Relfydess: Uses, Dosage & Side Effects
A botulinum toxin type A injectable for the temporary improvement of moderate to severe glabellar lines and crow’s feet in adults under 65
Relfydess (botulinum toxin type A) is a prescription injectable used for the temporary improvement of moderate to severe vertical lines between the eyebrows (glabellar lines) and moderate to severe lines at the outer corners of the eyes (crow’s feet). It works by blocking nerve impulses to injected muscles, causing localized muscle relaxation that smooths facial wrinkles. Relfydess is a ready-to-use liquid formulation that does not require reconstitution. It is administered exclusively by qualified healthcare professionals and is approved for adults under 65 years of age whose facial wrinkles significantly affect their wellbeing. Treatment effects typically appear within a few days and can last up to 6 months.
Quick Facts: Relfydess
Key Takeaways
- Relfydess contains botulinum toxin type A and is specifically approved for temporary improvement of moderate to severe glabellar lines (frown lines) and crow’s feet (lateral canthal lines) in adults under 65 years of age.
- It is a ready-to-use liquid formulation (100 U/mL) that does not require reconstitution, unlike many other botulinum toxin products that come as freeze-dried powder.
- Treatment must be administered by a qualified healthcare professional: 50 units for glabellar lines (5 injection sites), 60 units for crow’s feet (6 injection sites), or 110 units for combined treatment (11 injection sites).
- Effects typically appear within days and can last up to 6 months, with a minimum interval of 12 weeks between treatments. The units of Relfydess are not interchangeable with other botulinum toxin products.
- Relfydess must not be used in patients with myasthenia gravis, Lambert-Eaton syndrome, or ALS, during pregnancy, or in those not using contraception. The most common side effects are injection site reactions, headache, and eyelid drooping.
What Is Relfydess and What Is It Used For?
Relfydess contains the active substance botulinum toxin type A, one of the most well-studied and widely used biological agents in aesthetic and therapeutic medicine. Botulinum toxin type A is a purified protein produced by the bacterium Clostridium botulinum. When injected in carefully controlled, minute quantities into specific facial muscles, it acts as a highly targeted neuromuscular blocking agent that causes localized, temporary muscle relaxation. This muscle relaxation is the mechanism by which Relfydess smooths dynamic facial wrinkles—those lines that form through repeated muscle contraction during facial expressions such as frowning, squinting, and smiling.
The mechanism of action of botulinum toxin type A is well understood at the molecular level. When a nerve impulse reaches a neuromuscular junction (the point where a motor nerve meets a muscle fiber), the nerve terminal releases the neurotransmitter acetylcholine. Acetylcholine crosses the synaptic cleft and binds to receptors on the muscle fiber, triggering muscle contraction. Botulinum toxin type A disrupts this process by cleaving SNAP-25 (synaptosomal-associated protein of 25 kilodaltons), a protein that is essential for the fusion of acetylcholine-containing vesicles with the presynaptic membrane. Without functional SNAP-25, acetylcholine cannot be released, and the muscle fiber does not receive the signal to contract. The result is a dose-dependent, localized reduction in muscle activity at the injected site.
This chemodenervation effect is temporary. Over a period of weeks to months, new nerve endings sprout and form new neuromuscular junctions (a process called axonal sprouting and reinnervation), gradually restoring normal neuromuscular transmission. This is why the wrinkle-smoothing effect of Relfydess diminishes over time and repeat treatments are needed to maintain the cosmetic result. The typical duration of effect for Relfydess is up to 6 months, which is notably longer than some other botulinum toxin formulations where effects typically last 3 to 4 months.
Relfydess is specifically indicated for the temporary improvement of two types of dynamic facial wrinkles in adults under 65 years of age:
- Glabellar lines (frown lines): These are the vertical lines that form between the eyebrows when a person frowns or concentrates. They are caused by repeated contraction of the corrugator supercilii and procerus muscles. Over time, these dynamic lines can become static (visible even at rest), giving the face a tired, angry, or worried appearance.
