Spevigo 150 mg solution for injection in Pre-filled syringe – patient leaflet, side effects, dosage

What Spevigo is used for

Spevigo is used in adults and adolescents from of age to prevent flares of a rare inflammatory s disease called generalised pustular psoriasis (GP During a flare, patients may experience painful s blisters that develop suddenly over large areas o skin. These blisters, also called pustules, are fill pus. The skin may become red, itchy, dry, cracke scaly. Patients may also experience more general and symptoms, such as fever, headache, extrem tiredness, or a burning sensation of the skin. Spevigo clears pustules and other skin manifest and can therefore help to reduce the signs and symptoms of your disease.

12 years kin

P).

kin

f the

ed with d or

signs

e

ations

2. What you need to know before you us Spevigo

A doctor experienced in treating patients with inflammatory skin diseases will start and super your treatment.

Do not use Spevigo if you:

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

Warnings and precautions

e

vise

gredients

ions

Talk to your doctor or nurse before and during t Spevigo if you:

• currently have an infection or have an infectio keeps coming back. Fever, flu-like symptoms, ti or shortness of breath, a cough which will not warm, red and painful skin, or a painful rash w blisters can be signs and symptoms of an infe
• have, have had tuberculosis, or have been in c contact with someone with tuberculosis.

• have recently had a vaccination or plan to have a vaccination. You should not be given certain of vaccines (live vaccines) for at least 16 week being given Spevigo. Your doctor will check if need any vaccines before you start using Spev

  he use of

  n that

  redness go away, ith

  ction.

  lose

  types s after

  you

  igo.

• experience symptoms like weakness in your a legs that was not there before or numbness (lo sensation), tingling or a burning sensation in of your body. These might be signs of peripher neuropathy (damage of the peripheral nerves)

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

Every time you get a new pack of Spevigo, note the date and the batch number (which is on the p after “Lot”) and keep this information in a safe

Infections

Tell your doctor as soon as possible if you notic signs or symptoms of an infection while you are

rms or ss of

any part al

.

mber of

down ackaging place.

e any

using

Spevigo, see section 4 “Possible side effects”.

Allergic reactions

Seek medical help immediately if you notice any signs or symptoms of an allergic reaction while you are using or after you have used this medicine. You can also have allergic reactions some days or weeks after starting the use of Spevigo. For signs and symptoms see section 4 “Possible side effects”.

Children and adoles

Spevigo is not recomm

cents

ended for children under 12 years

of age because it has n

Other medicines and

Tell your doctor if you

• taking, have recently medicines.
• going to have or have should not be given vaccines) for at least

If you are not sure, talk nurse before and durin

Pregnancy and breas

Pregnancy

If you are pregnant, thi

ot been studied in this age group.

Spevigo

are:

taken or might take any other

recently had a vaccination. You certain types of vaccines (live 16 weeks after receiving Spevigo.

to your doctor, pharmacist or g the use of Spevigo.

t-feeding

nk you may be pregnant or are

planning to have a bab before using this medi known how this medic

It is therefore preferab during pregnancy. If you are pregnant, yo medicine if your docto

Breast-feeding

It is not known whethe Spevigo may pass into birth. You should there breast-feeding or plan doctor can decide if yo

y, ask your doctor for advice cine. This is because it is not ine will affect the baby.

le to avoid the use of Spevigo

u should only receive this r has clearly recommended it.

r Spevigo passes into breast milk. breast milk in the first days after fore tell your doctor if you are to breast-feed, so you and your u can use Spevigo.

Driving and using m

Spevigo is not expecte and use machines.

Spevigo contains po

This medicine contain each 1 mL pre-filled sy allergic reactions. Tell y allergies.

Spevigo contains so

This medicine contain (23 mg) per dose, that

achines

d to affect your ability to drive

lysorbate

s 0.4 mg of polysorbate 20 in ringe. Polysorbates may cause our doctor if you have any known

dium

s less than 1 mmol sodium is to say essentially ‘sodium free’.

3. How to use Spev

Always use this medici pharmacist has told yo pharmacist if you are n

How much Spevigo to

Adults and adolescent weighing at least 40 kg

How much 1^st dose 600 mg (fo

150 mg inj Further 300 mg (tw

igo

ne exactly as your doctor or u. Check with your doctor or ot sure.

use

s from 12 years of age and

? When?

ur

ections)

When your doctor tells you

o Every 4 weeks starting

doses 150 mg inj

The first dose should b

ections)

after the 1^st dose

e given by your doctor or nurse.

