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Spevigo (Spesolimab): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
300 mg/2 mL, 150 mg/mL, 60 mg/mL
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Spevigo

What is the most important information I should know about SPEVIGO?

SPEVIGO may cause serious side effects, including:

  • Infections. SPEVIGO may lower the ability of your or your child's immune system to fight infections and may increase your or your child's risk of infections. Your healthcare provider should check you or your child for infections and tuberculosis (TB) before starting treatment with SPEVIGO and may treat you or your child for TB before you begin treatment with SPEVIGO if you have a history of TB or have active TB. Your healthcare provider should watch you or your child closely for signs and symptoms of TB during or after treatment with SPEVIGO. Tell your healthcare provider right away if you or your child have an infection or have symptoms of an infection during or after treatment with SPEVIGO, including:
  • fevers, chills, or sweats
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm (mucus)
  • burning when you urinate
  • urinating more often than normal

  • Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your or your child's SPEVIGO injection. If you or your child have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO. If you or your child are given SPEVIGO in a vein (intravenously) and have an infusion-related reaction, your healthcare provider will stop your or your child's SPEVIGO infusion and treat your or your child's symptoms and may restart SPEVIGO at a slower infusion rate.

    Tell your healthcare provider or get emergency medical help right away if you or your child get any of the following symptoms during or after your or your child's SPEVIGO injection:

  • feeling faint, dizzy, or lightheaded
  • swelling of your face, eyelids, lips, mouth, tongue, or throat
  • trouble breathing or throat tightness
  • fever
  • mouth sores
  • chest tightness
  • hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP)
  • itching
  • swollen lymph nodes

See "What are the possible side effects of SPEVIGO?" for more information about side effects.

What is SPEVIGO?

SPEVIGO is a prescription medicine used to treat generalized pustular psoriasis (GPP) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg).

It is not known if SPEVIGO is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40 kg).

Do not receive SPEVIGO if you or your child have had a severe or life-threatening allergic reaction to spesolimab- sbzo or any of the ingredients in SPEVIGO. See the end of this Medication Guide for a complete list of ingredients in SPEVIGO.

Before you or your child receive SPEVIGO, tell your healthcare provider about all of your medical conditions, including if you or your child:

  • have an infection that does not go away or that keeps coming back. See "What is the most important information I should know about SPEVIGO?"
  • have TB or have been in close contact with someone with TB.
  • have recently received or are scheduled to receive an immunization (vaccine). You or your child should not receive live vaccines during and for at least 16 weeks after treatment with SPEVIGO. You or your child should be brought up to date with all vaccines before starting SPEVIGO.

  • are pregnant or plan to become pregnant. It is not known if SPEVIGO can harm your or your child's unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if SPEVIGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your or your child's baby during treatment with SPEVIGO.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.

How will I receive SPEVIGO?

When given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare:

  • Read the detailed "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 prefilled syringes.
  • SPEVIGO prefilled syringes come in two different strengths (300 mg/2 mL or 150 mg/mL). Your healthcare provider will prescribe the prefilled syringe that is right for you.
  • Your healthcare provider will tell you how much SPEVIGO to inject and when to inject it. Use SPEVIGO exactly as your healthcare provider tells you to use it.
  • If your healthcare provider decides that you or a caregiver can give your or your child's injections of SPEVIGO at home, you should receive training on the right way to prepare and inject SPEVIGO. Do not try to inject SPEVIGO until you have been shown the right way by your healthcare provider. In children 12 years of age and older, SPEVIGO should be given under the supervision of an adult.
  • If you miss a dose of SPEVIGO, inject your or your child's dose as soon as possible. Then, inject your or your child's next dose at the regular scheduled time. In case you are not sure when to inject SPEVIGO, call your healthcare provider.

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

  • Your healthcare provider will give you or your child SPEVIGO through a needle placed in your vein (intravenous infusion) over 90 minutes.
  • SPEVIGO is usually given one time. If GPP flare symptoms continue, your healthcare provider will decide if you should receive an additional treatment with SPEVIGO after 1 week.