- Lateral canthal lines (crow’s feet): These are the fan-shaped lines that radiate from the outer corners of the eyes, primarily caused by contraction of the orbicularis oculi muscle during smiling and squinting. They are among the earliest signs of facial aging due to the thin, delicate skin around the eyes.
An important qualification for Relfydess treatment is that the facial wrinkles must have a significant psychological impact on the patient’s wellbeing. This reflects the therapeutic philosophy that aesthetic treatments should address genuine patient distress rather than serve as purely cosmetic enhancements. Healthcare providers assess the severity of wrinkles using validated scales (such as the Glabellar Line Severity scale and the Lateral Canthal Lines Severity scale) and discuss the patient’s motivations and expectations before proceeding with treatment.
Relfydess distinguishes itself from several other botulinum toxin type A products on the market in one notable way: it is supplied as a ready-to-use liquid formulation at a concentration of 100 units per milliliter. Many other botulinum toxin products are supplied as lyophilized (freeze-dried) powders that must be reconstituted with saline before injection. The ready-to-use formulation of Relfydess eliminates the reconstitution step, potentially reducing preparation time, minimizing the risk of dosing errors associated with reconstitution, and ensuring consistent drug concentration across injections.
The dose units of Relfydess are specific to this product and are not interchangeable with those used for other preparations of botulinum toxin. Different botulinum toxin products have different potency assays and unit definitions. Switching between products requires a physician experienced in botulinum toxin treatments to determine the appropriate dose for the alternative product. Never attempt to convert units between different botulinum toxin brands on your own.
What Should You Know Before Taking Relfydess?
Before receiving Relfydess, your healthcare provider will conduct a thorough assessment of your medical history, current health status, and treatment goals. This evaluation is essential for ensuring that the treatment is both safe and appropriate for you. Botulinum toxin type A is a potent biological agent, and while it has an excellent safety record when used correctly by trained professionals, there are specific medical conditions, medications, and circumstances that can affect its safety and efficacy. Understanding these factors empowers you to have an informed conversation with your healthcare provider and to make the best decision about your treatment.
Contraindications
Relfydess must not be administered in any of the following circumstances. These are absolute contraindications, meaning the treatment should never be given:
- Allergy to botulinum toxin or excipients: If you have a known hypersensitivity (allergy) to botulinum toxin type A or to any of the other ingredients in Relfydess (including disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, potassium chloride, sodium chloride, polysorbate 80, L-tryptophan, or water for injections), you must not receive this treatment.
- Infection at injection sites: Active infection, inflammation, or skin disease at the proposed injection sites is a contraindication, as injecting into infected tissue can spread the infection and impair the action of the toxin.
- Neuromuscular disorders: Patients with myasthenia gravis, Lambert-Eaton myasthenic syndrome, or amyotrophic lateral sclerosis (ALS) must not receive Relfydess. These conditions affect the neuromuscular junction or motor neurons, and botulinum toxin can severely exacerbate muscle weakness in these patients, potentially leading to life-threatening respiratory failure.
Warnings and Precautions
Even if you do not have any of the absolute contraindications listed above, there are several conditions and situations that require special caution. Inform your healthcare provider before treatment if any of the following apply to you:
- Neurological conditions: Any disease affecting the nervous system (peripheral neuropathies, motor neuron disorders) may increase the risk of excessive muscle weakness after treatment.
- General weakness or fatigue: If you are experiencing generalized weakness, lack of strength, or debilitation from any cause, botulinum toxin may exacerbate these symptoms.
- Respiratory difficulties: Pre-existing breathing problems may be worsened if the toxin effect spreads to respiratory muscles, although this is extremely rare with facial injections.
- Swallowing difficulties: If you already have trouble swallowing or frequently experience aspiration (food or liquid entering the airway), botulinum toxin treatment may carry increased risk.
- Previous adverse reactions to botulinum toxin: If you have experienced side effects from prior botulinum toxin injections of any brand, or if your wrinkles did not improve significantly after previous treatment, inform your provider.
