Package Insert: Information for the User

Ilumetri 100mg pre-filled syringe injectable solution

tildrakizumab

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section4.

Ilumetri contains the active ingredient tildrakizumab. Tildrakizumab belongs to a group of medicines called interleukin inhibitors (IL).

This medicine works by blocking the activity of a protein called IL-23, a substance found in the body that participates in normal inflammatory and immune responses and is present in large quantities in diseases such as psoriasis.

Ilumetri is used to treat a skin condition called plaque psoriasis in adults with moderate to severe disease.

The use of Ilumetri will benefit you because it produces improvements in skin lesions and reduces symptoms.

Do not use Ilumetri:

• If you are allergic totildrakizumab or any of the other components of this medication (listed in section6).
• If you have an infection that your doctor considers important, for example, active tuberculosis, which is an infectious disease that mainly affects the lungs.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Ilumetri:

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

If you are unsure whether you are in any of the above circumstances, consult your doctor, pharmacist, or nurse before using Ilumetri.

Each time you receive a new package of Ilumetri, it is essential to note the date and batch number (which appears on the package after “Batch”) and to keep this information in a safe place.

Monitoring of infections and allergic reactions

Ilumetri may cause severe side effects, such as infections and allergic reactions. You should be aware of the signs of these conditions while using Ilumetri.

Stop using Ilumetri and inform your doctor or seek medical attention immediately if you observe signs indicating a possible severe infection or allergic reaction (see section4. Possible side effects).

Children and adolescents

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

Other medications and Ilumetri

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes vaccines and immunosuppressive medications (medications that affect the immune system).

Do not administer certain types of vaccines (live vaccines) while using Ilumetri. There are no available data on the simultaneous use of Ilumetri and live vaccines.

Pregnancy, breastfeeding, and fertility

It is preferable to avoid using Ilumetri during pregnancy. The effects of this medication on pregnant women are unknown.

If you are a fertile woman, it is recommended that you do not become pregnant and use an effective contraceptive method while receiving treatment with Ilumetri and for at least 17weeks after completing treatment.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The influence of Ilumetri on the ability to drive and operate machinery is negligible or insignificant.

Ilumetri contains polysorbates

This medication contains 0.5mg of polysorbate 80 (E433) in each pre-filled syringe, equivalent to 0.5mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Ilumetri should be used under the direction and supervision of a doctor with experience in diagnosing and treating psoriasis.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.This medication is for single use only.

The recommended dose of Ilumetri is 100mg subcutaneous injection at weeks0 and 4 and every 12weeks thereafter.

If you are a patient with a high disease burden or with a body weightabove90kg, your doctor may recommend a dose of 200mg.

Your doctor will decide the duration of treatment with Ilumetri.

After learning the correct subcutaneous injection technique, you may inject Ilumetri yourself if your doctor considers it appropriate.

To consult the instructions on how to inject Ilumetri, read the “Instructions for Use” found at the end of this leaflet.

Consult your doctor when you will receive injections and follow-up visits.

Use in children and adolescents

The safety and efficacy of Ilumetri in children and adolescents under 18years of age have not yet been established, so Ilumetri is not recommended for use in children and adolescents.

If you use more Ilumetri than you should

If more Ilumetri than prescribed has been administered or the dose has been administered earlier than indicated by your doctor's prescription, inform your doctor.

If you forget to use Ilumetri

If you have forgotten or missed an Ilumetri injection, administer the dose as soon as possible. Then, resume administration at the usual interval.

If you interrupt treatment with Ilumetri

The decision to interrupt treatment with Ilumetri should be made with your doctor. It is possible that your symptoms will recur when treatment is interrupted.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe Adverse Effects

If you notice any of the following symptoms, contact your doctor immediately:contact your doctor immediatelyimmediately:

• Swelling of the face, lips, or throat
• Difficulty breathing

These may be signs of an allergic reaction.

Other Adverse Effects

Most of the following adverse effects are mild. If any of the following adverse effects become intense, report them to your doctor or pharmacist.

Very Common(may affect more than 1 in 10people)

• Upper respiratory tract infections

Common(may affect up to 1 in 10people)

• Gastroenteritis
• Nausea
• Diarrhea
• Pain at the injection site
• Back pain
• Headache

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through the national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the pre-filled syringe label after CAD or EXP. The expiration date is the last day of the month indicated.

Store the medication in the original box to protect it from light. Do not shake.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

After removing the pre-filled syringe from the refrigerator, wait 30 minutes, approximately, for the Ilumetri solution in the syringe to reach room temperature (maximum 25°C). Do not heat in any other way.

Do not use if the liquid contains visible particles, is cloudy, or is clearly brown.

Once removed from the refrigerator, do not store tildrakizumab at a temperature above 25°C or re-refrigerate it.

