Spevigo

Package leaflet: Information for the patient

Spevigo 450 mg concentrate for solution for infusion

spesolimab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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 will be administered to you
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 called interleukin (IL) inhibitors. This medicine works by blocking the activity of IL36R, a protein involved in inflammation.

What Spevigo is used for
Spevigo is used alone in adults and adolescents aged 12 years and older for the treatment of flares of a rare inflammatory skin disease called generalized pustular psoriasis (GPP). A flare is characterized by the sudden appearance of painful blisters over large areas of the skin. These blisters, also known as pustules, are filled with pus. The skin may become red, dry, cracked, or scaly, and itching may occur. Patients may also experience more general signs and symptoms, such as fever, headache, extreme fatigue, or a burning sensation on the skin.

Spevigo helps heal skin lesions and reduces GPP symptoms that occur during a flare.

2. What you should know before being given Spevigo

Treatment will be initiated and carried out under the supervision of a physician experienced in the treatment of
patients with inflammatory skin diseases.
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 a history of recurrent infections. Fever, flu-like symptoms, fatigue, shortness of breath, persistent cough, warmth, redness and pain in the skin, or a painful rash with blisters may be signs and symptoms of an infection.
• you have or have had tuberculosis, or if you have been in close contact with someone who has tuberculosis.
• you have recently received or are due to receive a vaccine. Certain types of vaccines (live vaccines) must not be given for at least 16 weeks after receiving Spevigo.
• you experience symptoms such as new or worsening weakness in the arms or legs, numbness (loss of sensation), tingling, or a burning sensation anywhere in the body. These could be signs of peripheral neuropathy (damage to the peripheral nerves).

Infections
Inform 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
Seek immediate medical help if you notice any signs or symptoms of an allergic reaction during or after treatment with this medicine. An allergic reaction may occur even 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 children under 12 years of age, as it has not been studied in this age group.
Other medicines and Spevigo
Inform your doctor if:

• you are taking, have recently taken, or might take any other medicines, including any other medicines for the treatment of GPP.
• you are scheduled for or have recently received a vaccination. Certain types of vaccines (live vaccines) must not be given for at least 16 weeks after receiving Spevigo.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before receiving this medicine. This is because it is not known how this medicine may affect the unborn baby.
Therefore, use of Spevigo during pregnancy should preferably be avoided.
If you are pregnant, the medicine should only be administered if clearly recommended by your doctor.
Breastfeeding
It is not known whether Spevigo passes into breast milk. Spevigo may pass into breast milk in the first days after birth. Therefore, you must inform your doctor if you are breastfeeding or intend to breastfeed, so that you and your doctor can decide together whether you can receive Spevigo.
Driving and using machines
Spevigo is not expected to affect your ability to drive or operate machinery.
Spevigo contains polysorbate
This medicine contains 3 mg of polysorbate 20 per 7.5 mL vial. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
Spevigo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How Spevigo will be administered to you

The recommended dose in adults and adolescents aged 12 years and older with a body weight of 40 kg or more is 900 mg (two vials of 450 mg).
The recommended dose in adolescents aged 12 years 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 the medicine to you as an intravenous infusion (drip) into a vein over a period of 90 minutes, up to a maximum of 180 minutes if the infusion is slowed down or temporarily interrupted.
If symptoms of flare-up persist, your doctor may decide to administer a second dose of Spevigo one week after the first dose.
If you have any doubts about the use of this medicine, consult your doctor.
If you are given more Spevigo than you should receive
This medicine will be administered to you by your doctor or nurse. If you think you have received too much Spevigo, inform your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Seek immediate medical attention if you notice any sign or symptom of an allergic reaction during or after treatment with this medicine.
These may include:

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

An allergic reaction may also occur several days or weeks after receiving Spevigo.
Seek immediate medical attention if you develop a widespread rash that was not present before, fever, and/or swelling of the face, 2–8 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 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 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 side effects:
Very common (may affect more than 1 in 10 people)

• redness, swelling, hardening, warmth, pain, skin peeling, small firm lumps on the skin, itching, 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the vial after EXP and on the
carton after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C) (see the information for healthcare professionals at the
end of this leaflet).
Do not freeze.
Keep in the original packaging to protect the medicine from light.

6. Package contents and other information

What Spevigo contains

• The active substance is spesolimab. Each vial contains 450 mg of spesolimab 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, hydrochloride arginine, polysorbate 20 (E432) and water for injections.

Description of the appearance of Spevigo and contents of the pack
Spevigo concentrate for solution for infusion is a solution ranging from clear to slightly opalescent, from colourless to slightly yellowish-brown, supplied in a 10 mL colourless glass vial (type I glass) with a coated rubber stopper and an aluminium seal with a blue plastic flip-off cap.
Each pack contains two vials.

