Ebglyss 250 mg solution for injection in pre-filled pen

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Ebglyss is and what it is used for
2. What you need to know before you use Ebglyss
3. How to use Ebglyss
4. Possible side effects
5. How to store Ebglyss
6. Contents of the pack and other information
Instructions for use

• if you are allergic to lebrikizumab or any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Ebglyss.

Talk to your doctor, pharmacist or nurse before using Ebglyss.

Every time you get a new pack of Ebglyss, it is important that you note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Allergic reactions

Very rarely, this medicine can cause allergic (hypersensitivity) reactions. These reactions can occur shortly after you take Ebglyss, but also may happen later. If you notice symptoms of an allergic reaction, you should stop using this medicine and contact your doctor or get medical help immediately. Signs of an allergic reaction include:

• breathing problems
• swelling of the face, mouth, and tongue
• fainting
• dizziness
• feeling lightheaded (because of low blood pressure)
• hives, itching and skin rash

Eye problems

Talk to your doctor if you have any new or worsening eye problems, including redness and discomfort in the eye, eye pain or changes in vision.

Vaccination

Talk to your doctor regarding your current vaccinations plan. See section “Other medicines and Ebglyss”.

This medicine should not be used in children with atopic dermatitis below the age of 12 or adolescents 12 to 17 years of age and weighing less than 40 kg because it has not been tested in this age group.

Tell your doctor or pharmacist:

• if you are using, have recently used or might use any other medicines.
• if you have recently had a vaccination or plan to have one. You should not be given certain types of vaccines (live vaccines) while using Ebglyss.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The effects of this medicine in pregnant women are not known. It is better to avoid the use of Ebglyss during pregnancy unless your doctor advises you to use it.

It is not known whether lebrikizumab can pass into breast milk. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you will breast-feed or use Ebglyss. You should not do both.

Ebglyss is unlikely to influence your ability to drive and use machines.

This medicine contains 0.6 mg of polysorbate 20 (E 432) in each pre-filled syringe, which is equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Your doctor will decide how much Ebglyss you need and how long you will use it for.

The recommended dose is:

• Two initial injections of 250 mg lebrikizumab each (500 mg in total) at week 0 and week 2.
• One injection with 250 mg once every two weeks from week 4 up to week 16.
  Based on how you respond to the medicine, your doctor may decide to stop giving the medicine or to keep giving you one 250 mg injection every other week up to week 24.
• One injection with 250 mg every four weeks from week 16 onwards (maintenance dosing).

Ebglyss is given as an injection under your skin (subcutaneous injection) into the thigh or abdomen, except for 5 cm around the navel. If somebody else gives the injection, it can also be given into the upper arm. You and your doctor or nurse will decide if you can inject Ebglyss yourself.

It is recommended that you change the injection site with each injection. Ebglyss should not be injected into skin that is tender, damaged or has bruises or scars, or in an area of skin that is affected by atopic dermatitis or other skin lesions. For the initial 500 mg dose, administer two 250 mg injections consecutively in different injection sites.

It is important not to try to inject yourself until you have been trained by your doctor or nurse. A caregiver may also give you your Ebglyss injection after proper training. In adolescents 12 years of age and older, it is recommended that Ebglyss is administered by or under the supervision of an adult.

The pre-filled pen must not be shaken.

Read the “Instructions for use” for the pre-filled pen carefully before using Ebglyss.

If you took more Ebglyss than your doctor prescribed or you took the dose before it was scheduled, talk to your doctor, pharmacist or nurse.

If you have forgotten to inject a dose of Ebglyss, talk to your doctor, pharmacist or nurse.

If you forgot to inject Ebglyss when you usually have planned to do it, take it as soon as you remember. The next dose should be injected on the regular scheduled day.

Do not stop using Ebglyss without speaking to your doctor first.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is lebrikizumab. Each pre-filled pen contains 250 mg of lebrikizumab in a 2 mL solution (125 mg/mL).
• The other ingredients are histidine, glacial acetic acid (E 260), sucrose, polysorbate 20 (E 432) and water for injections.

Ebglyss is a clear to opalescent, colourless to slightly yellow to slightly brown sterile solution for injection, free of visible particles. It is supplied as carton packs containing one single-dose pre-filled pen, 2 single-dose pre-filled pens or 3 single-dose pre-filled pens, and as multipacks containing 4 single-dose pre-filled pens (2 packs of 2), 5 single-dose pre-filled pens (5 packs of 1) or 6 single-dose pre-filled pens (3 packs of 2). Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

• Your healthcare provider should show you how to prepare and inject Ebglyss using the pre-filled pen. Do not inject yourself or someone else until you have been shown how to inject Ebglyss.
• Each Ebglyss pre-filled pen contains 1 dose of Ebglyss (250 mg). The pre-filled pen is for one-time use only.
• The Ebglyss pre-filled pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new Ebglyss pre-filled pen for your injection.
• Your healthcare provider 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 works best for you.
• If you have vision or hearing problems, do not use Ebglyss pre-filled pen without help from a caregiver.

Prepare supplies:

• Ebglyss pre-filled pen from the refrigerator
• alcohol wipe
• cotton ball or piece of gauze
• sharps disposal container

Wait 45 minutes

Remove the Ebglyss pre-filled pen from the carton with the grey base cap on and allow the pre-filled pen to warm up to room temperature for 45 minutes before injecting.

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

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

Do not use the pre-filled pen (see Disposing of Ebglyss pre-filled pen) if the:

• Pen looks damaged
• medicine is cloudy, is discoloured, or contains particles
• expiry date printed on the label has passed

Wash your hands with soap and water

Your healthcare provider 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 cm (2 inches) away from the belly button (navel).
• Front of thigh —
  At least 5 cm (2 inches) above the knee and 5 cm (2 inches) below the groin.

Another person should inject into this area.

• Back of upper arm —
  Another person should 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 scarred, or in an area of skin that is affected by atopic dermatitis or other skin lesions.

1 Uncap the pre-filled pen

Make sure the pre-filled pen is locked.

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

Do not put the grey 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.

You will know the injection is complete when the grey plunger is visible. Then remove the pre-filled pen from the injection site.

Throw away the used pre-filled pen

Dispose of the used Ebglyss pre-filled pen in a sharps disposal container right away after use.

Do not throw away (dispose of) the Ebglyss pre-filled pen in your household waste.

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 labelled 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 local laws about how you should throw away needles and syringes.

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

Do not recycle your used sharps disposal container.

Q. What if I see bubbles in the pre-filled 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 grey 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 grey base cap?

A. Do not remove the grey base cap. Throw away (dispose of) the pre-filled 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 pre-filled 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 grey base cap. Store the pre-filled pen in a safe place to avoid an accidental needlestick.

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 grey plunger at the top of the clear base. The injection may take up to 15 seconds.

Q. What if I remove the pre-filled pen before the second loud click or before the grey plunger stops moving?

A. You may not have received your full dose. Do not give another injection. Call your healthcare provider 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 pre-filled pen. Do not remove the pre-filled pen from your skin until you hear the second loud click.

Read the full package leaflet for the pre-filled pen before using Ebglyss.