InfoCons Consumer Protection informs you – Spevigo – Package Leaflet
Spevigo – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Spevigo, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Spevigo is and what it is used for
What Spevigo is Spevigo contains the active substance spesolimab. Spesolimab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of a protein called IL36R, which is involved in inflammation.
What Spevigo is used for
Spevigo is used in adults and adolescents from 12 years of age to prevent flares of a rare inflammatory skin disease called generalised pustular psoriasis (GPP). During a flare, patients may experience painful skin blisters that develop suddenly over large areas of the skin. These blisters, also called pustules, are filled with pus. The skin may become red, itchy, dry, cracked or scaly. Patients may also experience more general signs and symptoms, such as fever, headache, extreme tiredness, or a burning sensation of the skin.
Spevigo clears pustules and other skin manifestations and can therefore help to reduce the signs and symptoms of your disease.
⚠️ 2. What you need to know before you use Spevigo
A doctor experienced in treating patients with inflammatory skin diseases will start and supervise your treatment.
Do not use Spevigo if you
- are allergic to spesolimab or any of the other ingredients of this medicine (listed in section 6).
- have active tuberculosis or other severe infections (see “Warnings and precautions”).
Warnings and precautions
Talk to your doctor or nurse before and during the use of Spevigo if you:
- currently have an infection or have an infection that keeps coming back. Fever, flu -like symptoms, tiredness or shortness of breath, a cough which will not go away, warm, red and painful skin, or a painful rash with blisters can be signs and symptoms of an infection.
- have, have had tuberculosis, or have been in close contact with someone with tuberculosis.
66 • have recently had a vaccination or plan to have a vaccination. You should not be given certain types of vaccines (live vaccines) for at least 16 weeks after being given Spevigo. Your doctor will check if you need any vaccines before you start using Spevigo.
- experience symptoms like weakness in your arms or legs that was not there before or numbness (loss of sensation), tingling or a burning sensation in any part of your body. These might be signs of peripheral neuropathy (damage of the peripheral nerves).
It is important to keep a record of the batch number of your Spevigo.
Every time you get a new pack of Spevigo, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.
Infections Tell your doctor as soon as possible if you notice any signs or symptoms of an infection while you are using Spevigo, see section 4 “Possible side effects”.
Allergic reactions Seek medical help immediately if you notice any signs or symptoms of an allergic reaction while you are using or after you have used this medicine. You can also have allergic reactions some days or weeks after starting the use of Spevigo. For signs and symptoms see section 4 “Possible side effects”.
Children and adolescents
Spevigo is not recommended for children under 12 years of age because it has not been studied in this age group.
Other medicines and Spevigo
Tell your doctor if you are:
- taking, have recently taken or might take any other medicines.
- going to have or have recently had a vaccination. You should not be given certain types of vaccines (live vaccines) for at least 16 weeks after receiving Spevigo.
If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Spevigo.
Pregnancy and breast -feeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.
It is therefore preferable to avoid the use of Spevigo during pregnancy.
If you are pregnant, you should only receive this medicine if your doctor has clearly recommended it.
Breast -feeding It is not known whether Spevigo passes into breast milk. Spevigo may pass into breast milk in the first days after birth. You should therefore tell your doctor if you are breast -feeding or plan to breast -feed, so you and your doctor can decide if you can use Spevigo.
Driving and using machines
Spevigo is not expected to affect your ability to drive and use machines.
Spevigo contains polysorbate
This medicine contains 0.8 mg of polysorbate 20 in each 2 mL pre -filled syringe. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
Spevigo contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.
💊 3. How to use Spevigo
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much Spevigo to use Adults and adolescents from 12 years of age and weighing at least 40 kg How much? When?
1st dose 600 mg (two 300 mg injections) When your doctor tells you Further doses 300 mg (one 300 mg injection) Every 4 weeks starting after the 1st dose The first dose should be given by your doctor or nurse.
You and your doctor or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor or nurse. A caregiver may also give your injections after they have been trained.
