What is Ebglyss™?

Ebglyss is a biologic medication. The generic name is lebrikizumab-lbkz. It is in a drug class known as a IgG4 monoclonal antibody.

Ebglyss is FDA-approved to treat moderate-to-severe eczema (atopic dermatitis). It is given as an injection under the skin. Patients have the option of taking Ebglyss in a doctor’s office or clinic, or self-administering it at home using an injectable pen or pre-filled syringe.

Ebglyss is used when eczema is not well controlled with topical prescription therapies or when those treatments cannot be used. It treats atopic dermatitis by stopping inflammation on the skin before it can start. The medication can reduce swelling and prevent moderate to severe eczema symptoms.

What is Ebglyss used for?

Ebglyss is a prescription medication used to treat moderate-to-severe atopic dermatitis. It is approved for adults and children 12 years of age or older who weigh at least 88 pounds. Ebglyss is prescribed to people whose eczema is not well controlled with topical corticosteroids (prescription creams or ointments) or who cannot use those types of topical therapies.

How does Ebglyss work for treating atopic dermatitis?

Ebglyss helps treat eczema by targeting the part of the immune system that causes skin inflammation. In people with eczema, the immune system can overreact. It can make too much of a protein called interleukin-13 (IL-13). When there’s excess IL-13, it can cause eczema symptoms such as swelling, raised bumps and itching.

Ebglyss works by attaching to IL-13 and neutralizing it. The medication blocks IL-13 from connecting with a receptor called IL-4Rα. This stops IL-13 from sending the signals that cause inflammation. It helps reduce swelling and severe disease symptoms.

Ebglyss can be used as an add-on treatment, meaning it can be taken alongside other medications your doctor prescribes. In particular, Ebglyss can be used with or without topical steroids.

If you’re prescribed Ebglyss, work together with your doctor on a treatment plan. Follow it closely, as the combination of medications you are prescribed may vary based on the severity of your condition. Regular appointments and open communication with your doctor can ensure your treatment plan is effective. Always follow your doctor’s instructions to get the best results.

Can Ebglyss be used in combination with other medications?

Ebglyss can be used as an add-on therapy, meaning it can be taken alongside other medications your doctor prescribes. It can be taken with or without prescription topical corticosteroids (creams and ointments).

Topical calcineurin inhibitors, which suppress the protein calcineurin that causes skin inflammation, can also be used as an add-on therapy. These are generally reserved for sensitive areas like the face, neck, and genital areas.

Are there any contraindications for using Ebglyss?

Ebglyss should not be used by people who are hypersensitive to lebrikizumab or any ingredients in the medication. If you’ve had allergic reactions to similar prescription medications such as other biologics, talk to your doctor before starting Ebglyss.

What is an IgG4 monoclonal antibody for the treatment of atopic dermatitis?

A monoclonal antibody is a special protein that is a clone, or exact copy, of one type of antibody. The word “mono” means one. Antibodies are proteins that help the body find and fight harmful things, like bacteria or proteins that cause disease.

For Ebglyss, the target protein is interleukin-13 (IL-13), which causes inflammation in the skin. Ebglyss attaches to IL-13 and blocks it. This helps reduce and control inflammation and other eczema symptoms.

What is the dosage for Ebglyss?

Ebglyss dosing to treat atopic dermatitis starts with two loading doses to help build up the medication in your body and work faster.

The loading dose is 500 mg (two 250 mg injections) in the first week and again 2 weeks later. After the loading doses are complete, you take 250 mg (one injection) every 2 weeks until about four months (16 weeks) have passed, or until your symptoms improve. Once your eczema is under control, the maintenance dose is 250 mg every four weeks.

Ebglyss dosing is the same for adults and children ages 12 and older.

How is Ebglyss administered?

Ebglyss can be taken at a doctor’s office or clinic, or it can be self-administered at home by the patient or a caregiver. (The loading dose is typically given in the doctor’s office or clinic.) Your healthcare provider can show you how to use the medication correctly.

Ebglyss is a subcutaneous injection, meaning it’s injected under the skin. Ebglyss comes in two options: a single-dose pre-filled auto-injector pen or a single-dose prefilled syringe.

• Auto-injector pen: This is a device that automatically delivers the medication when you press it against your skin. It may be easier to take if you are uncomfortable with needles.
• Prefilled Syringe: This requires more manual handling, as you need to inject the medication by pressing down on the plunger head.

Children should receive the injections under the supervision of an adult.

The injection sites are the abdomen, thigh, or back of the upper arm. Injection in the back of the upper arm should only be done by a caregiver or healthcare professional. Do not inject within 2 inches of the naval or into areas where the skin is tender, bruised, hard, or affected by eczema symptoms.

Ebglyss can be administered at home by the patient or a trained caregiver. Administering Ebglyss at home offers flexibility in managing treatment. If you’re uncomfortable administering it yourself, talk to your doctor about other options.

