Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ilumetri 200 mg solution for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tildrakizumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
What you need to know before you take it
e 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. 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.
How to take it
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 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.
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 (see below):
United Kingdom 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.
How to store it
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 prefilled syringe 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 syringe from the refrigerator, wait approximately 30 minutes to allow the Ilumetri solution in the syringe to reach room temperature (up to 25oC). 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 25oC 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 syringe 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.
Contents of the pack and other information
What Ilumetri contains
- The active substance is tildrakizumab. Each pre-filled syringe contains 200 mg of tildrakizumab.
- The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injections. What Ilumetri looks like and contents of the pack Ilumetri 200 mg solution for injection in pre-filled syringe is a clear to slightly opalescent and colourless to slightly yellow solution. Ilumetri 200 mg solution for injection in pre-filled syringe is available in unit packs containing 1 prefilled syringe. Not all pack sizes may be marketed. 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: Great Britain Almirall Ltd Tel: 0800 0087 399
This leaflet was last revised in June 2024
INSTRUCTIONS FOR USE Before using the pre-filled syringes: Important points to know • Before you use Ilumetri pre-filled syringes, read and carefully follow all the step-by-step instructions. Keep the instructions for use and refer to them as needed. • The pre-filled syringes must not be shaken. • Read the Ilumetri Package Leaflet to learn more about your medicine. PRODUCT DESCRIPTION This is what Ilumetri pre-filled syringe looks like:
PREPARATION 1. Take the pack from the refrigerator (if stored in the refrigerator)
- Make sure the syringe dose corresponds to that prescribed by your doctor.
- Take a carton pack out of the refrigerator and place the original and unopened carton pack on a clean and flat working surface. 2. Wait for 30 minutes (if stored in the refrigerator)
- Leave the pre-filled syringe in the outer carton (with the lid closed) and let it sit at room temperature for 30 minutes. 3. Inspect the medicine
- Remove the pre-filled syringe from the carton when ready to inject.
- Check the expiry date on the carton and pre-filled syringe and discard if the date has passed.
- DO NOT pull off the needle cover until you are ready to inject.
- Inspect Ilumetri visually for particulate matter and discoloration prior to administration.
- Ilumetri is a clear to slightly opalescent and colourless to slightly yellow solution.
- DO NOT use if the liquid contains visible particles or 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 damaged.
4. Collect all the materials you need
- On a clean, well-lit work surface, place the:
- alcohol wipes
- cotton ball or gauze pad
- sticking plaster
- sharps disposal container 5. Wash your hands
- Wash your hands thoroughly with soap and water.
6. Choose an injection site
- Choose an injection site with clear skin and easy access such as abdomen, thighs or upper arm.
- DO NOT administer 5 cm around the navel or where the skin is tender, bruised, abnormally red, hardened or affected by psoriasis.
- DO NOT inject into scars, stretch marks, or blood vessels.
- The upper arm is only suitable when someone else is injecting you. 7. Clean injection site
- Clean the injection site with an alcohol wipe and allow the skin to dry.
- Do not touch this area again before giving the injection.
8. Pull off the needle cover
- While holding the body of the pre-filled syringe, remove the needle cover as shown and discard. You may see 1 or 2 drops of liquid and that is okay. – –
DO NOT touch the white plunger yet. DO NOT use if pre-filled syringe or needle is bent.
9. Pinch skin & insert needle
- Gently pinch your skin at the chosen injection site.
- Insert the entire needle into the pinched skin between your fingers at a 45- to 90-degree angle.
- DO NOT place your finger on the plunger while inserting the needle.
- Hold the pre-filled syringe steady.
10. Inject
- After inserting the needle, let go of the skin gently.
- Press down the white plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
- A complete dose is administered if the white plunger cannot go any further, and there are no spills.
11. Remove the used syringe •
Remove the needle from the skin entirely before letting go of the white plunger. –
After the white plunger is released, the safely lock will draw the needle inside the needle guard.
• •
Dispose of used syringe in a sharps disposal container right away after use If there is some residual fluid or a tiny bit of blood, clean the injection site with a cotton ball or gauze pad WITHOUT applying any pressure. If you feel the need, you can use a sticky plaster to cover the injection site.
Frequently asked questions about Ilumetri 200 mg solution for injection in pre-filled syringe
How do I take Ilumetri 200 mg solution for injection in pre-filled syringe?
Ilumetri 200 mg solution for injection in pre-filled syringe comes as injection containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ilumetri 200 mg solution for injection in pre-filled syringe?
