Spevigo 300 mg solution for injection in pre-filled syringe

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Spevigo 300mg solution for injection in pre-filled syringe

espesolimab

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read the entire leaflet carefully, as 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 side effects, consult your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Spevigo is and what it is used for
2. What you need to know before using Spevigo
3. How to use Spevigo
4. Possible side effects
5. How to store 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 spesolimab. Spesolimab belongs to a group of medicines known as 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 aged 12 years and older for maintenance treatment of a rare inflammatory skin disease called generalized pustular psoriasis (GPP). During a flare, patients may develop painful skin blisters that suddenly appear over large areas of the skin. These blisters, also known as pustules, are filled with pus. The skin may become itchy, red, dry, cracked, or scaly. Patients may also experience more general signs and symptoms, such as fever, headache, extreme fatigue, or a burning sensation in the skin.

Spevigo clears pustules and other skin manifestations and, therefore, may help reduce the signs and symptoms of the disease.

2. What you need to know before using Spevigo

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

Do not use Spevigo if:

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

Warnings and precautions

Talk to your doctor or nurse before starting and during treatment with Spevigo if:

• you currently have an infection or have an infection that keeps recurring. Fever, flu-like symptoms, fatigue, difficulty breathing, persistent cough, skin that is hot, red and painful, or a painful rash with blisters may be signs and symptoms of infection.
• you have, have had, or have been in close contact with someone who has tuberculosis.
• you have recently received or are planning to receive a vaccine. You must not receive certain types of vaccines (live microorganism vaccines) for at least 16 weeks after receiving Spevigo. Your doctor will check whether you need any vaccinations before starting Spevigo.
• you experience symptoms such as new weakness in your arms or legs, or numbness (loss of sensation), tingling, or a burning sensation anywhere in your body. These could be signs of peripheral neuropathy (damage to the peripheral nerves).

It is important to keep a record of the batch number of Spevigo.

Each time you obtain a new package of Spevigo, write down the date and the batch number (shown on the packaging after “Batch”) and keep this information in a safe place.

Infections

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

Allergic reactions

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

Children and adolescents

Use of Spevigo is not recommended in children under 12 years of age, as 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 need to take any other medicines.
• you are due to receive or have recently received a vaccine. You must not receive certain types of vaccines (live microorganism vaccines) for at least 16 weeks after receiving Spevigo.

If you are unsure, talk to your doctor, pharmacist, or nurse before using Spevigo and during treatment.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor before using this medicine. This is because it is not known how this medicine may affect your unborn child.

Therefore, use of Spevigo during pregnancy should be avoided.

If you are pregnant, you should only use this medicine if clearly recommended by your doctor.

Breastfeeding

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

Driving and using machines

Spevigo is not expected to affect your ability to drive or operate machinery.

Spevigo contains polysorbate

This medicine contains 0.8 mg of polysorbate 20 in each 2 ml pre-filled syringe. Polysorbates may cause allergic reactions. Inform 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 to use Spevigo

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Amount of Spevigo to use

Adults and adolescents aged 12 years and older, and weighing at least 40 kg

The first dose will be administered by your doctor or nurse.

You and your doctor or nurse will decide whether you should self-inject this medicine. Do not inject this medicine yourself unless your doctor or nurse has trained you to do so. A caregiver may also administer the injections after being trained to do so.

Read the “Instructions for use” section at the end of this leaflet before injecting Spevigo.

Adolescents 12 years of age and older weighing between 30 and less than 40 kg

• Another pharmaceutical concentration is available for administration of the 150 mg dose.

Spevigo will be administered to you by your doctor or nurse.

If you use more Spevigo than you should

If you have used more Spevigo than you should, or if you have received the dose earlier than prescribed, consult your doctor.

If you forget to use Spevigo

If you forget to use Spevigo, inject the dose as soon as you remember. Consult your doctor if you are unsure what to do.

If you stop using Spevigo

Do not stop treatment with Spevigo without first consulting your doctor. If you stop treatment, your symptoms may return or you may experience a flare-up.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you notice any sign or symptom of an allergic reaction during or after using this medicine. These may include:

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

You may also experience allergic reactions several days or weeks after using Spevigo.

