Ilumetri: detailed information

Patient Information Leaflet: Information for the User

Ilumetri 100 mg solution for injection in pre-filled syringe

tildrakizumab
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Ilumetri is and what it is used for
What you need to know before using Ilumetri
How to use Ilumetri
Possible side effects
How to store Ilumetri
Contents of the pack and other information

1. What Ilumetri is and what it is used for

Ilumetri contains the active substance tildrakizumab. Tildrakizumab belongs to a group of medicines called interleukin (IL) inhibitors.
This medicine works by blocking the activity of a protein called IL-23, a substance in the body involved in normal inflammatory and immune responses, which is present at higher than normal levels in diseases such as psoriasis.
Ilumetri is used to treat a skin condition called moderate to severe plaque psoriasis in adults.
Treatment with Ilumetri will benefit you by improving skin clearance and reducing symptoms.

2. What you need to know before using Ilumetri

Do not use Ilumetri:

if you are allergic to tildrakizumab or to any of the other ingredients of this medicine (listed in section 6).
if you have an infection that your doctor considers serious, for example active tuberculosis, which is an infectious disease primarily affecting the lungs.

Warnings and precautions
Talk to your doctor or pharmacist before using Ilumetri:

if you experience allergic reactions with symptoms such as chest tightness, wheezing, swelling of the face, lips, or throat; do not inject Ilumetri and contact your doctor immediately.
if you currently have an infection or suffer from long-term or recurrent infections.
if you have recently been vaccinated or plan to get vaccinated.

If you are unsure whether any of the conditions described above apply to you, consult your doctor, pharmacist, or nurse before taking Ilumetri.
Each time you receive a new package of Ilumetri, it is important to record the date and the batch number (shown on the packaging after "Batch") and keep this information in a safe place.
Be vigilant for possible infections and allergic reactions.
Ilumetri may potentially cause serious adverse effects, including infections and allergic reactions. You must be attentive to signs of these conditions while taking Ilumetri.
Immediately stop using Ilumetri and contact your doctor immediately if you notice any signs suggesting a serious infection (see section 4. Possible side effects).

Children and adolescents
Ilumetri is not recommended for children and adolescents under 18 years of age, as it has not yet been evaluated in this patient group.

Other medicines and Ilumetri
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include vaccines and immunosuppressants (medicines that affect the immune system).
You must not receive certain types of vaccines (live vaccines) while using Ilumetri. There is no data available on the concomitant use of Ilumetri and live vaccines.

Pregnancy, breastfeeding, and fertility
It is preferable to avoid using Ilumetri during pregnancy. The effects of this medicine in pregnant women are unknown.
If you are a woman of childbearing age, you are advised to avoid becoming pregnant and must use an effective method of contraception during treatment with Ilumetri and for at least 17 weeks after treatment.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Ilumetri has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Ilumetri contains polysorbates
This medicine contains 0.5 mg of polysorbate 80 (E 433) per pre-filled syringe, equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Ilumetri

Ilumetri is intended for use only under the guidance and supervision of a physician experienced in the
diagnosis and treatment of psoriasis.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist. Ilumetri is for single use only.
The recommended dose of Ilumetri is 100 mg by subcutaneous injection at weeks 0 and 4, and
subsequently every 12 weeks.
If you are a patient with high disease burden or with a body weight greater than 90 kg, your doctor may
decide that a dose of 200 mg is recommended for you.
Your doctor will decide for how long you should continue treatment with Ilumetri.
After adequate training in subcutaneous injection technique, you may self-inject Ilumetri if your doctor
determines this is appropriate.
For instructions on how to self-inject Ilumetri, see the “Instructions for use” at the end of this leaflet.
Discuss with your doctor the scheduling of injection appointments and follow-up visits.
Use in children and adolescents
The safety and efficacy of Ilumetri in children and adolescents under 18 years of age have not yet been
established; therefore, the use of Ilumetri is not recommended in children or adolescents.
If you use more Ilumetri than you should
If you have administered more Ilumetri than you should, or if the dose was given earlier than indicated by
your doctor, inform your doctor immediately.
If you forget to use Ilumetri
If you have forgotten or missed an injection of Ilumetri, take the dose as soon as possible. Then, resume
treatment at the regularly scheduled intervals.
If you stop using Ilumetri
The decision to discontinue treatment with Ilumetri should be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
If you notice any of the following effects, contact your doctor immediately:

swelling of the face, lips or throat
breathing difficulties
These could be signs of a severe allergic reaction.