You and your doctor or

nurse will decide if you should

inject this medicine yo

urself. Do not inject yourself with

this medicine unless y

ou have been trained by your

doctor or nurse. A care

giver may also give your

injections after they ha

ve been trained.

Read the ‘Instructions

for use’ at the end of this leaflet

before injecting Spevi

go yourself.

Adolescents from 12 y

ears of age weighing 30 to less

than 40 kg

How

much?

When?

1^st dose

300 m 150 m

g (two

g injections)

When your doctor tells you

Further doses

150 m 150 m

g (one

g injection)

Every 4 weeks starting after the 1^st dose

Spevigo should be given by your doctor or nurse.

If you use more Spevigo than you should

If you have used more Spevigo than you should or the dose has been given sooner than prescribed, talk to your doctor.

If you forget to use Spevigo

If you forget to use Spevigo, inject a dose as soon as you realise. Talk to your doctor if you are not sure what to do.

If you stop using Spevigo

Do not stop using Spevigo without talking to your doctor

firs bac

If y me

4.

Lik alt

See or s you• d

t. If you stop treatment, your symptoms m k or you may experience a flare.

ou have any further questions on the use dicine, ask your doctor, pharmacist, or nur

Possible side effects

e all medicines, this medicine can cause si hough not everybody gets them.

k medical help immediately if you notice ymptoms of an allergic reaction while usi have used this medicine. These may incl ifficulty breathing or swallowing

ay come

of this

se.

de effects,

any signs ng or after

ude:

• ^s• s

  b• fe

You aft

See

wid and me rea

Tel sig

welling of the face, lips, tongue or throat evere itching of the skin, with a red rash or umps, that is different from your GPP sym eling faint.

can also have allergic reactions some da er you have used Spevigo.

k medical help immediately if you develo espread skin rash that was not there befo /or facial swelling 2-8 weeks after you ha dicine. These might be signs of a delayed ction (hypersensitivity).

l your doctor as soon as possible if you no ns or symptoms of an infection. These ma

raised

ptoms

ys or weeks

p any

re, fever, ve used the allergic

tice any

y include:

Ver• fe

Co• fr b in

Tell oth

Ver• re o it

y common (may affect more than 1 in 10 ver, cough

mmon (may affect up to 1 in 10 people) equent urination, pain or burning while ur loody urine, which may be symptoms of u fections

your doctor or nurse if you get any of the er side effects:

y common (may affect more than 1 in 10 dness, swelling, hardening, warmth, pain, f the skin, small, solid raised bumps on th ching, skin rash, or hives at the injection s

people)

inating or rinary tract

following

people)

peeling e skin,

ite

Co• it• fe

No

ava

• ^a

Re

If y Thi lea det pro me

mmon (may affect up to 1 in 10 people) ching

eling tired

t known (frequency cannot be estimated f ilable data)

llergic reaction

porting of side effects

ou get any side effects, talk to your doctor s includes any possible side effects not lis flet. You can also report side effects direct ails below). By reporting side effects you c vide more information on the safety of thi dicine.

rom the

or nurse. ted in this ly (see

an help s

Yell We MH

1. 5. Kee chi

Do

sta The

Sto not

ow Card Scheme

bsite: www.mhra.gov.uk/yellowcard or sea RA Yellow Card in the Google Play or Appl

How to store Spevigo

p this medicine out of the sight and reach ldren.

not use this medicine after the expiry date ted on the pre-filled syringe and the carto expiry date refers to the last day of that m

re in a refrigerator (2 °C – 8 °C). Do not fre use Spevigo if frozen, even if it has been

rch for

e App Store

of

which is n after EXP. onth.

eze. Do

thawed.

If n

eeded, Spevigo can be stored at temperat

ures up to

25

°C for up to 14 days. Throw away Spevigo i

f it has

bee

n kept at temperatures up to 25 °C for mo

re than

14

days.

Sto

re in the original package in order to prote

ct from

ligh

t.

Do

not use this medicine if the liquid is cloud

y or

con

tains flakes or large or coloured particles.

Do

not throw away any medicines via wastew

ater or

ho

usehold waste. Ask your pharmacist how t

o throw

aw

ay medicines you no longer use. These me

asures will

hel

p protect the environment.

6. Contents of the pack and other information

What Spevigo contains

• The active substance is spesolimab. Each pre-filled syringe contains 150 mg spesolimab in 1 mL solution.

• The other ingredients are sodium acetate trihydrate (E262), glacial acetic acid (E260) (for pH adjustment), sucrose, arginine hydrochloride, polysorbate 20 (E432) and water for injections.

