Ilumetri 200 mg solucion inyectable en jeringa precargada

Package Insert: Information for the User

Ilumetri 200 mg Injectable Solution in Pre-filled Syringe

Tildrakizumab

Read this package insert carefully before starting to use this medicine, as 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 adverse 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 adverse 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 adverse 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 is no available data on the simultaneous use of Ilumetri and live vaccines.

Pregnancy, breastfeeding, and fertility

It is recommended 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 the diagnosis and treatment of psoriasis.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 have not yet been established in children and adolescents under 18years of age, 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 before the doctor's prescription indicates, 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 interrupt treatment with Ilumetri

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

Ifyou 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 Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on 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 ºC). 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 a temperature above 25 ºC or refrigerate it again.

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. This will help protect the environment.

Composition of Ilumetri

• The active ingredient is tildrakizumab. Each pre-filled syringe contains 200 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 200 mg solution for injection in a pre-filled syringe is a transparent or slightly opalescent, colourless or slightly yellowish solution. Ilumetri 200 mg solution for injection in a pre-filled syringe is available in single-dose packs containing 1 pre-filled syringe.

Marketing Authorisation Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona, Spain

Responsible Person for Manufacturing

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 syringe:

Important points to be aware of

DESCRIPTION OF THE PRODUCT

The pre-filled syringe of Ilumetri has the following appearance:

PREPARATION

1. Take the pack out of the refrigerator (if stored in the refrigerator)

• Ensure that the dose of the pre-filled syringe corresponds to the prescribed dose by your doctor.
• Take the pack out of the refrigerator and place it, without opening, on a clean and flat work surface.

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

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

1. Inspect the medicinal product

• Take the pre-filled syringe out of the carton 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 ready to administer the injection.

• Inspect the medicinal product visually for the presence of particles and any change in colour.
• Ilumetri is a transparent or slightly opalescent, colourless or slightly yellowish solution.
• Do not use if the solution contains visible particles or if the pre-filled syringe is damaged.It is possible that there are air bubbles; there is no need to remove them.
• Do not use the product if it has fallen onto a hard surface or is damaged.

1. Prepare 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

1. Wash your hands

• Wash your hands thoroughly with water and soap.

1. 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.

1. 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.

1. Remove the cap from the needle

• While holding the pre-filled syringe body, remove the cap from the needle as shown and discard it. It may be possible to see 1 or 2 drops of liquid; this is normal.

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

9.Pinch the skin and insert the needle

• Pinch the skin at the chosen injection site.
• Insert the entire needle into the pinched skin 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

• If the white 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 before releasing the white plunger.

• After releasing the white plunger, the safety mechanism will pull the needle back into the needle guard.

• Dispose of the used syringe in a container for disposing of sharp objects immediately after use.

If there is any residual liquid or a little 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.