Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Depemokimab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
EXDENSUR contains the active substance depemokimab, a monoclonal antibody, a type of protein designed to recognise and bind to a specific substance in the body. It is used to treat asthma in adults and adolescents over 12 years of age who are on a maximum moderate-dose or high-dose inhaled corticosteroids (ICS) plus another asthma controller. EXDENSUR is also used to treat severe CRSwNP (chronic rhinosinusitis with nasal polyps) in adults. EXDENSUR works by blocking a key protein and reducing inflammation that plays a major role in asthma and CRSwNP. The active substance in EXDENSUR, blocks a protein called interleukin-5. By blocking the action of this protein, it limits the production of eosinophils (a type of white blood cell) from the bone marrow and lowers the number of eosinophils in the bloodstream. Asthma Inflammation in your lungs and airways leads to the signs and symptoms of asthma. If your asthma is not well controlled by your existing treatment, EXDENSUR may reduce your number of asthma attacks. Severe chronic rhinosinusitis with nasal polyps (CRSwNP) 1
Inflammation in your nose and sinuses can cause symptoms such as a blocked nose and loss of smell, and soft jelly-like growths (called nasal polyps) to form inside the nose. EXDENSUR helps reduce symptoms (e.g. nasal congestion, nasal discharge, loss of smell), the size of your nasal polyps and the use of oral corticosteroid medicines. EXDENSUR may help prevent surgery for your nasal polyps. 2.
e EXDENSUR
Do not use EXDENSUR: if you are allergic to depemokimab or any of the other ingredients of this medicine (listed in section 6). ➔
Check with your doctor if you think this applies to you.
Warnings and precautions Talk to your doctor before using this medicine. Worsening of asthma EXDENSUR must not be used to treat sudden breathing problems that may occur with asthma. Some people get asthma-related side effects, or their asthma may become worse, during treatment with EXDENSUR. ➔
Tell your doctor or nurse if your asthma remains uncontrolled, or gets worse, after you start EXDENSUR treatment.
Allergic reactions Medicines of this type (monoclonal antibodies) can cause allergic reactions when injected into the body (see section 4, 'Possible side effects'). If you have had a similar reaction to any injection or medicine: ➔
Tell your doctor before you are given EXDENSUR
Parasitic infections EXDENSUR may weaken your resistance to infections caused by parasites. If you have a parasitic infection, it should be treated before you start treatment with EXDENSUR. If you live in a region where these infections are common or if you are travelling to such a region: ➔
Check with your doctor if you think any of these may apply to you.
Keeping a record It is important to keep a record of the batch number of your medicine. Every time you get a new pack of EXDENSUR pre-filled pen keep a note of the batch number (which is on the packaging after Lot) and keep this information to hand when talking to your doctor or pharmacist. Children and adolescents
2
This medicine is not intended for use in children below 12 years of age for the treatment of asthma, or in children or adolescents below 18 years of age for the treatment of severe CRSwNP. Other medicines and EXDENSUR Tell your doctor if you are taking, have recently taken or might take any other medicines. Other medicines for asthma or CRSwNP Don't suddenly stop taking your medicines for your asthma or CRSwNP once you have started EXDENSUR. These medicines (especially ones called corticosteroids) must be stopped gradually, under the direct supervision of your doctor. 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 for advice before using this medicine. It is not known whether the ingredients of EXDENSUR can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use EXDENSUR. Driving and using machines EXDENSUR is unlikely to affect your ability to drive or use machines. EXDENSUR contains polysorbates This medicine contains 0.2 mg of polysorbate 80 per 100 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies. EXDENSUR contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially "sodium-free". 3.
How to use EXDENSUR
Asthma The recommended dose for adults and adolescents aged 12 years and over is 100 mg. You will have 1 injection every 6 months under the skin (subcutaneous). Severe CRSwNP The recommended dose for adults is 100 mg. You will have 1 injection every 6 months under the skin.
EXDENSUR is given by injection under the skin. Your doctor or nurse will decide if you or your caregiver can inject EXDENSUR. They will then provide training to show you or your caregiver the correct way to use EXDENSUR. You can inject EXDENSUR under your skin in your stomach area (abdomen) or upper leg (thigh). Your caregiver can also inject EXDENSUR into your upper arm. You must not give injections into areas where the skin is tender, bruised, red, or hard.
