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.
Ebglyss 250 mg solution for injection in pre-filled syringe
⚠ 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 Lebrikizumab 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
Ebglyss contains the active substance lebrikizumab. Ebglyss is used to treat adults and adolescents 12 years and older with a body weight of at least 40 kg with moderate-to-severe atopic dermatitis, also known as atopic eczema, who can be treated with systemic treatments (a medicine given by mouth or injection). Ebglyss may be used with eczema medicines that you apply to the skin or it may be used on its own. Lebrikizumab is a monoclonal antibody (a type of protein) that blocks the action of another protein called interleukin-13. Interleukin-13 plays a major role in causing the symptoms of atopic dermatitis. By blocking interleukin-13, Ebglyss can improve your atopic dermatitis and reduce the related itching and skin pain. 2.
What you need to know before you take it
e Ebglyss
Do not use Ebglyss if you are allergic to lebrikizumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Ebglyss.
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Ebglyss. Every time you get a new pack of Ebglyss, it is important that you note down the date and the batch number (which is on the packaging after "Lot") and keep this information in a safe place. Allergic reactions Very rarely, this medicine can cause allergic (hypersensitivity) reactions. These reactions can occur shortly after you take Ebglyss, but also may happen later. If you notice symptoms of an allergic reaction, you should stop using this medicine and contact your doctor or get medical help immediately. Signs of an allergic reaction include:
- breathing problems
- swelling of the face, mouth and tongue
- fainting
- dizziness
- feeling lightheaded (because of low blood pressure)
- hives, itching and skin rash Eye problems Talk to your doctor if you have any new or worsening eye problems, including redness and discomfort in the eye, eye pain or changes in vision. Vaccination Talk to your doctor regarding your current vaccinations plan. See section "Other medicines and Ebglyss". Children and adolescents This medicine should not be used in children with atopic dermatitis below the age of 12 or adolescents 12 to 17 years of age and weighing less than 40 kg because it has not been tested in this age group. Other medicines and Ebglyss Tell your doctor or pharmacist:
- if you are using, have recently used or might use any other medicines.
- if you have recently had a vaccination or plan to have one. You should not be given certain types of vaccines (live vaccines) while using Ebglyss. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The effects of this medicine in pregnant women are not known. It is better to avoid the use of Ebglyss during pregnancy unless your doctor advises you to use it. It is not known whether lebrikizumab can pass into breast milk. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you will breast-feed or use Ebglyss. You should not do both. Driving and using machines Ebglyss is unlikely to influence your ability to drive and use machines.
Ebglyss contains polysorbates This medicine contains 0.6 mg of polysorbate 20 (E 432) in each pre-filled syringe, which is equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies. 3.
How to use Ebglyss
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How to take it
and for how long Your doctor will decide how much Ebglyss you need and how long you will use it for. The recommended dose is:
- Two initial injections of 250 mg lebrikizumab each (500 mg in total) at week 0 and week 2.
- One injection with 250 mg once every two weeks from week 4 up to week 16. Based on how you respond to the medicine, your doctor may decide to stop giving the medicine or to keep giving you one 250 mg injection every other week up to week 24.