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
Boehringer Ingelheim France
100‑104 Avenue de France
75013 Paris
France

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

België/Belgique/Belgien Lietuva
LEO Pharma N.V./S.A LEO Pharma A/S
Tél/Tel: +32 3 740 7868 Tel: +45 44 94 58 88

България Luxembourg/Luxemburg
LEO Pharma A/S LEO Pharma N.V./S.A
Teл.: +45 44 94 58 88 Tél/Tel: +32 3 740 7868

Česká republika Magyarország
LEO Pharma s.r.o. LEO Pharma A/S
Tel: +420 734 575 982 Tel.: +45 44 94 58 88

Danmark Malta
LEO Pharma AB LEO Pharma A/S
Tlf.: +45 70 22 49 11 Tel: +45 44 94 58 88

Deutschland Nederland
LEO Pharma GmbH LEO Pharma B.V.
Tel: +49 6102 2010 Tel: +31 205104141

Eesti Norge
LEO Pharma A/S LEO Pharma AS
Tel: +45 44 94 58 88 Tlf: +47 22514900

Ελλάδα Österreich
LEO Pharmaceutical Hellas S.A. LEO Pharma GmbH
Τηλ: +30 212 222 5000 Tel: +43 1 503 6979

España Polska
Laboratorios LEO Pharma, S.A. LEO Pharma Sp. z o.o.
Tel: +34 93 221 3366 Tel.: +48 22 244 18 40

France Portugal
Laboratoires LEO LEO Farmacêuticos Lda.
Tél: +33 1 3014 4000 Tel: +351 21 711 0760

Hrvatska România
LEO Pharma A/S LEO Pharma A/S
Tel: +45 44 94 58 88 Tel: +45 44 94 58 88

Ireland Slovenija
LEO Laboratories Ltd LEO Pharma A/S
Tel: +353 (0) 1 490 8924 Tel: +45 44 94 58 88

Ísland Slovenská republika
LEO Pharma A/S LEO Pharma s.r.o.
Sími: +45 44 94 58 88 Tel: +420 734 575 982

Italia Suomi/Finland
LEO Pharma S.p.A LEO Pharma Oy
Tel: +39 06 52625500 Puh/Tel: +358 20 721 8440

Κύπρος Sverige
LEO Pharma A/S LEO Pharma AB
Τηλ: +45 44 94 58 88 Tel: +46 40 3522 00

Latvija
LEO Pharma A/S
Tel: +45 44 94 58 88

This medicinal product has been granted a marketing authorisation “under exceptional circumstances”. This means that further data on this medicinal product are still required.
The European Medicines Agency will review new information on this medicinal product at least annually and this package leaflet will be updated if necessary.

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

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

Dosage and method of administration
The recommended dose in adults and adolescents aged 12 years and older with a body weight equal to or greater than 40 kg is a single dose of 900 mg (2 vials of 450 mg) administered as an intravenous infusion. If symptoms of relapse persist, an additional dose of 900 mg may be administered 1 week after the initial dose.

The recommended dose in adolescents aged 12 years and older with a body weight between ≥ 30 kg and < 40 kg is a single dose of 450 mg (1 vial of 450 mg) administered as an intravenous infusion. If symptoms of relapse persist, an additional dose of 450 mg may be administered 1 week after the initial dose.

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

After dilution with 9 mg/mL (0.9%) sodium chloride injectable solution, Spevigo is administered as a continuous intravenous infusion through an in-line sterile, pyrogen-free, low protein-binding filter (pore size 0.2 micron) over a period of 90 minutes. No other infusions should be administered concurrently using the same venous access.

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

Instructions for handling

• The vial should be visually inspected before use.
  o Spevigo is a solution ranging from colourless to slightly yellowish-brown, from clear to slightly opalescent.
  o If the solution appears cloudy, shows colour changes, or contains large or coloured particles, the vial must be discarded.
• Sterile spesolimab concentrate is for single use only.
• The infusion solution must be prepared using aseptic technique:
  o For the recommended 900 mg dose, withdraw and discard 15 mL of 9 mg/mL (0.9%) sodium chloride injectable solution from a 100 mL container and replace it slowly with 15 mL of sterile spesolimab concentrate (two vials of 450 mg/7.5 mL).
  o For the recommended 450 mg dose, withdraw and discard 7.5 mL of 9 mg/mL (0.9%) sodium chloride injectable solution from a 100 mL container and replace it slowly with 7.5 mL of sterile spesolimab concentrate (one vial of 450 mg/7.5 mL).
  o Gently mix before use. The diluted spesolimab infusion solution must be used immediately.
• Spevigo must not be mixed with other medicinal products. The diluted spesolimab infusion solution may be administered via an existing intravenous line. The line must be flushed with 9 mg/mL (0.9%) sodium chloride injectable solution before and after the infusion. No other infusions should be administered concurrently using the same venous access.
• Spevigo is compatible with infusion sets made of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene, and polyurethane (PUR), and with in-line filters using membranes made of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).

Storage conditions
Unopened vial

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

After opening

• From a microbiological standpoint, the medicinal product should be diluted and administered immediately after opening.

After preparation of the infusion

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

Patient information leaflet

Spevigo 150 mg solution for injection in pre-filled syringe

spesolimab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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
called interleukin (IL) inhibitors. This medicine works by blocking the activity of IL36R, a
protein involved in inflammation.

