Ebglyss: Uses, Side Effects and Dosage

What is Ebglyss used for?

• Ebglyss is a prescription medicine used to treat adults and adolescents 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. Ebglyss can be used with or without topical corticosteroids.

• It is not known if Ebglyss is safe and effective in adolescents with atopic dermatitis who weigh less than 40 kg or in children under 12 years of age.

How does Ebglyss work?

Ebglyss contains the active substance lebrikizumab.

Lebrikizumab is a monoclonal antibody. Monoclonal antibodies are a type of specialized protein that recognizes and binds specifically to certain proteins in the body.

Ebglyss works by blocking a protein called IL-13, which is found in higher amounts in people with atopic dermatitis. This can result in reduced inflammation, improved condition of your skin, and reduced itch, redness and scaling.

What are the ingredients in Ebglyss?

Medicinal ingredients: lebrikizumab

Nonmedicinal ingredients: glacial acetic acid, histidine, polysorbate 20, sucrose, and water for injection.

Ebglyss comes in the following dosage forms:

• 250 mg/2 mL single use prefilled pen
• 250 mg/2 mL single use prefilled syringe with needle shield
• Ebglyss prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex.

Do not use Ebglyss if:

You are allergic to lebrikizumab or to any of the other ingredients of this medicine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Ebglyss. Talk about any health conditions or problems you may have, including if you:

• have eye problems (e.g., itching, redness)
• have a parasitic worm (helminth) infection
• are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with Ebglyss.

• are pregnant or plan to become pregnant. It is not known if Ebglyss will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if Ebglyss passes into your breast milk.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Ebglyss:

• Inform your healthcare professional if you have recently had or are going to have a vaccination. You should not receive “live vaccines” while using Ebglyss.

How to take Ebglyss:

• See the Instructions for Use that comes with this Patient Medication Information about how to prepare and inject Ebglyss and how to properly store and throw away (dispose of) used Ebglyss prefilled pens and prefilled syringes.
• Use Ebglyss exactly as prescribed by your healthcare professional.
• Ebglyss comes as a single use prefilled pen or prefilled syringe with needle shield.
• Ebglyss is given by injection under the skin (subcutaneous injection).
• If your healthcare professional decides that you or a caregiver can give the injections of Ebglyss, you or a caregiver should receive training on the right way to prepare and inject Ebglyss.
• Do not try to inject Ebglyss until you have been shown the right way by your healthcare professional. In people under the age of 18 years, Ebglyss should be given by an adult.
• Inject Ebglyss in your stomach area (abdomen) or thigh, or have a caregiver inject Ebglyss in the back of your upper arm.
• Your healthcare professional may prescribe other medicines to use with Ebglyss. Use the other prescribed medicines exactly as your healthcare professional tells you to.
• If you have questions about when you should use Ebglyss, ask your healthcare professional.
• Do not use this medication if it looks cloudy or is leaking.

Usual dose:

Each prefilled pen and prefilled syringe with needle shield contain 250 mg of Ebglyss to be injected under the skin (subcutaneously).

• The initial dose of Ebglyss is 500 mg (two injections) at Week 0 and Week 2, followed by 250 mg (one injection) every two weeks until Week 16.
• The maintenance dose is 250 mg every four weeks starting at Week 16.

Overdose:

If you think you, or a person you are caring for, have taken too much Ebglyss, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, inject the missed dose as soon as possible, then continue dosing at your regularly scheduled time, starting on the new dosing day.

What are possible side effects from using Ebglyss?

These are not all the possible side effects you may have when taking Ebglyss. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects of Ebglyss include:

• Eye and eyelid inflammation, including redness, swelling, itching, and dryness
• Injection site reactions
• Shingles (herpes zoster)
• High count of certain white blood cells

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store refrigerated at 2°C to 8°C in the original carton to protect from light.

If necessary, Ebglyss may be kept at room temperature up to 30°C for up to 7 days in the original carton. Throw away Ebglyss if not used within 7 days at room temperature.

Do not freeze. Do not use Ebglyss if it has been frozen.

Do not shake.

Discard the Ebglyss single use prefilled pen or prefilled syringe with needle shield after use in a puncture-resistant container.

Keep out of reach and sight of children.

If you want more information about Ebglyss:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.lilly.ca, or by calling 1-800-545-5972.

Ebglyss is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

Last Revised : Jan 12, 2026

A2.0-EBG-0001-CA-PM20260112

INSTRUCTIONS FOR USE

^PrEBGLYSS^™ [EHB-glihs]

(lebrikizumab)

injection, for subcutaneous use

Single Use Prefilled Syringe with Needle Shield

Read these Instructions for Use before you use Ebglyss and carefully follow all the step-by-step instructions.

