Adtralza: Uses, Dosage & Side Effects

What Is Adtralza and What Is It Used For?

Adtralza contains the active substance tralokinumab, a fully human immunoglobulin G4 (IgG4) monoclonal antibody produced using recombinant DNA technology. It belongs to a class of biologic medicines known as interleukin inhibitors. Specifically, tralokinumab binds to and neutralizes interleukin-13 (IL-13), a type 2 cytokine that has been identified as a central mediator in the pathogenesis of atopic dermatitis. By blocking IL-13, Adtralza addresses one of the fundamental molecular drivers of the disease rather than simply suppressing the immune system broadly.

Interleukin-13 is a signaling protein produced predominantly by type 2 helper T cells (Th2 cells), innate lymphoid cells type 2 (ILC2s), and other immune cells. In atopic dermatitis, IL-13 is overexpressed in lesional and non-lesional skin, where it drives multiple pathological processes. IL-13 impairs the skin barrier by downregulating the production of structural proteins such as filaggrin, loricrin, and involucrin, which are essential for maintaining the integrity of the epidermal barrier. This barrier dysfunction allows increased transepidermal water loss and penetration of allergens, irritants, and microbes, perpetuating the cycle of inflammation. IL-13 also promotes the production of chemokines that recruit additional inflammatory cells to the skin, stimulates B-cell immunoglobulin class switching to IgE (contributing to the elevated IgE levels characteristic of atopic dermatitis), and directly activates sensory neurons to produce pruritus (itching).

By neutralizing IL-13, tralokinumab interrupts these interconnected pathological processes. Clinical studies have demonstrated that blocking IL-13 alone—without simultaneously blocking IL-4, which shares some signaling pathways—is sufficient to achieve significant clinical improvement in many patients with moderate-to-severe atopic dermatitis. This selective mechanism of action distinguishes Adtralza from other biologic treatments in this therapeutic area, such as dupilumab, which targets both IL-4 and IL-13 by blocking the IL-4 receptor alpha (IL-4Rα) subunit.

Adtralza is approved by the European Medicines Agency (EMA) and regulatory authorities in numerous other countries for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. In the United States, the same active substance is marketed under the brand name Adbry. Adtralza can be used as monotherapy or in combination with topical corticosteroids or other topical treatments for eczema.

Atopic dermatitis is one of the most common chronic inflammatory skin conditions, affecting approximately 2–5% of adults and up to 20% of children worldwide. The disease is characterized by intensely itchy, inflamed, and often oozing or crusted patches of skin that can significantly impair sleep, daily activities, mental health, and overall quality of life. While many patients with mild disease can be managed with emollients, topical corticosteroids, and topical calcineurin inhibitors, a substantial proportion of patients with moderate-to-severe disease require systemic treatment. Adtralza represents an important addition to the therapeutic arsenal for these patients, offering a targeted biologic approach with a favorable safety profile demonstrated across multiple large clinical trials.

What Should You Know Before Taking Adtralza?

Before you start treatment with Adtralza, it is essential that your doctor has a complete picture of your medical history, current health status, and any other medications you may be taking. While Adtralza is generally well tolerated, certain conditions and circumstances require special consideration. The following sections outline the key precautions, contraindications, and situations where additional medical advice is needed.

Contraindications

Adtralza must not be used if you have a known hypersensitivity (allergy) to tralokinumab or to any of the other ingredients in the formulation. The excipients include sodium acetate trihydrate, acetic acid, sodium chloride, polysorbat 80, and water for injections. If you have experienced an allergic reaction to any of these substances in the past, you must inform your doctor before being prescribed Adtralza.

If you think you may be allergic to any component, or if you are uncertain, consult your doctor, pharmacist, or nurse before starting treatment. Allergic reactions to monoclonal antibodies, while uncommon, can occur and may range from mild skin reactions to severe systemic events.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before using Adtralza if any of the following apply to you:

Allergic reactions: In rare cases, medicines can cause allergic reactions (hypersensitivity) and severe allergic reactions known as anaphylaxis. Be alert for signs of these reactions, including breathing difficulties, swelling of the face, mouth, or tongue, fainting, dizziness (due to low blood pressure), hives, itching, and rash. If you experience any of these symptoms while using Adtralza, stop the injection immediately and seek urgent medical attention. Signs of serious allergic reactions are described in more detail in the side effects section of this article.

