Description
Clinical Description
Azzalure 125IU (2 Vials) is a prescription-only injectable medicine containing botulinum toxin type A in the form of a powder for solution for injection. Each vial contains 125 Speywood units of botulinum toxin type A haemagglutinin complex. Azzalure is specifically indicated for the temporary improvement in the appearance of moderate to severe glabellar lines and lateral canthal lines in adults under 65 years of age when the severity of these lines has an important psychological impact.
Botulinum toxin type A acts as a local muscle relaxant. Following intramuscular administration, it inhibits the transport of the neurotransmitter acetylcholine across the neuromuscular junction. This reduces contraction of the targeted muscles and temporarily decreases their activity, producing a reduction in the appearance of dynamic facial lines.
Importantly, Azzalure Speywood units are specific to this preparation and are not interchangeable with units from other botulinum toxin products.
What Azzalure 125IU (2 Vials) Is Similar To
Azzalure belongs to the same broad therapeutic class as other botulinum toxin type A medicines used in aesthetic medicine, including BOTOX and BOCOUTURE. These products all act at the neuromuscular junction to temporarily reduce muscle activity, but their formulations, potency units, authorised indications and dosing recommendations differ.
For example, the UK SmPC for BOCOUTURE describes botulinum toxin type A for facial lines including glabellar and lateral periorbital lines. However, BOCOUTURE uses its own units and its recommended doses are not directly interchangeable with Azzalure Speywood units. BOTOX likewise has product-specific Allergan Units and separate dosing guidance.
Azzalure’s UK indication is specifically for moderate to severe glabellar and lateral canthal lines in adults under 65 who meet the stated indication criteria. Its clinical effect is temporary, with clinical studies demonstrating improvement for up to approximately four months for glabellar lines.
This comparison is provided for clinical orientation only and does not imply interchangeability.
Treatment Areas / Indications
The UK SmPC specifies the following authorised aesthetic indications:
- Glabellar lines — vertical lines between the eyebrows, assessed at maximum frown.
- Lateral canthal lines — commonly referred to as crow’s feet, assessed at maximum smile.
The indication applies to adults under 65 years of age where the severity of the lines has an important psychological impact on the patient.
Other facial areas, including forehead lines, nasal lines or perioral lines, are not provided as authorised indications for Azzalure in the current UK SmPC.
Usage / Administration (IFU / SmPC Only)
Azzalure should only be administered by a healthcare practitioner with appropriate qualifications and expertise in the treatment and the required equipment, in accordance with national guidelines.
Glabellar Lines
- Total recommended dose: 50 Speywood units.
- Number of injection sites: 5.
- Dose per site: 10 Speywood units.
- Injection volume: The reconstitution option of 0.63 mL of 0.9% sodium chloride produces 10 units per 0.05 mL; the 1.25 mL option produces 10 units per 0.1 mL.
- Injection location: Intramuscularly into five sites — two injections into each corrugator muscle and one into the procerus muscle.
- Injection direction: At right angles to the skin for the specified glabellar injection sites.
- Needle gauge: The SmPC states that a sterile suitable-gauge needle should be used; specific gauge not provided by manufacturer.
Lateral Canthal Lines
- Recommended dose per side: 30 Speywood units.
- Total recommended dose: 60 Speywood units for both sides.
- Injection sites: 3 sites per side.
- Dose per site: 10 Speywood units.
- Injection depth: Intramuscular and described as very superficial.
- Injection angle: Approximately 20–30° to the skin.
- Injection location: External portion of the orbicularis oculi muscle, sufficiently distant from the orbital rim, approximately 1–2 cm.
- Needle gauge: Specific gauge not provided by manufacturer.
- Treatment interval: Not more frequently than every three months.
Reconstitution must be performed with 0.9% sodium chloride solution for injection under appropriate aseptic conditions. Once reconstituted, Azzalure is intended for treatment of a single patient during a single session.
Ingredient List
Active ingredient:
- Botulinum toxin type A haemagglutinin complex
- 125 Speywood units per vial
Excipients:
- Human albumin 200 g/L
- Lactose monohydrate
Important: Azzalure Speywood units are product-specific and must not be converted directly into units of other botulinum toxin preparations.