- Eye problems: Pre-existing conditions such as drooping eyelids (ptosis) or dry eyes require careful evaluation, as treatment around the eyes can temporarily worsen these conditions.
- Muscle weakness or atrophy: If the muscles at the proposed injection sites are already weak or show signs of wasting, the risk of excessive weakness after injection is increased.
- Bleeding disorders: If you have a condition that causes prolonged bleeding or are taking anticoagulant medications (blood thinners), there is an increased risk of bruising at injection sites.
In very rare cases, the effects of botulinum toxin may spread to areas of the body away from the injection site. This can cause symptoms such as difficulty swallowing, difficulty speaking, difficulty breathing, coughing, and choking when swallowing. These symptoms have been reported hours to weeks after injection. Seek immediate medical attention if you experience any difficulty breathing, swallowing, or speaking after receiving Relfydess.
Relfydess may cause dry eyes. If you experience symptoms of dry eyes such as eye irritation, light sensitivity, or changes in vision after treatment, contact your healthcare provider. Additionally, repeated treatment with botulinum toxin can potentially lead to muscle atrophy (wasting) of the treated muscles due to prolonged periods of reduced muscle activity. This is generally reversible once treatment is discontinued.
Use of botulinum toxin at too-frequent intervals or at excessive doses may lead to the formation of neutralizing antibodies. These antibodies can reduce the effectiveness of future treatments, potentially making the toxin less effective over time. To minimize this risk, the lowest effective dose should be used and the minimum recommended interval between treatments (12 weeks) should be respected.
Pregnancy and Breastfeeding
Relfydess must not be used during pregnancy, by women of childbearing potential who are not using effective contraception, or by women who are breastfeeding. The safety of botulinum toxin type A during pregnancy has not been established in clinical studies. Although animal reproductive toxicity studies have been conducted with botulinum toxin type A, the potential risks to a developing fetus in humans are not fully characterized. As a precautionary measure, treatment should be avoided during pregnancy and in women planning to become pregnant.
It is not known whether botulinum toxin type A or its metabolites are excreted in human breast milk. Given the lack of data, breastfeeding women should not receive Relfydess. If you discover you are pregnant during treatment, inform your healthcare provider immediately.
Children and Adolescents
Relfydess is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of this product have not been established in this age group. The aesthetic indications for which Relfydess is approved (glabellar lines and crow’s feet) are not relevant to pediatric patients.
Driving and Operating Machinery
Temporary visual disturbances or muscle weakness may occur after treatment with Relfydess. If you experience these symptoms, you should not drive or operate machinery until they resolve. It is your responsibility to assess whether you are fit to drive or perform tasks requiring alertness after treatment.
Relfydess contains 1.6 mg polysorbate 80 per vial (equivalent to 1.1 mg/mL). Polysorbates may cause allergic reactions in susceptible individuals. Inform your healthcare provider if you have known allergies to polysorbate. The product also contains potassium and sodium, but in amounts that are essentially “potassium-free” and “sodium-free” (less than 1 mmol per vial of each).
How Does Relfydess Interact with Other Drugs?
Drug interactions with Relfydess are primarily related to medications that affect neuromuscular transmission or muscle function. Because botulinum toxin type A works by blocking acetylcholine release at the neuromuscular junction, any medication that also affects this pathway can potentially amplify or modify the effects of Relfydess. Understanding these interactions is important for ensuring safe treatment outcomes.
The known and potential drug interactions with Relfydess fall into several categories. While the cosmetic doses used for facial wrinkle treatment are relatively small compared to therapeutic doses used for other medical conditions, the possibility of interactions should still be considered, particularly in patients taking multiple medications.
