100 mg solution for injection in a pre-filled syringe of
tildrakizumab
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 inhibitors (IL inhibitors).
This drug works by blocking the activity of a protein called IL-23, a substance that is found in the body and is involved in normal inflammatory responses and immune responses and which occurs in elevated levels in diseases such as psoriasis.
Ilumetry is used to treat a skin condition called plaque psoriasis in adults with moderate to severe illness. Using Ilumetri will help you by improving your skin’s healing ability and reducing your symptoms.
2. What you need to know before using 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 that your doctor considers significant, e.g. active tuberculosis which is an infectious disease that mainly affects the lungs.
Warnings and cautions
Talk to your doctor or pharmacist 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 a long-term or recurrent infection ,
- if you have recently received or are planning to receive 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.
Pay attention to your infection and allergic reactions
Ilumetry can cause serious side effects, including infections and allergic reactions. You must be aware of the signs of these conditions when taking Ilumetri.
Stop using Ilumetri and tell your doctor or seek medical help immediately if you notice any signs of a possible serious infection or an allergic reaction (see section 4 Possible side effects ).
Children and young people
Ilumetri is not recommended for use in children and adolescents under 18 years of age. This is because the drug has not yet been evaluated for this patient group.
Other drugs and Ilumetri
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include vaccines and immunosuppressive drugs (drugs that affect the immune system).
You should not receive certain types of vaccines (live vaccines) when using Ilumetri. Experience is lacking from the concomitant use of Ilumetri and live vaccine.
Pregnancy, breastfeeding and fertility
The use of Ilumetri should preferably be avoided during pregnancy. It is not known what effect the drug has on pregnant women.
Women of childbearing potential should avoid becoming pregnant and must use effective contraception while being treated with Ilumetri and for at least 17 weeks after treatment.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Ilumetri has no or little effect on the ability to drive and use machines.
3. How to use Ilumetri
Ilumetri is intended for use under the guidance and supervision of a physician experienced in diagnosing and treating psoriasis.
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. This medicine is for single use only.
The recommended dose of Ilumetri is 100 mg via subcutaneous injection at weeks 0 and 4 and every 12 weeks thereafter. In patients with special characteristics (eg severe disease, bodyweight ≥ 90 kg), 200 mg may have a greater effect.
Your doctor will decide for how long you need to use Ilumetri.
After proper training in subcutaneous injection techniques, you can inject Ilumetri yourself, if your doctor deems it appropriate.
Instructions on how to inject yourself with Ilumetri can be found in the “Instructions for Use” section at the end of this leaflet.
Talk to your doctor about when to get/take your injections and go on follow-up visits.
Use for children and adolescents
The safety and efficacy of Ilumetri in children and adolescents under 18 years of age have not yet been established and therefore Ilumetri is not recommended for use in children and adolescents.
If you take more Ilumetri than you should
Tell your doctor if you have injected too much Ilumetri or if you have taken a dose earlier than your doctor advised.
If you forget to use Ilumetri
If you have forgotten or skipped an injection with Ilumetri, take dose one as soon as possible. Then continue to take the doses according to the scheduled intervals.
If you stop using Ilumetri
The decision to stop using Ilumetri should be discussed with your doctor. Your symptoms may return if you stop using the medicine.
If you have any further questions on the use of this product, 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 are
If you notice any of the following, contact your doctor immediately :
- swelling of the face, lips or neck
- breathing difficulties
Because these may be signs of an allergic reaction.
Other side effects are
Most of the following side effects are mild. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
A very common side effect is (can occur in more than 1 in 10):
- upper respiratory tract infections
Common side effects are (may affect up to 1 in 10):
- gastrointestinal inflammation ( gastroenteritis )
- nausea
- diarrhea
- injection site pain
- back pain
- headache
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 label on the pre-filled syringe after EXP. The expiration date is the last day of the specified month.
Store the product in the original box until use. Sensitive to light. Do not shake.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Once a pre-filled syringe has been removed from the refrigerator, wait approximately 30 minutes for the Ilumetry solution in the syringe to reach room temperature (up to 25 ºC). Do not heat in any other way.
Do not use if the liquid contains visible particles, is cloudy, or browned.
Once a syringe has been removed from the refrigerator, it should not be stored at temperatures above 25 ºC and should not be refrigerated again. Write down the date when the syringe was taken out of the refrigerator in the box on the outer carton and the correct date of destruction. Use the syringe within 30 days of being taken out of the refrigerator or by the expiration date, whichever comes first.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is tildrakizumab. Each pre-filled syringe contains 100 mg tildrakizumab.
- The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injections.
What the medicine looks like and contents of the pack
Ilumetri is a solution that is clear to slightly opalescent and colorless to pale yellow.
Illumetri is available in packs containing 1 pre-filled syringe and a multi-pack containing 2 cartons of 1 pre-filled syringe each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Almirall, SA
Ronda General Miter, 151
08022 Barcelona, Spain
Manufacturer
SUN Pharmaceuticals Industries (Europe) BV
Polarisavenue 87
2132JH Hoofddorp, The Netherlands
Pharmaceutical Industries Almirall, SA
Ctra. of Martorell 41-61
08740 Sant Andreu de la Barca, Barcelona, Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
| België / Belgique / Belgien /Luxembourg / LuxemburgAlmirall NVTel: +32 (0) 2 257 26 63 | IcelandVistor hf.Phone: +354 535 70 00 |
| България / Česká republika / Eesti / Ελλάδα / España / Hrvatska / Κύπρος / Latvija / Lietuva / Magyarország / Malta / România / Slovenija / Slovenská republikaAlmirall, SATel / Tel: +34 93 291 30 00Tel (Czech Republic / Slovak Republic): +420 220 990 139 | ItalyAlmirall SpATel .: +39 02 346181 |
| Denmark / Norway / Suomi / Finland / SwedenAlmirall ApSTlf / Puh / Tel: +45 70 25 75 75 | The NetherlandsAlmirall BVTel: +31 (0) 307991155 |
| GermanyAlmirall Hermal GmbHTel .: +49 (0) 40 72704-0 | AustriaAlmirall GmbHTel .: +43 (0) 1/595 39 60 |
| FranceAlmirall SAS, 1Tel .: +33 (0) 1 46 46 19 20 | PolandAlmirall Sp.z ooTel .: +48 22 330 02 57 |
| Ireland / United Kingdom (Northern Ireland)Almirall, Satel: +353 (0) 1431 9836 | Portugal |