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.
Adtralza 300 mg solution for injection in pre filled pen
⚠ 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 Tralokinumab 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
Adtralza contains the active substance tralokinumab. Tralokinumab is a monoclonal antibody (a type of protein) that blocks the action of a protein called IL-13. IL-13 plays a major role in causing the symptoms of atopic dermatitis. Adtralza is used to treat adult and adolescent patients 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema. Adtralza may be used with eczema medicines that you apply to the skin or it may be used on its own. Using Adtralza for atopic dermatitis can improve your eczema and reduce the related itching and skin pain. 2.
What you need to know before you take it
e Adtralza®
Do not use Adtralza: if you are allergic to tralokinumab 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 Adtralza. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Adtralza. Allergic reactions Very rarely, medicines can cause allergic (hypersensitivity) reactions and severe allergic reactions called anaphylaxis. You must look out for signs of these reactions (such as breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (because of low blood pressure), hives, itching and skin rash) while you are using Adtralza. Stop using Adtralza and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction. Such signs are listed in the beginning of section 4. 1
Parasitic infection in the intestines Adtralza may reduce your resistance to infections caused by parasites. Any parasitic infection should be treated before you start treatment with Adtralza. Tell your doctor if you have diarrhoea, gas, upset stomach, greasy stools, and dehydration which could be signs of a parasitic infection. If you live in a region where these infections are common or if you are travelling to such a region, tell your doctor. Eye problems Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision. Children Do not give this medicine to children below the age of 12 years because the safety and benefits of Adtralza are not yet known in this population. Other medicines and Adtralza 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 are due to have one. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor for advice before using this medicine. The effects of Adtralza in pregnant women are not known; therefore, it is preferable to avoid using it during pregnancy unless your doctor advises you to use it. If applicable, you and your doctor should decide if you will breast-feed or use Adtralza. You should not do both. Driving and using machines Adtralza is unlikely to reduce your ability to drive and use machines. Adtralza contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 300 mg that is to say essentially "sodium-free". Adtralza contains polysorbate (E 433) This medicine contains 0.2 mg of polysorbate 80 in each pre-filled pen which is equivalent to 0.1 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies. 3.
How to use Adtralza®
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Each pre-filled pen contains 300 mg of tralokinumab.
How to take it
and for how long • Your doctor will decide how much Adtralza you need and for how long. • The recommended first dose is 600 mg (two 300 mg injections), followed by 300 mg (one 300 mg injection) given every 2 weeks. Based on how well the medicine works, your doctor may decide that you can have a dose every 4 weeks. Adtralza is given by injection under your skin (subcutaneous injection). You and your doctor or nurse can decide if you can inject Adtralza yourself. 2
Inject Adtralza yourself only after you have been trained by your doctor or nurse. A caregiver may also give you your Adtralza injection after proper training. Do not shake the pen. Read the "Instructions for Use" before injecting Adtralza. If you use more Adtralza than you should If you use more of this medicine than you should or the dose has been given too early, talk to your doctor, pharmacist or nurse. If you forget to use Adtralza If you miss injecting a dose at the right time, inject Adtralza as soon as possible. Then the next dose should be injected at the regular scheduled time. If you stop using Adtralza Do not stop using Adtralza 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. Adtralza can cause serious side effects, including allergic (hypersensitivity) reactions such as anaphylaxis; the signs may include: • breathing problems • swelling of the face, mouth, and tongue • fainting, dizziness, feeling lightheaded (low blood pressure) • hives • itching • skin rash Stop using Adtralza and tell your doctor or get medical help immediately if you notice any signs of allergic reaction. Other side effects Very common (may affect more than 1 in 10 people) • upper respiratory tract infections (i.e. common cold and sore throat) Common (may affect up to 1 in 10 people) • eye redness and itching • eye infection • injection site reactions (i.e. redness, swelling) Uncommon (may affect up to 1 in 100 people) • eye inflammation which may cause eye pain or decreased vision 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 at: 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. 3
5.
How to store Adtralza®
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 the original package in order to protect from light. Store in a refrigerator (2 °C to 8 °C). Do not freeze. If necessary, Adtralza may be kept at room temperature up to 30 °C in the original package for a maximum of 14 days. Do not store above 30 °C. Throw away Adtralza if it is not used within 14 days of storage at room temperature. If you need to permanently remove the carton from the refrigerator, write down the date of removal on the carton, and use Adtralza within 14 days. Adtralza must not be refrigerated again during this period. Do not use this medicine if you notice that it is cloudy, discoloured or has particles in it. Do not throw away any medicines via wastewater or household waste. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use. These measures will help protect the environment. 6.
