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Relfydess Solution For Injection 1.5ml Single Vial (100 units/mL)

Relfydess Solution For Injection 1.5ml Single Vial (100 units/mL)

Relfydess

Botulinum toxin type A neuromodulator
  • Licensed prescription Only medicine in the United Kingdom with an MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), listed on the electronic Medicines Compendium (emc).
  • Subject to additional safety monitoring (black triangle symbol) in the UK and EU to enable rapid identification of new safety information.
  • Marketing authorisation holder in Ireland: Ipsen Pharma, with Relfydess listed by the HPRA as a 100 units/mL solution for injection.
  • Approved in multiple markets, including TGA Listed in Australia for temporary improvement of moderate to severe glabellar and lateral canthal lines in adult patients.
  • Assessed by Swissmedic with a Swiss Public Assessment Report (SwissPAR) and associated risk Management plan outlining important risks and pharmacovigilance activities.
  • Manufactured to EU Good Manufacturing Practice (GMP) standards at Q Med AB in Uppsala, Sweden, as documented in regulatory product information.
Ready-to-use liquid botulinum toxin type A for glabellar and lateral canthal lines

Description

Relfydess Solution for Injection 100 units/mL (1.5 ml vial) is a premium, prescription-only botulinum toxin type A neuromodulator supplied as a clear, ready-to-use liquid. It contains 150 units of botulinum toxin type A in 1.5 ml of solution and is indicated in adults under 65 years for the temporary improvement of moderate to severe glabellar lines (vertical frown lines between the eyebrows) and lateral canthal lines (crow’s feet) when these lines have a significant psychological impact. Manufactured from Clostridium botulinum toxin type A free from complexing proteins, Relfydess chemically denervates the injected muscles, reducing muscle activity and softening dynamic wrinkles. Advanced purification and PEARL® liquid formulation technology provide a consistent, predictable onset, diffusion and duration of effect, with median onset at 2–3 days and a demonstrated treatment effect lasting up to 6 months in clinical trials.

Bnefits

  • Temporary improvement in the appearance of moderate to severe glabellar lines at maximum frown in adults under 65 years.
  • Temporary improvement in the appearance of moderate to severe lateral canthal (crow’s feet) lines at maximum smile, alone or in combination with glabellar treatment.
  • Ready-to-use liquid formulation (no reconstitution) with fixed concentration of 100 units/mL for precise dosing and reduced preparation error.
  • Predictable onset of action with median onset at 2–3 days and some patients experiencing visible effect within 1 day.
  • Sustained clinical effect demonstrated for up to 6 months, with up to approximately 75% of patients not returning to baseline wrinkle severity at 6 months in pivotal studies.
  • Highly purified botulinum toxin type A free from complexing proteins, formulated as relabotulinumtoxinA using PEARL® technology for a complex-free, low-immunogenicity neuromodulator.
  • Demonstrated low rate of neutralising antibody formation (~1.1% of treated subjects in clinical development), supporting continued responsiveness to treatment.
  • Clinically evaluated safety profile with most adverse reactions being mild to moderate, transient and related to injection technique (e.g. injection-site reactions, headache).

Indications

  • Temporary improvement in the appearance of moderate to severe glabellar lines 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) seen at maximum smile in adult patients under 65 years when the severity of these lines has an important psychological impact.
  • Combined treatment of moderate to severe glabellar and lateral canthal lines in adult patients under 65 years, where clinically appropriate.

Composition

  • Active substance: Botulinum toxin type A 100 units/mL manufactured from Clostridium botulinum, free from complexing proteins; each vial contains 150 units in 1.5 mL solution.
  • 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 vial (essentially sodium-free).
  • Contains less than 1 mmol potassium (39 mg) per vial (essentially potassium-free).

Formulation

  • Pharmaceutical form: Solution for injection (injection).
  • Clear, colourless to pale yellow ready-to-use liquid for intramuscular injection.
  • Concentration: 100 units/mL botulinum toxin type A (10 units per 0.1 mL), no reconstitution required.
  • Each Type I glass vial contains 1.5 mL (150 units) of solution.
  • RelabotulinumtoxinA (Relfydess) is a novel, complex-free, ready-to-use liquid formulation of botulinum toxin A1 produced using PEARL® technology to optimise stability, potency and low immunogenicity.
  • Intended route: intramuscular injection into specific facial muscles responsible for glabellar and lateral canthal lines, administered by appropriately qualified healthcare professionals.

Packaging

  • Pack size: cartons containing 1 or 10 glass vials of Relfydess 100 units/mL solution for injection; not all pack sizes may be marketed in every country.
  • Container: 2 mL Type I glass vial containing 1.5 mL of solution, closed with a bromobutyl rubber stopper and aluminium overseal with polypropylene flip-off top.
  • Each vial contains 150 units of botulinum toxin type A (100 units/mL).
  • Vials are supplied in an outer carton to protect from light and facilitate cold-chain storage.
  • Each vial is single-use and intended for treatment of a single patient during a single session; any residual solution must be inactivated and disposed of according to handling guidance.
  • Supplied with full prescribing information / SmPC or package leaflet, including dosing tables, contraindications and safety information.