In the space provided on the outer box, note the date when you removed the medication from the refrigerator and the disposal date that corresponds. Use the syringe before 30 days have passed since you removed it from the refrigerator or before the expiration date, whichever occurs first.

Medications should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Ilumetri

• The active ingredient is tildrakizumab. Each pre-filled syringe contains 100 mg of tildrakizumab.
• The other components are L-histidine, L-histidine hydrochloride monohydrate, polisorbate 80 (E 433), sucrose, and water for injection.

Appearance of Ilumetri and contents of the pack

Ilumetri 100 mg solution for injection in pre-filled syringe is a transparent or slightly opalescent, colourless or slightly yellowish solution.

Ilumetri 100 mg solution for injection in pre-filled syringe is available in single-dose packs containing 1 pre-filled syringe and in packs containing 2 pre-filled syringes.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona, Spain

Responsible Person for Manufacturing

SUN Pharmaceuticals Industries (Europe) B.V.

Polarisavenue 87

2132JH Hoofddorp, Netherlands

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell 41-61

08740 Sant Andreu de la Barca, Barcelona, Spain

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics: 06/2024

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agencyhttps://www.ema.europa.eu/.

INSTRUCTIONS FOR USE

Before using the pre-filled syringes:

Important points to be aware of

• Before using the pre-filled syringes of Ilumetri, read and follow carefully all the step-by-step instructions. Keep the instructions for use and consult them when needed.
• The pre-filled syringes must not be shaken.
• Read the package leaflet for Ilumetri for further information on the medicinal product.

DESCRIPTION OF THE PRODUCT

The pre-filled syringe of Ilumetri looks like this:

PREPARATION

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

• Ensure that the dose of the syringe corresponds to the dose prescribed by your doctor.
• For a dose of 100 mg, one syringe is needed, and for a dose of 200 mg, two syringes are needed.
• Remove the pack from the refrigerator and place it, without opening, on a clean and flat work surface.

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

• Leave the pre-filled syringe in the outer pack (with the cap closed) at room temperature for 30 minutes.

3. Inspect the medicinal product

• Remove the pre-filled syringe from the pack when ready for injection.
• • Check the expiry date on the carton and on the pre-filled syringe and discard it if the expiry date has passed.
  • Do not remove the cap from the needle until you are ready to administer the injection.
• Before administering Ilumetri, visually inspect it for the presence of particles and a change in colour.
• • Ilumetri is a transparent or slightly opalescent, colourless or slightly yellowish solution.
  • Do not use it if the liquid contains visible particles or if the syringe is damaged.
  • Do not use the product if it has fallen onto a hard surface or is damaged.

4. Gather all the materials you need

• On a clean and well-lit work surface, place the following:

• alcohol wipes
• swab or cotton ball
• bandage
• container for disposing of sharp objects

5. Wash your hands

• Wash your hands thoroughly with soap and water.

6. Choose the injection site

• Choose a site for the injection where the skin is healthy and easily accessible, such as the abdomen, thighs, or upper arm.
• • Do not administer the injection in the 5 cm around the navel or in areas of skin with sensitivity, haematomas, abnormal redness, hardening, or psoriasis lesions.
  • Do not inject into scars, stretch marks, or blood vessels.
  • The upper arm is only suitable if the injection is administered by someone else.
  • Alternate the injection sites for each administration.
  • In the case of a dose of 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 let the skin dry.

• Do not touch this area again before administering the injection.

INJECTION

If your dose is 200 mg, you will need to use 2 pre-filled syringes each time you administer the medicinal product.

8. Remove the cap from the needle

• While holding the body of the pre-filled syringe, remove the cap from the needle as shown and discard it. You may see 1 or 2 drops of liquid, which is normal.

• Do not touch the blue plunger yet.
• Do not use the product if the pre-filled syringe or needle is bent.

9. Pinch the skin and insert the needle

• Gently pinch the skin at the chosen injection site.
• Insert the entire needle into the skin that you have pinched, at an angle of 45 to 90 degrees.

• Do not place your finger on the plunger while inserting the needle.

• Hold the pre-filled syringe firmly.

10. Administer the injection

• Once the needle is inserted, release the skin gently.
• Pull the blue plunger down until it reaches the top. This will activate a safety mechanism that ensures the complete retraction of the needle after the injection.

• If the blue plunger reaches the top, it cannot be moved further and there will be no leakage, a full dose will have been administered.

11. Remove the used syringe

• Remove the needle from the skin completely before releasing the blue plunger.

• After releasing the blue plunger, the safety mechanism will draw the needle back into the needle guard.

• Dispose of the used syringe immediately after use and before administering a second syringe, if necessary.
• If there is any residual liquid or a small amount of blood, clean the injection site with a cotton ball or gauze while applying pressure. If necessary, you can use a bandage to cover the injection site.
• Repeat the procedure with the second syringe in a different area of skin if a dose of 200 mg is to be administered.