Patient leaflet - Ilumetri 200 mg solution for injection in Pre-filled pen
1. What Ilumetri is and what it is used for
Ilumetri contains the active substance tildrakizumab. Tildrakizumab belongs to a group of medicines called interleukin (IL) inhibitors.
This medicine works by blocking the activity of a protein called IL-23, a substance found in the body which is involved in normal inflammatory and immune responses and which is present at increased levels 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 by improvements of skin clearance and reducing your 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 which your doctor thinks is important, for example, active tuberculosis which is an infectious disease affecting mainly the lungs.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using 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 have long-term or repeated infections.
- If you have recently had or plan to have a vaccination.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Ilumetri.
Every time you get a niew pack of Ilumetri, it is important that you note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.
Look out for infections and allergic reactions
Ilumetri can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are taking Ilumetri.
Stop using Ilumetri and tell your doctor or seek medical help immediately if you notice any signs indicating a possible 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. This is because it has not yet been evaluated in this group of patients.
Other medicines and Ilumetri
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. These include vaccines and immunosuppressants (medicines that affect the immune system).
You should not be given certain types of vaccines (live vaccines) while using Ilumetri. No data are available with the concomitant use of Ilumetri and live vaccines.
Pregnancy, breastfeeding and fertility
It is preferable to avoid the use of Ilumetri in pregnancy. The effects of this medicine in pregnant women are not known.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use an effective method of contraception whilst having treatment with Ilumetri and for at least 17 weeks after treatment.
If you are pregnant or breast-feeding, 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 little effect on the ability to drive and use machines.
Ilumetri contains polysorbates
This medicine contains 1 mg of polysorbate 80 (E 433) in each pre-filled pen, which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3. How to use Ilumetri
Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine is for single use only.
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 high disease burden or with a body weight above 90 kg, your doctor may decide that a dose of 200 mg is recommended for you.
Your doctor will decide for how long you need to take Ilumetri.
After proper training in subcutaneous injection technique, you may inject Ilumetri yourself if your doctor determines that it is appropriate.
For instructions on how to inject Ilumetri yourself, see ‘Instructions for use’ at the end of this leaflet.
Talk to your doctor about when you will have your injections and follow-up appointments.
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 and therefore Ilumetri is not recommended for use in children or adolescents.
If you use more Ilumetri than you should
If you have administered more Ilumetri than you should or the dose has been administered sooner than according to your doctor’s prescription, tell your doctor.
If you forget to use Ilumetri
If you have forgotten or missed an Ilumetri injection, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.
If you stop using Ilumetri
The decision to stop using Ilumetri should be discussed with your doctor. Your symptoms may return upon discontinuation.
If you have any further questions on 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, contact your doctor immediately:
- Swelling of the face, lips or throat
- Breathing difficulties
As these may be signs of an allergic reaction.
Other side effects
Most of the following side effects are mild. If any of these side effects becomes severe, tell your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)
- Upper respiratory infections
Common (may affect up to 1 in 10 people)
- Gastroenteritis
- Nausea
- Diarrhoea
- Injection site pain
- Back pain
- Headache
Reporting of side effects
If you get 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 via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store 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 the label of the pre-filled pen after EXP. The expiry date refers to the last day of that month.
Keep the product in the original carton in order to protect from light. Do not shake.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
After taking a pre-filled pen from the refrigerator, wait approximately 45 minutes to allow the Ilumetri solution in the pen to reach room temperature (up to 25 ºC). Do not warm in any other way.
Do not use if the liquid contains visible particles, is cloudy or is distinctly brown.
Once taken out of the refrigerator, do not store tildrakizumab above 25 ºC or refrigerate it again.
Write down the date of removal from the refrigerator in the space provided on the outer carton and appropriate discard date. Use the pen within 30 days after taking it out of the refrigerator or by the expiry date whichever occurs first.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Ilumetri contains
- The active substance is tildrakizumab. Each pre-filled pen contains 200 mg of tildrakizumab.
- The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80 (E 433), sucrose and water for injections.
What Ilumetri looks like and contents of the pack
Ilumetri 200 mg solution for injection (injection) in pre-filled pen is a clear to slightly opalescent and colourless to slightly yellow solution.
Ilumetri 200 mg solution for injection (injection) in pre-filled pen is available in unit packs containing 1 pre-filled pen.
Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona, Spain
Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
08740 Sant Andreu de la Barca, Barcelona, Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom Almirall Limited Tel: 0800 0087 399 |
|---|
This leaflet was last revised in December 2024
INSTRUCTIONS FOR USE
After proper training in subcutaneous injection technique, you may inject this medication yourself if your doctor determines that it is appropriate.
Read all the instructions including the Storage, Warnings, and Pre-filled Pen Parts at the top of these instructions before administering this medication.
Storage
The pre-filled pen should be refrigerated at 2oC to 8oC and stored in the original carton (see Figure A).
DO NOT freeze.
Store in the carton to protect from light.
Warnings
Ilumetri is for use under the skin only (subcutaneous).
DO NOT share the pre-filled pen with another person.
DO NOT remove the purple needle cap until you are ready to inject.
DO NOT put hand, fingers, or thumb over the yellow needle guard.
Keep the pre-filled pen and purple cap (when removed) out of the reach of children and pets.
Pre-filled Pen Parts
DO NOT use if the purple needle cap has been removed or damaged.
DO NOT use if the yellow plunger rod is visible in the window.
Step 1: Get Ready
1A Remove Pre-filled Pen from Refrigerator and Wait 45 Minutes
- Remove one Ilumetri pre-filled pen from the refrigerator (see Figure B).
- Remove the pre-filled pen by holding it from the middle (see Figure C).
Allow the pre-filled pen to warm to room temperature for at least 45 minutes before injecting (see Figure D).
DO NOT shake the carton or pre-filled pen.
DO NOT warm the pre-filled pen any other way, such as in a microwave, hot water, or direct sunlight.
1B Gather Additional Supplies Needed
Gather the following supplies (see Figure E):
- Alcohol Wipes
- Cotton Ball or Gauze
- Adhesive Bandage
- Sharps Disposal Container
1C Check Pre-filled Pen
- Check the pre-filled pen to make sure the expiration date has not passed (see Figure F).
- Check the liquid medicine through the viewing window (see Figure G). It should be colorless to 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 looks cloudy, discoloured, or has foreign particles.
1D Wash Hands
- Wash your hands well with soap and water (see Figure H).
- Dry your hands.
1E Choose Injection Site
Choose the injection site (see Figure I). The recommended sites are:
- Front of thighs,
- Abdomen (except the 2-inch area around the belly button), and
- Back of upper arms
Altern injection sites for every administration.
DO NOT inject into skin that is tender, abnormally red, bruised, hardened or affected by psoriasis.
1F Clean Injection Site
- Clean the injection site by wiping the skin with an alcohol wipe (see Figure J).
- Allow the skin to air dry.
DO NOT blow on skin to dry.
DO NOT touch the injection site after it has been cleaned.
Step 2: Inject
2A Remove Needle Cap
- Remove the purple needle cap from the pre-filled pen by pulling it straight off (see Figure K).
- It may take some force to remove the cap.
DO NOT touch the yellow needle guard.
DO NOT put the purple needle cap back onto the pre-filled pen.
DO NOT twist or bend the needle guard while removing it, as this may damage the needle.
2B Position Pre-filled Pen
- Hold the pre-filled pen with the viewing window facing you.
- Stretch the skin and place the pre-filled pen straight on the cleaned injection site with the yellow needle guard flat on the skin (see Figure L).
2C Give Injection
To start the injection:
- Press and hold the pre-filled pen all the way down against the skin. This will make the yellow needle guard slide up into the pre-filled pen (see Figure M).
- You will hear the 1st “Click” that lets you know the injection has started (see Figure M).
- A 2nd‚ “Click” lets you know the injection is almost complete (see Figure N). Hold the pre-filled pen for a total of 15 seconds after the injection has started to make sure that all the medicine has been injected. Count slowly to fifteen seconds an ensure the second “click” has been heard.
- Check the viewing window. The color of the viewing window will be filled yellow.
- Lift the pre-filled pen straight up from the skin (see Figure O).
- If the window does not turn completely yellow, remove the pen and call your healthcare provider.
DO NOT use the pre-filled pen if the yellow needle guard does not slide into the pre-filled pen; immediately discard it into a sharps disposal container.
Step 3: Dispose
3A Throw Away Pre-filled Pen and Care for Injection Site
- Dispose of the used pre-filled pen into an approved sharps disposal container (see Figure P).
- There may be a small drop of blood at the injection site, this is normal. Press a cotton ball or gauze on the area and apply an adhesive bandage, if needed (see Figure Q).
DO NOT dispose of used pre-filled pens in regular trash.
DO NOT rub the injection site.