Presentation & Longevity
Presentation
- 2 × 125 Speywood-unit vials
- Powder for solution for injection
- Type I glass vial with stopper and aluminium seal
- Prescription-only medicine
Storage
Unopened Azzalure should normally be stored refrigerated at 2–8°C and should not be frozen. The current SmPC states a shelf life of 2 years for the unopened product.
Reconstituted Product
Chemical and physical in-use stability has been demonstrated for 24 hours at 2–8°C. From a microbiological perspective, the product should generally be used immediately unless the reconstitution process prevents microbial contamination.
Duration
For glabellar lines, clinical studies demonstrated an optimal effect for up to 4 months, with some patients remaining responders at 5 months. For lateral canthal lines, efficacy was demonstrated at several follow-up points through 16 weeks in clinical studies.
Individual duration can vary and should not be represented as a guaranteed treatment duration.
Safety Notes / Contraindications
Azzalure is contraindicated in patients with:
- Known hypersensitivity to botulinum toxin type A or any excipient.
- Infection at the proposed injection site.
- Myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis.
Additional precautions include careful consideration of pre-existing neuromuscular disorders, facial anatomy, muscle weakness or atrophy, inflammation at the injection site and prolonged bleeding time.
Azzalure should not be used during pregnancy, and use during breastfeeding cannot be recommended because sufficient clinical information is not available.
Rarely, effects of botulinum toxin may extend beyond the injection site and can result in significant muscle weakness, swallowing difficulties or respiratory problems. Immediate medical assessment is required if serious symptoms occur.
Regulatory Status
- UK Prescription Only Medicine (POM)
- Active ingredient: botulinum toxin type A
- Pharmaceutical form: powder for solution for injection
- UK Marketing Authorisation: PL 06958/0031
- Marketing Authorisation Holder: Ipsen Limited, according to the current UK SmPC.
- Current UK prescribing information is published through the Electronic Medicines Compendium and should be checked before clinical use.
Azzalure is therefore regulated as a medicinal product rather than a CE/UKCA-marked medical device.
FAQ
1. What is Azzalure 125IU used for?
Azzalure 125IU is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines and lateral canthal lines in adults under 65 years of age when the severity of the lines has an important psychological impact. It works by temporarily reducing activity in targeted muscles through inhibition of acetylcholine transmission at the neuromuscular junction. Its authorised UK aesthetic indications do not include all facial wrinkle areas, so use should follow the current UK prescribing information.
2. How does Azzalure work?
Azzalure contains botulinum toxin type A, a peripherally acting muscle relaxant. After intramuscular administration, it interferes with the transport of acetylcholine across the neuromuscular junction. This interrupts communication between the nerve ending and the muscle fibre, temporarily reducing contraction of the treated muscle. Muscle activity gradually returns as the neuromuscular junction recovers. The effect is therefore temporary rather than permanent.
3. How is Azzalure administered according to the UK SmPC?
Azzalure must be reconstituted before administration and given by an appropriately qualified healthcare practitioner. For glabellar lines, the recommended total dose is 50 Speywood units divided between five intramuscular injection sites. For lateral canthal lines, the recommended dose is 30 units per side across three sites per side. A sterile suitable-gauge needle is specified, but a particular needle gauge is not stated in the SmPC. Treatment should not be repeated more frequently than every three months.
4. How long does Azzalure last?
The duration of Azzalure’s effect is temporary and varies between individuals. In clinical studies, the optimal effect for glabellar lines was demonstrated for up to four months, with some patients still responding at five months. For lateral canthal lines, clinical benefit was demonstrated through several follow-up assessments, including 16 weeks. The actual duration should not be presented as guaranteed because response can differ according to patient characteristics and the treated indication.
5. Is Azzalure the same as Botox or Bocouture?
Azzalure, BOTOX and BOCOUTURE are all botulinum toxin type A medicines, but they are not identical products. Each uses its own formulation, potency units and prescribing information. Azzalure is measured in Speywood units, which the UK SmPC specifically states are not interchangeable with units from other botulinum toxin preparations. Consequently, dosing should always be based on the product-specific prescribing information rather than direct unit-for-unit substitution.
