Ilumetri 100 mg solucion inyectable en pluma precargada

Package Insert: Information for the User

Ilumetri 100 mg injectable solution in pre-filled pen

tildrakizumab

Read this package insert carefully before you start using this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

Ilumetri is not recommended for use 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, believe 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 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 prospectus.

Consult your doctor about 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:

• 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 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 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 pen 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 pen from the refrigerator, wait 30 minutes, approximately, for the Ilumetri solution in the pen to reach room temperature (maximum 25 ºC). 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 more than 25 ºC 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 pen 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 drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Ilumetri

• The active ingredient is tildrakizumab. Each pre-filled pen 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 pen is a transparent or slightly opalescent, colourless or slightly yellowish solution.

Ilumetri 100 mg solution for injection in pre-filled pen is available in single-dose packs containing 1 pre-filled pen.

Marketing Authorisation Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona, Spain

Manufacturer Responsible

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

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

INSTRUCTIONS FOR USE

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

Read all the instructions, including Storage, Warnings, Parts of the pre-filled pen that you will find at the top of these instructions before administering the medicinal product.

Warnings

Ilumetri is for subcutaneous administration only.

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

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

DO NOT touch the yellow shield of the needle.

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

Parts of the pre-filled pen

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

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

Step 1: Prepare

1A Take the pre-filled pen out of the refrigerator and wait 30 minutes

• Take a pre-filled pen of Ilumetri out of the refrigerator (see Figure B).
• Take the pre-filled pen by the middle (see Figure C).
• Let the pre-filled pen come to room temperature for at least 30 minutes before injecting (see Figure D).

DO NOT shake the packaging 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 direct sunlight.

1C Check the pre-filled pen

• Check the pre-filled pen to make sure it has not expired (see Figure F).
• Check the liquid medicine through the viewer (see Figure G). It should be colourless or slightly yellowish.

It is normal to see one or more air bubbles.

DO NOT use if it has expired.

DO NOT use if the liquid is cloudy, discoloured, or has 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 shield of the needle.

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

DO NOT twist or bend the yellow shield when removing it, as this may damage the needle.

2B Place the pre-filled pen

• Hold the pre-filled pen with the viewertowards you.
• Stretch the skin and place the pre-filled pen straight on the cleaned injection site with the yellow shield 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 make the yellow shield rise 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 finished (see Figure N). Hold the pre-filled pen for a total of 15 seconds from the start of the injection to make sure all the medicine is injected. Count slowly for 15 seconds and make sure you hear the second “click”.

• Check the viewer. The entire viewer should be filled with yellow colour.
• Lift and separate the pre-filled pen from the skin in a straight line (see Figure O).

• If the viewer 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 shield does not rise up the pre-filled pen; dispose of it immediately in a sharps container.

Step 3: Dispose

3A Throw away the pre-filled pen and care for the injection site

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

DO NOT dispose of the pre-filled pens in household waste.

DO NOT rub the injection site.