  What Spevigo looks like and contents of the pack

  Spevigo solution for injection is a clear to slightly opalescent, colourless to slightly brownish-yellow solution in a pre-filled syringe with safety cover. The liquid may contain tiny white or clear particles. Each pre-filled syringe contains 150 mg in 1 mL solution for injection.

  Each pack contains 2 pre-filled syringes.

  Marketing Authorisation Holder

  Boehringer Ingelheim Inte Binger Str. 173

  55216 Ingelheim am Rhei Germany

  Manufacturer

  Boehringer Ingelheim Pha Birkendorfer Strasse 65 88397 Biberach an der Ris Germany

  For any information abou the local representative of Holder:

  rnational GmbH n rma GmbH & Co. KG s t this medicine, please contact the Marketing Authorisation

  United Kingdom

  Boehringer Ingelheim Ltd. Tel: +44 1344 424 600

  This leaflet was last revise

  d in 09/2025.

Package leaflet: Information for the patient

Spevigo® 150 mg ABCD solution for injection

in pre-filled syringe

spesolimab

• This medicine is subject to additional monitorin

  by reporting any side effects you may get. See th

Read all of this leaflet carefully, because it c

• Keep this leaflet. You may need to read it agai
• If you have any further questions, ask your do

• If you get any side effects, talk to your doctor o See section 4.

  g. This will allow quick identification of e end of section 4 for how to report sid

  ontains important information f

  n.

  ctor or nurse.

  r nurse. This includes any possible sid

  new safety information. You can help e effects.

  or you.

  e effects not listed in this leaflet.

  A

  B C

Perigord No: 904002 P2

MASS A 25,5 mm MASS B 2,2 mm MASS C max. 44 mm Bleed 3 mm

Code Type: 128a

In-process control code specification

Spevigo® 150 mg solution for injection in pre-filled syringe

This “Instructions for use” contains 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 a solution for subcutaneous injection that helps to deliver a fixed dose of spesolimab.

Before you start using this medicine on your own or your child, first make sure that you get trained by your doctor or nurse. Then read the package leaflet and these instructions for use to make sure you get the correct dose. If you are visually impaired and cannot see well, you must be assisted by a trained caregiver.

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

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

This is what Spevigo pre-filled syringe looks like

Spevigo is a pre-filled syringe with a safety cover. The needle is pulled back into the safety cover after injection.

The following picture shows Spevigo before use and after use with the activated safety cover.

thumb pad

Before Use

After Use

covered needle

activated

safety cover

The needle should be inside the safety cover after use. plunger rod

finger grip

medicine safety cover

cap

syringe

body

Your healthcare professional has prescribed a dose of Spevigo for you or your child that requires two injections to deliver a complete dose. You must inject the contents of both pre-filled syringes that come in the carton to deliver the complete dose.

Important information you need to know before injecting Spevigo

• Do not use the pre-filled syringe until you have been shown the right way to give

  the injection and have read and understood these handling instructions.

• Inspect the carton that the product comes in to be sure that you have the correct

  medicine, the correct number of pre-filled syringes for your or your child’s prescribed dose, for any damage, and the expiry date.

• Do not remove the cap until you are ready to inject.

• Do not use Spevigo:

  • if the liquid is cloudy or contains flakes or large particles.
  • if the expiry date (EXP) has passed.
  • if the pre-filled syringes have been dropped or look damaged.

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

  Every time you get a new pack of Spevigo, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

• Inject Spevigo under the skin (subcutaneous injection) in either the upper thighs

  or stomach area (abdomen). Do not inject Spevigo into any other area of the body.

• If you have any problems with your injection, do not repeat the injection steps

  with Spevigo pre-filled syringe. Call your doctor for help.

• If you have further questions, ask your doctor or pharmacist.

  • Take the Spevigo carton out of the refrigerator and remove the pre-filled syringes from the carton.
  • Gather supplies listed on the left side and place them on a clean, flat work surface in a well-lit area.
  • If you do not have all the supplies listed, contact your pharmacist.

  • For disposal, see step 10: “Disposing of the used pre-filled syringes and caps.”

    • Clean the injection site with an alcohol wipe and let air dry.
    • Do not touch this area again before injecting.

    • Do not fan or blow on the clean area.

      • Hold the pre-filled syringe by the blue finger grip. Avoid touching the blue thumb pad.
      • Using a quick, “dart-like” motion, insert the needle into the pinched skin at about a 45-degree angle.
      • Do not move the needle while inserting or during the injection.

Important: Do not move the pre-filled syringe when inserting the needle into your skin, while injecting, or when removing the needle from your skin.

