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Relfydess 100U/mL x 1 Vial

Relfydess 100U/mL x 1 Vial

Relfydess

Prescription-only botulinum toxin neuromodulator
  • Authorised as a medicinal product in the United Kingdom by the MHRA as Relfydess 100 units/mL solution for injection (PL 03070/0010), with the Summary of Product Characteristics and Patient Information Leaflet published on the electronic medicines compendium.
  • Approved in multiple other markets (including Ireland, Sweden, Switzerland and Australia) by national medicines regulators such as HPRA, MPA, Swissmedic and TGA for specified aesthetic indications in adult patients under 65 years.
  • Manufactured and controlled according to European Union and UK Good Manufacturing Practice (GMP) standards for biological medicinal products.
  • Subject to additional pharmacovigilance monitoring (black triangle product) to enable rapid identification of new safety information; healthcare professionals are encouraged to report suspected adverse reactions.
  • Potency units are product Specific and not interchangeable with those of other botulinum toxin preparations; this requirement is clearly stated in regulatory product information to support safe prescribing and administration.
  • Use restricted to appropriately qualified healthcare professionals in line with national legislation, clinical governance frameworks, and professional guidelines for prescription Only botulinum toxin treatments, including obligations for informed consent, traceability and adverse event reporting.
Botulinum toxin type A solution for injection for upper facial dynamic lines

Description

Relfydess 100U/mL x 1 Vial is a prescription-only, ready-to-use liquid botulinum toxin type A (relabotulinumtoxinA) neuromodulator developed for aesthetic treatment of dynamic facial lines. Each vial contains 150 units of complex-free botulinum toxin type A in 1.5 mL of solution at a concentration of 100 units/mL. It is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical frown lines between the eyebrows) at maximum frown and moderate to severe lateral canthal lines (crow’s feet) at maximum smile, alone or in combination, in adult patients under 65 years when the severity of these lines has an important psychological impact. Relfydess acts by inhibiting acetylcholine release at the neuromuscular junction in targeted muscles, producing a reversible local muscle relaxation that softens dynamic wrinkles while maintaining natural expression when dosed appropriately. It is supplied as a clear, colourless to pale yellow solution that does not require reconstitution, enabling simple volumetric dosing and consistent, long-lasting results when administered intramuscularly by suitably trained healthcare professionals.

Bnefits

  • Ready-to-use liquid formulation at 100 units/mL, eliminating the need for reconstitution and reducing preparation variability.
  • Contains complex-free botulinum toxin type A1 (150 kDa neurotoxin) designed to provide predictable and consistent neuromodulator effects.
  • Specifically indicated for the temporary improvement of moderate to severe glabellar lines and lateral canthal lines, alone or in combination, in adults under 65 years.
  • Facilitates precise volumetric dosing (10 units per 0.1 mL), simplifying unit calculation, dose titration and documentation.
  • Median onset of effect within 2–3 days, with some patients noticing visible improvement as early as day 1 after injection.
  • Clinical data demonstrate improvement in glabellar and lateral canthal lines maintained for up to 6 months in a substantial proportion of patients.
  • Demonstrated high responder rates and sustained subject satisfaction and psychological benefit across the phase III READY clinical trial programme.
  • Packaged as a single-use vial for one patient and one treatment session, supporting infection control and safe handling practices.
  • Produced and regulated as a medicinal product under stringent Good Manufacturing Practice (GMP), with additional post-marketing safety monitoring in several jurisdictions.

Indications

  • Temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) 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.
  • Temporary improvement in the appearance of both moderate to severe glabellar lines and lateral canthal lines when treated in combination, in adult patients under 65 years where line severity significantly affects well-being.
  • Use only where treatment with botulinum toxin type A is clinically appropriate and where patients understand and accept the temporary nature of aesthetic results.