3
Call your doctor or nurse if you experience difficulties during the self-administration and have any concerns regarding an incomplete injection. If you forget to use EXDENSUR If your doctor or healthcare professional gives you your injection of EXDENSUR: ➔ Contact your doctor or hospital as soon as possible to re-schedule your appointment. If you or your caregiver forget to give the injection of EXDENSUR: ➔ If you miss a dose, inject a dose of EXDENSUR as soon as possible. After that, continue EXDENSUR on your usual injection day as planned. ➔ If you miss a dose by 1 month or more, inject a dose of EXDENSUR and restart your 6-month injection schedule from the day you take the missed dose. If you are not sure what to do, ask your doctor, pharmacist or nurse. Don't stop EXDENSUR without advice Do not stop injections of EXDENSUR unless your doctor advises you to. Interrupting or stopping the treatment with EXDENSUR may cause your symptoms to come back. If your symptoms get worse while receiving injections of EXDENSUR ➔ Call your doctor. 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 side effects (may affect up to 1 in 10 people):
not listed in this leaflet. You can also report side effects directly via 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.
EXDENSUR 4
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 and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2C – 8C). Do not freeze. Do not shake. Store in the original carton in order to protect from light. The pre-filled pen can be removed from the refrigerator and kept in its unopened carton for up to 7 days at room temperature (up to 30C), when protected from light. After 7 days out of the refrigerator, dispose of the pen according to local requirements. The pre-filled pen must be used within 8 hours once the carton is opened. Discard if not used within 8 hours. 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.
What EXDENSUR contains The active substance is depemokimab. Each mL of solution contains 100 mg of depemokimab. The other ingredients are histidine, histidine monohydrochloride, trehalose dihydrate, arginine hydrochloride, disodium edetate, polysorbate 80 (E 433), water for injections. What EXDENSUR looks like and contents of the pack EXDENSUR is supplied as a 1 mL colourless, yellow to brown, clear to opalescent solution in a single-use pre-filled pen. EXDENSUR is available in a pack containing 1 pre-filled pen. Marketing Authorisation Holder GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham 5
DL12 8DT United Kingdom Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only) Please be ready to give the following information: Product name Exdensur Reference number PL 19494/0328 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in May 2026.
6
7. Step by step instructions for using the pre-filled pen EXDENSUR (depemokimab) injection, for subcutaneous use 100 mg This Instructions for Use contains information on how to inject EXDENSUR. Read These Sections First Before using your EXDENSUR pre-filled pen, it is important that your healthcare provider explains your EXDENSUR dosing instructions, and shows you (or your caregiver) how to use the pen the right way. It is important to keep a record of the batch number of your medicine. Every time you get a new pack of EXDENSUR pre-filled pen keep a note of the batch number (which is on the packaging after Lot) and keep this information to hand when talking to your doctor or pharmacist. Important Information Read all of these instructions before using your pen. If you do not follow these instructions, you may not get all your medicine. Do not use EXDENSUR pen if:
Do not:
7
8
Storage Pen Stored In Carton Store EXDENSUR in a refrigerator (2°C to 8°C) in the original carton until you are ready to use it. Do not freeze. An unopened carton of EXDENSUR pen may be kept at room temperature up to 30°C for a maximum of 7 days. After being brought to room temperature, EXDENSUR must be used within 7 days or dispose of the pen according to local requirements. Pen Removed From Carton After the EXDENSUR pen is out of the carton, it must be used within 8 hours or dispose of the pen according to local requirements. Do not place back in the refrigerator. A. Prepare Gather supplies
A1
Supplied
Not supplied
Take the carton containing your pen out of the refrigerator
A2
•
•
•
Remove the tray from the carton and peel off the clear film cover from the corner of the tray. Holding the middle of the pen (near the inspection window), carefully take the pen out of the tray. Do not remove the clear needle cap at this step.
Check your pen
A3
• Check the expiration date and the • medicine EXP: Month-Year
• • • 9
Check the expiration date. Do not use if the expiration date has passed. Look at the medicine in the pre-filled pen through the inspection window. The medicine should be clear and colourless to slightly yellow. Do not inject if EXDENSUR is cloudy, discoloured, or has particles. It is normal to see air bubbles. You do not need to do anything about it. Do not shake the pen.
Wait 30 minutes
A4
• •
Wait 30 minutes
A5
Do not remove the clear cap. Place the pen on a clean, flat surface away from direct sunlight and out of the reach of children.
Only caregiver or healthcare provider Patient or caregiver or healthcare provider
• •
• •
A6
If you are giving yourself the injection, you can inject into your thighs or stomach (abdomen). A caregiver can inject into the upper arm, thigh, or abdomen. Do not inject yourself in the upper arm, as it is more difficult to avoid pen movement during the injection. Do not inject where the skin is bruised, tender, red, or hard. Do not inject within 2 inches (5 cm) of your belly button.