Important information for the Ebglyss Prefilled Syringe with Needle Shield:

Do not inject yourself or someone else until you have been shown how to inject Ebglyss. Your healthcare professional should show you or your caregiver how to prepare and inject Ebglyss before you do it yourself the first time. You and your caregiver should read these Instructions for Use before you start using Ebglyss and each time you get a refill. Keep these instructions and refer to them as needed. Call your healthcare professional if you have any questions.

Each single use prefilled syringe with needle shield (called “Ebglyss Prefilled Syringe” in these instructions) contains 250 mg of lebrikizumab for injection under the skin (subcutaneous injection). Do not share or reuse syringes.

When using the Ebglyss Prefilled Syringe

• Talk to your healthcare professional about how often you will need to inject the medicine.
• Use a different injection site each time you inject.
• If you have vision problems, do not use Ebglyss Prefilled Syringe without help from a caregiver.
• To reduce the risk of accidental needle sticks, each Prefilled Syringe has a Needle Shield that is automatically activated to cover the needle after you have given your injection.
• Throw away (dispose of) your used Ebglyss single use prefilled syringe immediately after use (see Dispose of the Syringe Safely).
• Do not use the Ebglyss Prefilled Syringe if it has been dropped on a hard surface or damaged.
• Do not use the Ebglyss Prefilled Syringe if the Needle Cap is missing or not securely attached.
• Do not touch the Plunger Rod until you are ready to inject.
• Do not get rid of any air bubble in the Ebglyss Prefilled Syringe.
• Do not pull back on the Plunger Rod at any time.
• Do not inject through clothes.
• Do not remove the Needle Cap until right before you are ready to give the injection.

• Do not re-use an Ebglyss Single Use Prefilled Syringe.

  INSTRUCTIONS FOR USE

Read these Instructions for Use before you use Ebglyss and carefully follow all the step-by-step instructions.

Parts of the Ebglyss Prefilled Syringe with Needle Shield

Before Use

Plunger Rod

Finger grips

Syringe with Label & Expiration Date

Viewing Window

Syringe Body

Needle after removal of Needle Cap

Needle Cap

After Use

How should I store Ebglyss?

• Keep Ebglyss Prefilled Syringes and all medicines out of the reach and sight of children.
• Store Ebglyss in a refrigerator, at 2°C to 8°C.
• Keep Ebglyss in the original carton until ready for use to protect from light.
• Ebglyss Prefilled Syringes can be stored at room temperature up to 30°C for up to 7 days. Throw away (dispose of) any Ebglyss Prefilled Syringes that have been left at room temperature for longer than 7 days.
• Do not heat or freeze the Ebglyss Prefilled Syringe.
• Do not shake the Ebglyss Prefilled Syringe.

• Do not put the Ebglyss Prefilled Syringe into direct sunlight.

  Plunger Rod

  Used Syringe with Label & Expiration Date

  Used Needle

  Activated Needle Shield

  Preparing to inject Ebglyss

  Prepare Supplies

  Make sure you have the following:

• 1 Ebglyss Prefilled Syringe with Needle Shield
• 1 alcohol wipe*
• 1 cotton ball or gauze*
• 1 sharps disposal container*

*Items not included with the product.

Remove Syringe from Carton

Remove the Ebglyss Prefilled Syringe from the carton by holding the middle of the Syringe Body.

Leave the Needle Cap on until you are ready to inject.

Inspect Prefilled Syringe

When you receive your Ebglyss Prefilled Syringes, always check to see that you have the correct medicine and dose and visually inspect the syringe.

Note: You may gently rotate the Plunger Rod to view the syringe label.

The label should read “Ebglyss”.

Do not use the Ebglyss Prefilled Syringe if the expiration date has passed.

Do not use the Ebglyss Prefilled Syringe if it has been damaged.

Look at the medicine through the Viewing Window on the Ebglyss Prefilled Syringe. The liquid should be clear and colorless to slightly yellow. Note: some air bubbles are normal.

Do not use the Ebglyss Prefilled Syringe if the liquid is discolored or cloudy, or it contains visible flakes or particles, or the syringe shows

Viewing Window

Label with expiration date

signs of damage, or the syringe has been dropped, or the medicine is frozen.

Bring to Room Temperature

Place the Ebglyss Prefilled Syringe on a flat surface and let it warm to room temperature naturally for at least 45 minutes.

Do not heat the Ebglyss Prefilled Syringe with a microwave or hot water.

Do not put the Ebglyss Prefilled Syringe into direct sunlight.

Do not keep Ebglyss Prefilled Syringes at room temperature above 30°C for more than 7 days. Throw away (dispose of) any Ebglyss Prefilled Syringes that have been left at room temperature for longer than 7 days.

Choose Your Injection Site

You or another person may inject into these areas.