Read the ‘Instructions for use’ at the end of this leaflet before injecting Spevigo yourself.
Adolescents from 12 years of age weighing 30 to less than 40 kg How much? When?
1st dose 300 mg (one 300 mg injection) When your doctor tells you Further doses 150 mg* Refer to the package leaflet for Spevigo 150 mg solution for injection in pre – filled syringe .
- Another pharmaceutical strength is available for administration of the 150 mg dose.
Spevigo should be given by your doctor or nurse.
If you use more Spevigo than you should
If you have used more Spevigo than you should or the dose has been given sooner than prescribed, talk to your doctor.
If you forget to use Spevigo
If you forget to use Spevigo, inject a dose as soon as you realise. Talk to your doctor if you are not sure what to do.
If you stop using Spevigo
Do not stop using Spevigo without talking to your doctor first. If you stop treatment, your symptoms may come back or you may experience a flare.
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.
Seek medical help immediately if you notice any signs or symptoms of an allergic reaction while using or after you have used this medicine. These may include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps, that is different from your GPP 68 symptoms
- feeling faint.
You can also have allergic reactions some days or weeks after you have used Spevigo.
Seek medical help immediately if you develop any widespread skin rash that was not there before, fever, and/or facial swelling 2 -8 weeks after you have used the medicine. These might be signs of a delayed allergic reaction (hypersensitivity).
Tell your doctor as soon as possible if you notice any signs or symptoms of an infection. These may include:
Very common (may affect more than 1 in 10 people)
- fever, cough
Common (may affect up to 1 in 10 people)
- frequent urination, pain or burning while urinating or bloody urine, which may be symptoms of urinary tract infections Tell your doctor or nurse if you get any of the following other side effects:
Very common (may affect more than 1 in 10 people)
- redness, swelling, hardening, warmth, pain, peeling of the skin, small, solid raised bumps on the skin, itching, skin rash, or hives at the injection site
Common ( may affect up to 1 in 10 people)
- itching
- feeling tired
Not known (frequency cannot be estimated from the available data)
- allergic reaction
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Spevigo
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 pre -filled syringe and the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Do not use Spevigo if frozen, even if it has been thawed.
If needed, Spevigo can be stored at temperatures up to 30 °C for up to 14 days. Throw away Spevigo if it has been kept at temperatures up to 30 °C for more than 14 days.
Store Spevigo pre-filled syringe in the original package in order to protect from light.
Do not use this medicine if the liquid is cloudy or contains flakes or large or coloured particles .
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 protect the environment.
📦 6. Contents of the pack and other information
What Spevigo contains
- The active substance is spesolimab. Each pre -filled syringe contains 300 mg spesolimab in 2 mL solution.
- The other ingredients are sodium acetate trihydrate (E262), glacial acetic acid (E260) (for pH adjustment), sucrose, arginine hydrochloride, polysorbate 20 (E432) and water for injections.
What Spevigo looks like and contents of the pack
Spevigo solution for injection is a clear to slightly opalescent, colourless to slightly brownish -yellow solution in a pre -filled syringe with safety cover . The liquid may contain tiny white or clear particles.
Each pre -filled syringe contains 300 mg in 2 mL solution for injection.
Each pack contains 1 pre-filled syringe.
Marketing Authorisation Holder
LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65 88397 Biberach an der Riss Germany 70 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien LEO Pharma N.V./S.A Tél/Tel: +32 3 740 7868 Lietuva LEO Pharma A/S Tel: +45 44 94 58 88 България LEO Pharma A/S Teл.: +45 44 94 58 88 Luxembourg/Luxemburg LEO Pharma N.V./S.A Tél/Tel: +32 3 740 7868 Česká republika LEO Pharma s.r.o.
Tel: +420 734 575 982 Magyarország LEO Pharma A/S Tel: +45 44 94 58 88 Danmark LEO Pharma AB Tlf: +45 70 22 49 11 Malta LEO Pharma A/S Tel: +45 44 94 58 88 Deutschland LEO Pharma GmbH Tel: +49 6102 2010 Nederland LEO Pharma B.V.
