SPEVIGO 450 MG CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Spevigo 450mg concentrate for solution for infusion

espesolimab

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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.

Contents of the pack

1. What Spevigo is and what it is used for
2. What you need to know before you are given Spevigo
3. How Spevigo is given
4. Possible side effects
5. Storage of Spevigo
6. Contents of the pack and other information

1. What Spevigo is and what it is used for

What Spevigo is

Spevigo contains the active substance espesolimab. Espesolimab belongs to a group of medicines called interleukin inhibitors (IL). 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 on its own in adults and adolescents from 12 years of age to treat flare-ups of a rare inflammatory skin disease called generalized pustular psoriasis (GPP). During a flare-up, patients may have painful skin blisters that suddenly form on large areas of the skin. These blisters, also called pustules, are filled with pus. The skin may become itchy and red, dry, cracked, or scaly. Patients may also experience more general signs and symptoms, such as fever, headache, extreme tiredness, or a burning sensation on the skin.

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

2. What you need to know before you are given Spevigo

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

You must not be given Spevigo if:

• you are allergic to espesolimab or any of the other ingredients of this medicine (listed in section 6).
• you have active tuberculosis or other severe infections (see “Warnings and precautions”).

Warnings and precautions

Tell your doctor or nurse before you are given Spevigo if:

• you currently have an infection or have an infection that keeps coming back. Fever, flu-like symptoms, tiredness, or difficulty breathing, cough that won't go away, hot, red, painful skin, or a painful rash with blisters may be signs and symptoms of an infection.
• you have or have had tuberculosis or have been in close contact with someone with tuberculosis.
• you have recently received or are scheduled to receive a vaccine. You must not receive certain types of vaccines (live organism vaccines) for at least 16 weeks after receiving Spevigo.
• you experience symptoms such as weakness in your arms or legs that you didn't have before, or numbness (loss of sensation), tingling, or a burning sensation in any part of your body. These could be signs of peripheral neuropathy (damage to the peripheral nerves).

Infections

Tell your doctor as soon as possible if you notice any signs or symptoms of an infection after receiving Spevigo (see section 4 “Possible side effects”).

Allergic reactions

See a doctor immediately if you notice any signs or symptoms of an allergic reaction during or after receiving this medicine. You may also have allergic reactions several days or weeks after receiving Spevigo. For signs and symptoms, see section 4 “Possible side effects”.

Children and adolescents

Spevigo is not recommended for use in 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, including any other medicines to treat GPP.
• you are going to receive or have recently received a vaccine. You must not receive certain types of vaccines (live organism vaccines) for at least 16 weeks after receiving Spevigo.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before receiving this medicine. The reason is that it is not known how this medicine will affect your baby.

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

If you are pregnant, you should only receive this medicine if your doctor clearly recommends it.

Breastfeeding

It is not known whether Spevigo is excreted in breast milk. Spevigo may pass into breast milk during the first few days after birth. Therefore, you should tell your doctor if you are breastfeeding or planning to breastfeed so that you and your doctor can decide whether you can receive Spevigo.

Driving and using machines

Spevigo is not expected to affect your ability to drive or use machines.

Spevigo contains polysorbate

This medicine contains 3 mg of polysorbate 20 in each 7.5 ml vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Spevigo contains sodium

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

3. How Spevigo is given

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

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

Your doctor or nurse will give you this medicine by infusion (drip) into a vein. It will be given over a period of 90 minutes up to a maximum of 180 minutes if the infusion is slowed down or temporarily interrupted.

If you continue to experience symptoms of the flare-up, your doctor may decide to give you a second dose of Spevigo one week after the first.

If you have any further questions on the use of this medicine, ask your doctor.

If you receive more Spevigo than you should

This medicine will be given to you by your doctor or nurse. If you think you have been given too much Spevigo, tell your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

See a doctor immediately if you notice any signs or symptoms of an allergic reaction during or after receiving this medicine. These may be:

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

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

See a doctor immediatelyif you get a widespread skin rash that you haven't had before, fever, and/or swelling of the face between 2 and 8 weeks after receiving the medicine. These could 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.

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

• fever, cough
• Common(may affect up to 1 in 10 people)

• frequent urination, pain or burning when urinating, or blood in the 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 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

Frequency not known(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. Storage of 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 vial and carton after EXP or CAD. The expiry date is the last day of the month stated.

Store in a 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 from light.

6. Container contents and additional information

Composition of Spevigo

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

Appearance and container contents of the product

Spevigo concentrate for solution for infusion is a solution that is between transparent and slightly opalescent and between colorless and slightly brownish-yellow in color, presented in a 10 ml colorless glass vial (Type I glass), with a coated rubber stopper and a foldable aluminum cap with a blue plastic disc.

Each container contains two vials.

Marketing authorization holder

Boehringer Ingelheim International GmbH

Binger Str. 173

55216 Ingelheim am Rhein

Germany

Manufacturer

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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:{MM/YYYY}.

This medicinal product has been authorized with a "conditional approval". This approval means that more information is expected to be provided on this medicinal product.

The European Medicines Agency will review the new information on this medicinal product at least once a year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

Traceability

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

Posology and method of administration

The recommended dose in adults and adolescents from 12 years of age 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 from 12 years of age with a weight ≥ 30 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.< p>

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

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

In case the infusion is slowed down or temporarily interrupted, the total infusion time (including the interruption time) should not exceed 180 minutes.

Handling instructions

• The vial should be inspected visually before use.
• • Spevigo is a solution that is between colorless and slightly brownish-yellow in color and between transparent and slightly opalescent.
  • If the solution is turbid, has changed color, or contains large or colored particles, the vial should be discarded.

• Sterile espesolimab concentrate is for single use only.

• Aseptic technique should be used to prepare the infusion solution:
• • For the recommended dose of 900 mg, withdraw and discard 15 ml from a 100 ml container of injectable solution containing 9 mg/ml sodium chloride (0.9%) and slowly replace it with 15 ml of sterile espesolimab concentrate (two vials of 450 mg/7.5 ml).
  • For the recommended dose of 450 mg, withdraw and discard 7.5 ml from a 100 ml container of injectable solution containing 9 mg/ml sodium chloride (0.9%) and slowly replace it with 7.5 ml of sterile espesolimab concentrate (one vial of 450 mg/7.5 ml).
  • Gently mix the solution before use. The diluted espesolimab infusion solution should be used immediately.

• Spevigo should 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 should be flushed with an injectable solution containing 9 mg/ml sodium chloride (0.9%) before and after the infusion. No other infusion should be administered in parallel through the same intravenous access.

• Spevigo is compatible with infusion equipment made of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene, and polyurethane (PUR), and with in-line filters made of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).

Storage conditions

Unopened vial

• Store in a refrigerator (between 2°C and 8°C). Do not freeze.
• Keep the container in the outer carton to protect from light.

• Before use, the unopened vial may be stored at temperatures up to 30°C for a maximum of 24 hours if kept in the outer carton to protect from light.

After opening

• From a microbiological point of view, the product should be diluted and administered immediately.

After preparation of the infusion

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