The active substance in Ilumetri 200 mg solution for injection in pre-filled syringe is tildrakizumab.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ilumetri 200 mg solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ilumetri 200 mg solution for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tildrakizumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
4.2. Posology and method of administration
This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Posology
The recommended dose is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter.
At the physician's discretion, in patients with high disease burden or in patients above 90 kg of body weight a dose of 200 mg may provide greater efficacy.
Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks.
Missed dose
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
Special populations
Elderly
No dose adjustment is required (see section 5.2).
Renal or hepatic impairment
Ilumetri has not been studied in these patient populations. No dose recommendations can be made. For further information on elimination of tildrakizumab, see section 5.2.
Paediatric population
The safety and efficacy of Ilumetri in children and adolescents below the age of 18 years have not yet been established. No data are available.
Method of administration
This medicinal product is administered by subcutaneous injection. Injection sites should be alternated. Ilumetri should not be injected into areas where the skin is affected by plaque psoriasis or is tender, bruised, red, hard, thick, or scaly. The syringe or the pen must not be shaken. Each syringe or pen is for single use only.
After proper training in subcutaneous injection technique, patients may self-inject Ilumetri if a physician determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients should be instructed to inject the full amount of tildrakizumab according to the instructions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Clinically important active infection, e.g. active tuberculosis (see section 4.4).
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Infections
Tildrakizumab has the potential to increase the risk of infection (see section 4.8).
Caution should be exercised when considering the use of tildrakizumab in patients with a chronic infection or a history of recurrent or recent serious infection.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur. If a patient develops a serious infection, the patient should be closely monitored and tildrakizumab should not be administered until the infection resolves (see section 4.3).
Pre-treatment evaluation for tuberculosis
Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection. Patients receiving tildrakizumab should be closely monitored for signs and symptoms of active TB during and after treatment. Anti-TB therapy should be considered prior to initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Hypersensitivity
If a serious hypersensivity reaction occurs, administration of tildrakizumab should be discontinued immediately and appropriate therapy initiated (see section 4.3).
Vaccinations
Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines. If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab. Patients treated with tildrakizumab should not receive live vaccines during treatment and for at least 17 weeks after treatment (see section 4.5).
Excipients
This medicine contains 1 mg of polysorbate 80 (E 433) in each pre-filled syringe, which is equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
Vaccines
No data are available on the response to live or inactivated vaccines. Live vaccines should not be given concurrently with tildrakizumab (see section 4.4).
Interactions with cytochrome P450
Concomitant medicinal products affecting tildrakizumab pharmacokinetics are not expected since it is cleared from the body by general protein catabolism processes with no contribution of cytochrome P450 (CYP450) enzymes, and it is not eliminated by renal or hepatic pathways. Furthermore, tildrakizumab does not impact the pharmacokinetics of concomitant medicinal products metabolised by CYP450 enzymes either through direct or indirect mechanisms (see section 5.2).
Interactions with other immunosuppressive agents or phototherapy
The safety and efficacy of tildrakizumab in combination with other immunosupressive agents, including biologics, or phototherapy has not been evaluated.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.
Pregnancy
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy.
Breast-feeding
It is unknown whether tildrakizumab is excreted in human milk. Available toxicological data in cynomolgus monkey have shown negligible levels of Ilumetri in milk on postnatal day 28 (see section 5.3). In humans, during the first few days after birth antibodies may be transferred to the newborns through milk. In this short period, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ilumetri therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
The effect of Ilumetri on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Ilumetri has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most common adverse reactions are upper respiratory tract infections (12.6%), headache (4.0%), diarrhoea (1.6%), gastroenteritis (1.5%), back pain (1.5%), nausea (1.3%) and injection site pain (1.3%).
Tabulated list of adverse reactions
Adverse reactions from clinical studies (Table 1) are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 1. List of adverse reactions
MedDRA System organ class
Preferred term
Frequency category
Infections and infestations
Upper respiratory tract infectionsa
Very common
Nervous system disorders
Headache
Common
Gastrointestinal disorders
Gastroenteritis
Common
Diarrhoea
Common
Nausea
Common
General disorders and administration site conditions
Back pain
Common
Injection site pain
Common
aIncluding nasopharyngitis.
Long-term Safety
The safety profile of tildrakizumab observed during the long-term extensions periods of reSURFACE 1 and reSURFACE 2 was consistent with that of the double-blind periods.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Doses up to 10 mg/kg intravenously have been safely administered in clinical trials.
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment be instituted immediately.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ILUMETRI 100 mg prescriptionTILDRAKIZUMABUM · injection / infusion
- ILUMETRI 200 mg prescriptionTILDRAKIZUMABUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- IlumetriTildrakizumabum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Ilumetri 200 mg solution for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.