How to store it
Adtralza Keep this medicine out of the sight and reach of children. Contains small parts. • Store Adtralza pre-filled pens in a refrigerator between 2 oC and 8 oC. • Store Adtralza pre-filled pens in the original package and protect from light • until you are ready to use them. Do not freeze Adtralza pre-filled pens. Do not use if they have been frozen. • Adtralza can be stored in the original package at room temperature up to 30°C for up to 14 days. • If removed permanently from the refrigerator, write down the date of removal on the carton, and use Adtralza within 14 days. Discard pens if left out of the refrigerator for more than 14 days. Step 1: Setting up Adtralza injection
Adtralza pre-filled pen
Cotton balls or gauze
Alcohol swab Puncture-resistant container
1a: Gather the supplies needed for your injection For each Adtralza dose you will need: A clean, flat, well-lit work surface, like a table • 1 Adtralza pre-filled pen • An alcohol swab (not included in the carton) • Clean gauze pads or cotton balls (not included in the carton) • A puncture-resistant sharps disposal container (not included in the carton) •
1b: Take the Adtralza carton out of the refrigerator Check the expiry date (EXP) on the carton. Do not use if the expiry date on the carton has • passed. When using the first pre-filled pen in the carton, check to make sure the seal on the carton is • intact. Do not use the Adtralza pre-filled pens if the seal on the carton is broken. Do not use the Adtralza pre-filled pens if the pre-filled pens have been stored at room temperature for more than 14 days.
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1c: Remove the Adtralza pre-filled pen from the carton Remove 1 pre-filled pen from the carton. When using the first pre-filled pen, put the carton with the remaining pre-filled pen back in the refrigerator. Do not remove the cap on the pre-filled pen until you have reached Step 3 and are ready to • inject.
min Waiting time
1d: Let the Adtralza pre-filled pen reach room temperature Place the pre-filled pen on the flat surface and wait at least 45 minutes before you inject Adtralza to let the pre-filled pen reach room temperature (20 oC to 30 oC). This will help to make injection of Adtralza more comfortable. Do not heat the pre-filled pen in any way. • Do not shake the pre-filled pen. • Do not put the pre-filled pen back in the refrigerator once it has reached room temperature. •
Viewing window
1e: Inspect the Adtralza pre-filled pen Make sure the label shows the correct name of the medicine, Adtralza. • Check the expiry date on the pre-filled pen label. • Check the medicine through the viewing window. The medicine should be clear to opalescent, • colourless to pale yellow. You may see small air bubbles in the liquid. This is normal. You do not need to do anything • about it. •
Do not use the Adtralza pre-filled pen if: o the expiry date on the pre-filled pen has passed 8
o the medicine is cloudy, discoloured, or has particles in it o the pre-filled pen looks damaged or has been dropped If you cannot use the pre-filled pen, dispose of it in a puncture-resistant container and use a new prefilled pen. Step 2: Choosing and preparing injection area
Injection by caregiver only Self-injection or by caregiver
2a: Choose the area for your injection You may inject into: • o your stomach area (abdomen) o your thighs o your upper arm. To inject into your upper arm, you will need a caregiver to give you the injection. Do not inject where the skin is tender, bruised, scaly, scarred, damaged, hard or covered with • eczema. Do not inject within 5 cm of your belly button (navel). • It is recommended that you use a different injection area for each new injection. Do not • use the same body area 2 times in a row.
2b: Wash your hands and prepare your skin Wash your hands with soap and water. • Clean the injection area with an alcohol swab using a circular motion. • o Let the area dry completely. o Do not blow on or touch the cleaned area before injecting.
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Step 3: Injecting Adtralza
3a: Pull off the Adtralza cap Hold the pre-filled pen with one hand, pull the cap straight off with your other hand and throw it into the puncture-resistant container. The needle guard is now exposed. It is there to prevent you from touching the needle. Do not try to recap the pre-filled pen. This could cause the injection to happen too soon or • damage the needle. Do not try to touch or push on the needle guard with your finger. This could cause needle stick • injury.