What are the possible side effects of SPEVIGO?

SPEVIGO may cause serious side effects.

  • See "What is the most important information I should know about SPEVIGO?"

The most common side effects of SPEVIGO for GPP flare treatment include:

  • feeling tired or weak
  • headache
  • nausea
  • itching or itchy bumps
  • a collection of blood under the skin at the infusion site or bruising
  • urinary tract infection

The most common side effects of SPEVIGO for treatment of GPP when not experiencing a flare include:

  • redness, pain, swelling, hardening, hives, or warmth at the injection site
  • urinary tract infection
  • joint pain
  • itching

These are not all of the possible side effects of SPEVIGO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SPEVIGO?

  • Store SPEVIGO prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze SPEVIGO. Do not use SPEVIGO if frozen, even if it has been thawed.
  • Store SPEVIGO in the original carton until use to protect from light.
  • If needed, SPEVIGO 300 mg/2 mL prefilled syringes may also be stored at room temperature up to 77°F (25°C) for up to 14 days. Throw away (dispose of) SPEVIGO 300 mg/2 mL prefilled syringes that have been left at room temperature for more than 14 days.

Keep SPEVIGO and all medicines out of the reach of children.

General information about the safe and effective use of SPEVIGO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SPEVIGO for a condition for which it was not prescribed. Do not give SPEVIGO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SPEVIGO that is written for health professionals.

What are the ingredients in SPEVIGO?

Active ingredient: spesolimab-sbzo

Inactive ingredients: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, and Water for Injection

Manufactured by: LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Denmark

Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

U.S. License No. 2169

SPEVIGO® is a registered trademark of LEO Pharma A/S.

© 2026 LEO Pharma Inc. All rights reserved.

For more information about SPEVIGO, including current prescribing information and Medication Guide, go to www.SPEVIGO.com, or call LEO Pharma, Inc. at 1-833-SPEVIGO.

INSTRUCTIONS FOR USE

SPEVIGO® (spea VEE go) (spesolimab-sbzo)

injection, for subcutaneous use 150 mg/mL

Two 150 mg/mL single-dose prefilled syringes for a total of 300 mg dose

This Instructions for Use contains information on how to inject SPEVIGO.

Read both sides of this 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 provider about your or your child's medical condition or treatment. Your healthcare provider should show you or your child the right way to inject SPEVIGO before you try to inject yourself or your child for the first time. In children 12 years of age and older, SPEVIGO should be given under the supervision of an adult.

SPEVIGO is for one-time use only. Do not reuse the prefilled syringes.

Your healthcare provider has prescribed a dose of SPEVIGO for you or your child that requires 2 injections (2 prefilled syringes) to deliver a complete dose.

You must inject the contents of both SPEVIGO prefilled syringes that come in the carton to deliver the complete dose.

Getting to know SPEVIGO:

SPEVIGO comes in a prefilled syringe with a safety cover. The needle is pulled back into the safety cover after injection.

Guide to parts:

The figure below shows SPEVIGO before use, and after use with the activated safety cover.

Important information you need to know before injecting SPEVIGO:

  • You must inject the contents of both SPEVIGO prefilled syringes to deliver a complete dose.
  • Inspect the SPEVIGO carton to be sure that you have the correct medicine, 2 prefilled syringes for your or your child's prescribed dose, for any damage, and the expiration date (EXP).
  • Do not use SPEVIGO if the liquid is cloudy or contains flakes or large or colored particles.
  • Do not use SPEVIGO if the expiration date (EXP) has passed.
  • Do not use SPEVIGO if the prefilled 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:

  • Store SPEVIGO prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze SPEVIGO. Do not use SPEVIGO if frozen, even if it has been thawed.
  • Store SPEVIGO in the original carton until use to protect from light.