Parasitic infections: Adtralza may reduce your body’s ability to fight infections caused by parasites (helminths). IL-13 plays a role in the immune defense against parasitic worms, so blocking it could theoretically impair this protective response. Any existing parasitic infection should be fully treated before you begin Adtralza therapy. If you develop symptoms such as diarrhea, excessive gas, abdominal discomfort, greasy stools, or dehydration during treatment, tell your doctor promptly, as these may indicate a parasitic infection. If you live in or have recently traveled to a region where parasitic infections are common (including many tropical and subtropical areas), discuss this with your doctor before starting treatment.

Eye problems: Talk to your doctor if you experience new or worsening eye problems during treatment, including eye pain, changes in vision, redness, or discharge. Conjunctivitis (inflammation of the eye surface) and keratitis (inflammation of the cornea) have been reported in patients receiving Adtralza, and prompt evaluation by an ophthalmologist may be needed in some cases.

Children under 12 years: Adtralza should not be given to children younger than 12 years of age because the safety and benefits of the medicine have not been established in this age group.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before using Adtralza. The effects of tralokinumab on human pregnancy are not well established. Animal reproductive studies with tralokinumab have not shown direct harmful effects on fertility, embryonic development, or postnatal development. However, as a precaution, Adtralza should preferably not be used during pregnancy unless the expected clinical benefit to the mother justifies the potential risk to the developing fetus.

It is not known whether tralokinumab passes into human breast milk. Human IgG antibodies are known to be present in breast milk, particularly during the first days after birth. You and your doctor should discuss together whether you should breastfeed or use Adtralza; the recommendation is generally to avoid doing both simultaneously unless your doctor advises otherwise based on your individual circumstances.

Driving and Operating Machinery

Adtralza is not expected to affect your ability to drive or operate machinery. No studies on the effects of tralokinumab on the ability to drive or use machines have been performed, but the known pharmacological properties of the medicine make it unlikely to impair these abilities.

Vaccinations

Tell your doctor if you have recently received a vaccination or if you plan to be vaccinated. While there are no specific contraindications regarding inactivated or non-live vaccines, the use of live or live-attenuated vaccines during Adtralza treatment has not been studied. As a general precaution with immunomodulatory biologic therapies, discuss the timing of any planned vaccinations with your doctor to ensure optimal immune response.

How Does Adtralza Interact with Other Drugs?

One of the advantages of biologic therapies like Adtralza is their relatively low potential for pharmacokinetic drug–drug interactions compared with small-molecule systemic immunosuppressants. As a monoclonal antibody, tralokinumab is catabolized (broken down) through general protein degradation pathways rather than being metabolized by cytochrome P450 (CYP450) enzymes in the liver. This means that Adtralza is unlikely to directly affect the metabolism of other drugs that are processed through these enzyme systems.

However, it is important to be aware that chronic inflammation can alter the activity of certain CYP450 enzymes. Elevated levels of cytokines such as IL-13 in patients with atopic dermatitis may suppress the expression of some CYP450 enzymes. When Adtralza reduces IL-13 levels and inflammation improves, the normal expression of these enzymes may be restored, potentially changing the plasma concentrations of concomitant medications that are CYP450 substrates. This is a theoretical concern that applies to many anti-inflammatory biologic therapies and is most clinically relevant for drugs with a narrow therapeutic index.

Interactions Requiring Caution

Vaccines and Immune Response

While Adtralza is not a broad immunosuppressant, its effect on IL-13 signaling could theoretically influence immune responses to certain vaccines. Inactivated (non-live) vaccines, such as influenza, COVID-19, and tetanus vaccines, are generally considered safe to administer during Adtralza treatment. However, the immune response to these vaccines has not been formally studied in patients receiving tralokinumab. Live vaccines (such as MMR, varicella, or yellow fever) should be avoided during treatment as a precautionary measure, since the potential for IL-13 blockade to affect the clearance of live vaccine strains has not been established.

If you require vaccination, discuss the optimal timing with your doctor. In general, it is advisable to bring all routine vaccinations up to date before starting biologic therapy when possible.

What Is the Correct Dosage of Adtralza?

Always use Adtralza exactly as your doctor, pharmacist, or nurse has instructed. If you are unsure about any aspect of your dosing regimen, ask your healthcare provider for clarification. Each pre-filled pen contains 300 mg of tralokinumab in 2 mL of solution.