3b: Place the Adtralza pre-filled pen at the injection site so that you can see the viewing window You can gently pinch the skin where you cleaned the injection area or give the injection without pinching the skin. Follow your healthcare professional ́s instructions on how to inject. •
Place the needle guard of the pre-filled pen flat against your skin (90-degree angle) at the injection site you have cleaned. Make sure you can see the viewing window.
•
Do not change the position of the pre-filled pen after the injection has started.
If the pre-filled pen is removed too soon, you may see a stream of medicine coming from the prefilled pen. If this happens you may not have received your full dose. Call your doctor, pharmacist or nurse.
10
sec
3c: Press down on the Adtralza pre-filled pen and hold pressure Press the pre-filled pen down firmly and hold it in place. You will hear a "click" to let you know that the injection has started and the yellow plunger will start to move. The yellow plunger will move to the bottom of the viewing window as the medicine is being injected. It may take up to 15 seconds to inject the full dose. You will hear a second "click" when the yellow plunger fills the viewing window. Keep pressing.
sec
3d: Continue to press down for another 5 seconds After the second "click", continue to press the pen firmly against your skin for 5 seconds to make sure you get your full dose.
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3e: Remove the Adtralza pre-filled pen Pull the pre-filled pen straight away from the injection site. The needle guard will slide down and lock into place over the needle. • •
Place a dry cotton ball or gauze pad over the injection site for a few seconds. Do not rub the injection site. There may be a small amount of blood or liquid where you injected. This is normal. If needed, cover the injection area with a small bandage. Before use: Viewing window
After use:
3f: Check the viewing window Check the viewing window to make sure all the liquid has been injected. If the yellow plunger does not fill the viewing window you may not have received the full dose. If this happens or if you have any other concerns, call your doctor, pharmacist or nurse.
Step 4: Disposing of Adtralza pre-filled pen
•
Put the used Adtralza pre-filled pen in a puncture-resistant container straight away after use. o Do not throw the Adtralza pre-filled pen in your household trash.
•
If you do not have a puncture-resistant container, you may use a household container that is: o made of heavy-duty plastic, o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, o upright and stable during use, 12
• •
o leak-resistant, and o properly labelled to warn of hazardous waste inside the container. When your puncture-resistant container is almost full, you will need to follow your community guidelines for the right way to dispose of your puncture-resistant container. Do not recycle your used puncture-resistant container.
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Contents of the pack and other information
What Adtralza contains The active substance is tralokinumab. Each pre-filled pen contains 300 mg of tralokinumab in 2 ml solution for injection. The other ingredients are sodium acetate trihydrate (E 262), acetic acid (E 260), sodium chloride, polysorbate 80 (E 433) and water for injections. What Adtralza looks like and contents of the pack Adtralza is a clear to opalescent, colourless to pale yellow solution, supplied in a pre-filled pen. Adtralza is available in unit packs containing 2 pre-filled pens or in multipacks containing 6 (3 packs of 2) pre-filled pens. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom LEO Laboratories Ltd Tel: +44 (0) 1844 347333
4
This leaflet was last revised in February 2026 Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu The Instructions for Use with information about on how to inject Adtralza is shown on the other side of this leaflet.
For information in large print, Braille or audio/CD, telephone +44 (0)1844 347333.
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Instructions for Use Adtralza®300 mg solution for injection in pre-filled pen tralokinumab Read these instructions before you start using Adtralza pre-filled pens and each time you get a new package. There may be new information. You should also talk to your healthcare professional about your medical condition or your treatment. Keep this Instructions for Use so you can read it again if necessary. Each pre-filled pen contains 300 mg of tralokinumab. The Adtralza pre-filled pens are for single-use only. IMPORTANT INFORMATION Important information you need to know before injecting Adtralza: • Before you inject Adtralza for the first time, your healthcare professional will show you how to prepare and inject Adtralza using the pre-filled pen. • Do not inject Adtralza until you have been shown how to inject it the right way. • Talk to your healthcare professional if you have any questions about how to inject Adtralza the right way. • To receive your full dose, you will need to have 1 Adtralza injection. • It is recommended that you use a different injection area for each new injection. • The Adtralza pre-filled pen has a needle guard that will automatically cover the needle after the injection is finished. Do not remove the cap until just before you give the injection. • Do not share or reuse your Adtralza pre-filled pens. • Adtralza pre-filled pen parts: Before use
After use
Label with expiry date
Yellow plunger
Viewing window
Needle guard
Cap
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Frequently asked questions about Adtralza 300 mg solution for injection in pre filled pen
How do I take Adtralza 300 mg solution for injection in pre filled pen?