- One injection with 250 mg every four weeks from week 16 onwards (maintenance dosing). Ebglyss is given as an injection under your skin (subcutaneous injection) into the thigh or abdomen, except for 5 cm around the navel. If somebody else gives the injection, it can also be given into the upper arm. You and your doctor or nurse will decide if you can inject Ebglyss yourself. It is recommended that you change the injection site with each injection. Ebglyss should not be injected into skin that is tender, damaged or has bruises or scars, or in an area of skin that is affected by atopic dermatitis or other skin lesions. For the initial 500 mg dose, administer two 250 mg injections consecutively in different injection sites. It is important not to try to inject yourself until you have been trained by your doctor or nurse. A caregiver may also give you your Ebglyss injection after proper training. In adolescents 12 years of age and older, it is recommended that Ebglyss is administered by or under the supervision of an adult. The pre-filled syringe must not be shaken. Read the "Instructions for use" for the pre-filled syringe carefully before using Ebglyss. If you use more Ebglyss than you should If you took more Ebglyss than your doctor prescribed or you took the dose before it was scheduled, talk to your doctor, pharmacist or nurse. If you forget to use Ebglyss If you have forgotten to inject a dose of Ebglyss, talk to your doctor, pharmacist or nurse. If you forgot to inject Ebglyss when you usually have planned to do it, take it as soon as you remember. The next dose should be injected on the regular scheduled day. If you stop using Ebglyss Do not stop using Ebglyss without speaking to your doctor first. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
- Redness and discomfort in the eye (conjunctivitis)
- Inflammation of the eye due to an allergic reaction (conjunctivitis allergic)
- Eye dryness
- Injection site reactions Uncommon (may affect up to 1 in 100 people)
- Shingles, a painful, blistering rash in one part of the body (herpes zoster)
- Increase in eosinophils (a type of white blood cell; eosinophilia)
- Inflammation of the cornea (the transparent layer that covers the front of the eye; keratitis)
- Eyelid itching, redness and swelling (blepharitis) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 the 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
Ebglyss
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light. Do not use this medicine if you notice that the solution is cloudy or discoloured or if it contains visible particles. After removal from the refrigerator, Ebglyss must be stored below 30oC and used within 7 days or discarded. Once stored out of refrigeration, do not place back in the refrigerator. The date of removal from the refrigerator may be recorded on the carton. This medicine is for single use only. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Ebglyss contains The active substance is lebrikizumab. Each pre-filled syringe contains 250 mg of lebrikizumab in a 2 mL solution (125 mg/mL). The other ingredients are histidine, glacial acetic acid (E 260), sucrose, polysorbate 20 (E 432) and water for injections.
What Ebglyss looks like and contents of the pack Ebglyss is a clear to opalescent, colourless to slightly yellow to slightly brown sterile solution for injection, free of visible particles. It is supplied as carton packs containing one single-dose, glass, prefilled syringe, 2 single-dose pre-filled syringes or 3 single-dose pre-filled syringes, and as multipacks containing 4 single-dose pre-filled syringes (2 packs of 2), 5 single-dose pre-filled syringes (5 packs of 1) or 6 single-dose pre-filled syringes (3 packs of 2). Not all pack sizes may be marketed. Marketing Authorisation Holder Almirall, S.A. Ronda General Mitre, 151 08022 Barcelona Spain Manufacturer Industrias Farmacéuticas Almirall, S.A. Ctra. de Martorell 41-61 08740 Sant Andreu de la Barca, Barcelona Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Almirall Limited Tel: 0800 0087 399 This leaflet was last revised in: 02/2026.
Instructions for use Read these "Instructions for Use" before you use this medicine and carefully follow all the step-bystep instructions. Important information for the Ebglyss pre-filled syringe with needle safety device: Do not inject yourself or someone else until you have been shown by your healthcare professional how to inject Ebglyss. Call your healthcare provider if you have any questions. When using the Ebglyss pre-filled syringe
- Talk to your healthcare provider about how often you will need to inject the medicine.
- If you have vision problems, do not use Ebglyss pre-filled syringe without help from a caregiver.
- To reduce the risk of accidental needle sticks, each pre-filled syringe has a needle safety device that is automatically activated to cover the needle after your injection.
- Throw away (dispose of) your used Ebglyss single-dose pre-filled syringe immediately after use.
- Do not use Ebglyss pre-filled syringe if it has been dropped on a hard surface or damaged.
- Do not use Ebglyss pre-filled syringe if the needle cap is missing or not securely attached.
- Do not touch the plunger rod until you are ready to inject.
- Do not get rid of any air bubbles in the Ebglyss pre-filled syringe.
- Do not pull back on the plunger rod at any time.
- Do not inject through clothes.
- Do not remove the needle cap until right before you are ready to give the injection.
- Do not re-use an Ebglyss single-dose pre-filled syringe.
Parts of the Ebglyss pre-filled syringe with needle safety device Before use Plunger Rod
Finger grips Syringe with label & expiry date Viewing window Syringe body Needle after removal of needle cap
Needle cap
After Use Plunger rod
Used syringe with label & expiry date
Used needle Activated needle safety device
Preparing to inject Ebglyss Prepare supplies
Make sure you have the following:
- 1 Ebglyss pre-filled syringe with needle safety device from the refrigerator
- 1 alcohol wipe*
- 1 cotton ball or gauze*
- 1 sharps disposal container* *Items not included with the product.
Remove pre-filled syringe from carton
Remove the Ebglyss pre-filled syringe from the carton by holding the middle of the syringe body. Leave the needle cap on until you are ready to inject.
