BTXA (Botulinum Toxin Type A)

BTXA (Botulinum Toxin Type A)

Botulinum A Toxin

blepharospasm,

idiopathic cervical dystonia (spastic torticollis) is mainly a rotational form,

spasticity of the arm muscles after a stroke,

facial wrinkles.

In/m. The drug can only be administered by doctors with special training, as well as experience in handling botulinum toxin and equipment for electromyography. The doctor sets the dosage and number of injection sites in the muscle for each patient individually.

Blepharospasm: after dissolution, Xeomin is injected with a sterile needle 27-30 G.

The recommended initial dose is 1.25-2.5 units (0.05–0.1 ml) at each injection site, the drug is injected into the medial and lateral parts of the circular eye muscle (m. orbicularis oculi) the upper eyelid and the lateral part of the circular eye muscle of the lower eyelid.

If vision is impaired due to spasms in the forehead, lateral areas of the circular eye muscle and the upper part of the face, additional injections may be made in these areas. The effect of the drug begins, on average, within 4 days after the injection. The effect of each procedure lasts, as a rule, 3-4 months, although it can last significantly longer or less.

If the effect of the initial dose was insufficient (duration <2 months), with repeated procedures, the dose of the drug can be increased by 2 times. The initial dose should not exceed 25 units per 1 eye. In each place, do not enter a dose exceeding 5 units. In the treatment of blepharospasm, the total dosage for 12 weeks of treatment should not exceed 100 units.

Spastic torticollis: in the treatment of spastic torticollis, the dosage should be selected for each patient individually, depending on the position of the neck and head, the localization of pain, muscle volume (hypertrophy, atrophy), the patient's body weight and his reaction to therapeutic procedures. In the practice of treatment, the maximum dose of the drug during a single procedure should usually not exceed 200 units, but a dosage of up to 300 units is possible. In the same place, do not inject a dose of the drug that exceeds 50 units.

Therapy for spastic torticollis includes injections into the sternocleidomastoid muscle, the scapula lifting muscle, the stair muscles, the belt muscle, and/or the trapezius muscle.

Do not inject into both sternocleidomastoid muscles, as this increases the risk of adverse effects of the drug (in particular dysphagia), which occur with bilateral injections of the drug into this muscle, or at doses exceeding 100 units.

For injections into the superficial muscles, use needles number 25, 27 and 30 G, and for deep muscles — needle number 22 G.

In spastic torticollis, electromyography may be necessary to determine the muscles involved. Performing injections in several places allows the drug to evenly cover areas of the muscles subject to dystonia (especially when injected into large muscles). The optimal number of injection sites depends on the size of the muscle. The effect of the drug begins, on average, within 7 days after the injection. The effect of each procedure lasts approximately 3-4 months, but can last significantly longer or less. The interval between the procedures should be at least 10 weeks.

Dissolution of the drug: when diluting the drug, it is forbidden to open the bottle by removing the stopper.

Remove the protective plastic cap from the bottle. Immediately before diluting the contents of the bottle, the central part of the cork should be treated with alcohol.

The solution for injection is prepared by piercing the stopper with a sterile needle and injecting a sterile isotonic solution of sodium chloride for injection, 0.9%. Carefully turn the bottle, mixing the lyophilizate with the solvent until completely dissolved.

The drug is not used if, after dissolution, the resulting solution is opaque or contains visible flakes and particles. It should remain transparent and colorless.

The drug is dissolved in the required volume according to the table.

The dosages recommended for Xeomine cannot be used for recalculation when using other drugs containing botulinum toxin.

Since the drug does not contain antimicrobial agents, it is recommended to use it immediately after dissolution. If necessary, the dissolved product can be stored in the original bottle for up to 24 hours in the refrigerator at a temperature of 2 to 8 °C, provided that the dissolution was carried out under aseptic conditions.

allergy to the components of the drug,

neuromuscular transmission disorders (myasthenia gravis, Lambert-Eaton syndrome, with caution-amyotrophic lateral sclerosis, neurological diseases resulting from motor neuron degeneration, and other diseases with neuromuscular transmission disorders),

elevated temperature,

acute infectious or non-communicable diseases,

pregnancy,

lactation,

children and adolescents under 18 years of age.