Adtralza 300 mg solution for injection in pre filled pen comes as injection containing 300mg. 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 Adtralza 300 mg solution for injection in pre filled pen?
The active substance in Adtralza 300 mg solution for injection in pre filled pen is tralokinumab.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Adtralza 300 mg solution for injection in 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.
Can I get Adtralza 300 mg solution for injection in pre filled pen 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: tralokinumab
- 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
Adtralza is indicated for the treatment of moderate‑to‑severe atopic dermatitis in adult and adolescent patients 12 years and older 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 tralokinumab for adult and adolescent patients 12 years and older is an initial dose of 600 mg administered as two 300 mg injections given by pre-filled pens.
This initial dose is followed by a 300 mg injection administered every other week as one 300 mg injection given by pre-filled pen.
At prescriber's discretion, every fourth week dosing may be considered for patients who achieve clear or almost clear skin after 16 weeks of treatment. The probability of maintaining clear or almost clear skin may be lower with every fourth week dosing (see section 5.1).
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve further with continued treatment every other week beyond 16 weeks.
Tralokinumab can be used with or without topical corticosteroids. The use of topical corticosteroids, when appropriate, may provide an additional effect to the overall efficacy of tralokinumab (see section 5.1). Topical calcineurin inhibitors 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
No dose adjustment is recommended for elderly patients (see section 5.2). Limited data are available in patients > 75 years of age.
Renal impairment
No dose adjustment is needed in patients with renal impairment. Very limited data are available in patients with severe renal impairment (see section 5.2).
Hepatic impairment
No dose adjustment is needed in patients with hepatic impairment. Very limited data are available in patients with moderate or severe hepatic impairment (see section 5.2).
High body weight
For patients with high body weight (> 100 kg), who achieve clear or almost clear skin after 16 weeks of treatment, reducing the dose to every fourth week might not be appropriate (see section 5.2).
Paediatric population
The safety and efficacy of tralokinumab in children below the age of 12 years have not yet been established. No data are available.
Method of administration
For subcutaneous use.
The pre-filled pen should not be shaken. After removing the pre‑filled pens from the refrigerator, they should be allowed to reach room temperature by waiting for 45 minutes before injecting the pre-filled pen.
Tralokinumab is administered by subcutaneous injection into the thigh or abdomen, except the 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used.
For the initial 600 mg dose, two 300 mg pre-filled pens should be administered consecutively in different injection sites within the same body area.
It is recommended to rotate the injection site with each dose. Tralokinumab should not be injected into skin that is tender, damaged or has bruises or scars.
A patient may self‑inject tralokinumab or the patient's caregiver may administer tralokinumab if their healthcare professional determines that this is appropriate. Proper training should be provided to patients and/or caregivers on the administration of tralokinumab 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 tralokinumab should be discontinued and appropriate therapy initiated.
Conjunctivitis
Patients treated with tralokinumab 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 tralokinumab 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 tralokinumab. If patients become infected while receiving tralokinumab and do not respond to antihelminth treatment, treatment with tralokinumab should be discontinued until infection resolves.
Vaccinations
Live and live attenuated vaccines should not be given concurrently with tralokinumab as clinical safety and efficacy have not been established. Immune responses to the non‑live tetanus and meningococcal vaccines were assessed (see section 4.5). It is recommended that patients should be brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with tralokinumab.
Excipients
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially “sodium‑free”.
Adverse reactions to excipients
Adtralza contains polysorbate 80 (E 433) as an excipient, which may cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
The safety and efficacy of concurrent use of tralokinumab with live and live attenuated vaccines has not been studied.
Immune responses to non‑live vaccines were assessed in a study in which adult patients with atopic dermatitis were treated with an initial dose of 600 mg (four 150 mg injections) followed by 300 mg every second (other) week administered as subcutaneous injection. After 12 weeks of tralokinumab administration, patients were vaccinated with a combined tetanus, diphtheria, and acellular pertussis vaccine, and a meningococcal vaccine and immune responses were assessed 4 weeks later. Antibody responses to both tetanus vaccine and meningococcal vaccine were similar in tralokinumab‑treated and placebo‑treated patients. No adverse interactions between either of the non‑live vaccines or tralokinumab were noted in the study. Therefore, patients receiving tralokinumab may receive concurrent inactivated or non‑live vaccinations.