Keep SPEVIGO and all medicines out of the reach of children.

Step 1Gather supplies
  • Take the SPEVIGO carton out of the refrigerator and remove the prefilled syringes from the carton.
  • Gather supplies listed above and place them on a clean, flat work surface in a well-lit area.
  • If you do not have all the supplies listed above, contact your pharmacist.
  • See Step 10: "Disposing of the used SPEVIGO prefilled syringes and caps."
Step 2Preparing to inject SPEVIGO
  • 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 prefilled syringes in direct sunlight.
  • Do not remove the needle cap until you are ready to inject.
  • Wash your hands well with soap and water and dry them.
Step 3Inspecting the prefilled syringes

Check both prefilled syringes now:

  • Check to make sure the medicine name SPEVIGO and the dose on your prefilled syringes match your or your child's prescribed dose.
  • Check the expiration date (EXP) on both prefilled syringes. Do not use if the expiration date has passed.
  • Check both prefilled syringes for damage, cracks, and leakage. Do not use if any part of the prefilled syringes appear cracked, broken, or are leaking.
  • Make sure the medicine in both prefilled syringes is clear and colorless to slightly brownish-yellow. It may contain tiny white or clear particles. Do not use if the medicine is cloudy or has flakes or large or colored particles in it.
  • It is normal to see air bubbles, they do not need to be removed.
  • Do not use if the SPEVIGO prefilled syringes have been dropped.
Preparing for your first injection

Prepare for the first of 2 injections.

You will repeat the following steps with the second syringe right away after your first injection.

2 injections are needed for a complete dose.

Step 4Choosing the injection site

Choose an injection site.

  • You may use an area on your:

    • upper thighs or
    • stomach-area (abdomen), except for an area 2 inches around your navel (belly button).
  • Choose a different injection site each time you inject, at least 1 inch away from the last injection site. Alternate between upper thigh or stomach-area for each complete dose.
  • Do not inject 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 5Clean 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 6Removing the cap from the prefilled syringe

  • Hold the prefilled 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.
  • Throw away the cap. See Step 10: "Disposing of the used SPEVIGO prefilled syringes and caps."

  • Proceed to the next step 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 7Pinch 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 your injection is complete. See Step 8C:

    "Checking injection is complete."

Step 8Injecting SPEVIGO

A. Inserting the needle:

  • Hold the prefilled 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.

B. Injecting the medicine:

  • 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.

C. Checking injection is complete:

  • 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 provider. 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.

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

Step 9Second injection

  • Choose a different injection site.

    The new injection site should be at least 1 inch away from last injection site. Alternate between upper thigh or stomach-area for each complete dose.

  • Get second prefilled syringe.
  • Repeat steps 4 through 8 right away.
  • Then continue to step 10.

Important:

You must inject the contents of both SPEVIGO prefilled syringes to give a complete dose.

Step 10Throwing away (disposing of) the used SPEVIGO prefilled syringes and caps
  • Put the used prefilled syringes and caps in an FDA-cleared sharps disposal container right away after use.

  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

    • made of a heavy-duty plastic,
    • can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

  • Do not reuse the prefilled syringes.
  • Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

If you have any problems with your injection, do not use another SPEVIGO prefilled syringe. Call your healthcare provider or pharmacist for help.

For more information call 1-833-SPEVIGO.

Manufactured by: LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Denmark

Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

U.S. License No. 2169

SPEVIGO® is a registered trademark of LEO Pharma A/S.

© 2026 LEO Pharma Inc. All rights reserved.

For more information about SPEVIGO, including current prescribing information and Medication Guide, go to www.SPEVIGO.com, or call LEO Pharma, Inc. at 1-833-SPEVIGO.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 03/2026

INSTRUCTIONS FOR USE

SPEVIGO® (spea VEE go) (spesolimab-sbzo)

injection, for subcutaneous use 300 mg/2 mL

One 300 mg/2 mL single-dose prefilled syringe for a total of 300 mg dose

This Instructions for Use contains information on how to inject SPEVIGO.

