider the patient's anatomy and goals when planning treatments. Ask the patient to frown, smile hard, close her/his eyes, or make any other movement or expression that may help you determine which muscles are used the most, and what are the best sites to inject β0ToxinA® keeping in mind that the location, size, and use of the muscles that create a furrowed brow vary markedly among individuals. It is up to you whether you mark with a pen the areas that need injecting, use an EMG machine to tell you the correct place to inject, or directly inject the sites that you have already agreed with the patient. Please note that precision and the correct injection technique is crucial to success. The area to be treated must be thoroughly disinfected. Make sure to inject only under sterile conditions, using a disposable syringe with a very small, fine needle. Before injecting, press on the bevel of the syringe until a drop is visible at the tip of the needle. The injection should be administered slowly in minute amounts into the dermis perpendicularly to the centre of the age wrinkle, about 1 mm from the bone, for a total of 4 to 16 points of injection for the whole visum.

3.5 After-care A short period of observation is recommended for patients having just received β0ToxinA® therapy. No recovery time is needed. Any redness that may result from the procedure at the site of each injection may be minimize by applying some Facial Powder, while any immediate bruising may be camouflaged with a touch of Liquid Concealer. The patient may resume normal activity immediately with minimal restrictions. She/he is only required not to touch, massage or rub the treated area for 12 hours after the injections as this may cause the toxin to spread beyond the treated area. It is also crucial that she/he keep her/his head upright and does not lie down for 4 hours after injection (no naps, exercising, bending down...). Also, they should avoid exposure to sunlight, or extreme temperatures (solarium, sauna, high mountains). However, the use of sunglasses for the first few days is highly advisable. Using many facial expressions for the first day helps to work β0ToxinA® into the muscles, and should therefore be encouraged.

4 SIDE EFFECTS Side effects are usually very minor and typically local. Tenderness, bruising, temporary swelling, or mild pain at the injection site for a day or two is the most common complication, especially when the eyes and forehead have been treated. Patients who use aspirin, other non-steroidal antiinflammatory drugs, or anti-coagulants are at higher risk for bruising and should avoid these medications for a few days before the treatment. Less frequent side effects, especially when the forehead is treated, are: headache, respiratory infection, flu-like symptoms, nausea. In rare instances (less than 1%), β0ToxinA® can spread into neighbouring muscles and cause temporary paralysis of adjacent muscles such as eyebrow or eyelids resulting in ptosis, a drooping of the eyelid, drawback of the lower eyelid, reduced blinking, incomplete closing of the eyelid, weakness of facial muscles. However, all such symptoms disappear spontaneously within 3 to 8 weeks. Temporary and different degree of ptosis of the eyelid, vertical deviation and rarely mydriasis, related to the diffusion of the toxin to the muscles adjacent to the eye, may occur in some patients who receive β0ToxinA® therapy near the eye; however, all such symptoms disappear spontaneously within 3 to 8 weeks. Prescription eye drops like Iopidine may help improve this while you wait for the side effect to wear off. β0ToxinA® can block neuromuscular conduction by inhibiting the release of acetylcholine and therefore can cause local muscle flaccid paralysis. Double vision is very rare and can, like any other side effect, last 6 months at a maximum, that is as long as the toxin stays in the body. Most of these adverse reactions can be avoided by proper injection technique (accurate choice of injection site, injecting not too deeply, using a lower dose). Serious and/or immediate hypersensitivity reactions have been rarely reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further β0ToxinA® treatment should be discontinued and appropriate medical therapy immediately instituted.

5 SAFETY / PRECAUTIONS The fact that β0ToxinA® is a neurotoxin should not be overlooked. A β0ToxinA® treatment must therefore be treated as a medical procedure and only administered under careful medical supervision. β0ToxinA® should not be injected more frequently than once every three months, and the lowest effective dose should be used. Administering physicians must have good knowledge of extraocular and facial muscle anatomy and be proficient at electromyographic amplifier technique. A short period of observation is recommended for patients having just received β0ToxinA® therapy. 1:1000 adrenaline should be prepared in case of accident. It is important to keep in mind that, with us, you have the unique opportunity of neutralizing any adverse reactions, both right after the injection, or some time later as we are the only pharmaceutical firm dealing with botulinum toxin type A producing also an antidote to it, "Anti β0ToxinA®".

6 DRUG INTERACTIONS The effects of β0ToxinA® may be potentiated by the use of certain antibiotics (such as aminoglycosides – e.g. Gentamycin) or other drugs interfering with neuromuscular transmission (e.g., curare-like compounds) and therefore should not be administered while under such therapy. The effect of administering different botulinum neurotoxin serotypes at the same time or within less than 4 months of each other is unknown. However, neuromuscular paralysis may be potentiated by co-administration or overlapping administration of different botulinum toxin serotypes.

7 IMMUNOGENICITY According to the tests on immunogenicity performed, the body may in some cases react to the proteins contained in the Botulinum toxins by forming antibodies. And when such antibodies are formed, the effect may be that one is no longer able to respond to the therapy. Such event is rare as β0ToxinA® contains a minimal amount of neurotoxin complex proteins. However, it is recommended that you start with a smaller amount and then increase to a larger dose, and that the treatment is not administered more frequently than once every three months. Professor Lowe has pointed out in his book "Skin Secrets" that a very small percentage of first-time patients are resistant to Botulinum Toxin Type A. That is probably due to the fact that they have unknowingly had a slight bout of botulism leaving them with antibodies to it.

8 STORAGE AND EXPIRATION Maximum solution temperature is 36°C. The reconstituted β0ToxinA® should be used at once or stored in the refrigerator at 2 to 8 °C and be used within 4 hours as it does not contain a preservative. The vial and the syringe used in the administration of the drug as well as any residual β0ToxinA® solution should be disposed of after sterilization according to standard medical waste practices.

The results show that freeze-dried β0ToxinA® will keep its efficiency at room temperature for one week, with a little drop in efficiency for 10 days, and a 15~20% drop in efficiency for 3~12 months.

β0ToxinA® shelf life is of 3 years from the date of freeze-drying in correct storage conditions, that is at a temperature of -5 to -20°C.

Like any other medication, it must not be used after the expiration date stamped on the vial.

Medical disclaimer

The information contained in the Manual above is exclusively provided for informational purposes of the medical community. It is not intended to substitute formal medical training, nor to cater to the needs of individual patients.


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