ILUMETRI 100 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Introduction

Package Leaflet: Information for the User

Ilumetri 100 mg solution for injection in pre-filled pen

tildrakizumab

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 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.

Contents of the pack

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

1. What is Ilumetri and what is it used for

Ilumetri contains the active substance 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 that is found in the body and is involved 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.

Using Ilumetri will benefit you because it improves skin lesions and reduces symptoms.

2. What you need to know before you use Ilumetri

Do not use Ilumetri:

• If you are allergic to tildrakizumab or any of the other ingredients of this medicine (listed in section 6).
• 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 suffer from 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 get long-term or repeated infections.
• If you have been recently vaccinated or are planning to be vaccinated.

If you are not sure if you are in any of the above circumstances, consult your doctor, pharmacist, or nurse before using Ilumetri.

Each time you receive a new pack of Ilumetri, it is important that you note the date and batch number (which appears on the pack after "Batch") and keep this information in a safe place.

Monitoring of infections and allergic reactions

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

Stop using Ilumetri and inform your doctor or seek medical attention immediately if you notice signs that may indicate a serious infection or an allergic reaction (see section 4. Possible side effects).

Children and adolescents

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

Other medicines and Ilumetri

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes vaccines and immunosuppressive medicines (medicines that affect the immune system).

Certain types of vaccines (live vaccines) should not be administered while using Ilumetri. There are no data available on the use of Ilumetri with live vaccines.

Pregnancy, breastfeeding, and fertility

It is recommended to avoid using Ilumetri during pregnancy. The effects of this medicine in pregnant women are unknown.

If you are a woman of childbearing age, it is recommended that you do not become pregnant and should use an effective method of contraception while receiving treatment with Ilumetri and for at least 17 weeks after the end of treatment.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Ilumetri has no or negligible influence on the ability to drive and use machines.

Ilumetri contains polysorbates

This medicine contains 0.5 mg of polysorbate 80 (E 433) in each pre-filled pen, equivalent to 0.5 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

3. How to use Ilumetri

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

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

The recommended dose of Ilumetri is 100 mg by subcutaneous injection at weeks 0 and 4 and every 12 weeks thereafter.

If you are a patient with a high disease burden or with a body weight over 90 kg, your doctor may recommend a dose of 200 mg.

Your doctor will decide the duration of treatment with Ilumetri.

After you have correctly learned the technique of subcutaneous injection, you can inject Ilumetri yourself if your doctor considers it appropriate.

To consult the instructions on how to inject Ilumetri, read the "Instructions for use" at the end of this leaflet.

Consult your doctor when you will have injections 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 been established, so the use of Ilumetri in children and adolescents is not recommended.

If you use more Ilumetri than you should

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

If you forget to use Ilumetri

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

If you stop treatment with Ilumetri

The decision to stop treatment with Ilumetri should be made together with your doctor. It is possible that your symptoms may recur when stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

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

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

These may be signs of an allergic reaction.

Other side effects

Most of the following side effects are mild. If any of the following side effects gets serious, inform your doctor or pharmacist.

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

• Upper respiratory tract infections

Common(may affect up to 1 in 10 people)

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

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ilumetri

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

Do not use this medicine after the expiry date which is stated on the carton and on the label of the pre-filled pen after EXP. The expiry date refers to the last day of the month shown.

Store the medicine in the original carton to protect it from light. Do not shake.

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

After removing the pre-filled pen from the refrigerator, wait for approximately 30 minutes for the Ilumetri solution in the pen to reach room temperature (maximum 25 °C). Do not heat it 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 more than 25 °C or refrigerate it again.

In the space provided on the outer carton, note the date you removed the medicine from the refrigerator and the disposal date that corresponds. Use the pen before 30 days have passed since you removed it from the refrigerator or before the expiry date, whichever comes first.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Ilumetri Composition

• The active ingredient is tildrakizumab. Each pre-filled pen contains 100 mg of tildrakizumab.
• The other components are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E 433), sucrose, and water for injectable preparations.

