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Relfydess Single Pack (100 units/mL)

Relfydess Single Pack (100 units/mL)

Relfydess

Botulinum toxin type A neuromodulator
  • Authorised as a prescription Only medicine in the UK with an MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet.
  • Subject to additional pharmacovigilance monitoring in the UK and EU (black triangle ▼) to support rapid detection of new safety information.
  • Assessed and approved by other national regulatory agencies including HPRA (Ireland), TGA (Australia) and Swissmedic for the same aesthetic indications.
  • Manufactured to EU Good Manufacturing Practice (GMP) standards by or on behalf of Galderma using proprietary PEARL™ Technology to produce a complex Free liquid botulinum toxin formulation.
Ready-to-use liquid botulinum toxin type A (relabotulinumtoxinA) for glabellar and lateral canthal lines

Description

Relfydess Single Pack (100 units/mL) is a premium, prescription-only botulinum toxin type A neuromodulator supplied as a ready-to-use liquid solution for injection. Containing 150 units of relabotulinumtoxinA in 1.5 mL (100 units/mL), Relfydess is the first and only liquid neuromodulator created with PEARL™ Technology and developed and manufactured by Galderma. It is indicated in adults for the temporary improvement in the appearance of moderate-to-severe glabellar lines (vertical frown lines) and lateral canthal lines (crow’s feet) when their severity has an important psychological impact. The complex-free toxin formulation offers predictable onset (often within 2–3 days, with some patients as early as day 1), reliable diffusion and sustained results for up to around 6 months, while its ready-to-use format eliminates the need for reconstitution and supports accurate volumetric dosing.

Bnefits

  • First and only ready-to-use liquid botulinum toxin type A neuromodulator created with PEARL™ Technology.
  • Indicated for the temporary improvement of moderate-to-severe glabellar lines and lateral canthal (crow’s feet) lines in adults.
  • Ready-to-use solution at 100 units/mL (10 units per 0.1 mL) – no reconstitution required, simplifying preparation and reducing dosing error.
  • Complex-free, highly purified relabotulinumtoxinA designed to minimise immunogenicity and preserve molecule integrity.
  • Predictable, rapid onset of effect – many patients show improvement within 2–3 days, with some from day 1 in clinical studies.
  • Sustained clinical efficacy for up to 6 months in a high proportion of patients following a single treatment.
  • Optimised for consistent diffusion and natural-looking softening of dynamic lines without excessive loss of facial expression when correctly dosed.
  • Liquid format supports simple volumetric dosing and precise unit delivery across treatment sites.

Indications

  • Temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines between the eyebrows) at maximum frown in appropriately selected adult patients.
  • Temporary improvement in the appearance of moderate-to-severe lateral canthal lines (crow’s feet) at maximum smile in appropriately selected adult patients.
  • Combined treatment of glabellar and lateral canthal lines in adult patients where clinically appropriate and within recommended dosing limits.

Composition

  • Active substance: Botulinum toxin type A 100 units/mL (relabotulinumtoxinA) manufactured from Clostridium botulinum, free from complexing proteins; each 1.5 mL vial contains 150 units.
  • Disodium hydrogen phosphate dihydrate.
  • Sodium dihydrogen phosphate dihydrate.
  • Potassium chloride.
  • Sodium chloride.
  • Polysorbate 80 (E433) – 1.6 mg per 150-unit vial (1.1 mg/mL).
  • L-tryptophan.
  • Water for injections.
  • Contains less than 1 mmol sodium (23 mg) per 150-unit vial – essentially sodium-free.
  • Contains less than 1 mmol potassium (39 mg) per 150-unit vial – essentially potassium-free.

Formulation

  • Pharmaceutical form: clear, colourless to pale yellow solution for injection (intramuscular).
  • Ready-to-use liquid formulation at a fixed concentration of 100 units/mL (10 units per 0.1 mL).
  • Complex-free relabotulinumtoxinA produced with PEARL™ Technology to preserve activity and reduce denaturation.
  • Supplied as a sterile, preservative-free liquid in a 2 mL Type I glass vial containing 1.5 mL of solution (150 units).
  • Intended exclusively for intramuscular injection into specific facial muscles by qualified healthcare professionals.

Packaging

  • Single pack: 1 × 2 mL Type I glass vial containing 1.5 mL of Relfydess solution (150 units at 100 units/mL).
  • Vial closed with bromobutyl rubber stopper and aluminium overseal with polypropylene flip-off cap.
  • Temperature-controlled, restricted item supplied in an outer carton to protect from light.
  • Product information and prescribing guidance provided via SmPC/PIL from Galderma; vial is single-use for one patient and one treatment session only.
  • DD Group listing identifies product code 600066 and Galderma code 012083.

