What is ALLUZIENCE 200SU/ML Solution for injection used for?

Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at maximum frown in adult patients up to 65 years of age, when the severity of these lines has an important psychological impact on the patient.

What is the active ingredient in ALLUZIENCE 200SU/ML Solution for injection?

Toxinum botulinicum A ad iniectabile

What pharmaceutical form is ALLUZIENCE 200SU/ML Solution for injection available in?

ALLUZIENCE 200SU/ML Solution for injection: Proszek do sporządzania roztworu do wstrzykiwań 125 jednostek Speywood

What are the side effects of ALLUZIENCE 200SU/ML Solution for injection?

Summary of the safety profile The majority of adverse reactions reported from clinical studies with Alluzience were of mild to moderate intensity and reversible. The most commonly reported adverse reaction was headache and injection site reactions. The incidence of adverse reactions showed a decreasing trend with repeated treatment. Very rarely, adverse reactions related to the spread of the toxin effect to sites distant from the site of administration have been reported with b

Who should NOT take ALLUZIENCE 200SU/ML Solution for injection?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Presence of infection at the proposed injection sites; Presence of myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis.

Does ALLUZIENCE 200SU/ML Solution for injection interact with other medications?

Concomitant treatment with Alluzience and aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) should be administered with caution, as the effect of botulinum toxin may be potentiated. No interaction studies have been performed.

Can ALLUZIENCE 200SU/ML Solution for injection be used during pregnancy?

Pregnancy Data on the administration of botulinum toxin type A to pregnant women are limited. Animal reproductive toxicity studies do not indicate direct or indirect harmful effects (see section 5.3). Administration of Alluzience during pregnancy is not recommended as a precautionary measure. Breast-feeding It is not known whether Alluzience is excreted into human breast milk. Alluzience should not be used during breast-feeding. Fertility There are no clinical data examining th

What ATC class does ALLUZIENCE 200SU/ML Solution for injection belong to?

ALLUZIENCE 200SU/ML Solution for injection: ATC M03AX01. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

ALLUZIENCE 200SU/ML Solution for injection

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: other peripherally acting muscle relaxants, ATC code: M03AX01 Mechanism of action The primary pharmacodynamic effect of botulinum toxin type A is chemical denervation of the treated muscle, resulting in a measurable decrease in compound muscle action potential.‍‍‍‍‍‍‍‍‍‍‍‍‍ This causes a localised reduction in muscle activity. Botulinum toxin type A is a muscle relaxant that temporarily weakens muscle activity. After injection, botulinum toxin type A acts by blocking the transport of the neurotransmitter acetylcholine at the neuromuscular junctions located between the nerve ending and the muscle fibre. The mechanism of action involves 4 main phases. For the effect to occur, all of these phases must proceed correctly. The consequence is cessation of contractions of the target muscles. The effect persists until the junction recovers and muscle activity is restored. Clinical efficacy and safety In 2 pivotal studies, a total of 372 patients with moderate to severe glabellar lines were treated, 250 at the recommended dose of 50 Speywood units and 122 with placebo. The majority of patients subjectively reported an effect within 2 to 3 days, including 23% of patients who reported an effect within 1 day. One month after injection, the responder rate according to investigator assessment was statistically significantly higher in patients treated with Alluzience compared with placebo (primary efficacy endpoint), as well as at all other time points from 8 days to 6 months (Table 2). Table 2: Investigator Live Assessment at maximum frown – response rate (%) at various time points Post-injection visit Alluzience (n=250) Placebo (n=122) 8 days 80.0% 2.5% 1 month 87.6% 2.5% 2 months 76.8% 1.7% 3 months 57.6% 1.7% 4 months 36.3% 1.8% Post-injection visit Alluzience (n=250) Placebo (n=122) 5 months 17.5% 0.9% 6 months 10.0% 0.9% Note: A responder is defined as a subject who has a severity grade of moderate or severe at baseline and a severity grade of none or mild at the given visit. The response rate, the primary efficacy endpoint at Day 29, was statistically significantly different from placebo (p <0.0001). Response rates at other time points were nominally different from placebo (p-values ranging from ≤0.0001 to 0.0008). The proportion of responders according to patient self-assessment was higher in patients treated with Alluzience compared with placebo at all time points from 8 days to 6 months (Table 3). Table 3: Patient self-assessment – response rate (%) at various time points Post-injection visit Alluzience (n=250) Placebo (n=122) 8 days 66.0% 4.9% 1 month 76.8% 5.7% 2 months 72.4% 2.5% 3 months 48.8% 3.4% 4 months 32.7% 4.3% 5 months 23.1% 4.3% 6 months 15.1% 2.6% Note: A responder is defined as a subject who has a severity grade of moderate or severe at baseline and a severity grade of none or mild at the given visit. Response rates were nominally different from placebo, with p-values ≤0.0001 at all time points. Patient satisfaction levels 1 month after injection showed that 85.2% of patients after Alluzience treatment were either satisfied or very satisfied, compared with 9% of patients treated with placebo. Aesthetic and psychological improvement was assessed using Face-Q scales. For the overall facial appearance scale (which includes subject ratings for facial symmetry, end-of-day appearance, facial freshness, rested appearance, appearance upon waking, and appearance under harsh lighting) and the psychological well-being scale (which includes subject ratings for feeling well, self-acceptance, feeling comfortable with oneself, feeling that I like myself, feeling happy, feeling attractive, and feeling confident), one month after injection, patients treated with Alluzience showed improvement in scores for each of these scales compared with patients treated with placebo (nominal p <0.0001). In a long-term open-label phase III study lasting 12 months, a total of 595 patients received up to 5 treatment cycles with Alluzience. Based on investigator assessment, patient assessment, patient satisfaction, and FACE-Q questionnaires, efficacy was maintained over 12 months. The proportion of responders at maximum frown as assessed by the investigator 1 month after injection persisted across repeated injection cycles (between 82.2% and 87.8%). Corresponding proportions at 3 months after injection ranged between 45.3% and 56.8% across 5 treatment cycles. Patients (total 595) who received Alluzience over 12 months were tested for antibody formation. No patients tested positive for toxin-neutralising antibodies.