What Spevigo is used for
Spevigo is used in adults and adolescents aged 12 years and older to prevent flare-ups of a rare
inflammatory skin disease called generalized pustular psoriasis (GPP). A flare-up is characterized
by the sudden appearance of painful blisters over large areas of the skin. These blisters, also known
as pustules, are filled with pus. The skin may become red, dry, cracked, or scaly, and itching may
occur. Patients may also experience more general signs and symptoms, such as fever, headache,
extreme fatigue, or a burning sensation on the skin.
Spevigo clears pustules and other skin manifestations and can thus help reduce the signs and
symptoms of the disease.

2. What you need to know before using Spevigo

Treatment will be initiated and carried out under the supervision of a physician experienced in the treatment of patients with inflammatory skin diseases.

Do not use 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 and during treatment with Spevigo if:

• you currently have an infection or have a history of recurrent infections. Fever, flu-like symptoms, fatigue, shortness of breath, persistent cough, warmth, redness and pain in the skin, or a painful rash with blisters may be signs and symptoms of an infection.
• you have or have had tuberculosis, or if you have been in close contact with someone who has tuberculosis.
• you have recently received or are due to receive any vaccination. Certain types of vaccines (live vaccines) must not be administered for at least 16 weeks after administration of Spevigo. Your doctor will check whether you need any vaccinations before starting Spevigo.
• you experience symptoms such as new or worsening weakness in your arms or legs, numbness (loss of sensation), tingling, or a burning sensation anywhere in your body. These could be signs of peripheral neuropathy (damage to peripheral nerves).

It is important to record the batch number of your Spevigo pack.
Each time you receive a new pack of Spevigo, write down the date and the batch number (found on the pack after “Lotto/Lot”) and keep this information in a safe place.

Infections
Inform 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
Seek immediate medical attention if you notice any signs or symptoms of an allergic reaction while using this medicine or after using it. An allergic reaction may occur several days or weeks after starting Spevigo. For signs and symptoms, see section 4 “Possible side effects”.

Children and adolescents
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
Inform your doctor if:

• you are taking, have recently taken, or might take any other medicines.
• you are about to receive or have recently received a vaccination. Certain types of vaccines (live vaccines) must not be administered for at least 16 weeks after receiving Spevigo.

If you have any doubts, talk to your doctor, pharmacist, or nurse before and during treatment with Spevigo.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine. This is because it is not known how this medicine may affect the unborn baby.
Therefore, it is preferable to avoid using Spevigo during pregnancy.
If you are pregnant, the medicine should only be administered if clearly recommended by your doctor.

Breastfeeding
It is not known whether Spevigo passes into breast milk. Spevigo may pass into breast milk in the first few days after birth. Therefore, you must inform your doctor if you are breastfeeding or intend to breastfeed, so that you and your doctor can decide together 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 0.4 mg of polysorbate 20 per 1 mL pre-filled syringe.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

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

3. How to use Spevigo

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Spevigo to use
Adults and adolescents aged 12 years and older, and weighing at least 40 kg

	How much?	When?
1st dose	600 mg (four 150 mg injections)	When your doctor tells you
Subsequent doses	300 mg (two 150 mg injections)	Every 4 weeks starting after the 1st dose

The first dose must be administered by a doctor or nurse.
You and your doctor or nurse may decide whether you can self-administer this medicine.
Do not self-administer the medicine unless a doctor or nurse has shown you how to do so.
A caregiver may also administer the injections after being trained to do so.
Before self-injecting Spevigo, read the “Instructions for use” at the end of this patient information leaflet.
Adolescents aged 12 years and older with a body weight of 30 kg to less than 40 kg

	How much?	When?
1st dose	300 mg (two injections of 150 mg)	When your doctor tells you
Subsequent doses	150 mg (one injection of 150 mg)	Every 4 weeks starting after the 1st dose

Spevigo must be administered to you by a doctor or nurse.
If you use more Spevigo than you should
If you have used more Spevigo than you should, or if the dose was administered earlier than prescribed, contact your doctor.
If you forget to use Spevigo
If you forget to use Spevigo, inject a dose as soon as you remember. If you have any doubts, contact your doctor.
If you stop using Spevigo
Do not stop using Spevigo without first talking to your doctor. If you stop treatment, symptoms may return or you may experience a worsening of the condition.
If you have any doubts about the use of this medicine, contact your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Seek immediate medical attention if you notice any signs or symptoms of an allergic reaction while
using or after using this medicine. These may include:

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

An allergic reaction may also occur several days or weeks after using Spevigo.
Seek immediate medical attention if you develop a widespread rash that was not present before, fever and/or facial swelling, 2–8 weeks after using 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 infection.
These may include:
Very common (may occur in more than 1 in 10 people)

• fever, cough

Common (may occur in 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 side effects:
Very common (may occur in more than 1 in 10 people)

• redness, swelling, hardening, warmth, pain, skin peeling, small hard lumps on the skin, itching, rash, or hives at the injection site

