Ilumetri 100 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ilumetri 100mg solution for injection in pre-filled syringe

tildrakizumab

Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 found in the body that plays a role in normal inflammatory and immune responses and is present 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 by improving skin lesions and reducing 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 get infections that last a long time or occur repeatedly.
• 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 pack of Ilumetri, it is important to record the date and the batch number (shown on the packaging after "Batch") and keep this information in a safe place.

Monitoring for 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 immunosuppressive medicines (medicines that affect the immune system).

You should not be given certain types of vaccines (live microbial vaccines) while 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 age, 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 treatment ends.

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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) per 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 exactly. If in doubt, consult your doctor or pharmacist again. This medicine is for single use only.

The recommended dose of Ilumetri is 100 mg 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-administer Ilumetri, refer to 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 in children and adolescents under 18 years of age has not yet been established; 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 by your doctor, inform your doctor immediately.

If you forget to use Ilumetri

If you have missed or skipped an Ilumetri injection, administer the dose as soon as possible. Then resume administration 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 can 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 the injection site
• Back pain
• Headache

Reporting of 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 leaflet. You may also report them directly through the national reporting system included 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 pre-filled syringe 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 pre-filled syringe from the refrigerator, wait approximately 30 minutes for the Ilumetri solution in the syringe to reach room temperature (up to 25 °C). Do not heat by any other method.

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 temperatures above 25 °C nor refrigerate it again.

In the space provided on the outer carton, record the date on which the medicine was removed from the refrigerator and the corresponding date of disposal. Use the syringe within 30 days after removal 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 container and other information

Composition of Ilumetri

• The active substance is tildrakizumab. Each pre-filled syringe 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 container

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

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

Only some pack sizes may be marketed.

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

More information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Date of the latest review of this leaflet: 06/2024

Other sources of information

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

INSTRUCTIONS FOR USE

Before using the prefilled syringes:

Important points you should know

• Before using Ilumetri prefilled syringes, read and carefully follow all step-by-step instructions. Keep these instructions for use and refer to them whenever needed.
• Do not shake the prefilled syringes.
• Read the Ilumetri package leaflet for further information about the medicine.

PRODUCT DESCRIPTION

The Ilumetri prefilled syringe looks like this:

PREPARATION

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

   • Make sure the syringe dose corresponds to the one prescribed by your doctor.
   • One syringe is required for a 100 mg dose and two syringes for a 200 mg dose.
   • Remove the carton from the refrigerator and place it, unopened, on a clean, flat work surface.

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

   • Leave the prefilled syringe in the outer carton (with the lid closed) at room temperature for 30 minutes.

3. Inspect the medicine

   • Remove the prefilled syringe from the carton when ready to administer the injection.
     • Check the expiry date printed on the carton and on the prefilled syringe, and discard if this date has passed.
     • DO NOT remove the needle cap until you are ready to administer the injection.
   • Before administering Ilumetri, visually inspect the solution for particles and discoloration.
     • Ilumetri is a clear or slightly opalescent solution, colorless to slightly yellow.
     • DO NOT use if the liquid contains visible particles or if the syringe is damaged. Air bubbles may be present; there is no need to remove them.
     • DO NOT use the product if it has been dropped on a hard surface or is damaged.

4. Gather all materials needed
   • On a clean, well-lit work surface, place the following:

• alcohol wipes
• cotton ball or gauze
• adhesive bandage
• sharps disposal container

5. Wash your hands
   • Wash your hands thoroughly with soap and water.

6. Choose the injection site

   • Select an injection site with healthy, easily accessible skin, such as the abdomen, thighs, or upper arm.
     • Do NOT administer the injection within 5 cm of the navel or in areas of skin with tenderness, bruising, unusual redness, hardness, or psoriasis lesions.
     • Do NOT inject into scars, stretch marks, or blood vessels.
     • The upper arm is suitable only if another person administers the injection.
     • Rotate injection sites with each administration.
     • If your dose is 200 mg (2 prefilled 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 allow the skin to dry.

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

INJECTION

If your dose is 200 mg, you will need to use 2 prefilled syringes each time you administer the medicine.

1. Remove the needle cap
   • While holding the body of the prefilled syringe, remove the needle cap as shown and discard it. You may see one or two drops of liquid; this is normal.

• DO NOT touch the blue plunger yet.
• DO NOT use the product if the prefilled syringe or needle is bent.

2. Pinch the skin and insert the needle
   • Gently 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 prefilled syringe firmly.

3. Administer the injection
   • Once the needle is inserted, release the skin gently.
   • Push the blue plunger down completely until it stops. This activates a safety mechanism that ensures full retraction of the needle after the injection is administered.

• If the blue plunger reaches the end, cannot move further, and there is no leakage, a full dose has been administered.

4. Remove the used syringe
   • Completely remove the needle from the skin before releasing the blue plunger.

• After releasing the blue plunger, the safety lock will retract the needle into the needle shield.

• Immediately dispose of the used syringe in a sharps disposal container after use and before injecting with a second syringe, if necessary.
• If there is residual liquid or a small amount of blood, clean the injection site with a cotton ball or gauze while applying pressure. If desired, you may use an adhesive bandage to cover the injection site.
• Repeat the procedure with the second syringe at a different skin site if administering a 200 mg dose.