For information on live and live attenuated vaccines, see section 4.4.
Interactions with cytochrome P450
Tralokinumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. Clinically relevant interactions between tralokinumab and inhibitors, inducers, or substrates of metabolising enzymes are not expected, and no dose adjustment is needed.
The effects of tralokinumab on the pharmacokinetics (PK) of CYP substrates, caffeine (CYP1A2), warfarin (CYP2C9), metoprolol (CYP2D6), omeprazole (CYP2C19) and midazolam (CYP3A), were evaluated in atopic dermatitis patients after repeated administration. No effects were observed for caffeine and warfarin. Small numerical changes, which were not clinically significant, were observed for Cmax of omeprazole, AUC of metoprolol and AUC and Cmax of midazolam (the largest difference being for midazolam Cmax with a decrease of 22%). Therefore, clinically relevant impact of tralokinumab on the pharmacokinetics of concomitant medicinal products metabolised by the CYP enzymes is not expected.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is limited amount of data from the use of tralokinumab 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 tralokinumab during pregnancy.
Breast‑feeding
It is unknown whether tralokinumab is excreted in human milk or absorbed systemically after ingestion. A decision must be made whether to discontinue breast‑feeding or to discontinue tralokinumab therapy taking into account the benefit of breast‑feeding for the child and the benefit of therapy for the woman.
Fertility
Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology (see section 5.3).
4.7. Effects on ability to drive and use machines
Tralokinumab 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 upper respiratory tract infections (23.4%; mainly reported as common cold), injection site reactions (7.2%), conjunctivitis (5.4%) and conjunctivitis allergic (2.0%).
Tabulated list of adverse reactions
Adverse reactions observed from clinical trials and post-marketing experience are presented in Table 1 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, undesirable effects are presented in order of decreasing seriousness. The frequencies are based on the initial treatment period of up to 16 weeks in the pool of 5 studies in the atopic dermatitis population.
Table 1: List of adverse reactions
MedDRA System Organ Class
Frequency
Adverse reaction
Infections and infestations
Very commonCommon
Upper respiratory tract infections
Conjunctivitis
Blood and lymphatic system disorders
Common
Eosinophilia
Eye disorders
Common
Uncommon
Conjunctivitis allergic
Keratitis
General disorders and administration site conditions
Common
Injection site reactions
The long‑term safety of tralokinumab was assessed in 2 monotherapy studies up to 52 weeks, and in a combination study with topical corticosteroids up to 32 weeks. The long-term safety of tralokinumab is further assessed in an open-label extension study (ECZTEND) for up to 5 years of treatment in adults and up to 2 years in adolescents 12 years and older with moderate-to-severe AD (atopic dermatitis) receiving 300 mg of tralokinumab every two weeks (Q2W). The long-term safety data were generally consistent with the safety profile observed up to week 16 in the pool of 5 adult studies.
Description of selected adverse reactions
Conjunctivitis and related events
Conjunctivitis occurred more frequently in atopic dermatitis patients who received tralokinumab (5.4%) compared to placebo (1.9%) in the initial treatment period of up to 16 weeks in the pool of 5 studies. Conjunctivitis was reported at a higher frequency in patients with severe atopic dermatitis compared to subjects with moderate atopic dermatitis in both the tralokinumab group (6.0 vs 3.3%; initial treatment period) and placebo group (2.2 vs 0.8%; initial treatment period). Most patients recovered or were recovering during the treatment period.
The rate of conjunctivitis in the initial 16 weeks treatment period was 22.0 events/100 patient years of exposure. The rate of conjunctivitis in the treatment period of the long-term open-label extension study (ECZTEND) was 2.93 events/100 patient years of exposure.
Keratitis was reported in 0.5% of subjects treated with tralokinumab during the initial treatment period. Of these, half were classified as keratoconjunctivitis, all were non‑serious and mild or moderate in severity, and none led to treatment discontinuation.
The rate of keratitis in the initial 16 weeks treatment period was 1.7 events/100 patient years of exposure. The rate of keratitis in the treatment period of the long-term open-label extension study (ECZTEND) was 0.11 events/100 patient years of exposure.