Appearance of Ilumetri and Container Contents

Ilumetri 100 mg solution for injection (injection) in a pre-filled pen is a clear or slightly opalescent solution, colorless or slightly yellow.

Ilumetri 100 mg solution for injection (injection) in a pre-filled pen is available in single-unit packs with 1 pre-filled pen.

Marketing Authorization Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona, Spain

Manufacturer

SUN Pharmaceuticals Industries (Europe) B.V.

Polarisavenue 87

2132JH Hoofddorp, Netherlands

Almirall, S.A.

Ctra. de Martorell 41-61

08740 Sant Andreu de la Barca, Barcelona, Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:06/2024

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website https://www.ema.europa.eu/.

INSTRUCTIONS FOR USE

After receiving proper training in subcutaneous injection technique, you may self-inject this medication if your doctor considers it appropriate.

Read all instructions, including Storage, Warnings, and Parts of the pre-filled pen, which you will find at the top of these instructions before administering the medication.

Warnings

Ilumetri is for subcutaneous administration only.

DO NOT share the pre-filled pen with another person.

DO NOT remove the gray cap from the needle until you are ready to inject.

DO NOT put your hand, fingers, or thumb on the yellow needle protector.

Keep the pre-filled pen and the gray cap (when removed) out of the reach of children and pets.

Parts of the pre-filled pen

DO NOT use if the gray cap of the needle is removed or damaged.

DO NOT use if the yellow plunger is visible in the window.

Step 1: Prepare

1A Remove the pre-filled pen from the refrigerator and wait 30 minutes

• Remove an Ilumetri pre-filled pen from the refrigerator (see Figure B).
• Remove the pre-filled pen by holding it in the middle (see Figure C).
• Allow the pre-filled pen to reach room temperature for at least 30 minutes before injecting (see Figure D).

DO NOT shake the container or the pre-filled pen.

DO NOT heat the pre-filled pen in any other way, such as in the microwave, in hot water, or in direct sunlight.

1C Check the pre-filled pen

• Check the pre-filled pen to ensure that it has not passed the expiration date (see Figure F).
• Check the liquid medication through the window (see Figure G). It should be colorless or slightly yellow.

It is normal to see one or more air bubbles.

DO NOT use if it has passed the expiration date.

DO NOT use if the liquid appears cloudy, discolored, or with foreign particles.

DO NOT blow on the skin to dry it.

DO NOT touch the injection site once cleaned.

Step 2: Inject

DO NOT touch the yellow needle protector.

DO NOT put the gray cap back on the pre-filled pen.

DO NOT twist or bend the needle protector when removing it, as it may damage the needle.

2B Place the pre-filled pen

• Hold the pre-filled pen with the window toward you.
• Stretch the skin and place the pre-filled pen straight on the cleaned injection site with the yellow needle protector flat on the skin (see Figure L).

2C Administer the injection

To start the injection:

• Press and hold the pre-filled pen against the skin. This will cause the yellow needle protector to move up the pre-filled pen (see Figure M).
• You will hear a first "click", which indicates that the injection has started (see Figure M).
• A second "click" indicates that the injection is almost complete (see Figure N). Hold the pre-filled pen for a total of 15 seconds from the start of the injection to ensure that all the medication has been injected. Count slowly to fifteen seconds and make sure you have heard the second "click".

• Check the window. The entire window will be occupied by the yellow color.
• Lift and separate the pre-filled pen from the skin in a straight line (see Figure O).

• If the window does not turn completely yellow, remove the pre-filled pen and call your healthcare provider.

DO NOT use the pre-filled pen if the yellow needle protector does not move up the pre-filled pen; discard it immediately in a sharps container.

Step 3: Dispose

3A Dispose of the pre-filled pen and care for the injection site

• Dispose of the used pre-filled pen in an approved sharps container (see Figure P).
• There may be a small drop of blood at the injection site, which is normal. Press a cotton ball or gauze onto the area and apply a band-aid if necessary (see Figure Q).

DO NOT dispose of pre-filled pens in household trash.

DO NOT rub the injection site.