Major Interactions
| Drug / Drug Class | Mechanism | Clinical Effect |
|---|---|---|
| Aminoglycoside antibiotics (e.g., gentamicin, tobramycin, amikacin) | Inhibit presynaptic acetylcholine release and reduce postsynaptic sensitivity to acetylcholine | Enhanced neuromuscular blockade; increased risk of muscle weakness, respiratory compromise |
| Other botulinum toxin preparations (e.g., onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA) | Additive neuromuscular blockade at overlapping or nearby injection sites | Excessive muscle weakness; increased risk of distant spread effects including dysphagia and respiratory difficulties |
| Neuromuscular blocking agents (e.g., tubocurarine, pancuronium, succinylcholine) | Additive blockade of neuromuscular transmission through complementary mechanisms | Potentiated and prolonged muscle paralysis; avoid concurrent use |
Minor Interactions
| Drug / Drug Class | Mechanism | Clinical Effect |
|---|---|---|
| Anticoagulants (e.g., warfarin, heparin, DOACs) | Impaired platelet function and clotting cascade | Increased bruising at injection sites; no effect on botulinum toxin efficacy |
| Antiplatelet agents (e.g., aspirin, clopidogrel) | Inhibited platelet aggregation | Increased bruising and ecchymosis at injection sites |
| Spectinomycin, polymyxins, tetracyclines, lincomycin | Various effects on neuromuscular transmission | Theoretical enhancement of botulinum toxin effect; clinical significance uncertain at cosmetic doses |
It is important to note that because Relfydess is a biologic protein product rather than a small-molecule drug, it is not metabolized by cytochrome P450 (CYP) enzymes in the liver. This means that the traditional pharmacokinetic drug interactions seen with many oral medications (where one drug affects the metabolism of another through CYP enzyme inhibition or induction) do not apply to Relfydess. The interactions described above are pharmacodynamic in nature—they relate to additive or synergistic effects at the neuromuscular junction rather than changes in drug metabolism or blood levels.
Always provide your healthcare provider with a complete list of all medications you are currently taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins. This is particularly important if you are scheduled for any surgical procedure that may involve neuromuscular blocking agents for anesthesia, as recent botulinum toxin treatment can affect the response to these agents.
What Is the Correct Dosage of Relfydess?
Relfydess must only be administered by healthcare professionals with relevant competence and specialized knowledge in this treatment, using the appropriate equipment in accordance with national guidelines and regulations. It is a ready-to-use formulation at a concentration of 10 units per 0.1 mL, and no reconstitution or dilution is required. Each vial should be used for a single patient at a single treatment session, and any remaining product must be discarded after treatment.
Adults (Under 65 Years)
Glabellar Lines (Frown Lines)
Total dose: 50 units (0.5 mL)
Administration: 5 injections of 10 units (0.1 mL) each
Injection sites: 2 injections into the corrugator muscle on each side and 1 injection into the procerus muscle near the nasofrontal angle
Crow’s Feet (Lateral Canthal Lines)
Total dose: 60 units (0.6 mL)
Administration: 6 injections of 10 units (0.1 mL) each
Injection sites: 3 injections into the orbicularis oculi muscle on each side
Combined Treatment (Glabellar Lines + Crow’s Feet)
Total dose: 110 units (1.1 mL)
Administration: 11 injections of 10 units (0.1 mL) each
Injection sites: 5 injections for glabellar lines and 6 injections for crow’s feet as described above
| Treatment Area | Total Dose | Number of Injections | Dose per Injection |
|---|---|---|---|
| Glabellar lines | 50 units (0.5 mL) | 5 | 10 units (0.1 mL) |
| Crow’s feet | 60 units (0.6 mL) | 6 (3 per side) | 10 units (0.1 mL) |
| Combined treatment | 110 units (1.1 mL) | 11 | 10 units (0.1 mL) |
Children and Adolescents
Relfydess is not recommended for use in children and adolescents under 18 years of age. The aesthetic indications for Relfydess are not applicable to this age group, and the safety and efficacy of the product have not been established in pediatric patients.
Elderly Patients (65 Years and Over)
Relfydess is approved for adults under 65 years of age. There is limited clinical data on the use of Relfydess in patients aged 65 years and over. If botulinum toxin treatment is being considered for this age group, the treating physician should carefully evaluate the individual risk-benefit profile.