Eosinophilia
Adverse reactions of eosinophilia were reported in 1.3% of patients treated with tralokinumab and 0.3% of patients treated with placebo during the initial treatment period of up to 16 weeks in the pool of 5 studies. Tralokinumab‑treated patients had a greater mean initial increase from baseline in eosinophil count compared to patients treated with placebo. Eosinophilia (≥ 5 000 cells/mcL) was measured in 1.2% of tralokinumab‑treated patients and 0.3% of placebo‑treated patients in the initial treatment period. However, the increase in the tralokinumab‑treated patients was transient, and mean eosinophil counts returned to baseline during continued treatment. The safety profile for subjects with eosinophilia was comparable to the safety profile for all subjects.
Eczema herpeticum
Eczema herpeticum was reported in 0.3% of the subjects treated with tralokinumab and in 1.5% of subjects in the placebo group in the initial treatment period of up to 16 weeks in the pool of 5 studies in atopic dermatitis. The rate of eczema herpeticum in the initial 16 weeks treatment period was 1.2 events/100 patient years of exposure. The rate of eczema herpeticum in the treatment period of the long-term open-label extension study (ECZTEND) was 0.67 events/100 patient years of exposure.
Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity with tralokinumab.
Anti‑drug‑antibody (ADA) responses were not associated with any impact on tralokinumab exposure, safety, or efficacy in patients receiving tralokinumab for up to 6 years (in phase 2/phase 3 atopic dermatitis studies followed by the long-term extension study ECZTEND).
No immunogenicity-related adverse events such as immune-complex disease, serum sickness/serum sickness-like reactions, or anaphylaxis were observed.
In ECZTRA 1, ECZTRA 2, ECZTRA 3, and the vaccine‑response study, the incidence of ADA up to 16 weeks was 1.4% in patients treated with tralokinumab and 1.3% in patients treated with placebo; neutralising antibodies were seen in 0.1% of patients treated with tralokinumab and 0.2% of patients treated with placebo.
The ADA incidence in patients who received tralokinumab up to 52 weeks was 4.6%; 0.9% had persistent ADA and 1.0% had neutralising antibodies.
ADA incidences in patients who received tralokinumab for up to 6 years (in phase 2/phase 3 atopic dermatitis studies followed by the long-term extension study ECZTEND) were similar to those observed after 52 weeks in ECZTRA 1 and 2.
Injection site reactions
Injection site reactions (including pain and redness) occurred more frequently in patients who received tralokinumab (7.2%) compared to placebo (3.0%) in the initial treatment period of up to 16 weeks in the pool of 5 studies. Across all treatment periods in the 5 studies in atopic dermatitis, the vast majority (99%) of injection site reactions were mild or moderate in severity, and few patients (< 1%) discontinued tralokinumab treatment. Most injections site reactions reported had a short duration with approximately 76% of the events resolving within 1 to 5 days.
The rate of injection site reactions in the initial 16 weeks treatment period was 51.5 events/100 patient years of exposure. The rate of injection site reactions in the treatment period of the long-term open-label extension study (ECZTEND) was 5.89 events/100 patient years of exposure.
Paediatric population
The safety of tralokinumab was assessed in patients 12 to 17 years of age (adolescents) with moderate‑to‑severe atopic dermatitis in a monotherapy study of 289 adolescents (ECZTRA 6) and in a long-term open-label extension study (ECZTEND) including 127 adolescents transferred from ECZTRA 6. The safety profile of tralokinumab in these patients followed through the initial treatment period of 16 weeks and maintenance treatment period of 52 weeks in ECZTRA 6, as well as in the long-term treatment period of up to 2 years in ECZTEND, was overall similar to the safety profile from studies in adults. In the initial treatment period of 16 weeks, however, conjunctivitis was reported at lower frequency with tralokinumab in adolescents (1.0% in ECZTRA 6) than in adults (5.4% in the pool of 5 studies), and, unlike in adults, the frequency of conjunctivitis allergic was similar for tralokinumab and placebo in adolescent patients.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is no specific treatment for tralokinumab overdose. In clinical studies with tralokinumab, single intravenous doses of up to 30 mg/kg and multiple subcutaneous doses of 600 mg every 2 weeks for 12 weeks were found to be well tolerated.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ADTRALZA 150 mg prescriptionTRALOKINUMABUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- AdtralzaTralokinumabum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
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