Usage

  • Relfydess is a prescription-only medicine and must only be administered by healthcare professionals with appropriate training in botulinum toxin injections and access to necessary emergency equipment.
  • Before treatment, obtain a full medical history and perform a clinical examination to assess the severity and psychological impact of glabellar and/or lateral canthal lines and to exclude contraindications.
  • The solution is ready-to-use at 100 units/mL; do not dilute or reconstitute. Draw up the required volume using aseptic technique and a suitable syringe and fine needle.
  • Glabellar lines: the recommended dose is 50 units (0.5 mL) administered as five 10-unit (0.1 mL) intramuscular injections – two injections into each corrugator supercilii muscle and one into the procerus muscle near the nasofrontal angle.
  • Lateral canthal lines (crow’s feet): the recommended dose is 60 units (0.6 mL) administered as six 10-unit (0.1 mL) intramuscular injections – three injections into the orbicularis oculi muscle on each side, placed according to individual wrinkle pattern while orienting the bevel away from the eye.
  • Combined treatment of glabellar and lateral canthal lines: follow each individual dosing regimen above for a total recommended dose of 110 units (1.1 mL) per session.
  • Use aseptic technique and inject intramuscularly at the correct depth; avoid intravascular injection and take care to minimise spread to adjacent muscles (e.g. levator palpebrae superioris, zygomaticus).
  • Units of Relfydess are specific to this product and are not interchangeable with units of other botulinum toxin preparations; do not substitute dose based on another toxin product.
  • Treatment intervals should not be less than 12 weeks. The need for and timing of retreatment should be based on clinical response, patient preference, and safety considerations.
  • Dispose of any unused solution in the vial after the session; inactivate residual toxin with an appropriate disinfectant (e.g. dilute sodium hypochlorite) and discard according to local regulations for biological/cytotoxic waste.

Contraindications

  • Hypersensitivity to botulinum toxin type A or to any of the excipients (e.g. polysorbate 80).
  • Presence of infection at the proposed injection sites.
  • Known neuromuscular junction disorders such as myasthenia gravis, Eaton–Lambert syndrome, or amyotrophic lateral sclerosis.
  • Pregnancy or breast-feeding.
  • Use in children and adolescents under 18 years of age (safety and efficacy not established).
  • Patients with significant pre-existing swallowing or breathing difficulties or severe asthenia in whom even local spread of toxin may pose a serious risk.
  • Uncontrolled bleeding disorders or clinically significant coagulation abnormalities where intramuscular injections pose unacceptable risk, unless carefully assessed by a physician.

Adverse Effects

  • Very common or common reactions include injection-site pain, bruising, erythema, swelling, pruritus and headache.
  • Eyelid ptosis is a recognised adverse effect in glabellar treatment, usually mild to moderate and transient.
  • Other uncommon adverse effects may include dizziness, dry eye, blurred vision, lacrimation changes, eyelid edema, brow ptosis and local muscle weakness.
  • Hypersensitivity reactions including rash, urticaria, pruritus and, very rarely, anaphylaxis have been reported with botulinum toxin products.
  • Spread of toxin effect beyond the injection site can cause symptoms such as asthenia, generalized muscle weakness, diplopia, dysphagia, dysphonia, dysarthria or respiratory difficulties; these events can be serious and require urgent medical attention.
  • Local muscle atrophy may occur with repeated treatment of the same muscles over time.
  • Most adverse reactions are mild to moderate and transient, resolving without intervention; any unexpected, persistent or severe reaction should be evaluated promptly.

Storage Conditions

  • Store in a refrigerator at 2 °C – 8 °C.
  • Do not freeze.
  • Keep the vial in the outer carton in order to protect from light.
  • Unopened vial may be brought to room temperature (up to 25 °C) and protected from light; stability of the unopened vial has been demonstrated for up to 24 hours at room temperature.
  • Do not use this medicine after the expiry date stated on the label and carton (expiry refers to the last day of the stated month).
  • Keep out of the sight and reach of children.
  • Use only if the solution is clear and colourless to pale yellow and the vial/closure are intact; discard any damaged or compromised vials.
  • Single-use vial: discard any unused solution after first use, following appropriate inactivation and disposal procedures for botulinum toxin products.

Duration

In clinical studies, a single treatment with Relfydess provided significant improvement in glabellar and lateral canthal lines with effects typically lasting up to 6 months, and a high proportion of patients not returning to baseline wrinkle severity by Month 6. Retreatment should not occur more frequently than every 12 weeks and long-term treatment plans should consider cumulative dose and individual response.

Onset

Onset of action is generally observed within 2\u20133 days after injection, with some patients noticing effect as early as day 1. Maximum effect is usually reached around 1 month after treatment.

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