Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Alluzience, 200 Speywood units/ml, solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Botulinum toxin type a may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Alluzience contains the active substance botulinum toxin A, which causes muscles to relax. Alluzience acts at the junction between the nerves and muscle to prevent the release of a chemical messenger called acetylcholine from the nerve endings. This prevents muscles from contracting. The muscle relaxation is temporary and gradually wears off. The well-being of some people can be impacted when lines appear on their face. Alluzience is used in adults under 65 years to temporarily improve the appearance of any moderate to severe glabellar lines (the vertical frown lines between the eyebrows). 2.
What you need to know before you take it
e Alluzience
Do not have an Alluzience injection if: • • •
you are allergic to botulinum toxin A or any of the other ingredients of this medicine (listed in Section 6). you have an infection at the proposed site of injection. you have myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis.
Warnings and precautions Talk to your doctor, pharmacist or other healthcare practitioner before you have the Alluzience injection if: • you have any neuromuscular disorders • you often have difficulty swallowing food (dysphagia) • you find that you often have problems with food or drink getting into your airways causing you to cough or choke • you have inflammation at the proposed site of injection • the muscles at the proposed site of injection are weak or show signs of wasting
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Alluzience, 200 Speywood units/ml, solution for injection – approved UK PIL – 2May2023
• • •
you suffer from a bleeding disorder which means that you continue to bleed for longer than normal, such as haemophilia (hereditary bleeding disorders caused by deficiencies of clotting factor) you have had surgery on your face, or are likely to undergo facial or other types of surgery soon you had no significant improvement of your lines after your last treatment with botulinum toxin
This information will help your doctor or other healthcare practitioner to make an informed decision about the risk and benefit of your treatment. Special warnings: Side effects possibly related to the spread of toxin effect away from the site of injection have been reported very rarely with botulinum toxin (e.g. muscle weakness, difficulty swallowing or unwanted food or liquid in the airways). Seek immediate medical attention if you experience difficulties in swallowing, speaking or breathing. When Alluzience is used in the muscles around the eye, your eyes may become dry which may harm the surface of your eyes. In order to prevent this, you may need treatment with protective drops, ointments or protective covering which closes the eye. Your doctor will tell you if this is required. When botulinum toxins are used more than once every 3 months or at higher doses to treat other conditions, antibody formation has been noted rarely in patients. The formation of neutralising antibodies may reduce the effectiveness of treatment. If you are seeing a doctor for any reason, make sure that you tell them that you have been treated with Alluzience. Children and adolescents Alluzience is not recommended for use in patients under the age of 18 years. Other medicines and Alluzience Tell your doctor, pharmacist or other healthcare practitioner if you are using, have recently used or might use any other medicines. This is important because some of these medicines may increase the effect of Alluzience: • antibiotics for an infection (e.g. aminoglycosides such as gentamicin or amikacin); or • other muscle relaxant drugs. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or other healthcare practitioner for advice before taking this medicine. Alluzience should not be used during pregnancy or if you are breast-feeding. Driving and using machines You may experience temporary visual disturbances or muscle weakness following treatment with Alluzience. If affected, do not drive or use machinery. Alluzience contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodiumfree'. 3.
How to take it
Alluzience
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Alluzience, 200 Speywood units/ml, solution for injection – approved UK PIL – 2May2023
Alluzience should only be administered by a doctor or other healthcare practitioner with appropriate qualifications and expertise in this treatment and having the required equipment. Your doctor or other healthcare practitioner will give the injections. A vial of Alluzience should be used only for you and only for a single treatment session. The recommended dose for glabellar lines is 50 Speywood units, injected as 10 Speywood units at each of 5 injection sites in your forehead in the area above your nose and eyebrows. Doses recommended in Speywood units are different from other botulinum toxin preparations. The effect of the treatment should be noticeable within a few days after injection, and could last for up to 6 months. The interval between treatments with Alluzience will be decided by your doctor or other healthcare practitioner. You should not have treatment more often than every 3 months. Use in children and adolescents Alluzience is not recommended for use in patients under the age of 18 years. If you receive more Alluzience than you should If you are given more Alluzience than you need, muscles other than the ones that were injected may begin to feel weak. Excessive doses may cause paralysis of respiratory muscles. This may not happen straight away. If this happens, speak to your doctor or other healthcare practitioner immediately. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or other healthcare practitioner. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Very rarely (may affect up to 1 in 10,000 people), side effects experienced in muscles other than the ones that were injected have been reported with botulinum toxin. These include excessive muscle weakness, difficulty swallowing, coughing and choking when swallowing (if food or liquid enters your airway as you attempt to swallow, respiratory problems can occur, such as lung infections). If this happens, speak to your doctor immediately. Seek urgent medical help if: • •
You have difficulties breathing, swallowing or speaking Your face swells or skin goes red or you get an itchy lumpy rash. This may mean you are having a serious allergic reaction to Alluzience.