Contact your doctor immediately if you develop a widespread skin rash that you have not had before, fever, and/or swelling of the face between 2 and 8 weeks after using the medicine. These could be signs of a delayed allergic reaction (hypersensitivity).

Tell your doctor as soon as possible if you notice any sign or symptom 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 when urinating, or blood in the urine, which may be symptoms of urinary tract infections

Tell your doctor or nurse if you experience any of the following additional adverse effects:

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

• redness, swelling, hardening, warmth, pain, skin peeling, small solid lumps 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 available data)

• allergic reaction

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the pre-filled syringe and outer carton following EXP or CAD. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Do not use Spevigo if it has been frozen, even if subsequently thawed.

If necessary, Spevigo may be stored at temperatures up to 30 °C for a maximum of 14 days. Discard Spevigo if it has been stored at temperatures up to 30 °C for longer than 14 days.

Keep the pre-filled syringe of Spevigo in its original packaging to protect it from light.

Do not use this medicine if the solution is cloudy or contains flakes or large or coloured particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Spevigo

• The active substance is espesolimab. Each pre-filled syringe contains 300 mg of espesolimab in 2 ml of solution.
• The other components are sodium acetate trihydrate (E262), glacial acetic acid (E260) (for pH adjustment), sucrose, arginine hydrochloride, polysorbate 20 (E432), and water for injections.

Nature of the product and pack contents

Spevigo injectable solution is a solution that is transparent to slightly opalescent and colourless to slightly yellowish-brown in a pre-filled syringe with a safety guard. The liquid may contain very small white or transparent particles. Each pre-filled syringe contains 300 mg in 2 ml of injectable solution.

Each pack contains one pre-filled syringe.

Marketing Authorization Holder

LEO Pharma A/S

Industriparken 55

DK 2750 Ballerup

Denmark

Manufacturer

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Boehringer Ingelheim Pharma GmbH & Co. KG

Birkendorfer Strasse 65

88397 Biberach an der Riss

Germany

More information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Other sources of information

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

Instructions for use

Spevigo 300 mg solution for injection in a pre-filled syringe

These “Instructions for use” contain information on how to inject Spevigo if the prescribed dose for you or your child requires 1 pre-filled syringe of Spevigo 300 mg.

Description of Spevigo

The pre-filled syringe contains the active substance espesolimab in a solution for subcutaneous injection, which helps deliver a fixed dose of espesolimab.

Before you start using this medicine on yourself or your child, make sure your doctor or nurse has trained you in its use. Then read the leaflet and these instructions for use to ensure you administer the correct dose. If you have visual impairment or poor eyesight, a caregiver trained in using the device should assist you.

If you have further questions, consult your doctor, pharmacist, or nurse.

Spevigo is for single use only. Do not reuse the pre-filled syringe.

Appearance of the Spevigo pre-filled syringe

Spevigo is a pre-filled syringe with a safety shield. The needle retracts into the safety shield after injection.

The following image shows the Spevigo pre-filled syringe before use and after use with the safety shield activated.

Important information you need to know before injecting Spevigo

• Do not use the pre-filled syringe until you have been trained in the correct way to administer the injection and have read and understood these handling instructions.

• Inspect the product packaging to ensure it contains the correct medicine, the correct number of pre-filled syringes for the dose prescribed for you or your child, to rule out any damage, and check the expiration date.

• Do not remove the cap until you are ready for the injection.

• Do not use Spevigo:

  • if the liquid is cloudy or contains flakes or large particles
  • if the expiration date (CAD or EXP) has passed
  • if the pre-filled syringe has been dropped or appears damaged

• It is important that you keep a record of the batch number of Spevigo. Each time you receive a new pack of Spevigo, record the date and the batch number (shown on the packaging after “Lote”) and keep this information in a safe place.

• Inject Spevigo under the skin (subcutaneous injection) in the upper thigh or abdominal area (abdomen). Do not inject Spevigo in any other part of the body.

• If you experience any problems with the injection, do not continue with the injection steps using the Spevigo pre-filled syringe. Contact your doctor for assistance.

• If you have any further doubts, consult your doctor or pharmacist.

Follow the steps below when using Spevigo