Adults and Adolescents (12 Years and Older)

Children Under 12 Years

Adtralza is not recommended for children under 12 years of age. The safety and efficacy of tralokinumab have not been established in this population, and appropriate dosing has not been determined.

Elderly Patients

No dose adjustment is required for elderly patients. In clinical trials, patients aged 65 years and older were included, and the safety and efficacy profile was generally consistent with that observed in younger adults. However, as with all medicines, elderly patients should be monitored appropriately, and individual clinical judgement should guide treatment decisions.

How to Administer Adtralza

Adtralza is administered as a subcutaneous injection (under the skin). Suitable injection sites include the abdomen (avoiding the area within 5 cm of the navel), the front of the thighs, and the upper arms (the upper arm should only be used if a caregiver is giving the injection). You should rotate injection sites with each dose and avoid injecting into skin that is tender, bruised, scarred, or affected by eczema.

Before injecting, remove the pre-filled pen from the refrigerator and allow it to reach room temperature (20–30°C) for at least 45 minutes. Do not warm the pen by any other method, and do not shake it. Inspect the solution through the viewing window: it should be clear to opalescent, colorless to slightly yellow, and free from visible particles. Do not use the pen if the solution appears cloudy, discolored, or contains particles.

You may self-inject after being trained by a healthcare professional. A trained caregiver may also administer the injection. The pre-filled pen is designed for single use only and features an automatic needle shield that covers the needle after injection is complete.

Missed Dose

If you miss a dose of Adtralza, inject the missed dose as soon as possible. Then resume your regular dosing schedule from the next planned injection date. Do not inject a double dose to make up for a missed one.

Overdose

If you use more Adtralza than you should, or if a dose is given earlier than scheduled, tell your doctor, pharmacist, or nurse. In clinical trials, no dose-limiting toxicities were identified with tralokinumab at doses up to 600 mg administered subcutaneously. If an overdose occurs, monitor for signs of adverse reactions and provide supportive treatment as necessary.

What Are the Side Effects of Adtralza?

Like all medicines, Adtralza can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity and do not require treatment discontinuation. Adtralza has been evaluated in multiple large clinical trials involving thousands of patients, providing a well-characterized safety profile.

Serious Side Effects

Adtralza can cause serious allergic reactions (hypersensitivity), including, in rare cases, anaphylaxis. Signs and symptoms of a serious allergic reaction may include:

• Breathing difficulties or wheezing
• Swelling of the face, mouth, lips, or tongue
• Fainting, dizziness, or feeling lightheaded (due to low blood pressure)
• Hives (urticaria) or widespread rash
• Severe itching

Side Effect Frequency

The following side effects have been reported in clinical trials with Adtralza. They are categorized by how frequently they occur:

Eye-Related Side Effects

Conjunctivitis and other eye-related side effects have been observed with Adtralza and other biologic treatments targeting the IL-13/IL-4 pathway in atopic dermatitis. The mechanism behind this association is not fully understood, but it may relate to the role of type 2 cytokines in maintaining the ocular surface. In most cases, conjunctivitis is mild and manageable with standard ophthalmic treatments such as lubricating eye drops. However, if you develop significant eye pain, changes in vision, increased light sensitivity, or persistent eye symptoms, contact your doctor or an ophthalmologist promptly, as keratitis (corneal inflammation) requires timely evaluation and treatment.

Injection Site Reactions

Injection site reactions are common with subcutaneous biologics and are usually mild and transient. They typically include redness, swelling, itching, or mild pain at the injection site. These reactions generally decrease in frequency and intensity with continued use. Rotating injection sites and allowing the pre-filled pen to reach room temperature before injection can help minimize injection site discomfort.

If you experience any side effects, including those not listed here, tell your doctor, pharmacist, or nurse. You can also report suspected side effects to your national medicines regulatory authority (e.g., the EMA in Europe, FDA MedWatch in the United States, or MHRA Yellow Card Scheme in the United Kingdom) to help monitor the ongoing safety profile of Adtralza.

How Should You Store Adtralza?

Proper storage of Adtralza is essential to maintain the medicine’s effectiveness and safety. Keep this medicine out of the sight and reach of children, as the pre-filled pens contain small parts.