• You can inject into your thigh or stomach area (abdomen), except for 5 centimeters around your belly button (navel).
• If you chose the front of your thigh, you should inject at least 5 centimeters above the knee and 5 centimeters below the groin.
• If you choose the outer area of the upper arm, you will need a caregiver to help you.

• Choose a different injection site each time you inject Ebglyss.

Do not inject into areas where the skin is tender, bruised, red, hard or in an area of skin that is affected by atopic dermatitis or other skin lesions.

Another person must inject into this area.

Prepare Your Skin

Wash your hands thoroughly. Clean the injection site with an alcohol wipe. Let the injection site dry before injecting.

Do not touch the injection site again or blow on it before the injection.

Injecting Ebglyss

1

Remove Needle Cap

Hold the Ebglyss Prefilled Syringe in the middle of the Syringe Body with the Needle pointing away from you, and pull off the Needle Cap.

Do not put the Needle Cap back on.

Do not touch the Needle.

Inject your medicine immediately after removing the Needle Cap.

2

Pinch the Injection Site

Gently pinch a fold of skin at the injection site (thigh or stomach, except for 5 centimeters around your belly button, or outer area of the upper arm if injected by your caregiver).

3

Insert the Needle

Insert the Needle completely into the fold of skin at about a 45º angle.

4

Push in the Plunger Rod

Gently relax the pinch while keeping the needle in place. Slowly and steadily push the Plunger Rod down all the way until it stops and the syringe is empty.

Note: It is normal to feel some resistance.

5

Release and Remove

Lift your thumb to release the Plunger Rod until the Needle is covered by the Needle Shield, and then remove the Syringe from the injection site.

Lightly press a cotton ball or gauze on the injection site if you see any blood.

Do not put the Needle Cap back on.

Do not rub your skin after injection.

Dispose of the Syringe Safely

Put your used Ebglyss Prefilled Syringe and Needle Cap in a sharps disposal container immediately after use.

Do not dispose of (throw away) Ebglyss Prefilled Syringes and Needle Caps in your household trash.

If you do not have a sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• able to be closed with a tight-fitting, puncture resistant lid to keep sharps from falling out,
• upright and stable during use,
• leak-resistant, and

• properly labeled to warn of hazardous waste inside the container

  Syringe

  Needle Cap

  Sharps Disposal Container

When your sharps disposal container is almost full, follow your community guidelines for the right way to dispose of it. There may be provincial or local laws regarding the disposal of used needles and syringes.

For more information about safe sharps disposal, ask your healthcare professional about options available in your area.

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle your used sharps disposal container.

Do not put the Needle Cap back on.

If you have more questions about how to use the Ebglyss Prefilled Syringe:

• Call your healthcare professional
• Call 1-888-545-5972
• Visit www.lilly.ca

Read the Patient Medication Information insert for Ebglyss inside this box to learn more about your medicine.

Eli Lilly Canada, Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

Ebglyss is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

Copyright © 2024, Eli Lilly and Company. All rights reserved.

Document Issued: June 24, 2024

EBG-0001-CA-PFS-IFU-20240624

INSTRUCTIONS FOR USE

^PrEBGLYSS^™ [EHB-glihs]

(lebrikizumab)

injection, for subcutaneous use

Prefilled Pen (250 mg/2 mL)

This Instructions for Use contains information on how to inject Ebglyss.

Before you use the Ebglyss prefilled pen (Pen), read and carefully follow all the step-by-step instructions.

Important Information You Need to Know Before Injecting Ebglyss

• Your healthcare professional should show you how to prepare and inject Ebglyss using the Pen. Do not inject yourself or someone else until you have been shown how to inject Ebglyss.
• Keep this Instructions for Use and read it as needed.
• Each Ebglyss Pen contains 1 dose (250 mg) of Ebglyss. The Pen is for one-time use only.
• The Ebglyss Pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new Ebglyss Pen for your injection.
• Your healthcare professional may help you decide where on your body to inject your dose. You can also read the Choose and Clean your injection site section of these instructions to help you choose which area can work best for you.
• If you have vision or hearing problems, do not use Ebglyss Pen without help from a caregiver.

• See Storing Ebglyss for important storage information.

  INSTRUCTIONS FOR USE

Before you use the Ebglyss Pen, read and carefully follow all the step-by-step instructions.

Parts of the Ebglyss Pen

Top

Bottom

Purple

injection button

Gray base cap

Lock ring

Medicine

Lock or unlock symbols

Needle

Clear base

Preparing to inject Ebglyss

Gather supplies:

• Ebglyss Pen from the refrigerator

• alcohol wipe

  • cotton ball or piece of gauze
  • sharps disposal container

Wait 45 minutes

With the gray base cap on, allow the Pen to warm up to room temperature for 45 minutes before injecting.

