Spevigo 450 mg concentrado para solucion para perfusion

Patient Information Leaflet

Spevigo 450mg Concentrate for Solution for Infusion

espesolimab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

1.What isSpevigoand what it is used for

2.What you need to know before you are givenSpevigo

3.How to administerSpevigo

4.Possible adverse effects

5.Storage ofSpevigo

6.Contents of the pack and additional information

What is Spevigo

Spevigocontains the active ingredient espesolimab. Espesolimab belongs to a group of medicines known as interleukin inhibitors (IL). This medicine acts by blocking the activity of a protein called IL36R, which is involved in inflammation.

How is Spevigo used

Spevigois used as monotherapy in adults and adolescents aged 12 years and older to treat flare-ups of a rare inflammatory skin disease called generalized pustular psoriasis (GPP). During a flare-up, patients may experience painful skin blisters that form suddenly in large areas of the skin. These blisters, also known as pustules, are filled with pus. The skin may become itchy and red, dry, cracked, or flaky. Patients may also experience more general symptoms, such as fever, headache, extreme fatigue, or a sensation of burning in the skin.

Spevigoimproves skin lesions and reduces symptoms of GPP during a flare-up.

A doctor with experience in treating patients with inflammatory skin diseases will initiate and supervise your treatment.

You should not receive Spevigo if:

• you are allergic to espesolimab or any of the other components of this medication (listed in section6).
• you have active tuberculosis or other serious infections (see “Warnings and precautions”).

Warnings and precautions

Consult your doctor or nurse before receiving Spevigo if:

• you currently have an infection or have a recurring infection. Fever, flu-like symptoms, fatigue, or difficulty breathing, persistent cough, hot, red, and painful skin, or painful rash with blisters may be signs and symptoms of an infection.
• you have, had tuberculosis, or have been in close contact with someone with tuberculosis.
• you have recently received or plan to receive a vaccine. You should not receive certain types of vaccines (live microorganism vaccines) for at least 16weeks after receiving Spevigo.
• you experience symptoms such as weakness in your arms or legs that you did not have before, numbness, tingling, or a burning sensation in any part of your body. These could be signs of peripheral neuropathy (nerve damage).

Infections

Inform your doctor as soon as possible if you notice any signs or symptoms of an infection after receiving Spevigo (see section4 “Possible side effects”).

Allergic reactions

Consult your doctor immediately if you notice any signs or symptoms of an allergic reaction during or after receiving this medication. You may also experience allergic reactions several days or weeks after receiving Spevigo.For signs and symptoms, see section4 “Possible side effects”.

Children and adolescents

Spevigo is not recommended for children under 12years of age because it has not been studied in this age group.

Other medications and Spevigo

Inform your doctor if:

• you are taking, have taken recently, or may need to take any other medication,including any other medication for treating PPG.
• you are to receive or have recently received a vaccine. You should not receive certain types of vaccines (live microorganism vaccines) for at least 16weeks after receiving Spevigo.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication. The reason is that it is not known how this medication will affect your child.

Therefore, it is preferable to avoid using Spevigo during pregnancy.

Only receive this medication if your doctor clearly recommends it.

Breastfeeding

It is unknown whether Spevigo is excreted in breast milk. Spevigo may pass into breast milk during the first few days after delivery. Therefore, inform your doctor if you are breastfeeding or plan to do so, so that you and your doctor can decide whether you can receive Spevigo.

Driving and operating machines

Spevigo is not expected to affect your ability to drive and operate machines.

Spevigo contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”.

The recommended dose in adults and adolescents 12 years of age and older and weighing at least 40 kg is 900 mg (two vials of 450 mg).

The recommended dose in adolescents 12 years of age and older weighing between 30 and less than 40 kg is 450 mg (one vial of 450 mg).

Your doctor or nurse will administer this medication through an infusion (IV) in a vein. It will be administered for a period of 90 minutes up to a maximum of 180 minutes if the infusion is slowed or temporarily interrupted.

If you continue to experience symptoms of the outbreak, your doctor may decide to administer a second dose of Spevigo one week after the first.

If you have any other questions about the use of this medication, ask your doctor.

If you receive more Spevigo than you should

This medication will be administered by your doctor or nurse. If you believe you have been given too much Spevigo, inform your doctor or nurse immediately.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Consult your doctor immediately if you notice any signs or symptoms of an allergic reaction during or after administration of this medicine. These may be:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• intense itching on the skin, with a red rash or different bumps from the symptoms of PPG
• feeling of dizziness

You may also have allergic reactions several days or weeks after receiving Spevigo.

Consult your doctor immediatelyif a generalized skin rash appears that you have not had before, fever, and/or swelling of the face between 2 and 8weeks after receiving the medicine. These could be signs of a delayed allergic reaction (hypersensitivity).

Inform your doctor as soon as possible if you notice any signs or symptoms of an infection.

