Ebglyss
Generic name: lebrikizumab-lbkz
Dosage form: Subcutaneous injection (250 mg/2 mL)
What is Ebglyss?
Ebglyss (lebrikizumab) is a biologic treatment for moderate-to-severe atopic dermatitis to help relieve itch and clear skin. Ebglyss is used for atopic dermatitis (moderate to severe) that is not well-controlled using prescription topical medicines in patients 12 years and older.
Ebglyss targets the cause of atopic eczema inflammation to help improve dry, itchy and irritated skin. In atopic eczema, a protein called IL-13 (Interleukin 13) is involved in the inflammation that causes atopic dermatitis. Ebglyss works by blocking IL-13, which reduces inflammation and improves atopic dermatitis symptoms. It is from a class of medicines called an interleukin-13 antagonist.
Ebglyss is given as an injection under the skin (subcutaneous injection) every two weeks until Week 16 or later and then as a single monthly injection for maintenance dosing.
Who can use Ebglyss?
Ebglyss is FDA-approved for moderate-to-severe atopic dermatitis (eczema) that is not well controlled using topical prescription therapies. It can be used in adults and children 12 years and older who weigh at least 88 pounds (40 kg).
How well does Ebgyss work?
In the clinical trials for atopic dermatitis ADvocate 1 and 2, Ebglyss cleared or almost-cleared skin in 38% of patients at week 16, compared to 12% using a placebo. At 16 weeks, 43% of Ebglyss patients felt itch relieved, compared to 12% who used a placebo.
How long does it take Ebglyss to work?
Ebglyss started working as early as four weeks when 10% of treatment patients' dermatitis had cleared or almost cleared, and by week 16, 38% of patients had cleared or almost cleared compared to 12% using a placebo.
Ebglyss started working for itch as early as two weeks for 5% of patients, and by 16 weeks, 43% of patients had itch relief compared to 12% of patients on a placebo.
Ebglyss Side Effects
Common Ebglyss side effects
The most common Ebglyss side effects are injection site pain or reactions, shingles (herpes zoster), and eye and eyelid inflammation, including redness, swelling, and itching (conjunctivitis). These side effects occurred in 1% or more patients using this medicine.
Serious Ebglyss side effects
Serious Ebglyss side effects may include:
- Allergic reactions that may sometimes be severe. Stop using this medicine and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
- breathing problems or wheezing
- itching
- swelling of the face, lips, mouth, tongue or throat
- fainting, dizziness, feeling lightheaded
- skin rash
- hives
- cramps in your stomach area (abdomen)
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088
Warnings
Do not use this medicine if you are allergic to the active ingredient lebrikizumab-lbkz or to any of the inactive ingredients in this medicine. See below for a complete list of ingredients.
This medicine may cause hypersensitivity reactions, including swelling (angioedema) and hives (urticaria). Stop using this medicine if you have a serious hypersensitivity reaction.
This medicine can cause pink eye (conjunctivitis) and inflammation of the cornea (keratitis). Report new onset or worsening eye symptoms to a healthcare provider.
Parasitic (Helminth) Infections: Before starting this medicine, treat patients with pre-existing worm (helminth) infections. If patients become infected while receiving this medicine and do not respond to antihelminth treatment, stop treatment with Ebglyss until the infection resolves.
Avoid the use of live vaccines during treatment with this medicine.
Before using this medicine
Before using this medicine, tell your healthcare provider about all your medical conditions, including if you:
- Have a parasitic (helminth) infection.
- Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with this medicine.
Pregnancy
Tell your healthcare professional if you are pregnant, plan to become pregnant or become pregnant as it is not known if Ebglyss will harm your unborn baby. If you become pregnant during treatment with this medicine, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.
Breastfeeding
Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.
How should I take Ebglyss?
Ebglyss instructions:
- Ebglyss is given as an injection under the skin (subcutaneous administration) using a prefilled pen or prefilled syringe with a needle shield.
- Before injection, remove the pen or prefilled syringe from the refrigerator and leave at room temperature for 45 minutes without removing the needle cap. Do not warm by using a heat source such as hot water, microwave, or direct sunlight. Protect from light until use. Do not shake.
- Injections may be given into the abdomen, thigh, and back of the upper arm. It may also be given in the back of the upper arm by a caregiver or healthcare provider.
- Alternate the injection site with each injection. Do not inject within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by atopic dermatitis or skin lesions.
- Ebglyss is intended for use under the guidance of a healthcare professional. Patients and caregivers should be properly trained on the subcutaneous injection technique to be used. Adult patients may self-inject, or caregivers may inject after training in subcutaneous injection technique. For pediatric patients, caregivers may give injections after training in subcutaneous injection technique.
- Injections should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit. Ebglyss is clear to opalescent, colorless to slightly yellow to slightly brown solution. Do not use if the liquid contains visible particles, is discolored, or cloudy.
- Refer to the Instructions for Use for complete administration instructions with illustrations provided with medicine.
- Before starting this medicine complete all age-appropriate vaccinations according to current immunization guidelines.
- Ebglyss can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) may be used, but reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas.
Ebglyss Dosing Information
The recommended Ebglyss dosage is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg (one injection) every 2 weeks until Week 16 or later when adequate clinical response is achieved.
The maintenance Ebglyss dose is 250 mg every 4 weeks.
Ebglyss is available as:
- 250 mg/2 mL in a single-dose prefilled pen
- 250 mg/2 mL in a single-dose prefilled syringe with needle shield
What other drugs will affect Ebglyss?
Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- If necessary, pen or prefilled syringes can be stored in the original carton at room temperature up to 30°C (86°F) for up to 7 days. Dispose of medicine that has been left at room temperature for longer than 7 days.
- Store in the original carton to protect from light until use.
- Do not freeze. Do not use it if it has been frozen.
- Do not shake.
- Do not microwave, run hot water over it, or leave it in direct sunlight.
Ingredients
Active Ingredient: lebrikizumab-lbkz
Inactive ingredients: glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0.
Not made with natural rubber.
Manufacturer
Eli Lilly and Company, Indianapolis, IN 46285, USA
References
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.