Clean the injection site • • • •
Wash your hands with soap and water. Clean the injection site with an alcohol swab. Allow skin to air dry. Do not fan or blow on the cleaned injection site. Do not touch the cleaned injection site again until you have finished your injection.
B. Inject Pull off the clear cap
B1
•
•
• •
10
Remove the clear cap by pulling it straight off, away from the yellow needle guard. It may take some force to remove the clear cap. Do not twist the cap. Do not press the yellow needle guard. Do not put the cap back on the pen. This could accidentally start the injection. You may see a drop of medicine at the end of the needle. This is normal. Inject as soon as possible and within 5 minutes after you remove the clear cap.
B2
Position the pen at the injection site • •
Place the yellow needle guard flat against your skin. Make sure you can see the inspection window.
Press firmly to start the injection, do not lift
B3
• • •
•
•
B4
The yellow needle guard will slide up into the pen. You may hear a "click" that tells you the injection has started. Keep the pen held down against the skin. Do not lift or move the pen until the injection is complete. The yellow indicator will move down through the inspection window during the injection. Do not use the pen if the yellow needle guard does not slide up into the pen. Throw away the pen and clear cap according to local requirements.
Continue to hold down, check the injection is complete before lifting Your injection is done when you hear the second ''click''. You must wait for the injection to complete before removing the pen to ensure you receive the full dose of medicine. Injection may take up to 20 seconds. If you do not hear the second ''click'', check the following before removing the pen: •
The inspection window is filled with the yellow indicator.
11
Lift pen after injection completes
B5
• •
Do not rub the injection site. Do not put the clear cap back onto the EXDENSUR pen.
C. Throw away
Sharps Disposal Container
Dispose of your used pen and clear cap, according to local requirements. Ask your doctor or pharmacist for advice if necessary. Keep your used pens and needle caps out of the sight and reach of children.
12
Exdensur 100 mg/1 ml Solution for injection in a pre-filled pen comes as injection containing 100mg / 1ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Exdensur 100 mg/1 ml Solution for injection in a pre-filled pen is depemokimab.
Medicines with the same active substance, strength and form include: Exdensur 100 mg/1 ml Solution for injection in a pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Exdensur 100 mg/1 ml Solution for injection in a pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Asthma
EXDENSUR is indicated as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on maximum moderate-dose or high-dose inhaled corticosteroids (ICS) plus another asthma controller.
Chronic rhinosinusitis with nasal polyps (CRSwNP)
EXDENSUR is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.
EXDENSUR should be prescribed by physicians experienced in the diagnosis and treatment of asthma or CRSwNP.
Posology
Asthma
Adults and adolescents aged 12 years and over
The recommended dose of depemokimab is 100 mg administered subcutaneously once every 6 months. Dosing at intervals shorter than 6 months is not recommended.
CRSwNP
Adults
The recommended dose of depemokimab is 100 mg administered subcutaneously once every 6 months. Dosing at intervals shorter than 6 months is not recommended.
Missed dose
If a dose is missed, administer as soon as possible. If the missed dose is taken 1 month or longer after the scheduled dose, resume the 6-monthly injection schedule from the date when the missed dose was given.
Special populations
Elderly
No dose adjustment is required for elderly patients aged ≥ 65 years old (see section 5.2).
Renal or hepatic impairment
No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).
Paediatric population
Asthma
The safety and efficacy of depemokimab in children aged less than 12 years have not yet been established. No data are available.
CRSwNP
The safety and efficacy in children with CRSwNP below the age of 18 years have not been established. No data are available.
Method of administration
The pre-filled pen must be used for subcutaneous injection only.
EXDENSUR may be self-administered by adult or adolescent patients or administered by a caregiver if their healthcare professional determines that it is appropriate, and only after the patient or caregiver are trained in injection techniques.
For self-administration the recommended injection sites are the abdomen or thigh. A caregiver can also inject EXDENSUR into the upper arm.
Comprehensive instructions for subcutaneous administration of EXDENSUR in a pre-filled pen are provided in the instructions for use in the package leaflet.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 reactions
Acute and delayed systemic reactions, including hypersensitivity reactions (such as urticaria and pruritus), have occurred following administration of depemokimab. These reactions generally occur within hours of administration, but some had a delayed onset (i.e., days). In the event of a hypersensitivity reaction, appropriate treatment should be initiated and clinical judgement must be used regarding re-administration of depemokimab.