Tell your doctor or other healthcare practitioner if you notice any of the following side effects: Very Common (may affect more than 1 in 10 people) • Headache • Injection site reactions (such as pain, tingling, bruising, redness, swelling, itching, rash, irritation, discomfort, stinging), generalised weakness, tiredness and flu-like symptoms. Common (may affect up to 1 in 10 people) • Temporary facial paralysis • Drooping of the upper eyelid, swelling of the eyelid, drooping of eyebrow, tired eyes or dim vision, dry eye, twitching of muscles around the eye, watering eyes. Uncommon (may affect up to 1 in 100 people) • Eyelid twitching, disturbed, blurred or double vision • Eye allergy, hypersensitivity, rash. Not known (frequency cannot be estimated from the available data): Page 3 of 6
Alluzience, 200 Speywood units/ml, solution for injection – approved UK PIL – 2May2023
Numbness Muscle wasting
• •
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or other healthcare practitioner. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.
How to store it
Alluzience
Keep this medicine out of the sight and reach of children. Do not use Alluzience after the expiry date which is stated on the label. Store Alluzience in a refrigerator (2 ̊C – 8 ̊C). Do not freeze. Keep the vial in the outer carton in order to protect from light. After taking the vial from the refrigerator, it is recommended to allow the vial to reach room temperature. Alluzience may be held at temperatures up to a maximum of 25°C for a single period of 12 hours when unopened and protected from light. Alluzience should be discarded if not used within 12 hours of removal from refrigeration. Once the vial is opened, the product should be used immediately. 6.
Contents of the pack and other information
What Alluzience contains The active substance is botulinum toxin type A*, 200 Speywood units/ml. One vial contains 125 Speywood units in 0.625 ml of solution. The other ingredients are: L-histidine, Sucrose, Sodium chloride, Polysorbate 80, Hydrochloric acid, Water for injections *
Clostridium botulinum (a bacteria) toxin A haemagglutin complex.
Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Speywood units are different from other botulinum toxin preparations. What Alluzience looks like and contents of the pack Alluzience is a solution for injection. It comes in an individual pack size of 1 or 2 vials or in a multipack comprising 6 individual packs, each containing 2 vials. Not all pack sizes may be marketed. Alluzience is a clear colourless solution. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Ipsen Biopharm Limited, Ash Road, Wrexham Industrial Estate, Wrexham, LL13 9UF, UK.
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Alluzience, 200 Speywood units/ml, solution for injection – approved UK PIL – 2May2023
Manufacturer: Ipsen Biopharm Limited, Ash Road, Wrexham Industrial Estate, Wrexham, LL13 9UF, UK.
This leaflet was last revised in March 2023 If you would like any more information, or would like the leaflet in a different format, please contact Galderma (U.K.) Limited, tel. +44 (0) 300 3035674. Distributed by: Galderma (U.K.) Limited Evergreen House North Grafton Place London NW1 2DX United Kingdom ————————————————————————————————————-The following information is intended for healthcare professionals only: Posology and method of administration: Please refer to section 3 of the Patient Information Leaflet Special precautions for disposal and other handling: The instructions for use, handling and disposal should be strictly followed. RECOMMENDATIONS FOR THE DISPOSAL OF CONTAMINATED MATERIALS Immediately after use and prior to disposal, unused Alluzience (which may be present in the vial or in the syringe) should be inactivated with dilute hypochlorite (bleach) solution (1% available chlorine) Spillage of Alluzience should be wiped up with an absorbent cloth soaked in dilute hypochlorite solution. Used vials, syringes and materials should not be emptied and must be discarded into appropriate containers and disposed of in accordance with local requirements. RECOMMENDATIONS SHOULD ANY INCIDENT OCCUR DURING THE HANDLING OF BOTULINUM TOXIN • • • • • •
Any spills of the product must be wiped up with dry, absorbent material. The contaminated surfaces should be cleaned using absorbent material impregnated with a solution of sodium hypochlorite (bleach), then dried. If a vial is broken, proceed as mentioned above by carefully collecting the pieces of broken glass and wiping up the product, avoiding any cuts to the skin. If the product comes into contact with the skin, wash the affected area with a solution of sodium hypochlorite (bleach) then rinse abundantly with water. If product enters into contact with the eyes, rinse thoroughly with plenty of water or with an ophthalmic eyewash solution. If product enters into contact with a wound, cut or broken skin, rinse thoroughly with plenty of water and take the appropriate medical steps according to the dose injected.