Common (may occur in up to 1 in 10 people)

• itching sensation
• feeling of tiredness

Not known (frequency cannot be estimated from the available data)

• allergic reaction

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 after EXP
and on 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 it has been frozen, even
if it has been thawed.
If necessary, Spevigo can be stored at temperatures up to 25 °C for a maximum of 14 days.
Discard Spevigo if it has been kept at temperatures up to 25 °C for more than 14 days.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if the solution is cloudy or contains flakes or large or coloured particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Spevigo contains

• The active substance is spesolimab. Each pre-filled syringe contains 150 mg of spesolimab in 1 mL of solution.
• The other components are sodium acetate trihydrate (E262), glacial acetic acid (E260) (for pH adjustment), sucrose, hydrochloride arginine, polysorbate 20 (E432) and water for injections.

Description of the appearance of Spevigo and contents of the pack
Spevigo for injection is a solution ranging from clear to slightly opalescent, from colourless to slightly yellowish-brown, in a pre-filled syringe with a safety device. The liquid may contain small white or transparent particles. Each pre-filled syringe contains 150 mg in 1 mL of injectable solution.
Each pack contains 2 pre-filled syringes.

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
LEO Pharma N.V./S.A LEO Pharma A/S
Tél/Tel: +32 3 740 7868 Tel: +45 44 94 58 88
България Luxembourg/Luxemburg
LEO Pharma A/S LEO Pharma N.V./S.A
Teл.: +45 44 94 58 88 Tél/Tel: +32 3 740 7868
Česká republika Magyarország
LEO Pharma s.r.o. LEO Pharma A/S
Tel: +420 734 575 982 Tel.: +45 44 94 58 88
Danmark Malta
LEO Pharma AB LEO Pharma A/S
Tlf.: +45 70 22 49 11 Tel: +45 44 94 58 88
Deutschland Nederland
LEO Pharma GmbH LEO Pharma B.V.
Tel: +49 6102 2010 Tel: +31 205104141
Eesti Norge
LEO Pharma A/S LEO Pharma AS
Tel: +45 44 94 58 88 Tlf: +47 22514900
Ελλάδα Österreich
LEO Pharmaceutical Hellas S.A. LEO Pharma GmbH
Τηλ: +30 212 222 5000 Tel: +43 1 503 6979
España Polska
Laboratorios LEO Pharma, S.A. LEO Pharma Sp. z o.o.
Tel: +34 93 221 3366 Tel.: +48 22 244 18 40
France Portugal
Laboratoires LEO LEO Farmacêuticos Lda.
Tél: +33 1 3014 4000 Tel: +351 21 711 0760
Hrvatska România
LEO Pharma A/S LEO Pharma A/S
Tel: +45 44 94 58 88 Tel: +45 44 94 58 88
Ireland Slovenija
LEO Laboratories Ltd LEO Pharma A/S
Tel: +353 (0) 1 490 8924 Tel: +45 44 94 58 88
Ísland Slovenská republika
LEO Pharma A/S LEO Pharma s.r.o.
Sími: +45 44 94 58 88 Tel: +420 734 575 982
Italia Suomi/Finland
LEO Pharma S.p.A LEO Pharma Oy
Tel: +39 06 52625500 Puh/Tel: +358 20 721 8440
Κύπρος Sverige
LEO Pharma A/S LEO Pharma AB
Τηλ: +45 44 94 58 88 Tel: +46 40 3522 00
Latvija
LEO Pharma A/S
Tel: +45 44 94 58 88

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Instructions for use

Spevigo 150 mg solution for injection in pre-filled syringe

These “Instructions for Use” contain information on how to inject Spevigo if the prescribed dose for you or your child requires 2 pre-filled syringes of Spevigo 150 mg.
Getting to know Spevigo
The pre-filled syringe contains the active substance spesolimab in solution for subcutaneous injection, allowing administration of a fixed dose of spesolimab.
Before starting to use this medicine on yourself or your child, make sure you have received appropriate training from your doctor or nurse. Then read the package leaflet and these instructions for use to ensure you administer the correct dose. If you have visual impairments or are partially sighted, you must be assisted by a properly trained caregiver.
If you have any doubts, consult your doctor, pharmacist, or nurse.
Spevigo is for single use only. Do not reuse the pre-filled syringe.

Description of the appearance of the Spevigo pre-filled syringe
Spevigo is a pre-filled syringe equipped with a safety device. After injection, the needle retracts into the safety device.
The following figure shows Spevigo before and after use, with the safety device activated.

Your doctor has prescribed you or your child a dose of Spevigo requiring two injections to administer a complete dose. To administer the full dose, you must inject the contents of both pre-filled syringes provided in the box.