Composition

  • Active substance: Botulinum toxin type A 100 units/mL (relabotulinumtoxinA), manufactured from Clostridium botulinum and free from complexing proteins; each vial contains 150 units in 1.5 mL of solution.
  • Disodium hydrogen phosphate dihydrate.
  • Sodium dihydrogen phosphate dihydrate.
  • Potassium chloride.
  • Sodium chloride.
  • Polysorbate 80 (E433) – excipient with known effect; 1.1 mg per mL of solution (1.6 mg per 150-unit vial).
  • L-tryptophan.
  • Water for injections.

Formulation

  • Pharmaceutical form: Solution for injection.
  • Appearance: Clear, colourless to pale yellow solution.
  • Strength: 100 units/mL botulinum toxin type A; 150 units per vial in 1.5 mL of solution.
  • Complex-free 150 kDa botulinum toxin type A1 neurotoxin in a ready-to-use aqueous solution (no reconstitution required).
  • Prescription-only medicinal product for intramuscular administration by appropriately qualified healthcare professionals.

Packaging

  • Nature of container: Type I glass vial with bromobutyl rubber stopper and aluminium overseal with polypropylene flip-off cap.
  • Contents of container: 1.5 mL of solution containing 150 units of botulinum toxin type A at 100 units/mL.
  • Pack sizes: Cartons containing 1 or 10 single-use vials of Relfydess 100 units/mL solution for injection (not all pack sizes may be marketed in every territory).
  • Each vial is intended for use for a single patient during a single treatment session only; any residual solution must be inactivated and discarded after use.
  • Outer carton labelled with product name, strength, total units per vial, batch number, expiry date, storage conditions, marketing authorisation details and relevant safety symbols (including additional-monitoring black triangle where applicable).

Usage

  • Relfydess is a prescription-only medicine and must only be administered by healthcare professionals with appropriate qualifications, training and expertise in the use of botulinum toxin type A and facial anatomy, in accordance with national legislation and professional guidelines.
  • The potency units of Relfydess are specific to this preparation and are not interchangeable with units of other botulinum toxin products; dosing from other toxins must not be directly converted or extrapolated.
  • Visually inspect the vial before use; the solution should be clear and colourless to pale yellow with no visible particulate matter and the container should be intact. Do not use if the solution is cloudy, discoloured, contains particles or if the vial is damaged.
  • Relfydess is supplied as a ready-to-use solution at 100 units/mL (10 units per 0.1 mL) and does not require reconstitution. Use aseptic technique to withdraw the required volume with a sterile syringe and needle.
  • Administer by intramuscular injection into the indicated facial muscles, following the dosing and injection patterns in the approved Summary of Product Characteristics (SmPC). Avoid intravascular injection by careful placement and technique.
  • Recommended dosing for glabellar lines in adults is 50 units (0.5 mL) administered as five injections of 10 units (0.1 mL) each: two injections on each side into the corrugator muscles and one injection into the procerus muscle near the nasofrontal angle.
  • Recommended dosing for lateral canthal lines in adults is 60 units (0.6 mL) administered as six injections of 10 units (0.1 mL) each: three injections (30 units/0.3 mL) on each side into the lateral orbicularis oculi muscle, with the needle bevel oriented away from the eye.
  • For combined treatment of glabellar and lateral canthal lines, administer a total of 110 units (1.1 mL) distributed as 11 injections of 10 units (0.1 mL) following the individual patterns for each area.
  • Identify anatomical landmarks at maximum frown or maximum smile as appropriate and follow the SmPC guidance (e.g. placing lateral corrugator injections at least 1 cm above the bony supraorbital ridge; avoiding injections too close to the central eyebrow) to minimise risks such as eyelid ptosis.
  • Use caution in patients with risk factors such as neuromuscular disorders, bleeding tendencies or concomitant medications that may potentiate neuromuscular blockade; adjust treatment according to warnings and precautions in the SmPC.
  • Do not exceed the maximum total dose per treatment session or treat more frequently than every 12 weeks. Consider the cumulative dose if other botulinum toxin products are used for other indications.
  • Each vial must be used for one patient in a single treatment session. Immediately after treatment, inactivate any residual solution in vial or syringe with an appropriate disinfectant (e.g. diluted sodium hypochlorite or sodium hydroxide solution) and dispose of in accordance with local requirements.
  • Advise patients about expected onset and duration of effect, common transient reactions (e.g. headache, injection-site pain or bruising) and serious warning signs (e.g. difficulty swallowing, speaking or breathing, visual changes) that require urgent medical attention.