Inspect pre-filled syringe Viewing Window
When you receive your Ebglyss pre-filled syringes, always check to see that you have the correct medicine and dose and visually inspect the pre-filled syringe. Note: You may gently rotate the plunger rod to view the syringe label. The label should read "Ebglyss".
Label with expiry date
Do not use the Ebglyss pre-filled syringe if the expiry date has passed. Do not use the Ebglyss pre-filled syringe if it has been damaged. Look at the medicine through the viewing window on the Ebglyss pre-filled syringe. The liquid should be clear, colourless to slightly yellow to slightly brown. Note: some air bubbles are normal.
Do not use the Ebglyss pre-filled syringe if the liquid is discoloured or cloudy, or it contains visible flakes or particles, or the syringe shows signs of damage, or the syringe has been dropped, or the medicine is frozen. Do not heat the Ebglyss pre-filled syringe with a microwave or hot water. Do not put the Ebglyss pre-filled syringe into direct sunlight.
Choose your injection site You or another person may inject into these areas.
Another person should inject into this area.
Prepare your skin
- You can inject into your thigh or stomach area (abdomen), except for 5 cm (2 inches) around your belly button (navel).
- If you chose the front of your thigh, you should inject at least 5 cm (2 inches) above the knee and 5 cm (2 inches) below the groin.
- If you choose the outer area of the upper arm, you will need a caregiver to help you.
- Choose a different injection site each time you inject Ebglyss. Do not inject into areas where the skin is tender, bruised, red, hard or scarred, or in an area of skin that is affected by atopic dermatitis or other skin lesions.
Wash your hands with soap and water. Clean the injection site with an alcohol wipe. Let the injection site dry before injecting. Do not touch the injection site again or blow on it before the injection.
Injecting Ebglyss
1
Remove needle cap Hold the Ebglyss pre-filled syringe in the middle of the syringe body with the needle pointing away from you, and pull off the needle cap. Do not put the needle cap back on. Do not touch the needle.
Inject your medicine immediately after removing the needle cap.
2
Pinch the injection site
3
Insert the needle
4
Push in the plunger rod
Gently pinch a fold of skin at the injection site (thigh or stomach, except for 5 cm (2 inches) around your belly button, or outer area of the upper arm if injected by your caregiver).
Insert the needle completely into the fold of skin at about a 45o angle.
Gently relax the pinch while keeping the needle in place. Slowly and steadily push the plunger rod down all the way until it stops and the prefilled syringe is empty. Note: It is normal to feel some resistance.
5
Release and remove Lift your thumb to release the plunger rod until the needle is covered by the needle safety device, and then remove the pre-filled syringe from the injection site. Lightly press a cotton ball or gauze on the injection site if you see any blood. Do not put the needle cap back on. Do not rub your skin after injection.
Dispose of the pre-filled syringe safely Put your used Ebglyss pre-filled syringe and needle cap in a sharps disposal container immediately after use. Do not dispose of (throw away) Ebglyss pre-filled syringes and needle caps in your household waste. If you do not have a sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- able to be closed with a tightfitting, puncture resistant lid to keep sharps from falling out,
- upright and stable during use,
- leak-resistant, and
- properly labelled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, follow your community guidelines for the right way to dispose of it. There may be local laws regarding the disposal of used needles and syringes. For more information about safe sharps disposal, ask your healthcare provider about options available in your area. Do not recycle your used sharps disposal container. Read the full package leaflet for the pre-filled syringe before using Ebglyss.
Frequently asked questions about Ebglyss 250 mg solution for injection in pre-filled syringe
How do I take Ebglyss 250 mg solution for injection in pre-filled syringe?
Ebglyss 250 mg solution for injection in pre-filled syringe comes as injection containing 250mg. 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 Ebglyss 250 mg solution for injection in pre-filled syringe?
The active substance in Ebglyss 250 mg solution for injection in pre-filled syringe is lebrikizumab.
Are there equivalent medicines to Ebglyss 250 mg solution for injection in pre-filled syringe?
Medicines with the same active substance, strength and form include: Ebglyss 250 mg solution for injection in pre-filled pen. 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 Ebglyss 250 mg solution for injection in pre-filled syringe, 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 Ebglyss 250 mg solution for injection in pre-filled syringe 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: lebrikizumab
- 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
Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.