Asthma-related adverse events or exacerbations
Depemokimab must not be used to treat acute asthma symptoms or acute exacerbations.
Asthma-related adverse events or exacerbations may occur during treatment with depemokimab. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with depemokimab.
Reduction of corticosteroid dosage
Abrupt discontinuation of background medications (including systemic and inhaled corticosteroids) after initiation of depemokimab therapy is not recommended. Reductions in the dosages of background medications, if appropriate, must be gradual and performed under the supervision of a physician.
Parasitic (helminth) infections
Eosinophils may be involved in the immunological response to some helminth infections. Patients with pre-existing helminth infections were excluded from participation in the clinical programme. Patients with pre-existing helminth infections should be treated for their infection prior to depemokimab therapy. If patients become infected while receiving treatment with depemokimab and do not respond to anti-helminth treatment, consider delaying administration of the next depemokimab dose until the infection resolves.
Excipients
This medicinal product contains polysorbate 80 (see section 2), which may cause allergic reactions.
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially “sodium-free”.
No formal drug interaction studies have been conducted with depemokimab.
Pregnancy
There are no or limited amount of data from the use of depemokimab in pregnanat women. Animal studies targeting IL-5 signalling pathways do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Monoclonal antibodies, such as depemokimab, are expected to be transported across the placenta as pregnancy progresses, therefore, potential exposure to the fetus is likely to be greater during the second and third trimester of pregnancy.
As a precautionary measure, it is preferable to avoid the use of depemokimab during pregnancy. Depemokimab should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Breast-feeding
There are no data regarding the excretion of depemokimab in human or animal milk. However, depemokimab is a humanised monoclonal antibody (immunoglobulin G1 [IgG1] kappa), and immunoglobulin G (IgG) is present in human milk in small amounts.
A decision must be made whether to discontinue breast-feeding or discontinue depemokimab, taking into account the importance of breast-feeding to the infant and the importance of the drug to the mother.
Fertility
There are no fertility data in humans. Animal studies have shown no adverse effects of anti-IL-5 treatment on fertility (see section 5.3).
EXDENSUR has no or negligible influence on the ability to drive and use machines.
Summary of the safety profile
The most common adverse reactions reported with depemokimab were local injection site reactions (2%).
Tabulated list of adverse reactions
The safety of depemokimab was studied in a clinical development programme in adult and adolescent patients aged 12 years and older with asthma (SWIFT-1 and SWIFT-2 studies) and in adult patients with CRSwNP (ANCHOR-1 and ANCHOR-2 studies). In these 4 randomised, 52-week, placebo-controlled, multicentre studies, patients received either subcutaneous (SC) depemokimab or placebo once every 6 months. A total of 773 patients received at least one dose of depemokimab 100 mg in these studies.
Other phase 3 clinical studies include an open-label 52-week extension study (AGILE) involving asthma patients (n = 629) who had previously completed either of the two asthma studies (SWIFT-1 or SWIFT-2), and an ongoing 52‑week study (NIMBLE) involving asthma patients who were previously treated with other anti-IL5/IL-5R biological medicines prior to study entry (n = 538).
Adverse reactions associated with depemokimab are presented in the table below (Table 1).
Frequencies are defined as 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) and very rare (< 1/10 000). Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness.
Table 1. Adverse reactions
System Organ Class
Adverse reactions
Frequency
Immune system disorders
Hypersensitivity reactions (systemic allergic)a b
Uncommon
Skin and subcutaneous tissue disorders
Pruritus
Common
General disorders and administration site conditions
Administration-related systemic reactions (non-allergic)b c
Local injection site reactionsd
Common
a Observed in a phase 1 study and in an open-label extension study
b The majority of events (85%) resolved in ≤7 days, with most events (65%) resolving in ≤2 days from their onset.
c Symptoms include headache, fatigue, rash.
d Symptoms include pain, erythema, swelling, and itching. The majority of events were mild in intensity and 79% resolved in ≤7 days, with most events (56%) resolving in ≤2 days from their onset.
Paediatric population
A total of fifteen adolescents (aged 12-17) received depemokimab in two placebo-controlled studies for asthma (SWIFT-1 and SWIFT-2) of 52 weeks duration. The safety profile was generally similar to that seen in adults. No additional adverse reactions were identified.
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 Yellow Card Scheme Website: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There is no clinical experience with overdose of depemokimab.
There is no specific treatment for an overdose with depemokimab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Further management should be as clinically indicated or recommended by the national poisons centre, where applicable.
Ask anything about Exdensur 100 mg/1 ml Solution for injection in a pre-filled pen. 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.