Usage

  • Relfydess is a prescription-only medicine and must only be administered by healthcare professionals with appropriate qualifications and expertise in botulinum toxin injections and with access to the necessary equipment and resuscitation facilities.
  • Indication and dose should be determined after a full medical history, clinical examination and assessment of glabellar and/or lateral canthal lines at maximum frown or smile, including evaluation of psychological impact and exclusion of contraindications.
  • Relfydess is supplied as a ready-to-use liquid at 100 units/mL (10 units per 0.1 mL); no reconstitution or dilution is required before intramuscular injection.
  • For 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 muscle and one into the procerus muscle near the nasofrontal angle.
  • For lateral canthal lines: the recommended dose is 60 units (0.6 mL) administered as six 10-unit (0.1 mL) intramuscular injections – three injections (30 units/0.3 mL) into the orbicularis oculi muscle on each side, with needle bevel up and oriented away from the eye; injection pattern (above/below canthus) is adjusted based on wrinkle distribution.
  • For combined treatment of glabellar and lateral canthal lines: follow the individual protocols above for a total dose of 110 units (1.1 mL) administered in 11 injections.
  • The treatment interval must not be shorter than 12 weeks; cumulative dose must be considered, particularly if the patient receives botulinum toxin products for other indications.
  • Prior to injection, cleanse the skin and use appropriate aseptic technique. Accurate anatomical landmark identification and correct injection depth are essential to optimise results and minimise complications (e.g., eyelid ptosis, asymmetric smile).
  • Avoid intravascular injection; always inject intramuscularly using a suitable fine needle and minimal effective volume at each site. Use care to avoid diffusion into adjacent unwanted muscles (e.g., levator palpebrae, zygomaticus).
  • Patients should be informed that onset is typically within 2–3 days (some within 1 day), maximum effect around 1 month and effect can last up to approximately 6 months, after which retreatment may be considered, respecting minimum intervals.
  • Relfydess units are specific to this product and are not interchangeable with units of any other botulinum toxin preparation; dosing of other toxins cannot be directly substituted.
  • Each vial must be used for a single patient during a single treatment session only; any unused product should be inactivated (e.g., with 0.1% sodium hypochlorite or 1% sodium hydroxide) and disposed of in accordance with local requirements for biological and cytotoxic waste.

Contraindications

  • Known hypersensitivity to any botulinum toxin product or to any of the excipients in the Relfydess formulation (including polysorbate 80).
  • Presence of infection at the proposed injection sites.
  • Presence of neuromuscular junction disorders such as myasthenia gravis, Eaton–Lambert syndrome or amyotrophic lateral sclerosis.
  • Use during pregnancy or in women of child-bearing potential not using effective contraception.
  • Use during breast-feeding.
  • Relfydess is not recommended in children or adolescents under 18 years due to lack of safety and efficacy data.
  • Patients with significant pre-existing swallowing or breathing difficulties, severe asthenia, or pneumopathy, in whom spread of toxin effect could pose serious risk.
  • Use in patients with uncontrolled bleeding disorders or on anticoagulant/antiplatelet therapy is not recommended unless the risk–benefit has been carefully evaluated.
  • Patients with marked facial asymmetry, ptosis, excessive skin laxity, deep dermal scarring or thick sebaceous skin at the treatment sites require caution and may not be suitable candidates.

Adverse Effects

  • Very common and common adverse reactions include injection-site reactions such as bruising, pain, itching, redness (erythema), swelling, discomfort, hypersensitivity, warmth and haematoma, and headache.
  • Common eye-related adverse effects include eyelid ptosis (drooping).
  • Uncommon adverse reactions include dizziness, blurred vision, dry eye, eye strain (asthenopia), swelling of the eyelids, brow ptosis, urticaria, muscular weakness, muscle spasm or twitching and local or generalized allergic reactions (including asthma or widespread urticaria).
  • Very rare but serious adverse reactions reported with botulinum toxin products include systemic spread of toxin effect beyond the injection site, leading to symptoms such as dysphagia, dysphonia, dysarthria, generalized muscle weakness, breathing difficulties and, in severe cases, aspiration or respiratory compromise, which can be life-threatening.
  • Dry eye, reduced blinking, reduced tear production and other corneal disorders can occur; increased lacrimation may also occur.
  • Muscle atrophy can develop in treated muscles after repeated injections due to sustained flaccid paralysis.
  • Hypersensitivity and anaphylactic reactions, including anaphylaxis, serum sickness, urticaria, soft-tissue oedema and dyspnoea, have been reported with botulinum toxin products; emergency treatment should be available.
  • Frequency categories in the SmPC classify headache and injection-site reactions as common, while most other non-serious reactions are uncommon; post-marketing data are used for very rare and unknown frequency reactions.
  • Overdose or inadvertent systemic exposure can result in profound neuromuscular paralysis, necessitating prolonged medical monitoring and possible respiratory support.

Storage Conditions

  • Store in a refrigerator at 2 °C to 8 °C.
  • Do not freeze.
  • Keep the vial in the outer carton to protect from light.
  • Unopened vials may be brought to room temperature (up to 25 °C) and protected from light; stability of unopened vials has been demonstrated for up to 24 hours at room temperature.
  • Do not use after the expiry date stated on the label and carton; the expiry date refers to the last day of that 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 and closure are intact.
  • Each vial is for single use only; after first opening, any residual solution must be inactivated (e.g. with 0.1% sodium hypochlorite or 1% sodium hydroxide) and disposed of as hazardous waste according to local requirements.

Duration

Clinical trials demonstrate that a single treatment with Relfydess provides visible improvement of glabellar and lateral canthal lines with a treatment effect sustained for up to 6 months, with approximately 75% of patients not returning to baseline wrinkle severity at 6 months. Retreatment should not occur more frequently than every 12 weeks, and long-term safety data currently extend to around 52 weeks of repeated administration.

Onset

Median onset of effect is 2\u20133 days after injection, with some patients experiencing noticeable improvement as early as 1 day. Response rates were high from Day 7, with maximal effect around 1 month and a sustained clinical effect observed through 6 months in pivotal phase 3 trials.

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