Relfydess 100iu Per ml x10 Vials
Relfydess
Botulinum toxin type A neuromodulatorReady-to-use liquid botulinum toxin type A (relabotulinumtoxinA) for glabellar and lateral canthal lines
Certifications
- Licensed as a prescription Only medicine in the UK with MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet.
- Listed by the MHRA and HPRA as Relfydess 100 units/mL solution for injection, supplied in packs of 1 or 10 vials (1.5 mL per vial).
- Subject to additional monitoring in the UK and EU (black triangle ▼) to allow rapid identification of new safety information; adverse events should be reported via national systems (e.g., MHRA Yellow Card, HPRA Pharmacovigilance) and to Galderma.
- Manufactured according to EU Good Manufacturing Practice (GMP) standards from a proprietary C. botulinum type A1 strain using PEARL™ Technology to produce a complex Free, highly purified liquid formulation.
- Supported by pivotal phase 3 clinical trials (READY 1 and READY 2) and subsequent phase IIIb data demonstrating rapid onset, long Lasting effect and favourable safety profile for aesthetic indications.
- Licensed as a prescription Only medicine in the UK with MHRA Approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet.
- Listed by the MHRA and HPRA as Relfydess 100 units/mL solution for injection, supplied in packs of 1 or 10 vials (1.5 mL per vial).
- Subject to additional monitoring in the UK and EU (black triangle ▼) to allow rapid identification of new safety information; adverse events should be reported via national systems (e.g., MHRA Yellow Card, HPRA Pharmacovigilance) and to Galderma.
- Manufactured according to EU Good Manufacturing Practice (GMP) standards from a proprietary C. botulinum type A1 strain using PEARL™ Technology to produce a complex Free, highly purified liquid formulation.
- Supported by pivotal phase 3 clinical trials (READY 1 and READY 2) and subsequent phase IIIb data demonstrating rapid onset, long Lasting effect and favourable safety profile for aesthetic indications.
Ready-to-use liquid botulinum toxin type A (relabotulinumtoxinA) for glabellar and lateral canthal lines
Description
Relfydess 100iu Per ml x10 Vials is a clinic-sized pack of relabotulinumtoxinA, a prescription-only, ready-to-use liquid botulinum toxin type A neuromodulator developed and manufactured by Galderma using proprietary PEARL™ Technology. Each Type I glass vial contains 1.5 ml of clear solution at a concentration of 100 units/mL (150 units per vial). Relfydess is indicated in adults for the temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) when the severity of these lines has an important psychological impact. The complex-free, highly purified liquid formulation is engineered for enhanced biological activity, refined purity, and simple volumetric dosing without reconstitution, delivering rapid onset (with up to 39% of patients seeing improvement from Day 1), long-lasting results (up to 75% maintaining improvement at 6 months) and a well-tolerated safety profile. This 10-vial pack is intended for high-throughput aesthetic practices seeking consistent, natural-looking outcomes and streamlined workflow.
Bnefits
- Ready-to-use liquid neuromodulator – no reconstitution required, simplifying preparation and reducing the risk of dosing errors.
- Indicated for the temporary improvement of moderate-to-severe glabellar lines and lateral canthal (crow’s feet) lines in appropriately selected adults.
- Formulated using PEARL™ (Precipitation-free Extraction and Activity-preserving, Refined Liquid) Technology to preserve molecule integrity and provide a complex-free, highly active botulinum toxin A1.
- Complex-free formulation with no human- or animal-derived components and no complexing proteins, supporting a clean, consistent treatment profile and low immunogenicity.
- Rapid onset of effect: in pivotal READY studies, up to 39% of patients reported visible improvement from Day 1, with a median onset of 2–3 days.
- Long-lasting efficacy: up to 75% of patients maintained clinically significant improvement through 6 months after a single treatment.
- High patient satisfaction: clinical study data report that up to 98% of patients would choose to return for repeat treatment.
- Optimised for simple volumetric dosing (10 units per 0.1 mL) to help ensure consistent dose/volume at every injection site.
- Engineered diffusion and refined molecular profile support natural-looking softening of dynamic lines while preserving facial expression when dosed correctly.
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 lines and lateral canthal lines in adult patients under 65 years, within recommended dosing limits.
Composition
- Active substance: Botulinum toxin type A 100 units/mL (relabotulinumtoxinA) manufactured from Clostridium botulinum, free from complexing proteins; each vial contains 150 units in 1.5 mL.
- 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.
- Sodium content: less than 1 mmol (23 mg) per vial – essentially sodium-free.
- Potassium content: less than 1 mmol (39 mg) per vial – essentially potassium-free.
Formulation
- Pharmaceutical form: solution for injection (intramuscular).
- Clear, colourless to pale yellow ready-to-use liquid at a concentration of 100 units/mL (10 units per 0.1 mL).
- Complex-free relabotulinumtoxinA obtained using PEARL™ Technology from a proprietary C. botulinum type A1 strain, with gentle purification to remove complexing proteins and impurities while maintaining activity and stability.
- Sterile, preservative-free liquid formulation supplied in 2 mL Type I glass vials containing 1.5 mL of solution.
- Intended solely for intramuscular injection into specific facial muscles involved in glabellar and lateral canthal lines, by appropriately qualified healthcare professionals.
Packaging
- Clinic pack containing 10 × 2 mL Type I glass vials, each filled with 1.5 mL of Relfydess solution (150 units at 100 units/mL).
- Each vial is sealed with a bromobutyl rubber stopper and aluminium overseal with polypropylene flip-off cap.
- Outer carton packaging provides protection from light and includes batch number and expiry date.
