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Azzalure Botulinum Type A

Azzalure Botulinum Type A

Azzalure

Prescription medicine
  • Licensed as a prescription Only medicine in the UK and EU for specified aesthetic indications.
  • Marketing Authorisation granted by the MHRA (UK) and corresponding EU competent authorities.
  • Manufactured in facilities operating to EU Good Manufacturing Practice (GMP) standards.
  • Subject to ongoing pharmacovigilance and safety monitoring via national systems such as the MHRA Yellow Card scheme.
  • ATC code M03AX01 (other muscle relaxants).
Botulinum toxin type A for aesthetic use

Description

Azzalure (2 x 125 Speywood units) is a prescription-only botulinum toxin type A product (Clostridium botulinum toxin A haemagglutinin complex) presented as a powder for solution for injection. Each vial contains 125 Speywood units of botulinum toxin type A, to be reconstituted with sodium chloride 9 mg/mL (0.9%) solution before intramuscular injection. Azzalure is a local muscle relaxant adapted from the Dysport neuromodulator and is specifically developed for aesthetic use. In aesthetics, it is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical frown lines between the eyebrows) and lateral canthal lines (crow’s feet) in adult patients under 65 years, when the severity of these lines has an important psychological impact.

Bnefits

  • Clinically proven botulinum toxin type A specifically developed and licensed for aesthetic indications.
  • Provides temporary improvement in the appearance of moderate to severe glabellar frown lines and lateral canthal (crow’s feet) lines in adults under 65 years.
  • Local muscle relaxant action by blocking acetylcholine release at the neuromuscular junction, leading to reversible relaxation of targeted facial muscles.
  • Improved facial expression and reduction of negative-looking frown lines, which may have a positive psychological impact on suitable patients.
  • Established safety and efficacy profile with extensive post-marketing experience in aesthetic use.
  • Formulated as a lyophilised powder in small vials, allowing flexible reconstitution volumes according to clinical practice (within SmPC recommendations).
  • Speywood unit system is specific to Azzalure/Dysport, ensuring consistent dosing within this product family.

Indications

  • Temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact.
  • Temporary improvement in the appearance of moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile in adult patients under 65 years, when the severity of these lines has an important psychological impact.
  • Use is restricted to appropriately qualified healthcare professionals experienced in the use of botulinum toxin.

Composition

  • Active substance: Botulinum toxin type A (Clostridium botulinum toxin A haemagglutinin complex) – 125 Speywood units per vial.
  • Excipients:
  • • Human albumin 200 g/L.
  • • Lactose monohydrate.

Formulation

  • Pharmaceutical form: Powder for solution for injection.
  • White lyophilised powder in clear glass vials.
  • After reconstitution with sodium chloride 9 mg/mL (0.9%) solution, forms a clear, colourless solution for intramuscular injection.
  • Speywood units are specific to Azzalure/Dysport and are not interchangeable with units of other botulinum toxin preparations.

Packaging

  • Packs containing 2 glass vials, each with 125 Speywood units of botulinum toxin type A powder for solution for injection.
  • Each vial closed with a rubber stopper and aluminium seal with flip-off cap.
  • Pack sizes may include 1- or 2-vial presentations; the commonly referenced aesthetic pack is 2 x 125-unit vials (2x125 IU).
  • Outer cardboard carton with product name, strength, batch number, expiry date and regulatory information.

Usage

  • Azzalure is a prescription-only medicine and must only be used by physicians appropriately qualified and experienced in the treatment of glabellar and lateral canthal lines, with the required training in botulinum toxin injection techniques and familiarity with facial anatomy.
  • Reconstitution and injection must be carried out strictly in accordance with the current Summary of Product Characteristics (SmPC) using aseptic technique and only with sodium chloride 9 mg/mL (0.9%) solution for injection.
  • The reconstituted solution is intended for intramuscular injection into specified facial muscles associated with glabellar frown lines and/or lateral canthal lines, following the dose and injection-site guidance in the SmPC.
  • Use the lowest effective dose and tailor treatment to the individual patient’s muscle mass, pattern of muscle activity and previous response.
  • Patients should be advised that the effect is temporary and that repeat treatments will be required to maintain results, with intervals guided by clinical need and SmPC recommendations.
  • Detailed dosing regimens, injection patterns and reconstitution volumes must be taken directly from the official SmPC and should not be modified outside evidence-based guidelines.

Contraindications

  • Hypersensitivity to the active substance (botulinum toxin type A) or to any of the excipients (human albumin, lactose monohydrate).
  • Presence of infection or inflammation at the proposed injection sites.
  • Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert–Eaton myasthenic syndrome, amyotrophic lateral sclerosis) where botulinum toxin may exacerbate weakness.
  • Pregnancy and breast-feeding: use is generally contraindicated or not recommended due to lack of adequate safety data in these populations.
  • Known bleeding disorders or current anticoagulant therapy require particular caution due to risk of injection-site haematoma; in some cases treatment may be unsuitable.
  • Concomitant use with certain aminoglycoside antibiotics or other agents interfering with neuromuscular transmission may potentiate the effect and requires particular caution.

Adverse Effects

  • Very common and common reactions in aesthetic indications include headache and reactions at the injection site (e.g. pain, erythema, swelling, bruising, tenderness).
  • Eyelid ptosis (drooping eyelid), brow ptosis, and eyebrow elevation can occur due to local spread of toxin effect; usually transient.
  • Localised muscle weakness near the injection site and asymmetry of facial expression.
  • Dry eye, lacrimation changes, eyelid oedema, visual disturbances or eye disorders, particularly when treating lateral canthal lines.
  • Flu-like symptoms, nausea and fatigue have been reported.
  • Allergic or hypersensitivity reactions, including pruritus, rash or, very rarely, more severe reactions (e.g. anaphylaxis) have been reported with botulinum toxin products.
  • Very rare reports of distant spread of toxin effect leading to exaggerated systemic weakness (e.g. dysphagia, dysphonia, respiratory compromise) have been described with botulinum toxin type A, usually in non-aesthetic or higher-dose indications; appropriate patient selection and adherence to SmPC dosing reduce this risk.
  • Any suspected adverse reactions should be reported via national pharmacovigilance systems (e.g. the MHRA Yellow Card scheme in the UK) and to Galderma medical information.

Storage Conditions

  • Unopened vials should be stored in a refrigerator (2°C – 8°C) in the original package to protect from light.
  • Do not freeze unopened vials.
  • After reconstitution, the product should be used immediately; if not used immediately, in-use storage times and conditions are the responsibility of the user but should not normally exceed the timeframe specified in the SmPC, and should be under refrigeration (2°C – 8°C).
  • Reconstituted solution should be visually inspected and discarded if particulate matter or discolouration is observed.
  • Keep out of the sight and reach of children.
  • Any unused product or waste material should be disposed of in accordance with local requirements for biological and cytotoxic waste, ensuring inactivation of residual toxin.

Duration

Onset of effect is usually seen within a few days, with maximum effect typically around 2 weeks after injection. The improvement in the appearance of lines generally lasts around 3\u20134 months, although duration may vary between individuals and with treatment area. Retreatment should not be performed more frequently than recommended in the SmPC (commonly not more often than every 12 weeks), and should be guided by clinical response and safety considerations.

Onset

Initial clinical effect is usually observed within 2\u20133 days after injection, with maximum effect typically reached around 2 weeks post-treatment. The effect is reversible, and muscle function gradually returns over several months as neuromuscular transmission is restored.

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