Treatment Interval
The treatment effect of Relfydess typically becomes noticeable within a few days after injection and can persist for up to 6 months. The interval between treatment sessions is determined by the treating physician based on the individual patient’s response, but the dosage should not exceed the maximum permitted doses and the treatment interval must be at least 12 weeks (3 months). More frequent treatment is not recommended, as it may increase the risk of antibody formation and reduce treatment effectiveness over time.
Overdose
Because Relfydess is administered by qualified healthcare professionals, overdose is unlikely. However, if more than the recommended dose is administered, muscles other than those that were injected may begin to feel weak. Overdose may cause difficulty swallowing, difficulty speaking, and difficulty breathing. These symptoms may not appear immediately but can develop hours to days after the injection. If you experience any of these symptoms after treatment, seek immediate medical attention. Treatment of overdose is supportive and may include hospitalization and, in severe cases, mechanical ventilation until respiratory function recovers.
What Are the Side Effects of Relfydess?
Like all medicines, Relfydess can cause side effects, although not everybody gets them. The majority of side effects associated with Relfydess are mild to moderate in severity, appear within the first month after injection, and are transient (they resolve on their own without requiring specific treatment). The side effects are primarily related to the local action of the toxin at or near the injection sites, or to the injection procedure itself.
Understanding the frequency and nature of potential side effects helps you make an informed decision about treatment and know when to contact your healthcare provider. The following side effects have been reported in clinical studies and post-marketing surveillance:
Contact emergency services immediately if you experience any of the following symptoms, which have been reported very rarely: difficulty breathing, difficulty swallowing, or difficulty speaking; swelling of the face, throat, or tongue; hives, wheezing, feeling faint, or shortness of breath (signs of a serious allergic reaction).
Common
May affect up to 1 in 10 people
- Injection site reactions: bruising, pain, itching, redness, swelling, discomfort, hypersensitivity, warmth
- Headache
- Drooping of the upper eyelid (eyelid ptosis)
Uncommon
May affect up to 1 in 100 people
- Muscle weakness
- Muscle twitching (fasciculations)
- Drooping eyebrow (brow ptosis)
- Allergic reaction (such as asthma or widespread hives)
- Local allergic reaction (such as hives at injection site)
- Blurred vision
- Dry eyes
- Eye strain (asthenopia)
- Swollen eyelids (eyelid edema)
Very Rare / Post-Marketing Reports
Reported after product approval
- Difficulty breathing (dyspnea)
- Difficulty swallowing (dysphagia)
- Difficulty speaking (dysarthria)
- Severe allergic reaction (anaphylaxis)
- Generalized muscle weakness (distant spread of toxin effect)
Injection site reactions are the most frequently reported side effects and are largely a consequence of the injection procedure itself rather than the pharmacological action of botulinum toxin. Bruising is particularly common and can be exacerbated by the use of anticoagulant or antiplatelet medications. Applying gentle pressure or ice to the injection sites immediately after treatment can help minimize bruising.
Eyelid drooping (ptosis) occurs when the botulinum toxin inadvertently affects the levator palpebrae superioris muscle, which lifts the upper eyelid. This is typically temporary and resolves within 2 to 6 weeks as the toxin effect wears off. The risk of ptosis can be minimized by careful injection technique, correct dosing, and avoidance of toxin migration after treatment (patients are typically advised not to rub the treated area and to remain upright for several hours after injection).
Dry eyes may occur, particularly in patients treated for crow’s feet, because the orbicularis oculi muscle plays a role in distributing tears across the eye surface during blinking. Partial weakening of this muscle can reduce blinking efficiency and tear film distribution. If you develop symptoms of dry eyes (irritation, grittiness, light sensitivity, or visual changes), inform your healthcare provider, who may recommend lubricating eye drops.