• Refrigerated storage: Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze: Adtralza must never be frozen. If it has been accidentally frozen, do not use it.
• Room temperature storage: If needed, Adtralza can be kept at room temperature up to 30°C (86°F) in the original packaging for a maximum of 14 days. Write the date of removal from the refrigerator on the carton.
• 14-day limit: If not used within 14 days at room temperature, the pre-filled pen must be discarded. Do not return it to the refrigerator after room temperature storage.
• Expiry date: Do not use after the expiry date (EXP) printed on the label and carton. The expiry date refers to the last day of the stated month.
• Visual inspection: Do not use if the solution is cloudy, discolored, or contains visible particles.

Dispose of used or expired pre-filled pens in a puncture-resistant sharps container. Do not dispose of medicines in household waste or wastewater. Ask your pharmacist how to properly dispose of medicines you no longer need in order to protect the environment.

What Does Adtralza Contain?

Active Substance

The active substance is tralokinumab. Each pre-filled pen contains 300 mg of tralokinumab in 2 mL of solution for injection (150 mg/mL). Tralokinumab is a fully human IgG4 monoclonal antibody produced in Chinese hamster ovary (CHO) cells using recombinant DNA technology.

Inactive Ingredients (Excipients)

• Sodium acetate trihydrate (E262)
• Acetic acid (E260)
• Sodium chloride
• Polysorbate 80 (E433)
• Water for injections

Sodium content: This medicine contains less than 1 mmol (23 mg) sodium per 300 mg dose, meaning it is essentially “sodium-free.”

Polysorbate 80: Each pre-filled pen contains 0.2 mg of polysorbate 80, which corresponds to 0.1 mg/mL. Polysorbates can, in rare cases, cause allergic reactions. If you have a known allergy to polysorbate 80, inform your doctor.

Appearance and Packaging

Adtralza is a clear to opalescent, colorless to slightly yellow solution supplied in a single-use pre-filled injection pen. The pen is designed with an automatic needle shield that covers the needle after the injection is complete, reducing the risk of accidental needle-stick injuries.

Adtralza is available in unit packs containing 2 pre-filled pens or in multipacks containing 6 pre-filled pens (3 packs of 2). Not all pack sizes may be available in every country.

How Do You Inject Adtralza Using the Pre-Filled Pen?

The following step-by-step instructions summarize how to use the Adtralza pre-filled pen. Your healthcare professional will demonstrate the technique before you self-inject for the first time. Do not attempt to inject until you have been properly trained. Always read the instructions for use included with your medicine.

Step 1: Preparation

• Gather your supplies: 1 Adtralza pre-filled pen, an alcohol swab, cotton ball or gauze, and a sharps disposal container.
• Remove the pen from the refrigerator and check the expiry date. Do not use if expired or if the carton seal is broken.
• Place the pen on a clean, flat surface and allow it to reach room temperature for at least 45 minutes. Do not warm it in any other way and do not shake it.
• Inspect the solution through the viewing window. It should be clear to opalescent, colorless to slightly yellow. Small air bubbles are normal. Do not use if cloudy, discolored, or containing particles.

Step 2: Choose and Prepare the Injection Site

• Suitable sites: abdomen (at least 5 cm from the navel), front of the thighs, or upper arms (caregiver only).
• Do not inject into skin that is tender, bruised, scarred, hardened, or covered by eczema.
• Rotate injection sites with each dose. Do not use the same spot twice in a row.
• Wash your hands with soap and water. Clean the injection site with an alcohol swab using a circular motion and allow it to dry completely.

Step 3: Inject

• Pull the cap straight off the pen. Do not replace the cap once removed.
• Place the pen’s needle shield flat against the skin at a 90-degree angle, ensuring you can see the viewing window.
• Press the pen firmly against the skin and hold. You will hear a first “click” as the injection begins and the yellow plunger starts to move.
• Continue holding the pen firmly. The injection takes up to 15 seconds.
• You will hear a second “click” when the yellow plunger fills the entire viewing window.
• After the second click, continue pressing for an additional 5 seconds to ensure you receive the full dose.
• Remove the pen straight out from the skin. The needle shield will automatically cover the needle.

Step 4: After Injection

• Hold a dry cotton ball or gauze over the injection site for a few seconds. Do not rub.
• A small amount of blood or fluid at the site is normal. Apply a small bandage if needed.
• Check the viewing window to confirm all solution has been injected (the yellow plunger should fill the entire window).
• Dispose of the used pen immediately in a sharps container. Do not recap, reuse, or share pens.