- Vials are supplied as a prescription-only, temperature-controlled product; each vial is single-use for one patient and one treatment session only.
- Pack is accompanied by full prescribing information, including Summary of Product Characteristics (SmPC) and/or Product Information and Patient Information Leaflet (PIL), accessible via included references and QR/URL links.
- Teleta listing identifies the pack as “Relfydess 100iu Per ml x10 Vials” with manufacturer Galderma and code PH-REL100/10.
Usage
- Relfydess is a prescription-only medicine and must be administered only by healthcare professionals who are appropriately trained in botulinum toxin injections and have suitable knowledge of facial anatomy and the required equipment for managing potential complications.
- Prior to treatment, perform a full medical history and clinical evaluation, including assessment of glabellar and/or lateral canthal lines at maximum frown or smile, psychological impact, and screening for contraindications and risk factors.
- The product is supplied as a ready-to-use liquid at 100 units/mL; do not reconstitute or dilute. Using aseptic technique, withdraw the required volume into a suitable syringe and attach a fine intramuscular injection needle.
- Recommended dosing (refer to SmPC/PI for full details): For glabellar lines, inject a total of 50 units (0.5 mL) as five 10-unit (0.1 mL) intramuscular injections – two into each corrugator supercilii muscle and one into the procerus muscle near the nasofrontal angle.
- For lateral canthal lines, inject a total of 60 units (0.6 mL) as six 10-unit (0.1 mL) intramuscular injections – three injections into the orbicularis oculi muscle on each side, with the needle bevel oriented away from the eye and injection points positioned according to the patient’s wrinkle pattern.
- For combined treatment of glabellar and lateral canthal lines, a total of 110 units (1.1 mL) is administered using the above protocols; observe maximum recommended dose and treatment interval.
- Inject intramuscularly at the appropriate depth using a fine needle and low injection volume per site, while avoiding intravascular injection and minimising spread into adjacent muscles such as levator palpebrae superioris or zygomaticus.
- Relfydess units are specific to this product and must not be interchanged with units of other botulinum toxin preparations; do not extrapolate dose equivalence from other toxins.
- Patients should be informed that onset of effect typically occurs within 2–3 days (with some experiencing visible changes from Day 1), that maximal effect is usually seen around 1 month, and that improvement can last for up to approximately 6 months.
- Retreatment should not be performed at intervals shorter than 12 weeks. The decision to retreat should be based on clinical response, patient expectations, and safety considerations, including cumulative exposure and risk of antibody formation.
- Each vial is single-use. After dosing the patient, any remaining solution must be inactivated (e.g., with diluted sodium hypochlorite or sodium hydroxide) and disposed of as hazardous biological waste in accordance with local regulations.
- Healthcare professionals should report any suspected adverse reactions via national pharmacovigilance systems (e.g., MHRA Yellow Card in the UK, HPRA in Ireland) and to Galderma as per product information.
Contraindications
- Hypersensitivity to botulinum toxin type A or to any of the excipients (including polysorbate 80).
- Presence of infection at the proposed injection sites.
- Pre-existing 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 appropriate contraception (not recommended).
- Use during breast-feeding.
- Use in children and adolescents under 18 years of age (safety and efficacy not established).
- Patients with clinically significant pre-existing dysphagia, breathing difficulties, severe asthenia or chronic respiratory disease, in whom spread of toxin effects could pose serious risk.
- Uncontrolled bleeding disorders or clinically relevant coagulation abnormalities, or patients receiving anticoagulant therapy where intramuscular injection risk is unacceptable without appropriate management.
- Patients with pronounced facial asymmetry, marked ptosis, heavy eyelids, excessive dermatochalasis or deep dermal scarring in the treatment area may not be suitable candidates or require extra caution and dose adjustment.
Adverse Effects
- Very common or common reactions include injection-site pain, tenderness, bruising, erythema, swelling, pruritus, irritation and headache.
- Eyelid ptosis is a known adverse reaction in glabellar treatment, usually mild to moderate in severity and transient.
- Other uncommon reactions may include dizziness, dry eye, blurred vision, lacrimation changes, eyelid edema, brow ptosis, local muscle weakness, muscle twitching or muscle pain.
- Hypersensitivity reactions, such as rash, urticaria, pruritus, soft-tissue swelling and, rarely, anaphylaxis, have been reported with botulinum toxin products and require prompt medical attention.
- Spread of toxin effect beyond the injection site can lead to asthenia, generalized muscle weakness, diplopia, dysphagia, dysphonia, dysarthria or respiratory difficulties; these reactions can be severe and require immediate evaluation and supportive care.
- Localised muscle atrophy may occur at injection sites after repeated treatments due to sustained denervation.
- Most adverse reactions are mild to moderate and resolve spontaneously; any unexpected, persistent or severe reaction should be reported via national pharmacovigilance systems and to Galderma, and managed according to the prescribing information and clinical best practice.
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 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, with no visible particles, and if the vial and closure are intact.
- Each vial is single-use; any unused solution after first opening must be inactivated and disposed of as hazardous waste in accordance with local regulations for botulinum toxin products.
Duration
A single treatment with Relfydess typically provides clinically meaningful improvement in glabellar and lateral canthal lines for up to 6 months, with phase 3 data showing up to 75% of patients maintaining improvement at Month 6. Treatment intervals must not be shorter than 12 weeks, and long-term treatment plans should consider individual response, patient goals and cumulative dose over time.
Onset
Visible improvement may begin as early as Day 1 for a proportion of patients, with most experiencing onset within 2\u20133 days after injection. Maximal aesthetic effect is usually observed around 1 month post-treatment, followed by a gradual reduction in effect over several months.