Read both sides of this 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 provider about your or your child's medical condition or treatment. Your healthcare provider should show you or your child the right way to inject SPEVIGO before you try to inject yourself or your child for the first time. In children 12 years of age and older, SPEVIGO should be given under the supervision of an adult.

SPEVIGO is for one-time use only. Do not reuse the prefilled syringe.

Your healthcare provider has prescribed a dose of SPEVIGO for you or your child that requires 1 injection to deliver a complete dose.

You must inject the contents of the SPEVIGO prefilled syringe that comes in the carton to deliver the complete dose.

Getting to know SPEVIGO:

SPEVIGO comes in a prefilled syringe with a safety cover. The needle is pulled back into the safety cover after injection.

Guide to parts:

The figure below shows SPEVIGO before use, and after use with the activated safety cover.

Important information you need to know before injecting SPEVIGO

  • Inspect the SPEVIGO carton to be sure that you have the correct medicine, 1 prefilled syringe for your or your child's prescribed dose, for any damage, and the expiration date (EXP).
  • Do not use SPEVIGO if the liquid is cloudy or contains flakes or large or colored particles.
  • Do not use SPEVIGO if the expiration date (EXP) has passed.
  • Do not use SPEVIGO if the prefilled 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:

  • Store SPEVIGO prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze SPEVIGO. Do not use SPEVIGO if frozen, even if it has been thawed.
  • Store SPEVIGO in the original carton until use to protect from light.
  • If needed, SPEVIGO 300 mg/2 mL prefilled syringe may also be stored at room temperature up to 77°F (25°C) for up to 14 days.
  • Throw away (dispose of) SPEVIGO 300 mg/2 mL prefilled syringe that has been left at room temperature for more than 14 days.

Keep SPEVIGO and all medicines out of the reach of children.

Step 1Gather supplies
  • Take the SPEVIGO carton out of the refrigerator and remove the prefilled syringe from the carton.
  • Gather supplies listed above and place them on a clean, flat work surface in a well-lit area.
  • If you do not have all the supplies listed above, contact your pharmacist.
  • See Step 9: "Disposing of the used SPEVIGO prefilled syringe and cap."
Step 2Preparing to inject SPEVIGO
  • 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 prefilled syringe in direct sunlight.
  • Do not remove the needle cap until you are ready to inject.
  • Wash your hands well with soap and water and dry them.
Step 3Inspecting the prefilled syringe

Check the prefilled syringe:

  • Check to make sure the medicine name SPEVIGO and the dose on the prefilled syringe match your or your child's prescribed dose.
  • Check the expiration date (EXP) on the prefilled syringe. Do not use if the expiration date has passed.
  • Check the prefilled syringe for damage, cracks, and leakage. Do not use if any part of the prefilled syringe appears cracked, broken, or is leaking.
  • Make sure the medicine in the prefilled syringe is clear and colorless to slightly brownish-yellow. It may contain tiny white or clear particles. Do not use if the medicine is cloudy or has flakes or large or colored particles in it.
  • It is normal to see air bubbles, they do not need to be removed.
Step 4Choosing the injection site

Choose an injection site.

  • You may use an area on your:

    • upper thighs or
    • stomach-area (abdomen), except for an area 2 inches around your navel (belly button).
  • Choose a different injection site each time you inject at least 1 inch away from the last injection site. Alternate between upper thigh or stomach-area for each complete dose.
  • 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 5Clean 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 6Removing the cap from the prefilled syringe

  • Hold the prefilled 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.
  • Throw away the cap. See Step 9: "Disposing of the used SPEVIGO prefilled syringes and caps."

  • Proceed to the next step 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 7Pinch 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.
  • Do not let go until your injection is complete. See Step 8C: "Checking injection is complete."
Step 8Injecting SPEVIGO

A. Inserting the needle:

  • Hold the prefilled syringe by the finger grip.
  • Do not touch the thumb pad yet.
  • 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.