These instructions for use handling and disposal should be strictly followed. Page 5 of 6
Alluzience, 200 Speywood units/ml, solution for injection – approved UK PIL – 2May2023
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Frequently asked questions about Alluzience, 200 Speywood units/ml, solution for injection
How do I take Alluzience, 200 Speywood units/ml, solution for injection?
Alluzience, 200 Speywood units/ml, solution for injection comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Alluzience, 200 Speywood units/ml, solution for injection?
The active substance in Alluzience, 200 Speywood units/ml, solution for injection is botulinum toxin type a.
Are there equivalent medicines to Alluzience, 200 Speywood units/ml, solution for injection?
Medicines with the same active substance, strength and form include: Azzalure, 125 Speywood units, powder for solution for injection, BOTOX 100 Allergan Units Powder for solution for injection, BOTOX 200 Allergan Units Powder for solution for injection. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Alluzience, 200 Speywood units/ml, solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Alluzience, 200 Speywood units/ml, solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: botulinum toxin type a
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.
4.2. Posology and method of administration
Posology:
Botulinum toxin product units differ depending on the medicinal products. Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Speywood units are different from other botulinum toxin preparations.
Paediatric Population
The safety and efficacy of Alluzience in children aged up to 18 years have not been established. The use of Alluzience is not recommended in patients under 18 years.
Method of administration:
Alluzience should only be administered by a healthcare practitioner with appropriate qualifications and expertise in this treatment and having the required equipment, in accordance with national guidelines.
A vial of Alluzience should only be used to treat a single patient, during a single session. Remove any make-up and disinfect the skin with a local antiseptic before administration.
The intramuscular injections should be performed using a sterile needle with a suitable gauge.
Dosing and treatment intervals depend on assessment of the individual patient's response.
The median time to onset as reported subjectively by patients was 3 days (the majority of patients reported an effect within 2 to 3 days with some patients reporting an effect within 24 hours). An effect has been demonstrated for up to 6 months after injection.
The treatment interval should be no more frequent than every 3 months.
The recommended injection points for glabellar lines are shown below:
Administration instructions:
The recommended dose is 0.25 ml of solution (50 Speywood units) divided into 5 injection sites, 0.05 ml of solution (10 Speywood units) administered intramuscularly into each of the 5 sites: 2 injections into each corrugator muscle and one into the procerus muscle, near the nasofrontal angle. The anatomical landmarks can be more readily identified if palpated and observed at patient maximum frown. Before injection, place the thumb or index finger firmly below the orbital rim in order to prevent extravasation below the orbital rim. The needle bevel should be pointed upward and medially during the injection. In order to reduce the risk of ptosis, avoid injections near the levator palpebrae superioris muscle, particularly in patients with larger brow-depressor complexes (depressor supercilii). Injections should be made into the central part of the corrugator muscle, at least 1 cm above the orbital rim.
General information
In the event of treatment failure or diminished effect following repeat injections, alternative treatment methods should be employed. In case of treatment failure after the first treatment session, the following approaches may be considered:
• Analysis of the causes of failure, e.g. incorrect muscles injected, inappropriate injection technique, and formation of toxin-neutralising antibodies
• Re-evaluation of the relevance of treatment with botulinum toxin A.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
Presence of infection at the proposed injection sites.
Presence of myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis.
4.4. Special warnings and precautions for use
Care should be taken to ensure that Alluzience is not injected into a blood vessel.
Injection of Alluzience is not recommended in patients with a history of dysphagia and aspiration.
Adverse reactions possibly related to the spread of toxin effect distant from the site of administration have been reported very rarely with botulinum toxin. Swallowing and breathing difficulties are serious and can result in death.
Very rare cases of death, occasionally in the context of dysphagia, pneumopathy (including but not limited to dyspnoea, respiratory failure, respiratory arrest) and/or in patients with significant asthenia have been reported following treatment with botulinum toxin A or B.
Patients should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties arise.
Alluzience should be used with caution in patients with a risk of, or clinical evidence of, marked defective neuro-muscular transmission. These patients may have an increased sensitivity to agents such as botulinum toxin, and excessive muscle weakness may follow treatment.
It is essential to study the patient's facial anatomy prior to administering Alluzience. Facial asymmetry, ptosis, excessive dermatochalasis, scarring and any alterations to this anatomy, as a result of previous surgical interventions, should be taken into consideration.
