Ebglyss: Uses, Dosage & Side Effects

What Is Ebglyss and What Is It Used For?

Ebglyss contains the active substance lebrikizumab, a humanized immunoglobulin G4 (IgG4) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. As a biologic medicine, lebrikizumab is a large, complex protein molecule designed to target a very specific component of the immune system – in this case, the cytokine interleukin-13 (IL-13). IL-13 is one of the central mediators of the type 2 inflammatory response, which is the predominant immunological pathway driving atopic dermatitis. By selectively binding to IL-13 with high affinity, lebrikizumab prevents the cytokine from interacting with the IL-13 receptor alpha 1 (IL-13Rα1)/IL-4 receptor alpha (IL-4Rα) heterodimer signaling complex, thereby inhibiting downstream inflammatory signaling.

Atopic dermatitis, commonly known as eczema, is one of the most prevalent chronic inflammatory skin diseases worldwide, affecting approximately 2–5% of adults and up to 20% of children globally. The condition is characterized by intensely itchy, red, dry, and thickened skin that can significantly impact quality of life, sleep, mental health, and daily functioning. In moderate-to-severe cases, the disease can be debilitating, with widespread lesions covering large areas of the body, persistent itching that disrupts sleep, and an increased risk of skin infections due to the impaired skin barrier. Many patients with moderate-to-severe atopic dermatitis find that topical treatments alone – such as emollients, corticosteroids, and calcineurin inhibitors – do not provide adequate disease control, necessitating systemic therapy.

The pathophysiology of atopic dermatitis is complex and multifactorial, involving genetic predisposition (particularly mutations in the filaggrin gene), environmental triggers, skin barrier dysfunction, and immune dysregulation. The type 2 inflammatory response, driven primarily by interleukins IL-4 and IL-13, plays a pivotal role. IL-13 in particular contributes to multiple pathological features of atopic dermatitis: it impairs the expression of barrier proteins such as filaggrin, loricrin, and involucrin; it stimulates the production of chemokines that recruit inflammatory cells to the skin; it promotes IgE class switching in B cells; and it directly activates sensory neurons involved in pruritus (itching). By selectively targeting IL-13, lebrikizumab addresses a central driver of the disease at its root cause.

What distinguishes lebrikizumab from other biologics in this therapeutic area is its unique binding mechanism. Lebrikizumab binds to a specific epitope on IL-13 that prevents the formation of the IL-13Rα1/IL-4Rα signaling complex, while leaving intact the ability of IL-13 to bind to IL-13Rα2, a decoy receptor that naturally dampens IL-13 activity. This targeted approach aims to specifically inhibit the pathogenic signaling of IL-13 while preserving some degree of natural regulatory mechanisms. Additionally, unlike dupilumab (which blocks both IL-4 and IL-13 signaling by targeting the shared IL-4Rα receptor subunit), lebrikizumab exclusively targets IL-13 itself, offering a distinct pharmacological profile.

Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older who weigh at least 40 kilograms, and who are candidates for systemic therapy. It can be used as monotherapy or in combination with topical corticosteroids or topical calcineurin inhibitors. The efficacy and safety of Ebglyss have been demonstrated in several large, randomized, double-blind, placebo-controlled phase 3 clinical trials, including the ADvocate 1 and ADvocate 2 studies. In these trials, patients treated with lebrikizumab showed statistically significant and clinically meaningful improvements in the Eczema Area and Severity Index (EASI), the Investigator’s Global Assessment (IGA), and pruritus (itch) scores compared with placebo, with onset of action observed as early as 2 weeks for itch reduction in some patients.

What Should You Know Before Taking Ebglyss?

Before starting treatment with Ebglyss, your doctor will conduct a thorough evaluation of your medical history, current medications, and overall health status. It is essential that you provide complete and accurate information to ensure the safe and effective use of this medication. Several important considerations must be addressed before and during treatment with lebrikizumab.

Contraindications

Ebglyss must not be used if you have a known hypersensitivity (allergy) to lebrikizumab or to any of the other excipients in the formulation. The excipients include histidine, acetic acid, sucrose, polysorbate 20, and water for injection. Allergic reactions can range from mild symptoms such as rash and urticaria to more severe reactions including angioedema and, rarely, anaphylaxis. If you have ever experienced a severe allergic reaction to any monoclonal antibody or biologic medicine, discuss this with your doctor before starting Ebglyss.