4.2. Posology and method of administration
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis.
Posology
The recommended dose of lebrikizumab is 500 mg (two 250 mg injections) at both week 0 and week 2, followed by 250 mg administered subcutaneously every other week up to week 16.
Consideration should be given to discontinuing treatment in patients who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may further improve with continued treatment every other week up to week 24.
Once clinical response is achieved, the recommended maintenance dose of lebrikizumab is 250 mg every fourth week.
Lebrikizumab can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.
Missed dose
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
Special populations
Elderly (≥ 65 years)
No dose adjustment is recommended for elderly patients (see section 5.2).
Renal and hepatic impairment
No dose adjustment is recommended for patients with renal or hepatic impairment (see section 5.2).
Body weight
No dose adjustment for body weight is recommended (see section 5.2).
Paediatric population
The safety and efficacy of lebrikizumab in children aged 6 months to <12 years or adolescents 12 to 17 years of age and weighing less than 40 kg have not yet been established. No data are available.
Method of administration
Subcutaneous use.
Lebrikizumab is administered by subcutaneous injection into the thigh or abdomen, except for 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used.
For the initial 500 mg dose, two 250 mg injections should be administered consecutively in different injection sites.
It is recommended to rotate the injection site with each injection. Lebrikizumab should not be injected into skin that is tender, damaged or has bruises or scars.
A patient may self-inject lebrikizumab or the patient's caregiver may administer lebrikizumab if their healthcare professional determines that this is appropriate. Proper training should be provided to patients and/or caregivers on the administration of lebrikizumab prior to use. Detailed instructions for use are included at the end of the package leaflet.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
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.
Hypersensitivity
If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of lebrikizumab should be discontinued and appropriate therapy initiated.
Conjunctivitis
Patients treated with lebrikizumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination (see section 4.8).
Helminth infection
Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if lebrikizumab will influence the immune response against helminth infections by inhibiting IL-13 signalling.
Patients with pre-existing helminth infections should be treated before initiating treatment with lebrikizumab. If patients become infected while receiving lebrikizumab and do not respond to antihelminth treatment, treatment with lebrikizumab should be discontinued until infection resolves.
Vaccinations
Prior to initiating therapy with lebrikizumab, it is recommended that patients are brought up to date with all age-appropriate immunisations according to current immunisation guidelines. Live and live attenuated vaccines should not be given concurrently with lebrikizumab as clinical safety and efficacy has not been established. Immune responses to non-live vaccines were assessed in a combined tetanus, diphtheria and acellular pertussis vaccine (TdaP) and a meningococcal polysaccharide vaccine (see section 4.5).
Excipients
This medicine contains 0.6 mg of polysorbate 20 (E 432) in each pre-filled syringe of 250 mg, which is equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Live vaccines
The safety and efficacy of concurrent use of lebrikizumab with live and live attenuated vaccines has not been studied. Live and live attenuated vaccines should not be given concurrently with lebrikizumab.
Non-live vaccines
Immune responses to non-live vaccines were assessed in a study (ADopt-VA) in which adult patients with atopic dermatitis were treated with lebrikizumab 500 mg at weeks 0 and 2 followed by lebrikizumab 250 mg every other week. After 12 weeks of lebrikizumab administration, patients were vaccinated with a combined tetanus, diphtheria, and acellular pertussis vaccine TdaP vaccine (T cell-dependent) and a meningococcal polysaccharide vaccine (T cell-independent) and immune responses were assessed 4 weeks later. Antibody responses to both non-live vaccines were not negatively impacted by the concomitant lebrikizumab treatment. No adverse interactions between the non-live vaccines and lebrikizumab were noted in the study. Therefore, patients receiving lebrikizumab may receive concurrent inactivated or non-live vaccinations. For information on live vaccines see section 4.4.
Concomitant therapies
Given that lebrikizumab is a monoclonal antibody, no pharmacokinetic interactions are expected.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data from the use of lebrikizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of lebrikizumab during pregnancy.
Breast-feeding
It is unknown whether lebrikizumab is excreted in human milk or absorbed systemically after ingestion. Maternal IgG is known to be present in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from lebrikizumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
Animal studies showed no impairment of fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Lebrikizumab has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most common adverse reactions are conjunctivitis (6.9%), injection site reactions (2.6%), conjunctivitis allergic (1.8%) and dry eye (1.4%).