Tel: +31 205104141 Eesti LEO Pharma A/S Tel: +45 44 94 58 88 Norge LEO Pharma AS Tlf: +47 22514900 Ελλάδα LEO Pharmaceutical Hellas S.A.
Τηλ: + 30 212 222 5000 Österreich LEO Pharma GmbH Tel: +43 1 503 6979 España Laboratorios LEO Pharma, S.A.
Tel: +34 93 221 3366 Polska LEO Pharma Sp. z o.o.
Tel.: +48 22 244 18 40 France Laboratoires LEO Tél: +33 1 3014 4000 Portugal LEO Farmacêuticos Lda.
Tel: +351 21 711 0760 Hrvatska LEO Pharma A/S Tel: +45 44 94 58 88 Ireland LEO Laboratories Ltd Tel: +353 (0) 1 490 8924 România LEO Pharma A/S Tel: +45 44 94 58 88 Slovenija LEO Pharma A/S Tel: +45 44 94 58 88 Ísland LEO Pharma A/S Sími: +45 44 94 58 88 Slovenská republika LEO Pharma s.r.o.
Tel: +420 734 575 982 Italia LEO Pharma S.p.A Tel: +39 06 52625500 Suomi/Finland LEO Pharma Oy Puh/Tel: +358 20 721 8440 Κύπρος LEO Pharma A/S Sverige LEO Pharma AB 71 Τηλ: +45 44 94 58 88 Tel: +46 40 3522 00 Latvija LEO Pharma A/S Tel: +45 44 94 58 88
This leaflet was last revised in {MM/YYYY}
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
72 Instructions for use Spevigo 300 mg solution for injection in pre-filled syringe This “Instructions for use” contains information on how to inject Spevigo if the prescribed dose for you or your child requires 1 pre-filled syringe of Spevigo 300 mg.
Getting to know Spevigo The pre -filled syringe contains the active substance spesolimab in a solution for subcutaneous injection that helps to deliver a fixed dose of spesolimab.
Before you start using this medicine on your own or your child, first m ake sure that you get trained by your doctor, or nurse. Then read the package leaflet and these instructions for use to make sure you get the correct dose . If you are visually impaired and cannot see well, you must be assisted by a trained caregiver .
If you have further questions, ask your doctor, pharmacist or nurse.
Spevigo is for single use. Do not reuse the pre -filled syringe.
This is what Spevigo pre -filled syringe looks like Spevigo is a pre -filled syringe with a safety cover . The needle is pulled back into the safety cover after injection.
The following picture shows Spevigo before use and after use with the activated safety cover.
Important information you need to know before injecting Spevigo
- Do not use the pre-filled syringe until you have been shown the right way to give the injection and have read and understood th ese handling i nstructions.
- Inspect the carton that the product comes in to be sure that you have the correct medicine, the correct number of pre -filled syringes for your or your child’s prescribed dose, fo r any damage, and the expiry date.
- Do not remove the cap until you are ready to inject.
73 • Do not use Spevigo
- if the liquid is cloudy or contains flakes or large particles.
- if the expir y date (EXP) has passed.
- if the pre -filled syringe has been dropped or looks damaged.
- It is important to keep a record of the batch number of your Spevigo. Every time you get a new pack of Spevigo, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.
- Inject Spevigo under the skin (subcutaneous injection) in either the upper thighs or stomach area (abdomen). Do not inject Spevigo into any other area of the body.
- If you have any problems with your injection, do not repeat the injection steps with Spevigo pre-filled syringe. Call your doctor for help.
- If you have further questions, ask your doctor or pharmacist.
Follow the steps below when you use Spevigo STEP 1 Gathering supplies
- Take the Spevigo carton out of the refrigerator and remove the pre -filled syringe from the carton.
- Gather supplies listed and place them on a clean, flat work surface in a well-lit area.
- If you do not have all the supplies listed, contact your pharmacist.
