Ilumetri 100 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ilumetri 100 mg solution for injection in a 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Ilumetri is and what it is used for
2. What you need to know before using Ilumetri
3. How to use Ilumetri
4. Possible side effects
5. How to store Ilumetri
6. 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 known as interleukin (IL) inhibitors.

This medicine works by blocking the activity of a protein called IL-23, a substance present in the body that plays a role in normal inflammatory and immune responses and is found in high levels in conditions 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 improves skin lesions and reduces 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 significant, for example, active tuberculosis, which is an infectious disease that primarily affects the lungs.

Warnings and precautions

Talk to 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 any more Ilumetri and contact your doctor immediately.
• If you currently have an infection or if you suffer from prolonged or recurrent infections.
• If you have recently been vaccinated or are planning to get vaccinated.

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

Each time you receive a new package of Ilumetri, it is important to record the date and the batch number (shown on the package after "Batch") and keep this information in a safe place.

Monitoring of infections and allergic reactions

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

Stop using Ilumetri and inform your doctor or seek immediate medical attention if you notice signs indicating a possible serious infection or allergic reaction (see section 4. Possible side effects).

Children and adolescents

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

Other medicines and Ilumetri

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes vaccines and immunosuppressants (medicines that affect the immune system).

Certain types of vaccines (live microbial vaccines) should not be administered while you are 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 potential, it is recommended that you avoid becoming pregnant and should use an effective method of contraception while receiving treatment with Ilumetri and for at least 17 weeks after stopping treatment.

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

Driving and using machines

The influence of Ilumetri on the ability to drive and use machines is none or negligible.

Ilumetri contains polysorbates

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

3. How to use Ilumetri

Ilumetri should be used under the direction and supervision of a physician experienced in the diagnosis and treatment of psoriasis.

Always follow your doctor's instructions for administering this medicine. If you are unsure, consult your doctor or pharmacist again. This medicine is for single use only.

The recommended dose of Ilumetri is 100 mg given as a subcutaneous injection at weeks 0 and 4, and every 12 weeks thereafter.

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

Your doctor will decide the duration of your treatment with Ilumetri.

After you have been properly trained in the subcutaneous injection technique, you may self-inject Ilumetri if your doctor considers it appropriate.

For instructions on how to self-inject Ilumetri, please read the “Instructions for use” at the end of this leaflet.

Consult your doctor regarding the timing of your 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 18 years of age; therefore, the use of Ilumetri is not recommended in children and 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 prescribed, inform your doctor immediately.

If you forget to use Ilumetri

If you have missed or skipped an injection of Ilumetri, administer the dose as soon as possible. Then resume treatment at the regular interval.

If you stop using Ilumetri

The decision to discontinue treatment with Ilumetri should be made together with your doctor. Your symptoms may return after stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious 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 severe, 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 injection site
• Back pain
• Headache

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the carton and on the label of the prefilled pen after CAD or EXP. The expiry date refers to the last day of the month indicated.

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 prefilled pen from the refrigerator, wait approximately 30 minutes for the Ilumetri solution in the pen to reach room temperature (up to a maximum of 25 ºC). Do not heat in any other way.

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

Once removed from the refrigerator, do not store tildrakizumab at temperatures above 25 ºC and do not refrigerate again.

In the space provided on the outer carton, record the date when you removed the medicine from the refrigerator and the corresponding disposal date. Use the pen within 30 days after removing it from the refrigerator or before the expiry date, whichever comes first.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ilumetri

• The active substance 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 injections.

Appearance of Ilumetri and contents of the pack

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

Ilumetri 100 mg solution for injection (injection) in pre-filled pen is available in unit packs containing 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, The 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 contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 06/2024

Other sources of information

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

INSTRUCTIONS FOR USE

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

Read all instructions, including Storage, Warnings, and Parts of the pre-filled pen found at the top of these instructions, before administering the medicine.

Warnings

Ilumetri is for subcutaneous administration only.

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

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

DO NOT place your hand, fingers, or thumb over the yellow needle shield.

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

Parts of the pre-filled pen

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

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

Step 1: Prepare

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

• Remove one Ilumetri pre-filled pen from the refrigerator (see Figure B).
• Remove the pre-filled pen by holding it at the center (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 by any other means, such as in a microwave, in hot water, or in direct sunlight.

1C Check the pre-filled pen

• Check the pre-filled pen to ensure it has not passed the expiration date (see Figure F).
• Inspect the liquid medication through the viewing 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 the expiration date has passed.

Do not use if the liquid appears cloudy, discolored, or contains foreign particles.

DO NOT blow on the skin to dry it.

DO NOT touch the injection site once it has been cleaned.

Step 2: Inject

DO NOT touch the yellow needle cap.

DO NOT replace the grey cap on the pre-filled pen.

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

2B Position the pre-filled pen

• Hold the pre-filled pen with the viewing window facing you.
• Stretch the skin and place the pre-filled pen straight onto the clean injection site, with the flat yellow needle cap lying against the skin (see figure L).

2C Administer the injection

To start the injection:

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

• Check the viewing window. The entire viewing window should be filled with yellow.

• Lift and remove the pre-filled pen straight away from the skin (see figure O).

• If the viewing window does not turn completely yellow, remove the pen and contact your healthcare provider.

DO NOT use the pre-filled pen if the yellow needle cap does not rise up the pen; discard it immediately into an approved 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 into 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 pad over the area and apply a bandage if needed (see figure Q).

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

DO NOT rub the injection site.