Patient Medication Information: uses, side effects, how to take - Spevigo

What is Spevigo used for?

Spevigo is a prescription medicine used in adults and children who are 12 years of age and older to treat and prevent:

painful skin blisters (also called pustules) developing suddenly over large areas of your skin.

These episodes are also known as a flare, and are related to a rare, inflammatory, skin disease called generalized pustular psoriasis (GPP). Spevigo helps to clear your skin and reduces your symptoms such as burning, itching, pain, redness, and fatigue during a flare.

How does Spevigo work?

Spevigo contains the active substance spesolimab. Spesolimab is a monoclonal antibody belonging to a group of medicines called interleukin (IL) inhibitors. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body. Spevigo works by blocking the activity of a protein called IL-36R, which can cause pustules, painful inflammation on the skin and fibrosis (scarring).

What are the ingredients in Spevigo?

Medicinal ingredient: spesolimab

Non-medicinal ingredients: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate, sucrose, water for injection.

Spevigo comes in the following dosage forms:

Spevigo is available as pre-filled syringes, 150 mg/syringe (150 mg/mL).

Each pack has two pre-filled syringes.

Spevigo is available as pre-filled syringes, 300 mg/syringe (150 mg/mL).

Each pack has one pre-filled syringe.

Spevigo is available as single use vials, 450 mg/vial (60 mg/mL).

Each pack has two vials.

The vial stopper does not contain natural rubber latex.

Do not use Spevigo if:

You are allergic to spesolimab or any of the other ingredients of this medicine. See What are the ingredients in Spevigo?

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Spevigo. Talk about any health conditions or problems you may have, including if you:

have an infection that does not go away or that keeps coming back;
have tuberculosis (TB) or have been in close contact with someone with TB;
have recently received or are scheduled to receive an immunization (vaccine). You should not receive live vaccines for at least 16 weeks after treatment with Spevigo;
are pregnant or plan to become pregnant. It is not known if Spevigo can harm your unborn baby;
are breastfeeding or plan to breastfeed. It is not known if Spevigo passes into your breast milk;
experience symptoms like new-onset weakness in your arms or legs or numbness (loss of sensation), tingling or burning sensation in any part of your body. These might be signs of peripheral neuropathy;
have any known allergies. Spevigo contains polysorbates that may cause allergic reactions.

Talk to your healthcare professional right away if you have any of the signs or symptoms of an allergic reaction, including:

difficulty breathing or swallowing;
swelling of the face, lips, tongue or throat;
severe itching of the skin, with a red rash or raised bumps that is different from your GPP symptoms;
feel faint.

You can also have allergic reactions days or weeks after receiving Spevigo. Call your doctor immediately if you develop any widespread skin rash not previously experienced, fever, and/or facial swelling 2-8 weeks after receiving the medication.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

How to take Spevigo:

When given under the skin (subcutaneously) for GPP flare prevention

Read the Instructions for Use that comes with Spevigo for information on how to prepare and inject a dose of Spevigo and how to properly throw away (dispose of) used Spevigo pre-filled syringes.

Spevigo pre-filled syringes come in two different forms (300 mg or 150 mg). Your healthcare provider will prescribe the pre-filled syringe that is right for you.
Your healthcare provider will tell you how often you should use Spevigo. Use Spevigo exactly as your healthcare provider tells you to use it.
Do not try to inject Spevigo until you have been shown the right way to give the injections by your healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of Spevigo at home, you should receive training on the right way to prepare and inject Spevigo.
If you miss a dose of Spevigo, inject your dose as soon as you remember. Then, take your next dose at your regular scheduled time. In case you are not sure when to inject Spevigo, call your healthcare provider.
Subcutaneous injection of Spevigo should not be used for GPP flare treatment.

When given in a vein (intravenously) for GPP flare treatment

Your healthcare provider will give you Spevigo through a needle placed in your vein (intravenous infusion) over 90 minutes.
Spevigo is usually given one time. Your healthcare provider will decide if you should receive an additional treatment after 1 week.
Intravenous infusion of Spevigo should not be used for GPP flare prevention.

Usual dose:

The usual dose for GPP flare prevention is a loading dose of 600 mg (4 x 150 mg/1mL syringes or 2 x 300 mg/2 mL syringes) followed by 300 mg (2 x 150 mg/1 mL syringes or 1 x 300 mg/2 mL syringe) administered subcutaneously 4 weeks later and every 4 weeks thereafter.

The usual dose for GPP flare treatment is a single dose of 900 mg (2 x 450 mg/7.5 mL vials) administered as an intravenous infusion.

If your flare persists, an additional 900 mg dose may be administered 1 week after the initial dose.

Overdose:

If you think that you or a person you are caring for have taken too much Spevigo, contact your healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

What are possible side effects from using Spevigo?