Important information to know before injecting Spevigo

• Do not use the pre-filled syringe until you have been shown the correct way to perform the injection and until you have read and understood these instructions for use.
• Check the product packaging to ensure you have the correct medicine, the correct number of pre-filled syringes for the dose prescribed to you or your child, and to verify any signs of damage and the expiration date.
• Do not remove the cap until you are ready to inject.
• Do not use Spevigo:
  • if the solution is cloudy or contains flakes or large particles.
  • if the expiration date (EXP) has passed.
  • if the pre-filled syringes have been dropped or appear damaged.
• It is important to record the batch number of the Spevigo package. Each time you receive a new package of Spevigo, note down the date and the batch number (found on the packaging after “Lotto/Lot”) and keep this information in a safe place.
• Inject Spevigo under the skin (subcutaneous injection) into the upper thigh or abdominal area (abdomen). Do not inject Spevigo into any other area of the body.
• If you experience any problems during injection, do not repeat the injection steps using the Spevigo pre-filled syringe. Contact your doctor for assistance.
• If you have any doubts, consult your doctor or pharmacist.

Follow the steps described below when using Spevigo

STEP 1	Prepare the materials
	Remove the Spevigo package from the refrigerator and take out the prefilled syringes from the box. •Prepare the materials listed on the left and place them on a clean, flat work surface in a well-lit area. •If any of the listed materials are not available, contact the pharmacist. •For disposal, refer to Step 10: “Disposal of used prefilled syringes and used caps.”
STEP 2	Prepare for Spevigo injection
	Wait 15–30 minutes for the medicine to reach room temperature to avoid discomfort during injection. Do not attempt to speed up the warming process in any way, for example by using a microwave or placing the syringe in warm water. •Do not expose the prefilled syringes to direct sunlight. •Wash hands thoroughly with soap and water, then dry them.
STEP 3	Inspect the prefilled syringes
	At this point, check both prefilled syringes: •Verify that the medicine name and dose shown on the prefilled syringes match your or your child’s prescription. •Check the expiration date (EXP) on both prefilled syringes. Do not use the prefilled syringes if the expiration date has passed. •Check that neither prefilled syringe shows any damage, cracks, or leaks. Do not use the prefilled syringes if any of their components are broken, cracked, or leaking. •Ensure that the medicine in both prefilled syringes is colorless to slightly yellow. It may contain small white or transparent particles. Do not use the medicine if it is cloudy or contains flakes or large particles. •It is normal to see air bubbles; they do not need to be removed. •Do not use Spevigo prefilled syringes if they have been dropped.
Preparation for the first injection
	Prepare for the first of the two injections. Remember that the following steps must be repeated with the second prefilled syringe immediately after the first injection. Two injections are required for a complete dose.
STEP 4	Select the injection site
	Select an injection site. •You may use one of these areas: upper thighs or abdominal area (stomach), except for the 5 cm area around the navel. •Choose a different injection site for each injection, at least 2 cm away from the previous injection site. •Do not administer the injection near the waistline or navel area. •Do not administer the injection in areas where the skin is tender, red, hardened, bruised, or scarred. •Do not administer the injection through clothing.
STEP 5	Clean the injection site
	Clean the injection site with an alcohol wipe and allow it to air dry. •Do not touch the area again before the injection. •Do not fan or blow on the cleaned area.
STEP 6	Remove the cap
	Holding the prefilled syringe by the finger grip with one hand, remove the cap with the other hand. oDo not pull or grasp the plunger rod. oDo not twist the cap. Twisting the cap may damage the needle. oDo not use the prefilled syringe if the needle is bent or damaged. If the needle becomes accidentally bent, do not attempt to straighten it. •Set the cap aside. •Use immediately after removing the cap. oDo not attempt to recap the needle. Doing so may cause a needle-stick injury. oDo not touch the needle and ensure the needle does not come into contact with anything before the injection.
STEP 7	Prepare the skin fold
	Gently lift a clean skin fold at the injection site and hold it firmly. •Keep the skin lifted throughout the injection. The injection will be administered into the skin fold. •Do not release the skin until the needle has been withdrawn from the skin at the end of the injection.
STEP 8	Before injecting, review steps A, B, and C to learn the correct injection technique
Important: Do not move the prefilled syringe when inserting the needle into the skin, during injection, or when removing the needle from the skin.
	Hold the prefilled syringe by the blue finger grip. Avoid touching the blue thumb button. •With a quick motion, as if throwing a dart, insert the needle into the skin fold at an angle of approximately 45 degrees. •Do not move the needle during insertion or injection.
A Needle insertion
	To inject Spevigo: •Using your thumb, slowly press the blue thumb button and push the plunger rod into the syringe barrel. •Continue applying pressure on the blue thumb button until the plunger rod reaches the end. •Ensure the blue thumb button cannot be pressed further to activate the built-in safety mechanism.
B Injecting the medicine
	Slowly remove your thumb from the blue thumb button to withdraw the needle from the skin and allow it to retract into the safety device. oCheck that the thumb button snaps back and that the needle has retracted into the safety device. oIf the needle does not retract into the safety device, contact your doctor. A full dose may not have been administered. •If bleeding occurs, press a cotton ball or gauze pad on the site for several seconds. •Do not rub the injection site. •If needed, apply a bandage.
C Confirming completion of injection
STEP 9	Second injection
	Select a different injection site. The new injection site must be at least 2 cm away from the previous injection site. •Take the second prefilled syringe. •Repeat steps 4 to 8 immediately. •Then proceed to Step 10. Important: To administer the complete dose, the contents of both Spevigo prefilled syringes must be injected.
STEP 10	Disposal of used prefilled syringes and used caps
	Dispose of used prefilled syringes and used caps immediately after use in a sharps disposal container. •Do not throw prefilled syringes into household waste. •Your doctor, pharmacist, or nurse will explain how to return the sharps disposal container when it is full. •Do not reuse prefilled syringes. Important: Always keep the sharps disposal container out of reach of children.