Contraindications

  • Known hypersensitivity to any botulinum toxin product or to any of the excipients (disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, potassium chloride, sodium chloride, polysorbate 80, L-tryptophan, water for injections).
  • Presence of infection or inflammation at the proposed injection sites.
  • Presence of generalised disorders of muscle activity such as myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis.
  • Use in patients with significant neuromuscular junction disorders or marked muscle weakness where botulinum toxin administration may pose additional risk, according to clinical judgement.
  • Patients with known severe reactions to previous botulinum toxin treatments where further exposure is considered unsafe.
  • Use in patients under 18 years of age for aesthetic indications (safety and efficacy not established; Relfydess is not recommended in this population).
  • Use in adults aged 65 years or older for the approved aesthetic indications is not recommended due to limited phase III data.
  • Pregnancy and breast-feeding: Relfydess should not be used during pregnancy or in women of child-bearing potential not using contraception, and should not be used during breast-feeding, in accordance with product information.
  • Use in patients with severe uncontrolled systemic illness, clinically significant swallowing or breathing difficulties, or severe asthenia where the risk of toxin spread or complications is considered high.
  • Intravenous or intra-arterial injection and injection into non-target tissues are strictly contraindicated.

Adverse Effects

  • Very common and common adverse reactions include headache and injection-site reactions such as pain, tenderness, bruising, erythema, pruritus, oedema and discomfort.
  • Eyelid ptosis, localised muscle weakness and facial asymmetry have been reported, particularly with glabellar treatment; these are usually mild to moderate and self-limiting.
  • For lateral canthal lines, reported reactions include headache, eyelid swelling, dry eye, eye irritation, asthenopia (eye strain) and localised weakness of periocular muscles.
  • Hypersensitivity reactions, including rash, pruritus, urticaria, soft-tissue oedema and very rarely anaphylaxis, may occur as with other botulinum toxin products.
  • Spread of toxin effect beyond the injection site has been reported very rarely with botulinum toxins and may result in symptoms such as generalised muscle weakness, asthenia, dysphagia, dysphonia, dysarthria, urinary incontinence or breathing difficulties, which can be life-threatening in severe cases.
  • Visual disturbances including blurred vision or diplopia have been reported with botulinum toxins and may temporarily affect the ability to drive or operate machinery.
  • As with any intramuscular injection, there is a risk of bleeding, haematoma formation, local pain and, rarely, infection at the injection site.
  • Repeated treatment can lead to local muscle atrophy due to prolonged disuse of the treated muscles.
  • The development of neutralising antibodies to botulinum toxin type A is possible, particularly with higher or more frequent dosing, and may reduce clinical efficacy over time.
  • Any serious, unexpected or persistent adverse reactions should be evaluated promptly, managed according to clinical guidelines and reported through appropriate pharmacovigilance systems.

Storage Conditions

  • Store in a refrigerator at 2°C–8°C. Do not freeze.
  • Keep vials in the outer carton to protect from light.
  • Unopened vials may be kept at room temperature (up to 25°C) protected from light for up to 24 hours; thereafter they should be returned to refrigerated storage or discarded according to local requirements and product guidance.
  • Do not use Relfydess after the expiry date printed on the vial and outer carton.
  • Once a vial has been opened and used for a patient treatment session, any remaining solution must be inactivated and disposed of and must not be stored for reuse.
  • Store out of the sight and reach of children and handle in accordance with local regulations for hazardous biological medicinal products.

Duration

Clinical data show that a single treatment with Relfydess can maintain improvement in glabellar and lateral canthal lines for up to approximately 6 months in many patients, with responder rates remaining above baseline through 6 months; individual duration may vary and some patients may seek retreatment after around 3\u20134 months.

Onset

Median time to onset is 2\u20133 days after injection, with some patients reporting visible effect within 1 day; maximum improvement is generally observed within 1\u20132 weeks.

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