Very common (may affect more than 1 in 10people). These may be:

• fever, cough

• frequent urination, pain or burning sensation while urinating, or blood in the urine, which may be symptoms of urinary tract infections

Inform your doctor or nurse if you experience any of the following other side effects:

Very common(may affect more than 1 in 10people)

• redness, swelling, hardening, heat, pain, peeling of the skin, small solid bumps on the skin, itching, skin rash, or nodules at the injection site

Common(may affect up to 1 in 10people)

• itching
• feeling of fatigue

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and the box after EXP or CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C)(see information for healthcare professionals at the end of this leaflet).

Do not freeze.

Store in the original packaging to protect it from light.

Composition of Spevigo

• The active principle is espesolimab. Each vial contains 450 mg of espesolimab in 7.5 ml of concentrate for solution for infusion.
• The other components are sodium acetate trihydrate (E262), glacial acetic acid (E260) (for pH adjustment), sucrose, arginine hydrochloride, polisorbate 20 (E432) and water for injection.

Appearance of the product and contents of the container

Spevigo concentrate for solution for infusion is a solution that is transparent or slightly opalescent and colorless or with a light yellowish brown color, which is presented in a colorless glass vial of 10 ml (type I glass), with a rubber stopper and a folding aluminum cap with a blue plastic disc.

Each pack contains two vials.

Marketing authorization holder

Boehringer Ingelheim International GmbH

Binger Str. 173

55216 Ingelheim am Rhein

Germany

Responsible for manufacturing

Boehringer Ingelheim Pharma GmbH & Co. KG

Birkendorfer Strasse 65

88397 Biberach an der Riss

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country:

Last update of the summary of product characteristics:{MM/AAAA}.

This medicinal product has been granted a conditional approval. This type of approval means that further information about this medicinal product is expected.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this summary of product characteristics will be updated as necessary.

Other sources of information

Further information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the medicinal product administered must be clearly recorded.

Dosage and administration

The recommended dose in adults and adolescents aged 12 years and older and weighing at least 40 kg is a single dose of 900 mg (two vials of 450 mg) administered as an intravenous infusion.

If symptoms of the flare persist, an additional dose of 900 mg may be administered one week after the initial dose.

The recommended dose in adolescents aged 12 years and older weighing ≥ 30 kg and <40 kg is a single dose of 450 mg (one vial mg) administered as an intravenous infusion. if symptoms the flare persist, additional may be one week after initial dose.< span>

Spevigo must be diluted before use. It must not be administered as an intravenous rapid bolus or injection.

After dilution with a 9 mg/ml (0.9%) sodium chloride solution, Spevigo is administered as an intravenous continuous infusion through a sterile, apyrogenic, and low protein-binding intravenous line filter (0.2 μm pore size) for 90 minutes. No other infusion should be administered in parallel through the same intravenous access.

If the infusion is slowed or temporarily interrupted, the total infusion time (including the pause time) must not exceed 180 minutes.

Handling instructions

• Visually inspect the vial before use.
• • Spevigo is a solution that is colorless or with a light yellowish brown color and transparent or slightly opalescent.
  • If the solution is turbid, has changed color, or contains large or colored particles, the vial must be discarded.

• Speesolimab concentrate is for single use.

• Use an aseptic technique to prepare the infusion solution:
• • For the recommended dose of 900 mg, remove and discard 15 ml from a 100 ml 9 mg/ml sodium chloride solution and replace it slowly with 15 ml of sterile espesolimab concentrate (two vials of 450 mg/7.5 ml).
  • For the recommended dose of 450 mg, remove and discard 7.5 ml from a 100 ml 9 mg/ml sodium chloride solution and replace it slowly with 7.5 ml of sterile espesolimab concentrate (one vial of 450 mg/7.5 ml).
  • Mix the solution gently before use. The diluted espesolimab infusion solution must be used immediately.

• Spevigo must not be mixed with other medicinal products. A pre-existing intravenous line may be used for the administration of the diluted espesolimab infusion solution. The line must be flushed with a 9 mg/ml sodium chloride solution before and after the infusion. No other infusion should be administered in parallel through the same intravenous access.

• Spevigo is compatible with infusion equipment composed of PVC, PE, PP, PB, and PUR, and with in-line filters composed of PES (neutral and positively charged) and PA (positively charged).

Storage conditions

Unopened vial

• Store in the refrigerator (between 2°C and 8°C). Do not freeze.
• Store in the original packaging to protect it from light.
• Before use, the unopened vial may be stored at temperatures up to 30°C for a maximum of 24 hours if stored in the original packaging to protect it from light.

After opening

• From a microbiological point of view, the medicinal product must be diluted and administered immediately after opening.

After preparation of the infusion

• The chemical and physical stability of the diluted infusion solution has been demonstrated under conditions of use for 24 hours between 2°C and 30°C.
• From a microbiological point of view, the diluted infusion solution must be used immediately. If not used immediately, the storage conditions in use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless the dilution has taken place in controlled and validated aseptic conditions. During the time between preparation and administration, the infusion solution must be protected from light following local usual procedures.