Azzalure® 125 Speywood Units

Botulinum Toxin Type A | Prescription Only Medicine

Azzalure® 125 Speywood units is a prescription-only medicinal product containing botulinum toxin type A (Clostridium botulinum toxin A haemagglutinin complex). It is supplied as a white powder for solution for injection and requires reconstitution before administration.

Each vial contains 125 Speywood units of botulinum toxin type A. Azzalure Speywood units are specific to this preparation and must not be converted or considered interchangeable with units of other botulinum toxin products.

Licensed indications

Azzalure is licensed for the temporary improvement in the appearance of moderate to severe:

• Glabellar lines — vertical lines between the eyebrows seen at maximum frown

• Lateral canthal lines — commonly referred to as crow's feet, seen at maximum smile

The licensed indication applies to adult patients under 65 years where the severity of the lines has an important psychological impact.

Why Azzalure?

Azzalure has an established clinical evidence base in the treatment of glabellar and lateral canthal lines. In clinical studies, the median onset of response for glabellar lines was 2–3 days, with an optimal effect demonstrated for up to 4 months following treatment. Some patients remained responders at 5 months.

For lateral canthal lines, clinical studies demonstrated a statistically significant reduction in severity compared with placebo at 4, 8 and 12 weeks following treatment.

Azzalure has also been studied with repeated treatment cycles, with clinical data supporting maintained efficacy across repeated treatments.

These clinical outcomes should be considered alongside individual patient assessment, treatment suitability and the current prescribing information.

Product information

• Product: Azzalure® 125 Speywood units

• Active ingredient: Botulinum toxin type A

• Strength: 125 Speywood units per vial

• Pharmaceutical form: Powder for solution for injection

• Route of administration: Intramuscular

• Legal category: Prescription Only Medicine (POM)

• Pack sizes: 1 or 2 vials

• Marketing Authorisation Holder: Galderma (U.K.) Limited

• UK product licence: PL 00538/0101

Reconstitution

Azzalure must be reconstituted using sodium chloride 9 mg/ml (0.9%) solution for injection before administration.

The current SmPC provides dilution instructions for achieving the required concentration. Reconstitution and administration should be undertaken using appropriate aseptic technique by a healthcare practitioner with the relevant qualifications and expertise.

Storage

Store Azzalure in a refrigerator at 2°C–8°C.

Do not freeze.

The current SmPC states that an unopened vial can be exposed to temperatures up to 25°C for a single period of up to 72 hours, after which it should be returned to refrigerated storage for the remainder of its shelf life.

Following reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C–8°C. From a microbiological perspective, the product should be used immediately where possible.

Professional supply

Supplied by Longeva Pharmacy to eligible UK healthcare professionals, subject to appropriate professional verification, prescription and applicable supply requirements.

Azzalure should only be administered by a healthcare practitioner with appropriate qualifications and expertise in its use and with the required equipment. The product is intended for treatment of one patient during a single treatment session.

Professional supply only. Prescription required.

Important prescribing information

Healthcare professionals should consult the current Azzalure 125 Speywood units Summary of Product Characteristics (SmPC) before prescribing, preparing or administering the product.

The SmPC contains full information regarding contraindications, warnings and precautions, adverse reactions, dosage, administration, interactions, storage and handling requirements.

Suspected adverse reactions should be reported through the MHRA Yellow Card Scheme.

At the basket, you will be asked per line whether each prescription-eligible item is being ordered on prescription for a named patient or as clinic stock under your responsibility.

Named-patient prescription supply. Lines marked for a named patient are dispensed against your prescription. The order is held for Superintendent Pharmacist review before despatch. Prescription supply is zero-rated for VAT.

Clinic stock supply. Lines marked as clinic stock are supplied under your professional responsibility for use in your practice. Standard VAT applies at checkout.

Orders containing prescription-only medicines (POM) are held until the Superintendent Pharmacist has cleared the prescription. Same-day dispatch applies once cleared.

For questions about prescription supply, contact admin@longevapharma.com or reply to your order confirmation email.

Dispatch: Orders approved before 3pm Monday to Friday ship the same day for next-working-day delivery via tracked courier. Cold-chain products travel in temperature-controlled packaging.

Returns: Sealed, in-date, unopened items may be returned within 14 days of delivery for a full refund. Cold-chain items cannot be returned once dispatched. Contact our pharmacy team to start a return.

Documentation: Every dispatch includes batch and expiry information suitable for your clinic's compliance records.