Warnings and Precautions

Several warnings and precautions apply to the use of Ebglyss. Talk to your doctor or pharmacist before using Ebglyss if any of the following situations apply to you:

• Eye problems (ocular events): Eye-related side effects, particularly conjunctivitis (inflammation of the outer membrane of the eye) and keratitis (inflammation of the cornea), have been reported in patients treated with lebrikizumab. Conjunctivitis was one of the most commonly observed adverse reactions in clinical trials. Keratitis, although less common, is potentially more serious and can affect vision if left untreated. If you develop new or worsening eye symptoms such as redness, pain, itching, excessive tearing, light sensitivity, blurred vision, or discharge, contact your doctor promptly. You may need to be referred to an ophthalmologist (eye specialist) for evaluation. Patients with a history of eye conditions should discuss the risks with their doctor before starting treatment.
• Parasitic (helminth) infections: Ebglyss may affect your immune response to certain parasitic infections. IL-13 plays a role in the body’s defense against parasitic worms (helminths). Patients with known pre-existing helminth infections should be treated before initiating therapy with Ebglyss. If you develop a helminth infection during treatment and do not respond to anti-helminth medication, your doctor may need to temporarily discontinue Ebglyss until the infection has been resolved.
• Vaccination: You must not receive live or live-attenuated vaccines during treatment with Ebglyss. The safety and effectiveness of live vaccines have not been established in patients taking lebrikizumab. However, you may receive inactivated (non-live) vaccines during treatment. It is recommended to ensure that you are up to date with all age-appropriate immunizations, including any planned live vaccinations, before starting treatment with Ebglyss.
• Asthma: If you have atopic dermatitis along with asthma, do not adjust or stop your asthma treatment without first talking to your doctor. Asthma symptoms may worsen if treatment is changed abruptly.
• Eosinophilia: In some patients, treatment with Ebglyss has been associated with transient increases in blood eosinophil counts (a type of white blood cell). While this is generally clinically non-significant and typically resolves during continued treatment, your doctor may monitor your eosinophil levels, particularly if they were already elevated before starting therapy.

Children and Adolescents

Ebglyss is approved for use in adolescents aged 12 years and older who weigh at least 40 kg. The dosing regimen for adolescents is the same as for adults. The safety and efficacy of lebrikizumab in children under 12 years of age or in adolescents weighing less than 40 kg have not yet been established. Therefore, Ebglyss should not be used in these populations. Clinical studies are ongoing to evaluate the use of lebrikizumab in younger children, and further data may become available in the future.

If you are the parent or caregiver of an adolescent who has been prescribed Ebglyss, ensure that they have been properly trained by a healthcare professional on how to prepare and inject the medication. Supervision of injections is recommended until the adolescent has demonstrated competence in self-injection technique.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using Ebglyss. As a precautionary measure, it is preferable to avoid the use of Ebglyss during pregnancy unless your doctor determines that the expected benefit to the mother outweighs the potential risk to the unborn baby. There is limited data from the use of lebrikizumab in pregnant women. Animal reproductive toxicity studies have not indicated direct harmful effects on pregnancy, embryo-fetal development, parturition, or postnatal development. However, as with all monoclonal antibodies, lebrikizumab is expected to cross the placental barrier, particularly during the third trimester, and the potential effects on the developing fetus are not fully known.

It is not currently known whether lebrikizumab passes into human breast milk or whether it is absorbed systemically after ingestion by the infant. Maternal IgG antibodies are known to be present in breast milk, particularly in the early postnatal period. Your doctor will help you weigh the benefits of breastfeeding for the baby against the benefits of treatment with Ebglyss for the mother to make the best decision for your situation.

Driving and Using Machines

Ebglyss is not expected to have any significant effect on the ability to drive or use machines. However, if you experience any visual disturbances (such as blurred vision related to ocular side effects like conjunctivitis or keratitis), you should exercise caution and avoid driving or operating machinery until your vision has returned to normal. Discuss with your doctor if you have concerns about visual changes during treatment.

How Does Ebglyss Interact with Other Drugs?

One of the advantages of monoclonal antibody therapies like lebrikizumab is that they are generally not metabolized by the cytochrome P450 (CYP) enzyme system in the liver, which is responsible for the metabolism of many conventional small-molecule drugs. Instead, monoclonal antibodies are catabolized (broken down) through intracellular proteolysis into smaller peptides and amino acids. This means that pharmacokinetic drug-drug interactions – where one drug affects the blood levels of another – are not expected to be clinically significant with Ebglyss.

However, it is important to note that elevated levels of certain cytokines, including IL-13, during chronic inflammation can alter the expression and activity of CYP enzymes. When lebrikizumab reduces IL-13 levels, there is a theoretical possibility that the metabolism of concomitant medications processed by CYP enzymes could be normalized, potentially altering their drug levels. This effect has been a consideration with other biologic therapies, though clinically meaningful interactions with lebrikizumab have not been observed in studies. Nevertheless, your doctor may monitor the levels of certain medications with a narrow therapeutic index (such as warfarin or theophylline) if you start or stop Ebglyss.