Patient information leaflet

Spevigo 300 mg solution for injection in pre-filled syringe

spesolimab
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

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
called interleukin (IL) inhibitors. This medicine works by blocking the activity of IL36R, a
protein involved in inflammation.
What Spevigo is used for
Spevigo is used in adults and adolescents aged 12 years and older for the prevention
of flare-ups of a rare inflammatory skin disease called generalized pustular psoriasis (GPP). A flare-up is characterized by the sudden appearance of painful blisters
over large areas of the skin. These blisters, also known as pustules, are filled with pus. The skin may
become red, dry, cracked, or scaly, and itching may occur. Patients may also
experience more general signs and symptoms, such as fever, headache, extreme fatigue, or a burning sensation on the skin.
Spevigo clears pustules and other skin manifestations and can thus help reduce the signs and symptoms of the disease.

2. What you need to know before using Spevigo

Treatment will be initiated and carried out under the supervision of a physician experienced in the treatment of patients with inflammatory skin diseases.

Do not use 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 and during treatment with Spevigo if:

• you currently have an infection or have a history of recurrent infections. Fever, flu-like symptoms, fatigue, shortness of breath, persistent cough, warmth, redness and pain in the skin, or a painful rash with blisters may be signs and symptoms of an infection.
• you have or have had tuberculosis, or if you have been in close contact with someone who has tuberculosis.
• you have recently received or are due to receive a vaccine. Certain types of vaccines (live vaccines) should not be administered for at least 16 weeks after receiving Spevigo. Your doctor will check whether you need any vaccinations before starting treatment with Spevigo.
• you experience symptoms such as new or worsening weakness in your arms or legs, numbness (loss of sensation), tingling, or a burning sensation anywhere in your body. These may be signs of peripheral neuropathy (damage to the peripheral nerves).

It is important to record the batch number of your Spevigo pack.
Each time you receive a new pack of Spevigo, write down the date and the batch number (found on the packaging after “Lotto/Lot”) and keep this information in a safe place.

Infections
Inform 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
Seek immediate medical help if you notice any signs or symptoms of an allergic reaction while using or after using this medicine. An allergic reaction may occur several days or weeks after starting treatment with 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, as it has not been studied in this age group.

Other medicines and Spevigo
Inform your doctor if:

• you are taking, have recently taken, or might take any other medicines.
• you are scheduled to receive or have recently received a vaccination. Certain types of vaccines (live vaccines) should not be administered for at least 16 weeks after receiving Spevigo.

If you have any doubts, consult your doctor, pharmacist, or nurse before and during treatment with Spevigo.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. This is because it is not known how this medicine may affect the unborn baby.
Therefore, it is preferable to avoid using Spevigo during pregnancy.
If you are pregnant, the medicine should only be administered if clearly recommended by your doctor.

Breastfeeding
It is not known whether Spevigo passes into breast milk. Spevigo may pass into breast milk in the first days after delivery. Therefore, you must inform your doctor if you are breastfeeding or intend to breastfeed, so that you and your doctor can decide together 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 per 2 mL pre-filled syringe.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

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

3. How to use Spevigo

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Spevigo to use
Adults and adolescents aged 12 years and older with body weight equal to or greater than 40 kg

	How much?	When?
1st dose	600 mg (two 300 mg injections)	When your doctor tells you
Subsequent doses	300 mg (one 300 mg injection)	Every 4 weeks starting after the 1st dose

The first dose must be administered by a doctor or nurse.
You and your doctor or nurse can decide whether you can self-administer this medicine.
Do not self-administer the medicine unless the doctor or nurse has explained how to do so.
The person assisting you may also administer the injections, after having been trained to do so.
Before self-injecting Spevigo, read the “Instructions for use” at the end of this package leaflet.
Adolescents aged 12 years and older with a body weight of 30 kg to less than 40 kg

	How much?	When?
1st dose	300 mg (one 300 mg injection)	As directed by your doctor
Subsequent doses	150 mg*	Refer to the package leaflet of Spevigo 150 mg solution for injection in pre-filled syringe.