Other side effects
Most of the following side effects are mild. If any of these side effects become severe, inform your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)

Upper respiratory tract infection

Common (may affect up to 1 in 10 people)

Gastroenteritis
Nausea
Diarrhoea
Pain at the injection site
Back pain
Headache

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ilumetri

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the label of the pre-filled syringe after Scad/EXP. The expiry date refers to the last day of that month.
Keep the product in its original packaging to protect it from light. Do not shake the product.
Store the product in the refrigerator (2 °C – 8 °C). Do not freeze the product.
After removing the pre-filled syringes from the refrigerator, allow approximately 30 minutes for the Ilumetri solution in the syringe to reach room temperature (up to 25 °C). Do not heat the product in any other way.
Do not use the product if the liquid contains visible particles, if it is cloudy, or if it is clearly brown.
Once removed from the refrigerator, do not store tildrakizumab at temperatures above 25 °C and do not refrigerate it again.
Write the date of removal from the refrigerator in the space provided on the outer carton, as well as the appropriate expiry date. Use the syringe within 30 days of removal from the refrigerator or by the expiry date, whichever comes first.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ilumetri contains

The active substance is tildrakizumab. Each pre-filled syringe contains 100 mg of tildrakizumab.
The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E 433), sucrose and water for injections.

Description of the appearance of Ilumetri and contents of the pack
Ilumetri 100 mg solution for injection (injection) in pre-filled syringe is a solution that is clear to
slightly opalescent and colourless to slightly yellow.
Ilumetri 100 mg solution for injection (injection) in pre-filled syringe is available in single packs
containing 1 pre-filled syringe and in packs containing 2 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona, Spain

Manufacturer:
SUN Pharmaceuticals Industries (Europe) B.V.
Polarisavenue 87
2132JH Hoofddorp, The Netherlands
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
08740 Sant Andreu de la Barca, Barcelona, Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/ Italy
Luxembourg/Luxemburg Almirall SpA
Almirall N.V. Tel: +39 02 346181
Tél/Tel: +32 (0)2 771 86 37

България/ Eesti/ Ελλάδα/ Spain/ Hrvatska/ Netherlands
Κύπρος/ Latvija/ Lietuva/ Magyarország/ Almirall B.V.
Malta/ România/ Slovenija Tel: +31 (0)307991155
Almirall, S.A.
Teл./Tel/Τηλ: +34 93 291 30 00

Česká republika/Slovenská republika
Almirall s.r.o
Tel: +420 739 686 638

Denmark/ Norway / Sweden Austria
Almirall ApS Almirall GmbH
Tlf./Tel: +45 70 25 75 75 Tel: +43 (0)1/595 39 60

Germany Poland
Almirall Hermal GmbH Almirall Sp. z o.o.
Tel: +49 (0)40 72704-0 Tel.: +48 22 330 02 57

France Portugal
Almirall SAS, 1 Almirall - Produtos Farmacêuticos, Lda.
Tél: +33(0)1 46 46 19 20 Tel: +351 21 415 57 50

Ireland Finland/Suomi
Almirall, S.A. Orion Pharma
Tel: +353 1800 849322 Puh/Tel: +358 10 4261

Iceland
Vistor hf.
Sími: +354 535 70 00

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

INSTRUCTIONS FOR USE

Before using the prefilled syringe:
Important points to know

Before using Ilumetri prefilled syringes, read and follow each step of the instructions carefully. Keep the instructions for use and refer to them whenever necessary.
Do not shake the prefilled syringes.
Read the Ilumetri package leaflet for more information about the medicine.

PRODUCT DESCRIPTION
This is what the Ilumetri prefilled syringe looks like:

Diagram of the pre-filled ILUMETRI syringe with labels indicating needle cap, needle shield, barrel, viewing window, grip, and blue plunger

PREPARATION

1. Remove the package from the refrigerator (if stored in the refrigerator)

Make sure the syringe dose corresponds to the dose prescribed by the doctor.
One syringe is required for a 100 mg dose, and two syringes are required for a 200 mg dose.
Remove one package from the refrigerator and place the original, still-closed package on a clean, flat working surface.

2. Wait for 30 minutes (if stored in the refrigerator)

Analog clock with white background and a blue section highlighting elapsed time up to the number 30, with black central hands

Leave the pre-filled syringe in its outer packaging (with the lid closed) and allow it to reach room temperature for 30 minutes.

3. Check the medicine

Remove the pre-filled syringe from the packaging when ready to inject.
- Check the expiry date on the packaging and on the pre-filled syringe, and discard if the date has been exceeded.
- DO NOT remove the needle cap until you are ready to inject.
Visually inspect Ilumetri for particles and colour before administration.
- Ilumetri is a solution that ranges from clear to slightly opalescent and from colourless to slightly yellow.
- DO NOT use if visible particles are present or if the syringe is damaged. Air bubbles may be present; there is no need to remove them.
- DO NOT use the product if it has fallen onto a hard surface or if it is damaged.

A hand holding a syringe with a circular magnification showing details of the text printed on the transparent part of the device barrel

4. Prepare all necessary materials

On a clean, well-lit surface, prepare the following:
- alcohol wipes
- cotton ball or gauze pad
- adhesive plaster
- sharps container

5. Wash your hands

Wash your hands thoroughly with water and soap.

Two hands being washed under a stream of water

6. Choose an injection site

Choose an injection site with healthy, easily accessible skin, such as the abdomen, thighs, or upper arm.
- DO NOT administer within 5 cm of the navel or where the skin is tender, bruised, abnormally red, hard, or affected by psoriasis.
- DO NOT inject near scars, stretch marks, or blood vessels.
- The upper arm is suitable only when another person administers the injection.
- Alternate injection sites for each administration.
- If the dose is 200 mg (2 pre-filled syringes of 100 mg), choose a different site for the second injection.