These are not all the possible side effects you may have when taking Spevigo. If you experience any side effects not listed here, tell your healthcare professional.

urinary tract infections;
upper respiratory tract infections;
itching;
feeling tired;
redness, swelling, hardening, warmth, pain, peeling of the skin, small solid raised bumps on the skin, itching, skin rash or hives at the injection site;
allergic reaction.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
VERY COMMON
Upper respiratory tract infections: fevers, chills or sweats, cough, shortness of breath		✓
COMMON
Urinary tract infections: burning when you urinate, urinating more often than normal		✓
UNKNOWN
Allergic (hypersensitivity) reactions and infusion reactions: feeling faint, swelling of your face, eyelids, lips, mouth, tongue or throat, chest tightness, skin rash			✓
Serious allergic reactions that may occur days to weeks after receiving Spevigo: skin rash that is different than the rash from GPP, fever, swollen lymph nodes, facial swelling, mouth sores		✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store Spevigo in a refrigerator at 2 to 8°C.
Do not freeze Spevigo. Do not use Spevigo if frozen, even if it has been thawed.
Store Spevigo in original carton until it is to be used to protect from light.

150 mg pre-filled syringe

If needed, Spevigo 150 mg pre-filled syringes can be stored at room temperature up to 25°C for up to 14 days.
Throw away Spevigo 150 mg pre-filled syringes if kept at room temperature up to 25°C for more than 14 days.

300 mg pre-filled syringe

If needed, Spevigo 300 mg pre-filled syringe can be stored at room temperature up to 30°C for up to 14 days.
Throw away Spevigo 300 mg pre-filled syringe if kept at room temperature up to 30°C for more than 14 days.

Keep Spevigo out of reach and sight of children.

If you want more information about Spevigo:

Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes
- this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.leo-pharma.ca), or by calling 1-800-263-4218.

The information in this leaflet is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.

Last Revised: 2026-03-26

Spevigo® is a registered trademark of LEO Pharma A/S used under license by LEO Pharma

Inc. Canada

INSTRUCTIONS FOR USE

SPEVIGO

(spesolimab injection)

Spevigo injection in pre-filled syringe for subcutaneous use

150 mg pre-filled syringe for administration of the subsequent dose

These “Instructions for Use” contain information on how to inject Spevigo when the prescribed dose for you or your child requires 2 pre-filled syringes of Spevigo.

Read these Instructions for Use before you use Spevigo for the first time and each time you get a refill. There may be new information.

This information does not take the place of talking to your healthcare professional about your or your child’s medical condition or treatment. Your healthcare professional should show you the right way to inject Spevigo before you try to inject yourself or your child for the first time.

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 Spevigo pre-filled syringes that come in the carton to deliver the complete dose.

Spevigo is for one-time use. Do not re-use the pre-filled syringe.

Getting to know Spevigo pre-filled syringe

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

Spevigo pre-filled syringe before use and after use with the activated safety cover

Important information you need to know before injecting Spevigo pre-filled syringe

150 mg pre-filled syringe for administration of the subsequent dose

You must inject the contents of both Spevigo pre-filled syringes to deliver a complete dose.
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 expiration date.
Do not use Spevigo if the liquid is cloudy or contains flakes or large particles.
Do not use Spevigo if the expiration date (EXP) has passed.
Do not use Spevigo if the pre-filled syringe has been dropped.
Do not remove the cap until you are ready to inject.
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.

Storing Spevigo:

If needed, Spevigo 150 mg pre-filled syringes can be stored at room temperature up to 25°C for up to 14 days.
Throw away Spevigo 150 mg pre-filled syringes if kept at room temperature for more than 14 days.

Keep Spevigo and all medicines out of the reach and sight of children.

Before Use

After Use

thumb pad

plunger rod

finger grip

medicine

safety cover

cap

covered needle

activated safety cover

The needle should be inside the safety cover after use.

syringe body

Follow the steps below when you use Spevigo:

STEP 1	Gathering supplies
1 sharps disposal container (not included) 2 Spevigo pre-filled syringes 2 cotton balls or gauze (not included) 2 alcohol wipes (not included)	Take the Spevigo carton out of the refrigerator and remove the pre-filled syringes from the carton. Gather supplies listed 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 Spevigo pre-filled syringes and caps.”
STEP 2	Preparing to inject Spevigo
Bring medicine to room temperature Wash hands 15-30 minutes	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.
STEP 3	Inspecting the pre-filled syringes
EXP MM YYYY medicine Check both pre-filled syringes now	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 prescribed dose. Check the expiration date on both pre-filled syringes. Do not use if the expiration date (EXP) 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.
Preparing for your first injection
	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.
STEP 4	Choosing the injection site
Injection areas Abdomen Upper thighs	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.
STEP 5	Cleaning the injection site
	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.
STEP 6	Removing the cap
Cap Cap	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 pre-filled 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.
STEP 7	Pinch the skin
	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.
STEP 8	Before injecting, review steps A, B, and C to learn the correct way to inject
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.
45°	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.
A Inserting the needle
Push firmly 45°	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.
B Injecting the medicine
45° Remove thumb to activate the safety cover	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 healthcare professional. 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 an adhesive bandage if needed.
C Checking injection is complete
STEP 9	Second injection
	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.
STEP 10	Disposing of the used Spevigo pre-filled syringes and caps
	Put the used syringes and caps in a sharps disposal container right away after use. Do not throw away (dispose of) 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.

Need help?

Call your doctor to talk about any questions you may have. For questions or concerns visit the manufacturer’s website (www.leo-pharma.ca) or call 1-800-263-4218.