Although formal drug interaction studies are limited for Ebglyss, some important considerations apply to concurrent medication use. Inform your doctor about all medications you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements, before starting treatment.

It is also worth noting that Ebglyss can be used concomitantly with topical corticosteroids, topical calcineurin inhibitors, and other topical eczema treatments. In the clinical trials (ADvocate 1 and 2, ADhere), many patients received lebrikizumab together with topical corticosteroids and demonstrated improved outcomes compared with topical treatments alone, with no evidence of adverse interactions between the medications.

If you are currently taking any other biologic medicine or systemic immunosuppressant for atopic dermatitis or another condition, discuss this with your doctor before starting Ebglyss. The concurrent use of Ebglyss with other biologic immunomodulators has not been studied and is generally not recommended due to the potential for additive immunosuppressive effects.

What Is the Correct Dosage of Ebglyss?

Ebglyss should be initiated by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. The dosing regimen consists of an initial loading phase followed by a maintenance phase. Your doctor will assess your response to treatment after the initial 16-week induction period to determine whether maintenance therapy should continue.

Adults

For adult patients, the recommended dosing regimen for Ebglyss follows a structured loading and maintenance approach. Treatment begins with an initial loading dose of 500 mg (administered as two consecutive subcutaneous injections of 250 mg each) at week 0 and again at week 2. This is followed by an induction phase of 250 mg (one injection) administered every 2 weeks from week 4 through week 16. The loading and induction doses are designed to rapidly achieve therapeutic drug levels and provide early relief from symptoms.

At week 16, your doctor will evaluate your clinical response to treatment. If you have achieved an adequate clinical response, the dosing frequency transitions to a maintenance regimen of 250 mg (one injection) every 4 weeks. This less frequent maintenance dosing offers improved convenience while maintaining disease control. If a clinical response has not been achieved by week 16, your doctor will discuss whether to continue treatment and may consider alternative therapeutic options.

No dose adjustment is required for patients with mild-to-moderate renal or hepatic impairment. However, Ebglyss has not been studied in patients with severe renal or hepatic impairment, and your doctor should exercise clinical judgment in these situations. Similarly, no dose adjustment is needed based on body weight for adult patients, as the pharmacokinetics of lebrikizumab were not meaningfully affected by body weight in the clinical trial population.

Adolescents (12 Years and Older, Weighing at Least 40 kg)

The dosing regimen for adolescents aged 12 years and older who weigh at least 40 kg is the same as that for adults. This includes the loading doses of 500 mg at weeks 0 and 2, the induction phase of 250 mg every 2 weeks from week 4 to week 16, and the maintenance phase of 250 mg every 4 weeks thereafter. Adolescents who weigh less than 40 kg or who are under 12 years of age should not receive Ebglyss, as safety and efficacy have not been established in these populations.

Adolescents should be trained by a healthcare professional on proper injection technique before self-administering Ebglyss. Parental or caregiver supervision is recommended until the adolescent has demonstrated competence and confidence in preparing and injecting the medication independently.

Injection Technique

Ebglyss is administered as a subcutaneous injection using the pre-filled pen provided. The recommended injection sites are the front of the thighs and the abdomen, excluding the 5 cm area immediately surrounding the navel. If another person is administering the injection (e.g., a caregiver), the outer upper arm may also be used. It is important to rotate injection sites with each dose and to avoid injecting into areas of skin that are tender, bruised, red, hard, scarred, or affected by eczema lesions.

Before injection, remove the pre-filled pen from the refrigerator and allow it to reach room temperature for approximately 45 minutes. Do not shake the pen. Do not use the pen if it has been dropped, if the pen appears damaged, or if the solution is cloudy, discolored, or contains visible particles. When two injections are required (for the loading doses), they should be administered at different injection sites – for example, one in each thigh or one in the thigh and one in the abdomen. Follow the detailed instructions for use provided with the medication and as demonstrated by your healthcare professional.

Missed Dose

If you miss a dose of Ebglyss, administer the injection as soon as possible. If more than 7 days have passed since the missed dose, skip the missed dose and administer the next dose at the regularly scheduled time. Then continue with your regular dosing schedule from that point forward. Do not inject a double dose to make up for a missed dose. If you are unsure about what to do after missing a dose, contact your doctor or pharmacist for guidance.

Overdose

There is no specific antidote for an overdose of Ebglyss. In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted as necessary. In clinical studies, doses of lebrikizumab up to 500 mg as a single subcutaneous injection were administered without dose-limiting toxicity. If you think you may have used more Ebglyss than you should, tell your doctor. Contact your local poison control center or seek emergency medical attention if you experience any unusual symptoms after an overdose.

