Spevigo 450 mg concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Spevigo 450mg concentrate for solution for infusion

espesolimab

This medicine 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. Section 4 at the end of this leaflet includes information on how to report side effects.

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 Spevigo is administered to you
3. How Spevigo is administered
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 as monotherapy in adults and adolescents from the age of 12 years to treat flares 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 improves skin lesions and reduces the symptoms of GPP during a flare.

2. What you need to know before Spevigo is administered to you

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

Do not receive Spevigo if:

• you are allergic to spesolimab 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 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, 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 should not receive certain types of vaccines (live microbial vaccines) for at least 16 weeks after receiving Spevigo.
• you experience symptoms such as weakness in your arms or legs that you did not have before, 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).

Infections

Tell your doctor as soon as possible if you notice any signs or symptoms of infection after receiving 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 administration of this medicine. You may also experience allergic reactions several days or weeks after receiving 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 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 need to take any other medicines, including any other medicines for treating PPP.
• you are going to receive or have recently received a vaccine. You should not receive certain types of vaccines (live microbial vaccines) for at least 16 weeks after receiving Spevigo.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor before receiving this medicine. This is because 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 delivery. Therefore, you should inform your doctor if you are breastfeeding or plan 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. 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; this is essentially “sodium-free”.

3. How Spevigo is administered

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

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

Your doctor or nurse will administer this medicine to you by intravenous 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 or temporarily interrupted.

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

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

If you receive more Spevigo than you should

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

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 administration of 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 receiving Spevigo.

Contact your doctor immediately if you develop a widespread skin rash you have not 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).

Inform your doctor as soon as possible if you notice any sign or symptom of an infection.

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

• fever, cough

Common (may affect up to 1 in 10 people)

• frequent urination, pain or burning during urination, 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 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, 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, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed 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 which is stated on the vial and the carton after 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) (see information for healthcare professionals at the end of this leaflet).

Do not freeze.

Keep in the original packaging to protect from light.

6. Contents of the pack and other 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 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 contents of the container

Spevigo concentrate for solution for infusion is a solution ranging from transparent to slightly opalescent and from colourless to pale yellowish-brown, supplied in a 10 ml colourless glass vial (Type I glass), with a coated rubber stopper and an aluminium flip-off seal with a blue plastic disc.

Each pack contains two vials.

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

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the latest review of this summary: {MM/YYYY}.

This medicinal product has been authorised with a "conditional approval". This type of approval means that further information on the medicine is expected.

The European Medicines Agency will review new information on this medicine at least once a year and this summary will be updated as necessary.

Other sources of information

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

This information is intended for healthcare professionals only:

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine should be clearly documented.

Dosage and method of administration

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

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

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

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

Handling instructions

• The vial should be inspected visually before use.

  • Spevigo is a solution ranging from colourless to a slight yellowish-brown colour and from transparent to slightly opalescent.
  • If the solution is cloudy, has changed colour, or contains large or coloured particles, the vial must be discarded.

• Sterile espesolimab concentrate is for single use only.

• Aseptic technique must 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 injection 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 injection 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 must not be mixed with other medicines. An existing intravenous line may be used for administration of the diluted espesolimab infusion solution. The line should be flushed with an injection solution containing 9 mg/ml sodium chloride (0.9%) before and after the infusion. No other infusion should be administered simultaneously 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 filter membranes composed 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 in the original packaging to protect from light.

• Before use, the unopened vial may be stored at temperatures up to 30 °C for a maximum of 24 hours, provided it is kept in the original packaging to protect from light.

After opening

• From a microbiological standpoint, once opened, the medicine should be diluted and administered immediately.

After preparation of the infusion

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