7. Clean the injection site

Clean the injection site with an alcohol wipe and allow the skin to dry.
o Do not touch the area again after cleaning until the injection is given.

Human body diagram with gray areas on the abdomen and thighs and black mesh-patterned zones on the upper arms

Black buttocks-shaped icon with a mesh pattern next to the text 'injection site, only if you have someone to assist'

INJECTION
If the dose is 200 mg, two pre-filled syringes must be used each time the product is administered.

8. Remove the needle cover

Holding the body of the pre-filled syringe, remove the needle cap as indicated and discard it. It is normal if there are 1 or 2 drops of liquid.
• DO NOT touch the blue plunger yet.
• DO NOT use if the pre-filled syringe or the needle is bent.

Two hands removing the protective cap from the syringe barrel with a gray arrow indicating movement to the left

9. Pinch the skin and insert the needle

Gently pinch the skin at the selected injection site.
Insert the entire needle into the pinched skin between your fingers, at an angle between 45 and 90 degrees. Do NOT place your finger on the plunger while inserting the needle.
Hold the prefilled syringe steady.

A hand holding a syringe with needle pointing downward while the

10. Inject

After inserting the needle, gently release the skin.
Press the blue plunger fully until it stops. This activates the safety mechanism, ensuring complete retraction of the needle after injection.
o The full dose is delivered when the blue plunger cannot be pressed further and there is no leakage.

Two hands holding an injection pen against the skin of the

11. Remove the used syringe

Completely remove the needle from the skin before releasing the blue plunger.
o After releasing the blue plunger, the safety mechanism retracts the needle into the protective shield.

Medical illustration of hands holding a syringe for a

Dispose of the used syringe immediately into a sharps container after use and before injecting a second syringe, if necessary.
If residual liquid or a small amount of blood remains, clean the injection site with a cotton ball or gauze pad, applying gentle pressure. If needed, you may use an adhesive bandage to cover the injection site.
Repeat the procedure with the second syringe at a different injection site if administering a 200 mg dose.

Patient Information Leaflet: Information for the user

Ilumetri 200 mg solution for injection in pre-filled syringe

tildrakizumab
Please read this leaflet carefully before using this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Ilumetri is and what it is used for
What you need to know before using Ilumetri
How to use Ilumetri
Possible side effects
How to store Ilumetri
Contents of the pack and other information

1. What Ilumetri is and what it is used for

Ilumetri contains the active substance tildrakizumab. Tildrakizumab belongs to a group of medicines
called interleukin (IL) inhibitors.
This medicine works by blocking the activity of a protein called IL-23, a substance in the body involved in normal inflammatory and immune responses, which is present at higher than normal levels in diseases such as psoriasis.
Ilumetri is used to treat a skin condition called plaque psoriasis in adults with moderate to severe disease.
Treatment with Ilumetri will benefit you by improving skin clearance and reducing symptoms.

2. What you should know before using Ilumetri

Do not use Ilumetri:

if you are allergic to tildrakizumab or to any of the other ingredients of this medicine (listed in section 6).
if you have an infection that your doctor considers serious, for example active tuberculosis, which is an infectious disease that primarily affects the lungs.

Warnings and precautions
Talk to your doctor or pharmacist before using Ilumetri:

If you experience allergic reactions with symptoms such as chest tightness, wheezing, swelling of the face, lips, or throat, do not inject Ilumetri and contact your doctor immediately.
If you currently have an infection or suffer from long-term or recurrent infections.
If you have recently been vaccinated or plan to get vaccinated.

If you are unsure whether any of the conditions described above apply to you, please consult your doctor, pharmacist, or nurse before taking Ilumetri.
Each time you receive a new package of Ilumetri, it is important to record the date and the batch number (indicated on the package after “Batch”) and keep this information in a safe place.
Be vigilant for possible infections and allergic reactions.
Ilumetri may potentially cause serious side effects, including infections and allergic reactions. You should be alert for signs of these conditions while taking Ilumetri.
Stop using Ilumetri immediately and contact your doctor immediately if you notice any signs indicating a possible serious infection (see section 4. Possible side effects).

Children and adolescents
Ilumetri is not recommended for children and adolescents under 18 years of age, as it has not yet been evaluated in this patient group.

Other medicines and Ilumetri
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes vaccines and immunosuppressants (medicines that affect the immune system).
You must not receive certain types of vaccines (live vaccines) while using Ilumetri. There are no data available on the concomitant use of Ilumetri and live vaccines.

Pregnancy, breastfeeding, and fertility
It is preferable to avoid using Ilumetri during pregnancy. The effects of this medicine in pregnant women are unknown.
If you are a woman of childbearing age, you are advised to avoid becoming pregnant and should use an effective method of contraception during treatment with Ilumetri and for at least 17 weeks after treatment.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Ilumetri has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Ilumetri contains polysorbates
This medicine contains 1 mg of polysorbate 80 (E 433) per pre-filled syringe, equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.