Dry eyes have been reported with use of Alluzience in periocular regions (see section 4.8). Attention to this side effect is important since dry eyes may predispose to corneal disorders. Protective drops, ointment, closure of the eye by patching or other means may be required to prevent corneal disorders.
The recommended dose and frequency of administration for Alluzience must not be exceeded.
Patients treated with the recommended dose may experience exaggerated muscle weakness.
Caution should be taken when Alluzience is used in the presence of inflammation at the proposed injection sites or when the targeted muscle(s) show excessive weakness or atrophy. Cases of muscle atrophy have been reported after the use of botulinum toxin (see section 4.8).
As with all intramuscular injections, use of Alluzience is not recommended in patients who have a prolonged bleeding time.
Each vial of Alluzience must be used for a single patient treatment during a single session.
Any excess of unused product must be disposed of as detailed in Section 6.6. Specific precautions must be taken for the inactivation and disposal of any unused solution (see Section 6.6).
Antibody formation
Injections at more frequent intervals or at higher doses may increase the risk of neutralising antibody formation to botulinum toxin. Clinically, the formation of neutralising antibodies may reduce the effectiveness of subsequent treatment.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Sodium content:
This medicine contains less than 1 mmol sodium (23 mg) per 125U vial, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant treatment with Alluzience and aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) should only be used with caution since the effect of botulinum toxin may be potentiated.
No interaction studies have been performed.
4.6. Fertility, pregnancy, lactation
Pregnancy
There are only limited data from the use of botulinum toxin type A in pregnant women. Animals studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Section 5.3). As a precautionary measure Alluzience should not be used during pregnancy.
Breastfeeding
It is unknown if Alluzience is excreted in human milk. Alluzience should not be used during breast-feeding.
Fertility
There are no clinical data examining the effect of Alluzience on fertility. There is no evidence of direct effect of Alluzience on fertility in animal studies (see section 5.3).
4.7. Effects on ability to drive and use machines
Alluzience has a minor or moderate influence on the ability to drive and use machines. There is a potential risk of localised muscle weakness or visual disturbances linked with the use of this medicinal product which may temporarily impair the ability to drive or operate machinery.
4.8. Undesirable effects
Summary of the safety profile
A majority of adverse reactions reported with Alluzience in clinical trials were of mild to moderate intensity and reversible. The most frequently reported adverse reactions were headache and injection site reactions. The incidence of adverse reactions tended to decrease with repeated treatments.
Adverse effects related to the spread of toxin effect distant from the site of administration have been very rarely reported with botulinum toxin (excessive muscle weakness, dysphagia, aspiration pneumonia with fatal outcomes in some cases) (see section 4.4).
The adverse reactions are presented from pivotal placebo-controlled clinical trials with Alluzience and also the pivotal placebo-controlled studies with the powder formulation of the same active substance, and organised according to primary system organ class (SOC) for each preferred term in MedDRA (Table 1).
Tabulated summary of adverse reactions
The frequency of undesirable effects is classified as follows:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Table 1: Adverse Drug Reactions Observed in Clinical Studies
Nervous system disorders
Very Common
Headache
Common
Facial paresis*
Uncommon
Dizziness*
Eye disorders
Common
Eyelid ptosis, eyelid oedema, brow ptosis, dry eye, lacrimation increased, asthenopia*, muscle twitching (twitching of muscles around the eye)*
Uncommon
Eyelid twitching, visual impairment*, vision blurred*, diplopia*
Rare
Eye movement disorder*
General disorders and administration site conditions
Very common
Injection site reactions (periorbital haematoma, haematoma, bruising, pain, paraesthesia erythema, swelling, pruritus, oedema*, rash*, irritation*, discomfort*, stinging*), asthenia*, fatigue*, influenza-like illness*
Immune system disorders
Uncommon
Hypersensitivity (eye allergy, hypersensitivity, rash)
Skin and subcutaneous tissue
Uncommon
Rash*, Pruritus*
Rare
Urticaria*
*additional adverse drug reactions only observed with powder formulation of the same active substance in clinical trials
Post-marketing experience
System Organ Class
Adverse Drug Reaction
Frequency
Nervous system disorders
Hypoaesthesia
Not known
Musculoskeletal and connective tissue disorders
Muscle atrophy
Not known
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Excessive doses of botulinum toxin may produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis. Symptomatic treatment may be necessary.
Symptoms of overdose may not be present immediately following injection.
Admission to hospital should be considered in patients with symptoms of botulinum toxin overdose (e.g. a combination of muscle weakness, ptosis, diplopia, swallowing and speech disorders, or paresis of the respiratory muscles).
💬 Ask about this leaflet
Ask anything about Alluzience, 200 Speywood units/ml, solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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