What Are the Side Effects of Ebglyss?

Like all medicines, Ebglyss can cause side effects, although not everybody gets them. Most side effects observed in clinical trials were mild to moderate in severity and generally did not require discontinuation of treatment. Understanding the potential side effects and their frequencies can help you recognize them early and seek appropriate medical advice when needed.

The safety profile of Ebglyss has been evaluated in multiple phase 3 clinical trials involving thousands of patients with moderate-to-severe atopic dermatitis. The most notable category of adverse reactions associated with lebrikizumab treatment is eye-related (ocular) events, which are thought to be related to the role of IL-13 in maintaining ocular surface homeostasis. Injection site reactions, which are common with most injectable biologic therapies, were also observed. Below is a summary of reported side effects categorized by frequency.

In addition to the side effects listed above, allergic reactions (including anaphylaxis) have been reported rarely with lebrikizumab. Signs of a severe allergic reaction may include difficulty breathing, swelling of the face, lips, tongue or throat, hives, dizziness, or a feeling of faintness. If you experience any of these symptoms, stop using Ebglyss and seek immediate medical attention.

It is important to report any new or worsening symptoms to your doctor during treatment with Ebglyss. Your doctor will weigh the benefits of continued treatment against the risks of any side effects you may experience. In most cases, the side effects associated with Ebglyss are manageable and do not require treatment discontinuation. However, your doctor may temporarily or permanently stop treatment if a side effect becomes severe or if a serious adverse reaction occurs.

You can also report suspected side effects to your national pharmacovigilance authority. Reporting side effects helps provide ongoing safety information about medications and can help identify new or rare adverse reactions. Ask your doctor or pharmacist for information on how to report side effects in your country.

How Should You Store Ebglyss?

Proper storage of Ebglyss is essential to maintain the integrity and effectiveness of the medication. As a biologic medicine containing a monoclonal antibody, lebrikizumab is a protein that can be damaged by extremes of temperature, light exposure, and physical agitation. Follow these storage instructions carefully to ensure your medication remains safe and effective.

• Refrigerated storage: Store the Ebglyss pre-filled pens in a refrigerator at 2–8°C (36–46°F). Keep the pens in their original carton to protect them from light. Do not store near the freezer compartment or in the coldest part of the refrigerator where the temperature may drop below 2°C.
• Do not freeze: Ebglyss must not be frozen at any time. If a pen has been accidentally frozen, do not use it. Dispose of the frozen pen safely and use a new one. Freezing can damage the protein structure of the antibody and reduce or eliminate its effectiveness.
• Temporary room temperature storage: If necessary, the pre-filled pen may be stored at room temperature (up to 30°C / 86°F) for a maximum of 7 days. Once removed from refrigeration and kept at room temperature, the pen must be used within 7 days or discarded. Do not return the pen to the refrigerator after it has been stored at room temperature.
• Protect from light: Keep the pre-filled pens in the original outer carton until you are ready to use them to protect the solution from light exposure, which can degrade the active ingredient.
• Keep out of the reach and sight of children: Store Ebglyss in a secure location that is not accessible to children. The pre-filled pen contains a needle that could cause injury.
• Do not use after the expiry date: Check the expiry date printed on the carton and on the pen label before each use. The expiry date refers to the last day of that month. Do not use the medicine if the expiry date has passed.
• Inspect before use: Before each injection, visually inspect the solution in the viewing window of the pre-filled pen. The solution should be clear to slightly opalescent, colorless to pale yellow. Do not use the pen if the solution is cloudy, discolored, or contains visible particles or flakes.

Dispose of used pre-filled pens in a sharps disposal container in accordance with local regulations. Do not dispose of pens in household waste. Ask your pharmacist about proper disposal of sharps containers in your area. Do not recycle sharps disposal containers.

What Does Ebglyss Contain?

Understanding the composition of your medication can help identify potential allergens and provides important information for your healthcare team. Each Ebglyss pre-filled pen delivers 250 mg of lebrikizumab in a volume suitable for subcutaneous injection.

Ebglyss is available in packs containing 1, 2, or 3 pre-filled pens. Not all pack sizes may be marketed in every country. The pre-filled pen is designed for single use only – each pen should be used once and then disposed of properly. The pen contains a fixed needle that is automatically shielded after use to reduce the risk of accidental needlestick injuries.

If you are allergic to any of the excipients listed above, inform your doctor before starting treatment. Although allergic reactions to excipients are rare, they can occur. In particular, polysorbate 20 (a surfactant commonly used in biologic formulations) has been associated with rare allergic reactions in susceptible individuals.