⚠️ Warnings

Care should be taken to ensure that Alluzience is not injected into a blood vessel. Injection of Alluzience is not recommended in patients with a history of dysphagia and aspiration. Very rarely, adverse reactions probably related to the spread of the toxin to sites distant from the site of administration have been reported with botulinum toxin.‍‍‍‍‍‍‍‍‍‍‍‍‍ Swallowing and breathing disorders are serious and may cause death. Very rarely, cases of death have been reported following treatment with botulinum toxin type A or B, occasionally in association with dysphagia, pneumopathy (including dyspnoea, respiratory failure, respiratory arrest, and other symptoms) and/or in patients with significant asthenia. Patients should be advised to seek immediate medical attention if they experience difficulties with swallowing, speech, or breathing. Alluzience should be used with caution in patients at risk of or with clinical signs of significant neuromuscular transmission disorders. These patients may have increased sensitivity to agents such as botulinum toxin, and excessive muscle weakness may follow treatment. Before administration of Alluzience, it is essential to examine the patient's facial anatomy. Facial asymmetry, ptosis, excessive dermatochalasis, scarring, and any changes in anatomy as a result of previous surgical intervention should be taken into account. Cases of dry eyes have been reported when Alluzience is used in the area around the eyes (see section 4.8). It is important to be aware of this adverse effect, as dry eyes may predispose to corneal disorders. Protective drops, ointment, eye patching, or other measures to protect the eye may be necessary for the prevention of corneal disorders. The recommended dose and frequency of administration of Alluzience must not be exceeded. Patients treated at the recommended dose may experience exaggerated muscle weakness. Caution is required if Alluzience is used in the presence of inflammation at the proposed injection site, or if the target muscle(s) show(s) excessive weakness or atrophy. Cases of muscle atrophy have been reported following the use of botulinum toxin (see section 4.8). As with all intramuscular injections, Alluzience is not recommended in patients who have a prolonged bleeding time. One vial of Alluzience must be used for the treatment of one patient during one session. Any remaining unused product must be disposed of as described in section 6.6. Special care must be taken in the inactivation and disposal of any remaining unused solution (see section 6.6). Antibody formation Injections at more frequent intervals or at higher doses may increase the risk of formation of neutralising antibodies to botulinum toxin. Clinically, the formation of neutralising antibodies may reduce the efficacy of subsequent treatment. Traceability In order to improve the traceability of biological medicinal products, the name of the administered product and the batch number should be clearly recorded. Sodium content This medicinal product contains less than 1 mmol (23 mg) of sodium per vial containing 125 units, that is to say, it is essentially 'sodium-free'.

ALLUZIENCE 200SU/ML Solution for injection

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