- For disposal , see step 9: “Disposing of the used pre – filled syringe and cap.” STEP 2 Preparing to inject Spevigo
- Wait 15 to 30 minutes to allow the medicine to reach room temperature to avoid discomfort during injection.
- Do not speed up the warming process in any way, such as using the microwave or placing the syringe in warm water.
- Do not leave the pre -filled syringe in direct sunlight.
- Wash your hands well with soap and water and dry them.
STEP 3 Inspecting the pre -filled syringe Check the pre -filled syringe:
- Check to make sure the medicine name and dose on the pre -filled syringe match your or your child’s prescribed dose.
- Check the expiry date (EXP) on the pre -filled syringe. Do not use if the expiry date has passed.
- Check the pre -filled syringe for damage, cracks, and leakage. Do not use if any part of the pre -filled 74 syringe appears cracked, broken, or is leaking.
- Make sure the medicine in the pre -filled syringe is colourless to slightly yellow. It may contain tiny white or clear particles. Do not use if the medicine is cloudy or has flakes or large or coloured particles in it.
- It is normal to see air bubbles, they do not need to be removed.
- Do not use if the Spevigo pre -filled syringe ha s been dropped.
STEP 4 Choosing the injection site Choose an injection site.
- You may use an area on your: o upper thighs or o stomach -area (abdomen) , except for an area 5 cm around your navel (belly button).
- Do not inject into an area near your waistline or belly button.
- Do not inject into areas that are tender, bruised, red, hard, or scarred.
- Do not inject through clothes.
STEP 5 Cleaning the injection site
- Clean the injection site with an alcohol wipe and let air dry.
- Do not touch this area again before injecting.
- Do not fan or blow on the clean area.
STEP 6 Removing the cap
- Hold the pre -filled syringe by the finger grip with one hand. With the other hand, pull the cap straight off. o Do not pull on or hold the plunger rod. o Do not twist the cap. Twisting the cap could damage the needle. o Do not use the prefilled syringe if the needle is bent or damaged. If you accidentally bend the needle do not attempt to straighten it.
- Proceed to the next step right away after removing the cap. o Do not try to recap the needle. Re -capping can lead to needle -stick injury. o Do not touch the needle or let the needle touch anything before injecting.
75 STEP 7 Pinch the skin
- Gently pinch the area of cleaned skin around your injection site and hold it firmly.
- Keep the skin pinched during the entire injection.
- Do not let go until you have finished step 8C “Checking injection is complete”.
STEP 8 Before injecting, review steps A, B, and C to learn the correct way to inject Important: Do not move the pre -filled syringe when inserting the needle into your skin, while injecting, or when removing the needle from your skin.
- Hold the pre -filled syringe by the finger grip.
- Do not touch the thumb pad yet.
- Using a quick, “dart -like” motion, insert the needle into the pinched skin at about a 45-degree angle.
- Do not move the needle while inserting or during the injection.
A Inserting the needle To inject Spevigo:
- Use your thumb to slowly press down on the thumb pad to push the plunger rod down inside the syringe body.
- Continue pressing on the thumb pad until the plunger rod has moved all the way down.
- Make sure that the thumb pad cannot be pressed any further so that you can activate the built -in safety cover.
B Injecting the medicine
- Slowly remove your thumb from the thumb pad to move the needle out of your skin and up into the safety cover. o Check that the thumb pad springs back and that the needle is inside the safety cover. o If the needle is not inside the safety cover call your healthcare professional. You may not have received a full dose.
- If there is bleeding, press a cotton ball or gauze on the site for a few seconds.
- Do not rub the injection site.
- Apply an adhesive plaster if needed. C Checking injection is complete 76 STEP 9 Disposing of the used pre -filled syringe and cap
- Put the used syringe and cap in a sharps disposal container right away after use.
- Do not throw away (dispose of) the pre -filled syringe in the household waste.
- Your doctor, pharmacist, or nurse will tell you how to return the full sharps disposal container.
- Do not reuse the pre -filled syringe.
Important: Always keep the sharps disposal container out of the reach of children.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Spevigo (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/22/1688).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.