The very rare occurrence of distant toxin spread—where the effects of botulinum toxin manifest in muscles far from the injection site—is the most serious potential concern. This is thought to occur when small amounts of toxin enter the bloodstream and affect distant neuromuscular junctions. Symptoms can include generalized weakness, difficulty swallowing, respiratory difficulty, and changes in voice. These events have been reported predominantly with higher doses used for therapeutic (non-cosmetic) indications, and the risk at the cosmetic doses used for facial wrinkle treatment is extremely low.
It is important to report suspected side effects after the medicine has been authorized. This allows for continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority (e.g., the EMA in Europe, the FDA in the United States, or the MHRA in the United Kingdom).
How Should You Store Relfydess?
Proper storage of Relfydess is essential for maintaining its potency and safety. As a biological product containing a protein (botulinum toxin type A), Relfydess is sensitive to temperature extremes, light exposure, and freezing. Incorrect storage can degrade the active ingredient, reducing its effectiveness or potentially altering its safety profile.
The following storage conditions must be observed:
- Refrigeration: Store Relfydess in a refrigerator at 2°C to 8°C (36°F to 46°F). This temperature range maintains the stability and potency of the botulinum toxin protein.
- Do not freeze: Freezing can damage the protein structure of botulinum toxin type A and alter the excipient matrix, potentially affecting drug stability and consistency.
- Light protection: Keep the vial in the outer carton at all times to protect from light. Botulinum toxin type A can be degraded by prolonged light exposure, particularly ultraviolet light.
- Room temperature excursion: An unopened vial may be allowed to reach room temperature (up to 25°C / 77°F) protected from light. Stability of the unopened vial has been demonstrated for up to 24 hours at room temperature.
- Expiry date: Do not use Relfydess after the expiry date printed on the label (EXP). The expiry date refers to the last day of the stated month.
- Single use: Each vial is for single-patient, single-session use only. Any unused product remaining in the vial after treatment must be discarded in accordance with local regulations for biological waste.
Keep Relfydess out of the sight and reach of children. The product should only be handled and stored by healthcare facilities and professionals trained in the proper handling of botulinum toxin products. Patients do not store or handle this product themselves under normal circumstances, as it is administered exclusively in healthcare settings.
What Does Relfydess Contain?
Understanding the composition of Relfydess is important for patients and healthcare professionals, particularly for identifying potential allergens and understanding the product’s formulation characteristics. Relfydess is a clear, colorless to slightly yellow solution for injection.
Active Ingredient
The active substance is botulinum toxin type A, present at a concentration of 100 units per milliliter. Each glass vial contains 150 units in 1.5 mL of solution. The botulinum toxin is produced by Clostridium botulinum bacteria and undergoes extensive purification during manufacturing. The units used to express the potency of Relfydess are specific to this product and are not comparable or interchangeable with units used for any other botulinum toxin preparation.
Excipients (Inactive Ingredients)
| Excipient | Function |
|---|---|
| Disodium hydrogen phosphate dihydrate | Buffer (maintains pH stability) |
| Sodium dihydrogen phosphate dihydrate | Buffer (maintains pH stability) |
| Potassium chloride | Tonicity agent (osmolality adjustment) |
| Sodium chloride | Tonicity agent (osmolality adjustment) |
| Polysorbate 80 | Surfactant (protein stabilizer, prevents adsorption to container) |
| L-tryptophan | Protein stabilizer |
| Water for injections | Solvent |
Packaging
Relfydess is available in packs containing 1 or 10 glass vials, each containing 1.5 mL of solution for injection. Not all pack sizes may be marketed in every country. The vials are made of Type I borosilicate glass with a rubber stopper, ensuring compatibility with the biological product and protection from contamination.
The marketing authorization holder for Relfydess is Ipsen Pharma (Paris, France), and the product is manufactured by Q-Med AB (Uppsala, Sweden). The local representative in the Nordic region is Galderma Nordic AB.