B. Injecting the medicine:

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

C. Checking injection is complete:

  • Slowly remove your thumb from the 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 provider. 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.

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

Step 9Throwing away (disposing of) the used SPEVIGO prefilled syringe and cap
  • Put the used prefilled syringe and cap in an FDA-cleared sharps disposal container right away after use.

  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

    • made of a heavy-duty plastic,
    • can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

  • Do not reuse the prefilled syringe.
  • Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

If you have any problems with your injection, do not use another SPEVIGO prefilled syringe. Call your healthcare provider or pharmacist for help.

For more information call 1-833-SPEVIGO.

Manufactured by: LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Denmark

Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

U.S. License No. 2169

SPEVIGO® is a registered trademark of LEO Pharma A/S.

© 2026 LEO Pharma Inc. All rights reserved.

For more information about SPEVIGO, including current prescribing information and Medication Guide, go to www.SPEVIGO.com, or call LEO Pharma, Inc. at 1-833-SPEVIGO.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 03/2026

INSTRUCTIONS FOR USE

SPEVIGO® (spea VEE go) (spesolimab-sbzo)

injection, for subcutaneous use 300 mg/2 mL

Two 300 mg/2 mL single-dose prefilled syringes for a total of 600 mg dose

This Instructions for Use contains information on how to inject SPEVIGO.

Read both sides of this 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 provider about your or your child's medical condition or treatment. Your healthcare provider should show you or your child the right way to inject SPEVIGO before you try to inject yourself or your child for the first time. In children 12 years of age and older, SPEVIGO should be given under the supervision of an adult.

SPEVIGO is for one-time use only. Do not reuse the prefilled syringes.

Your healthcare provider has prescribed a dose of SPEVIGO for you or your child that requires 2 injections (2 prefilled syringes) to deliver a complete dose.

You must inject the contents of both SPEVIGO prefilled syringes that come in the carton to deliver the complete dose.

Getting to know SPEVIGO:

SPEVIGO comes in a prefilled syringe with a safety cover. The needle is pulled back into the safety cover after injection.

Guide to parts:

The figure below shows SPEVIGO before use, and after use with the activated safety cover.

Important information you need to know before injecting SPEVIGO

  • You must inject the contents of both SPEVIGO prefilled syringes to deliver a complete dose.
  • Inspect the SPEVIGO carton to be sure that you have the correct medicine, 2 prefilled syringes for your or your child's prescribed dose, for any damage, and the expiration date (EXP).
  • Do not use SPEVIGO if the liquid is cloudy or contains flakes or large or colored particles.
  • Do not use SPEVIGO if the expiration date (EXP) has passed.
  • Do not use SPEVIGO if the prefilled 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

  • Store SPEVIGO prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze SPEVIGO. Do not use SPEVIGO if frozen, even if it has been thawed.
  • Store SPEVIGO in the original carton until use to protect from light.
  • If needed, SPEVIGO 300 mg/2 mL prefilled syringe may also be stored at room temperature up to 77°F (25°C) for up to 14 days.
  • Throw away (dispose of) SPEVIGO 300 mg/2 mL prefilled syringe that has been left at room temperature for more than 14 days.

Keep SPEVIGO and all medicines out of the reach of children.