In the treatment of blepharospasm

Often-ptosis (6.1%), dry eyes (2%).

Infrequently-paresthesia, conjunctivitis, dry mouth, skin rash, headache, muscle weakness.

In addition, when using a similar drug containing botulinum toxin type A and used in clinical trials along with the drug Xeomin, the following side effects were noted. They are also possible with the use of the drug Xeomin.

Often-superficial keratitis, lagophthalmos, irritation, photophobia, lacrimation.

Infrequently-keratitis, ectropia, diplopia, dizziness, diffuse skin rashes/dermatitis, inversion of the eyelid, focal paralysis of the facial nerve, weakness of the facial muscles, fatigue, visual impairment, blurred vision.

Rarely-local swelling of the eyelid skin.

Very rarely-acute angle-closure glaucoma, corneal ulceration.

In the treatment of spastic torticollis

Often-dysphagia (10%), muscle weakness (1.7%), back pain (1.3%).

Infrequently-inflammation or pressure at the injection site, headache, asthenia, increased sweating, tremor, hoarseness of voice, colitis, vomiting, diarrhea, dry mouth, bone pain, myalgia, skin rashes, itching, peeling of the skin, pain in the eyes.

In addition, when using a similar drug containing botulinum toxin type A and used in clinical trials along with the drug Xeomin, the following side effects were noted. They are also possible with the use of the drug Xeomin.

Very often, the pain.

Often — dizziness, high blood pressure, numbness, general weakness, cold symptoms, general malaise, dry mouth, nausea, headache, muscle rigidity, irritation at the injection site, rhinitis, upper respiratory tract infections.

Infrequently-shortness of breath, diplopia, fever, ptosis, speech disorders.

Dysphagia can be expressed from very mild to severe, with the possibility of aspiration, in rare cases, medical attention is required. Dysphagia may persist for 2-3 weeks from the moment of injection, but a case of three-month dysphagia has been recorded.

Dysphagia is a dose-dependent complication: according to clinical studies, dysphagia is rare if the total dose of the drug does not exceed 200 units per procedure.

Common side effects

The following information is based on data on the effect of other complex preparations containing botulinum toxin type A.

Information about severe negative effects that may be associated with damage to the cardiovascular system-such as arrhythmia and myocardial infarction, including with a fatal outcome — is extremely insignificant. Whether these deaths were caused by injections of botulinum toxin type A, or concomitant cardiovascular diseases, is not precisely established. One case of anaphylactic shock has been reported after administration of a complex drug containing botulinum toxin type A.

There are side effects such as exudative erythema polyforme, urticaria, psoriasis-like rashes, itching and allergic reactions, but their causation by the action of a complex drug containing botulinum toxin type A has not been confirmed.

Sometimes, after the injection of botulinum toxin type A, there were fluctuations in the electrophysiological background in some distant muscles, this side effect is not associated with either muscle weakness or other electrophysiological abnormalities.

Symptoms: high doses of Xeomin can lead to the development of severe muscle paralysis in places remote from the injection sites (in particular, general weakness, ptosis, diplopia, difficulty speaking and swallowing, as well as paralysis of the respiratory muscles, leading to the development of aspiration pneumonia).

Treatment: hospitalization with general supportive measures is required. With paralysis of the respiratory muscles, intubation and ventilation are necessary until the condition is normalized.

Xeomin acts selectively on peripheral cholinergic nerve endings, inhibiting the release of acetylcholine. Introduction into the cholinergic nerve endings occurs in 3 stages: binding of the molecule to the external components of the membrane, internalization of the toxin by endocytosis, and translocation of the endopeptidase domain of the toxin from the endosome to the cytosol. In the cytosol, the endopeptidase domain of the toxin molecule selectively cleaves SNAP-25, an important protein component of the mechanism that controls the membrane movement of exo-vesicles, thus stopping the release of acetylcholine. The final effect is to relax the injected muscle.

The effect of the drug begins, on average, within 4-7 days after the injection. The effect of each procedure lasts, as a rule, 3-4 months, although it can last significantly longer or less.

• Agents that affect neuromuscular transmission

Concurrent use of antibiotics — aminoglycosides or spectinomycin is not recommended. Peripheral muscle relaxants should be used with caution. The effect of the drug can be reduced by the action of 4-aminoquinoline derivatives.