• Put the used pre-filled syringes and caps in a sharps disposal container right away after use.
• Do not throw away the pre-filled syringes in the household waste.
• Your doctor, pharmacist, or nurse will tell you how to return the full sharps disposal container.
• Do not reuse the pre-filled syringes. Important: Always keep the sharps disposal container out of the reach of children.
• Choose a different injection site. The new injection site should be at least 2 cm away from last injection site.
• Take the second pre-filled syringe.
• Repeat steps 4 through 8 right away.
• Then continue to step 10.

Important: You must inject the contents of both Spevigo pre-filled syringes to give a complete dose.

To inject Spevigo:

• Use your thumb to slowly press down on the blue thumb pad to push the plunger rod down inside the syringe body.
• Continue pressing on the blue thumb pad until the plunger rod has moved all the way down.
• Make sure that the blue thumb pad cannot be pressed any further so that the built-in safety cover can be activated.

• Slowly remove your thumb from the blue thumb pad, to move the needle out of your skin and up into the safety cover. ° Check that the thumb pad springs back and that the needle is inside the safety cover.

  ° If the needle is not inside the safety cover call your doctor. You may not have received a full dose.

• If there is bleeding, press a cotton ball or gauze on the site for a few seconds.
• Do not rub the injection site.
• Apply a plaster if needed.

• Hold the pre-filled syringe by the finger grip with one hand. With the other hand, pull the cap straight off.

  ° Do not pull on or hold the plunger rod. ° Do not twist the cap. Twisting the cap

  could damage the needle.

  ° Do not use the prefilled syringe if the

  needle is bent or damaged. If you accidentally bend the needle, do not attempt to straighten it.

• Put the cap aside.

• Use right away after removing the cap. ° Do not try to recap the needle.

  Re-capping can lead to needle-stick injury.

  ° Do not touch the needle or let the needle

  touch anything before injecting.

• Gently pinch the area of cleaned skin around your injection site and hold it firmly.
• Keep the skin pinched during the entire injection. You will inject into the pinched skin.
• Do not let go until you have removed the needle from your skin at the end of the injection.
• Wait 15 to 30 minutes to allow the medicine to reach room temperature to avoid discomfort during injection. Do not speed up the warming process in any way, such as using the microwave or placing the syringe in warm water.
• Do not leave the pre-filled syringes in direct sunlight.
• Wash your hands well with soap and water and dry them.

Check both pre-filled syringes now:

• Check to make sure the medicine name and dose on the pre-filled syringes match your or your child’s prescription.
• Check the expiry date (EXP) on both pre-filled syringes. Do not use if the expiry date has passed.
• Check both pre-filled syringes for damage, cracks, and leakage. Do not use if any part of the pre-filled syringes appears cracked, broken, or is leaking.
• Make sure the medicine in both pre-filled syringes is colourless to slightly yellow. It may contain tiny white or clear particles. Do not use if the medicine is cloudy or has flakes or large particles in it.
• It is normal to see air bubbles, they do not need to be removed.
• Do not use if the Spevigo pre-filled syringes have been dropped.

Prepare for the first of two injections. Remember, you will repeat the following steps with the second pre-filled syringe right away after your first injection. Two injections are needed for a complete dose.

Choose an injection site.

• You may use an area on your:

  ° upper thighs or

  ° stomach area (abdomen), except for an

  area 5 cm around your navel (belly button).

• Choose a different injection site each time you inject, at least 2 cm away from the last injection site.
• Do not inject into an area near your waistline or belly button.
• Do not inject into areas that are tender, bruised, red, hard, or scarred.
• Do not inject through clothes.

Instructions for use

abcd

STEP 1

Gathering supplies

15-30

minutes

Bring medicine to room temperature

Wash hands

EXP MM YYYY

Injection areas

Abdomen

Upper thighs

2 Spevigo pre-filled syringes

2 cotton balls or gauze

(not included)

2 alcohol wipes

(not included)

1 sharps disposal container

(not included)

STEP 2

Preparing to inject Spevigo

STEP 3

Inspecting the pre-filled syringes

Preparing for your first injection

STEP 4

Choosing the injection site

STEP 5

Cleaning the injection site

STEP 6

Removing the cap

STEP 7

Pinch the skin

STEP 8

Before injecting, review steps A, B, and C to learn the correct way to inject

STEP 10

Disposing of the used pre-filled syringes and caps

STEP 9

Second injection

A Inserting the needle

P058761-003 Follow the steps below when you use Spevigo

Cap

B Injecting the medicine

Push firmly

45°

C Checking injection is complete

Remove thumb to activate the safety cover

45° 45°

medicine

Check both pre-filled syringes now