Spevigo must be administered to you by a doctor or nurse.
If you use more Spevigo than you should
If you have used more Spevigo than you should, or if the dose was administered earlier than prescribed, contact your doctor.
If you forget to use Spevigo
If you forget to use Spevigo, administer a dose as soon as you remember. If you have any doubts, consult your doctor.
If you stop using Spevigo
Do not stop using Spevigo without first talking to your doctor. If you stop treatment, symptoms may return or you may experience a worsening of the condition.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention if you notice any signs or symptoms of an allergic reaction while
using or after using this medicine. These may include:

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

An allergic reaction may also occur several days or weeks after using Spevigo.
Seek immediate medical attention if you develop a widespread rash not previously present, fever and/or facial swelling, 2 to 8 weeks after using 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 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 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 side effects:
Very common (may affect more than 1 in 10 people)

• redness, swelling, hardening, warmth, pain, skin peeling, small hard lumps on the skin, itching sensation, rash, or hives at the injection site

Common (may affect up to 1 in 10 people)

• itching sensation
• feeling of tiredness

Not known (frequency cannot be estimated from the available data)

• allergic reaction

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 after EXP
and on 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 it has been frozen, even
if it has been 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 kept at temperatures up to 30 °C for more than 14 days.
Keep the Spevigo pre-filled syringe in the original packaging to protect the medicine from light.
Do not use this medicine if the solution is cloudy or contains flakes, large particles, or coloured particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Spevigo contains

• The active substance is spesolimab. Each pre-filled syringe contains 300 mg of spesolimab 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.

Description of the appearance of Spevigo and contents of the pack
Spevigo injectable solution is a solution ranging from clear to slightly opalescent, from colourless to
slightly yellowish-brown, in a pre-filled syringe with a safety device. The liquid may
contain small white or transparent particles. Each pre-filled syringe contains 300 mg in 2 mL
of injectable solution.
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
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
LEO Pharma N.V./S.A LEO Pharma A/S
Tél/Tel: +32 3 740 7868 Tel: +45 44 94 58 88
България Luxembourg/Luxemburg
LEO Pharma A/S LEO Pharma N.V./S.A
Teл.: +45 44 94 58 88 Tél/Tel: +32 3 740 7868
Česká republika Magyarország
LEO Pharma s.r.o. LEO Pharma A/S
Tel: +420 734 575 982 Tel.: +45 44 94 58 88
Danmark Malta
LEO Pharma AB LEO Pharma A/S
Tlf.: +45 70 22 49 11 Tel: +45 44 94 58 88
Deutschland Nederland
LEO Pharma GmbH LEO Pharma B.V.
Tel: +49 6102 2010 Tel: +31 205104141
Eesti Norge
LEO Pharma A/S LEO Pharma AS
Tel: +45 44 94 58 88 Tlf: +47 22514900
Ελλάδα Österreich
LEO Pharmaceutical Hellas S.A. LEO Pharma GmbH
Τηλ: +30 212 222 5000 Tel: +43 1 503 6979
España Polska
Laboratorios LEO Pharma, S.A. LEO Pharma Sp. z o.o.
Tel: +34 93 221 3366 Tel.: +48 22 244 18 40
France Portugal
Laboratoires LEO LEO Farmacêuticos Lda.
Tél: +33 1 3014 4000 Tel: +351 21 711 0760
Hrvatska România
LEO Pharma A/S LEO Pharma A/S
Tel: +45 44 94 58 88 Tel: +45 44 94 58 88
Ireland Slovenija
LEO Laboratories Ltd LEO Pharma A/S
Tel: +353 (0) 1 490 8924 Tel: +45 44 94 58 88
Ísland Slovenská republika
LEO Pharma A/S LEO Pharma s.r.o.
Sími: +45 44 94 58 88 Tel: +420 734 575 982
Italia Suomi/Finland
LEO Pharma S.p.A LEO Pharma Oy
Tel: +39 06 52625500 Puh/Tel: +358 20 721 8440
Κύπρος Sverige
LEO Pharma A/S LEO Pharma AB
Τηλ: +45 44 94 58 88 Tel: +46 40 3522 00
Latvija
LEO Pharma A/S
Tel: +45 44 94 58 88
Other sources of information
More detailed information on this medicinal product 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 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.
Become familiar with Spevigo
The pre-filled syringe contains the active substance spesolimab in solution for subcutaneous injection,
allowing administration of a fixed dose of spesolimab.
Before starting to use this medicine on yourself or your child, make sure you have received
appropriate training from your doctor or nurse. Then read the package leaflet and these
Instructions for Use to ensure you administer the correct dose. If you have vision problems or are
visually impaired, you must be assisted by a person who has been adequately trained to assist you.
If you have any doubts, consult your doctor, pharmacist, or nurse.
Spevigo is for single use only. Do not reuse the pre-filled syringe.
Description of the appearance of the Spevigo pre-filled syringe
Spevigo is a pre-filled syringe equipped with a safety device. After injection, the needle retracts
into the safety device.
The following figure shows Spevigo before and after use, with the safety device activated.