Self-administration gives patients the freedom and empowerment to take the medication on their own schedule without going to the doctor’s office every 2-4 weeks. Follow the specific instructions provided by your healthcare provider. Get training from your doctor on how to correctly administer the injection, know the proper injection sites, and use the right technique. Talk with your doctor regularly to make sure you are injecting Ebglyss safely and effectively.

Important things to note when administering Ebglyss:

• Rotate the location of the injection site each time.
• Let Ebglyss warm to room temperature for 45 minutes before the injection.
• Do not use the medicine if it’s cloudy, discolored, or has visible particles.

What are the ingredients of Ebglyss?

Ebglyss is a clear to slightly yellow or brown solution available in a single-dose prefilled pen or syringe. It is preservative-free and latex-free. Each pen or syringe delivers 250 mg of medication in 2 mL.

• Active ingredient: lebrikizumab-lbkz. Lebrikizumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
• Inactive ingredients: Glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg), and water.

Storing Ebglyss at home

Ebglyss needs specific storage conditions to ensure it is safe and effective.

• Store Ebglyss in the refrigerator at 36°F to 46°F (2°C to 8°C).
• You can keep it at room temperature, up to 86°F (30°C), for up to 7 days in its original box. If it’s out for more than 7 days, throw it away. Ensure you mark the box with the date that the medication was removed from the refrigerator so you do not use it past 7 days. 
• Keep Ebglyss in its original box to protect it from light.
• Do not freeze, shake, heat up or microwave Ebglyss. Avoid hot water and direct sunlight.
• Keep it out of reach of children.

What are Ebglyss side effects?

Side effects of Ebglyss are usually mild and manageable. However, some patients may experience more serious reactions that need immediate medical attention.

Common side effects of Ebglyss:

• Eye and eyelid inflammation (redness, swelling, itching)
• Injection site reactions
• Shingles (herpes zoster)

Serious side effects of Ebglyss:

While serious side effects are less common, they can happen and may need immediate medical attention. It’s important to be aware of these risks.

Allergic Reactions: Some people who take Ebglyss may have a severe allergic reaction called anaphylaxis.

• Symptoms to watch for: Breathing problems, swelling of the face, mouth, or tongue, hives, severe itching, dizziness, skin rash, or stomach cramps.
• Action: Seek emergency medical help right away if you have a severe allergic reaction. Your doctor or healthcare provider will give you epinephrine as the first line of treatment. If you take Eblyss at home, you need a prescription for epinephrine. Take it at the first sign of symptoms.

Eye Problems: Ebglyss may cause new or worsening eye issues.

• Symptoms to watch for: Eye pain or changes in vision, like blurred vision.
• Action: Contact your healthcare provider if you notice any changes in your eyes or vision.

Before taking Ebglyss, tell your doctor or healthcare provider about all of your medical conditions. Provide a list of any other medications you’re taking that could cause drug interactions. Do not stop taking other medications unless instructed to do so by your healthcare provider.

Regular check-ups with your doctor are recommended to monitor side effects and ensure Ebglyss is working safely. Always inform your healthcare provider about any changes in your health.

How much does Ebglyss cost?

Biologics are expensive medications due to their complex production process and clinical trials. The list price for Ebglyss is $3,500 per device. Most people do not pay the list price. The actual cost will vary based on your insurance coverage. (Without insurance, you could spend about $38,500 after four months of treatment.) Savings programs are also available to help reduce costs.

The cost of Ebglyss may vary depending on where you live, your insurance, and the pharmacy. Check your health insurance plan to find out if Ebglyss is covered. When your doctor prescribes you Ebglyss, ask about financial assistance.

Eligible people who are commercially insured may pay as little as $5 each time you full your monthly Ebglyss prescription. If you have a commercial drug insurance plan that does not cover Ebglyss, you may pay as little as $25 each time you fill your monthly prescription. These price points are available through the Ebglyss Savings Card Program. Commercial insurance for Ebglyss does not apply to federal, state or government-funded healthcare programs.

In general, Medicare prescription drug plans (Part B and Part D) do not cover Ebglyss. Check with your specific Medicare plan to confirm whether these medications are covered.

For Medicaid, coverage for Ebglyss varies by state, as each state sets its own rules for drug coverage. Many states may require prior authorization for these medications, particularly if they are newer or more expensive. Patients should consult their state’s Medicaid program or their healthcare provider to understand the specific requirements and coverage options available to them.

To obtain these reduced prices, you need to enroll in a patient support program offered by Lilly USA, the drug manufacturer. You can enroll by:

• Visiting the Saving & Support webpage.
• Calling 800-LillyRX (800-545-4979), Monday to Friday, 8:00 am to 10:00 pm ET.
• Texting “EBS” to 85099.

Once enrolled, you will be assigned a Companion in Care representative who can help provider personalized support.

Charitable organizations such as The Assistance Fund, Inc., Patient Advocate Foundation and The Healthwell Foundation are dedicated to offering financial support to patients with specific medical conditions, irrespective of their chosen treatment. People with commercial or government insurance, including those under Medicare and Medicaid, can reach out directly to these foundations for financial assistance.