Frequently Asked Questions About Relfydess
Relfydess (botulinum toxin type A) is a prescription injectable used for the temporary improvement of moderate to severe vertical lines between the eyebrows (glabellar lines, also known as frown lines) and moderate to severe lines at the outer corners of the eyes (crow’s feet, also known as lateral canthal lines). It is approved for adults under 65 years of age whose facial wrinkles significantly affect their sense of wellbeing. The treatment works by temporarily relaxing the muscles responsible for these dynamic wrinkles.
The effects of Relfydess typically become noticeable within a few days after injection and can last for up to 6 months, which is longer than many other botulinum toxin products on the market. However, the actual duration varies between individuals depending on factors such as muscle mass, metabolism, the area treated, and the dose administered. Treatment sessions should be spaced at least 12 weeks (3 months) apart. Your healthcare provider will determine the optimal retreatment schedule for you.
No. While both Relfydess and Botox (onabotulinumtoxinA) contain botulinum toxin type A as their active ingredient, they are different products manufactured by different companies using different processes. They have different formulations, potency units, and excipients. The units of Relfydess are specific to this product and are not interchangeable with Botox units or those of any other botulinum toxin preparation. A notable difference is that Relfydess comes as a ready-to-use liquid solution, while Botox is supplied as a freeze-dried powder that requires reconstitution.
Most patients describe the injection as causing mild, brief discomfort rather than significant pain. The needles used for botulinum toxin injections are very fine (typically 30-gauge or smaller), and the volume injected at each site is small (0.1 mL). Some healthcare providers may apply a topical anesthetic cream or use ice packs before treatment to minimize discomfort. The entire injection procedure typically takes only 10 to 20 minutes. Some injection site tenderness, redness, or bruising may occur after the procedure but usually resolves within a few days.
No. Relfydess must not be used during pregnancy, by women of childbearing potential who are not using effective contraception, or by women who are breastfeeding. The safety of botulinum toxin type A has not been established in pregnant or breastfeeding women. If you discover that you are pregnant while undergoing treatment, inform your healthcare provider immediately. You should use effective contraception during treatment with Relfydess.
After receiving Relfydess injections, your healthcare provider will typically advise you to avoid rubbing or massaging the treated areas for at least 24 hours, as this can cause the toxin to spread to unintended muscles. You should remain upright (do not lie down) for at least 4 hours after treatment. Avoid strenuous physical exercise, excessive heat exposure (such as saunas, hot tubs, or sunbathing), and alcohol consumption for 24 hours. If you experience visual disturbances or muscle weakness, do not drive or operate machinery until symptoms resolve.
References
- European Medicines Agency (EMA). Relfydess Summary of Product Characteristics. Last updated 2025.
- Ipsen Pharma. Relfydess (botulinum toxin type A) Patient Information Leaflet. 2025.
- Carruthers J, Carruthers A. Botulinum toxin type A treatment of multiple upper facial sites: patient-reported outcomes. Dermatologic Surgery. 2007;33(1 Spec No.):S10–S17.
- Hexsel D, Brum C, do Prado DZ, et al. Field effect of two commercial preparations of botulinum toxin type A: a prospective, double-blind, randomized clinical trial. Journal of the American Academy of Dermatology. 2012;67(2):226–232.
- Sundaram H, Signorini M, Liew S, et al. Global aesthetics consensus: botulinum toxin type A—evidence-based review, emerging concepts, and consensus recommendations for aesthetic use, including updates on complications. Plastic and Reconstructive Surgery. 2016;137(3):518e–529e.
- World Health Organization (WHO). Model List of Essential Medicines. 23rd List, 2023.
- British Association of Dermatologists (BAD). Guidelines for the use of botulinum toxin in dermatological practice. 2023.
- American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Position paper on the use of botulinum toxin type A in facial aesthetics. 2023.
- Dressler D, Saberi FA. Botulinum toxin: mechanisms of action. European Neurology. 2005;53(1):3–9.
- Naumann M, Dressler D, Hallett M, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of adult spasticity in the upper and lower limbs. Toxicon. 2013;67:115–128.
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