Tabulated list of adverse reactions
Across all clinical studies in atopic dermatitis, a total of 1720 patients were administered lebrikizumab, of which, 891 patients were exposed to lebrikizumab for at least one year. Unless otherwise stated, the frequencies are based on a pool of 4 randomised, double-blind studies in patients with moderate-to-severe atopic dermatitis where 783 patients were treated with subcutaneous lebrikizumab during the placebo-controlled period (first 16 weeks of treatment).
Listed in Table 1 are adverse reactions observed from clinical trials presented by system organ class and frequency, using the following categories: 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). Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness.
Table 1. List of adverse reactions
MedDRA System Organ Class
Frequency
Adverse reaction
Infections and infestations
Common
Conjunctivitis
Uncommon
Herpes zoster
Blood and lymphatic system disorders
Uncommon
Eosinophilia
Eye disorders
Common
Conjunctivitis allergic
Dry eye
Uncommon
Keratitis
Blepharitis
General disorders and administration site conditions
Common
Injection site reaction
Description of selected adverse reactions
Conjunctivitis and related events
During the first 16 weeks of treatment conjunctivitis, conjunctivitis allergic, blepharitis and keratitis were reported more frequently in patients treated with lebrikizumab (6.9%, 1.8%, 0.8% and 0.6% respectively) compared to placebo (1.8%, 0.7%, 0.2% and 0.3%).
During maintenance treatment period (16-52 weeks) the incidence of conjunctivitis and conjunctivitis allergic with lebrikizumab was 5.0% and 5.9% respectively.
Across all clinical studies, among lebrikizumab-treated patients treatment discontinuation due to conjunctivitis and conjunctivitis allergic occurred in 0.7% and 0.3% of cases, respectively. Severe cases of conjunctivitis and conjunctivitis allergic occurred in 0.1% and 0.2% of cases, respectively. 72% of patients recovered, of those 57% recovered within 90 days.
Eosinophilia
Lebrikizumab-treated patients had a greater mean increase from baseline in eosinophil count compared to patients treated with placebo. In lebrikizumab treated patients 20.3% had any increase in eosinophil count compared to 11.7% with placebo. In general, the increase in the lebrikizumab-treated patients was mild or moderate and transient. Eosinophilia ≥5000 cells/mcL was observed in 0.4% lebrikizumab-treated patients and none of the placebo-treated patients. Adverse reactions of eosinophilia were reported in 0.6% of patients treated with lebrikizumab and with a similar rate in patients treated with placebo during the initial treatment period. Eosinophilia did not result in treatment discontinuation and no eosinophil-related disorders were reported.
Injection site reactions
Injection site reactions (including pain and erythema) were reported more frequently in patients who received lebrikizumab (2.6%) compared to placebo (1.5%). The majority (95 %) of injection site reactions were mild or moderate in severity, and few patients (< 0.5%) discontinued lebrikizumab treatment.
Herpes zoster
Herpes zoster was reported in 0.6% of the patients treated with lebrikizumab and none of the patients in the placebo group. All herpes zoster events reported were mild or moderate in severity and none led to permanent discontinuation of treatment.
Long term safety
The safety of lebrikizumab was assessed in adults and adolescents with up to 3 years of continuous treatment. A total of 1153 patients were enrolled in the ADjoin extension study, either directly or from studies ADvocate-1, ADvocate-2, and ADore, with up to 1 year of exposure, or from studies ADhere and Adopt-VA, with up to 16 weeks of exposure, and 771 patients completed 2 years of additional lebrikizumab treatment in ADjoin. The safety profile remained consistent with longer exposure to lebrikizumab, and no new safety concerns were observed.
Paediatric population
Adolescents 12 to 17 years of age
The safety of lebrikizumab was assessed in 372 patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, including 270 patients exposed for at least one year. The safety profile of lebrikizumab in these patients was similar to the safety profile in adults with atopic dermatitis.
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
Single intravenous doses up to 10 mg per kg of body weight and multiple subcutaneous doses up to 500 mg have been administered to humans in clinical trials without dose-limiting toxicity. There is no specific treatment for lebrikizumab overdose. In the event of overdose, the patient should be monitored for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
💬 Ask about this leaflet
Ask anything about Ebglyss 250 mg solution for injection in pre-filled syringe. 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.