Step 1Gather supplies
  • Take the SPEVIGO carton out of the refrigerator and remove the prefilled syringes from the carton.
  • Gather supplies listed above and place them on a clean, flat work surface in a well-lit area.
  • If you do not have all the supplies listed above, contact your pharmacist.
  • See Step 10: "Disposing of the used SPEVIGO prefilled syringes and caps."
Step 2Preparing to inject SPEVIGO
  • 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 prefilled syringe in direct sunlight.
  • Do not remove the needle cap until you are ready to inject.
  • Wash your hands well with soap and water and dry them.
Step 3Inspecting the prefilled syringes

Check both prefilled syringes now:

  • Check to make sure the medicine name SPEVIGO and the dose on your prefilled syringes match your or your child's prescribed dose.
  • Check the expiration date (EXP) on both prefilled syringes. Do not use if the expiration date has passed.
  • Check both prefilled syringes for damage, cracks, and leakage. Do not use if any part of the prefilled syringes appear cracked, broken, or are leaking.
  • Make sure the medicine in both prefilled syringes is clear and colorless to slightly brownish-yellow. It may contain tiny white or clear particles. Do not use if the medicine is cloudy or has flakes or large or colored particles in it.
  • It is normal to see air bubbles, they do not need to be removed.
Preparing for your first injection

Prepare for the first of 2 injections.

You will repeat the following steps with the second syringe right away after your first injection.

2 injections are needed for a complete dose.

Step 4Choosing the injection site

Choose an injection site.

  • You may use an area on your:

    • upper thighs or
    • stomach-area (abdomen), except for an area 2 inches around your navel (belly button).
  • Choose a different injection site each time you inject, at least 1 inch away from the last injection site. Alternate between upper thigh or stomach-area for each complete dose.
  • 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 5Clean 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 6Removing the cap from the prefilled syringe

  • Hold the prefilled 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.
  • Throw away the cap. See Step 10: " Disposing of the used SPEVIGO prefilled syringes and caps."

  • Proceed to the next step 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 7Pinch 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.
  • Do not let go until your injection is complete. See Step 8C: "Checking injection is complete."
Step 8Injecting SPEVIGO

A. Inserting the needle:

  • Hold the prefilled syringe by the finger grip.
  • Do not touch the thumb pad yet.
  • 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.

B. Injecting the medicine:

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

C. Checking injection is complete:

  • Slowly remove your thumb from the 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 provider. 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.

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

Step 9Second injection

  • Choose a different injection site.

    The new injection site should be at least 1 inch away from last injection site. Alternate between upper thigh or stomach-area for each complete dose.

  • Get second prefilled syringe.
  • Repeat steps 4 through 8 right away.
  • Then continue to step 10.

Important:

You must inject the contents of both SPEVIGO prefilled syringes to give a complete dose.

Step 10Throwing away (disposing of) the used SPEVIGO prefilled syringes and caps
  • Put the used prefilled syringes and caps in an FDA-cleared sharps disposal container right away after use.

  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

    • made of a heavy-duty plastic,
    • can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

  • Do not reuse the prefilled syringes.
  • Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

If you have any problems with your injection, do not use another SPEVIGO prefilled syringe. Call your healthcare provider or pharmacist for help.

For more information call 1-833-SPEVIGO.

Manufactured by: LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Denmark

Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

U.S. License No. 2169

SPEVIGO® is a registered trademark of LEO Pharma A/S.

© 2026 LEO Pharma Inc. All rights reserved.

For more information about SPEVIGO, including current prescribing information and Medication Guide, go to www.SPEVIGO.com, or call LEO Pharma, Inc. at 1-833-SPEVIGO.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 03/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761244 · View the label on DailyMed

Revision date stated in the text: March 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Spevigo

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Interleukin-36 Receptor Antagonist
Active ingredient Spesolimab
Dosage form Injection
Route Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) BOEHRINGER INGELHEIM PHARMACEUTICALS INC
FDA approval BLA 761244Biologics License Application (BLA) Approved September 1, 2022
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
300 mg/2 mL – 2 ml in 1 syringe, glass / 1 in 1 carton NDC 50222-362-12
300 mg/2 mL – 2 ml in 1 syringe, glass / 2 in 1 carton NDC 50222-362-12
150 mg/mL – 1 ml in 1 syringe, glass / 2 in 1 carton NDC 50222-361-11
60 mg/mL – 7.5 ml in 1 vial, glass / 2 in 1 carton NDC 50222-360-72

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.