• Do not warm up the Pen with a microwave, or hot water, or direct sunlight.
• Do not use the Pen if the medicine is frozen.

Inspect the Pen and the medicine

Make sure you have the right medicine. The medicine inside should be clear. It may be colorless to slightly yellow.

Do not use the Pen (see Disposing of Ebglyss) if the:

• Pen looks damaged
• medicine is cloudy, is discolored, or has particles
• expiration date printed on the label has passed

Wash your hands with soap and water

Choose and Clean your injection site

Your healthcare professional can help you choose the injection site that is best for you.

Clean the injection site with an alcohol wipe and let dry.

You or another person may inject into these areas.

• Stomach area (abdomen) —

  At least 5 centimeters away from the belly button (navel).

• Front of thigh —

  At least 5 centimeters above the knee and 5 centimeters below the groin.

Another person must inject into this area.

• Back of upper arm —

  Another person must inject into the back of your upper arm.

Do not inject in the exact same spot every time.

Do not inject into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by atopic dermatitis or other skin lesions.

Expiration date

Injecting Ebglyss

1

Uncap the Pen

Make sure the Pen is locked.

When you are ready to inject, twist off the gray base cap and throw it away in your household trash.

Do not put the gray base cap back on — this could damage the needle.

Do not touch the needle inside the clear base.

2

Place and Unlock

Place and hold the clear base flat and firmly against the skin.

Keep the clear base on the skin, then turn the lock ring to the unlock position.

3

Press and Hold for 15 Seconds

Press and Hold the purple injection button and Listen for two loud clicks:

• first click = injection started
• second click = injection completed

The injection may take up to 15 seconds.

Needle

Gray base cap

Clear base

15

seconds

You will know the injection is complete when the gray plunger is visible.

Gray Plunger

Disposing of Ebglyss

Throw away the used Pen

Put the used Ebglyss Pen in a sharps disposal container right away after use.

Do not throw away (dispose of) the Ebglyss Pen in your household trash.

If you do not have a sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.

There may be provincial or local laws about how you should throw away needles and pens.

Do not recycle your used sharps disposal container.

Commonly Asked Questions

Q.

What if I see bubbles in the Pen?

A.

Air bubbles are normal. They will not harm you or affect your dose.

Q.

What if there is a drop of liquid on the tip of the needle when I remove the gray base cap?

A.

A drop of liquid on the tip of the needle is normal. This will not harm you or affect your dose.

Q.

What if I unlock the Pen and press the purple injection button before twisting off the gray base cap?

A.

Do not remove the gray base cap. Throw away (dispose of) the Pen and use a new one.

Q.

Do I need to hold the purple injection button down until the injection is complete?

A.

You do not need to hold the purple injection button down, but it may help you keep the Pen steady and firm against your skin.

Q.

What if the needle did not retract after my injection?

A.

Do not touch the needle or replace the gray base cap. Store the Pen in a safe place to avoid an accidental needlestick and contact Lilly at 1-888-545-5979 for instructions on how to return the Pen.

Q.

What if there is a drop of liquid or blood on my skin after my injection?

A.

This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Q.

How can I tell if my injection is complete?

A.

After you press the purple injection button, you will hear 2 loud clicks. The second loud click tells you that your injection is complete. You will also see the gray plunger at the top of the clear base. The injection may take up to 15 seconds.

Q.

What if I remove the Pen before the second loud click or before the gray plunger stops moving?

A.

You may not have received your full dose. Do not give another injection. Call your healthcare professional for help.

Q.

What if I heard more than 2 clicks during my injection — 2 loud clicks and 1 soft one. Did I get my complete injection?

A.

Some people may hear a soft click right before the second loud click. That is the normal operation of the Pen. Do not remove the Pen from your skin until you hear the second loud click.

If you have more questions about how to use the Ebglyss Pen:

• Call your healthcare professional
• Call 1-888-545-5972
• Visit www.lilly.ca

Storing Ebglyss

• Store your Pen in the refrigerator between 2°C to 8°C.
• Your Pen may be stored at room temperature for up to 7 days. Do not store above 30°C. Throw away (dispose of) Ebglyss if not used within 7 days at room temperature.
• Do not freeze your Pen.
• Store your Pen in the original carton to protect your Pen from light.
• Do not microwave your Pen, or run hot water over it, or leave it in direct sunlight.
• Do not shake your Pen.
• Throw away (dispose of) your Pen if any of the above conditions are not followed.
• Keep your Pen and all medicines out of the reach and sight of children.

Read the Patient Medication Information insert for Ebglyss inside this box to learn more about your medicine.

Eli Lilly Canada, Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

Ebglyss is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

Copyright © 2024, Eli Lilly and Company. All rights reserved.

Document Issued: June 24, 2024

EBG-0001-CA-AI-IFU-20240624