Important information to know before injecting Spevigo

• Do not use the pre-filled syringe until you have been shown the correct way to administer the injection and until you have read and understood these Instructions for Use.
• Examine the product carton to ensure you have the correct medicine and the correct number of pre-filled syringes for the dose prescribed for you or your child, and check for any damage and the expiration date.
• Do not remove the cap until you are ready for injection.
• Do not use Spevigo
• if the solution is cloudy or contains flakes or large particles.
• if the expiration date (EXP) has passed.
• if the pre-filled syringe has been dropped or appears damaged.
• It is important to record the batch number of the Spevigo package. Each time you receive a new package of Spevigo, note the date and the batch number (located on the package after “Lotto/Lot”) and keep this information in a safe place.
• Inject Spevigo under the skin (subcutaneous injection) into the upper thigh or the abdominal area (abdomen). Do not inject Spevigo into any other area of the body.
• If you experience any problems with the injection, do not repeat the injection steps using the Spevigo pre-filled syringe. Contact your doctor for assistance.
• If you have any doubts, consult your doctor or pharmacist.

Follow the steps described below when using Spevigo

STEP 1	Preparation of materials
	Remove the Spevigo package from the refrigerator and take the prefilled syringe out of the box. •Prepare the listed materials and place them on a clean, flat surface in a well-lit area. •If any of the listed materials are missing, contact the pharmacist. •For disposal, see Step 9: “Disposal of the used prefilled syringe and used cap.”
STEP 2	Preparing for Spevigo injection
	Wait 15–30 minutes for the medicine to reach room temperature to avoid discomfort during injection. •Do not attempt to speed up the warming process in any way, for example, by using a microwave or placing the syringe in hot water. •Do not expose the prefilled syringe to direct sunlight. •Wash hands thoroughly with soap and water, then dry them.
STEP 3	Inspecting the prefilled syringe
	Check the prefilled syringe: •Verify that the medicine name and dose shown on the prefilled syringe match the prescribed dose for you or the child. •Check the expiration date (EXP) on the prefilled syringe. Do not use the prefilled syringe if the expiration date has passed. •Ensure the prefilled syringe has no damage, cracks, or leaks. Do not use the prefilled syringe if any of its components are broken, cracked, or leaking. •Make sure the medicine in the prefilled syringe is colorless to slightly yellow. It may contain small white or transparent particles. Do not use the medicine if it is cloudy or contains flakes or large or colored particles. •It is normal to see air bubbles; they do not need to be removed. •Do not use the Spevigo prefilled syringe if it has been dropped.
STEP 4	Selecting the injection site
	Select an injection site. •You may use one of these areas: the upper thighs or the stomach area (abdomen), except for the 5 cm zone around the navel. •Do not administer the injection near the waistline or navel. •Do not inject into areas where the skin is tender, red, hardened, bruised, or scarred. •Do not inject through clothing.
STEP 5	Cleaning the injection site
	Clean the injection site with an alcohol wipe and allow it to air dry. •Do not touch this area again before the injection. •Do not fan or blow on the cleaned area.
STEP 6	Removing the cap
	With one hand, hold the prefilled syringe by the finger grip. With the other hand, remove the cap. oDo not pull or grasp the plunger rod. oDo not twist the cap. Twisting the cap may damage the needle. oDo not use the prefilled syringe if the needle is bent or damaged. If the needle accidentally bends, do not attempt to straighten it. •Proceed immediately to the next step after removing the cap. oDo not attempt to recap the needle. Doing so may result in a needlestick injury. oDo not touch the needle and ensure the needle does not contact anything before injection.
STEP 7	Preparing the skin fold
	Gently lift a clean skin fold around the injection site and hold it firmly. •Keep the skin lifted throughout the injection. •Do not release the skin until Step 8C “Confirming completion of injection” is completed.
STEP 8	Before injection, review steps A, B, and C to learn the correct injection technique
Important: Do not move the prefilled syringe when inserting the needle into the skin, during injection, or when removing the needle from the skin.
	Hold the prefilled syringe by the finger grip. •For now, do not touch the thumb button. •With a quick motion, as if throwing a dart, insert the needle into the skin fold at an angle of approximately 45 degrees. •Do not move the needle during insertion or injection.
A Needle insertion
	To inject Spevigo: •Using your thumb, slowly press the thumb button and push the plunger rod into the syringe barrel. •Continue applying pressure on the thumb button until the plunger rod reaches the end. •Ensure the thumb button cannot be pressed further to activate the integrated safety device.
B Injecting the medicine
	Slowly remove your thumb from the thumb button to withdraw the needle from the skin and allow it to retract into the safety device. oCheck that the thumb button snaps back and that the needle has retracted into the safety device. oIf the needle does not retract into the safety device, contact the healthcare provider. The full dose may not have been delivered. •If bleeding occurs, press a cotton ball or gauze on the site for several seconds. •Do not rub the injection site. •If needed, apply an adhesive bandage.
C Confirming completion of injection
STEP 9	Disposal of the used prefilled syringe and used cap
	Immediately after use, dispose of the used syringe and used cap in a sharps disposal container. •Do not throw (dispose of) the prefilled syringe in household waste. •Your doctor, pharmacist, or nurse will explain how to return the sharps container when it is full. •Do not reuse the prefilled syringe. Important: Always keep the sharps disposal container out of the reach of children.