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WHY SPEVIGO

Is generalized pustular psoriasis (GPP) interfering with your life? Ask your dermatologist about SPEVIGO® (spesolimab-sbzo) injection.

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).

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ABOUT SPEVIGO

When it comes to treating GPP, what’s important to you? Learn more about SPEVIGO and ask your dermatologist about whether it may be an option for you.

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FIRST AND ONLY

SPEVIGO is the first and only FDA-approved medication indicated for the treatment of GPP in adults and children 12 years of age and older and weighing at least 88 lbs (40 kg).
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TARGETED TREATMENT

SPEVIGO works to help block a source of inflammation that may cause GPP flares.
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FOR PEOPLE WITH GPP

Patients and dermatologists are choosing SPEVIGO to treat GPP, not only to treat an active flare, but also when not experiencing a flare.

Individual results may vary. 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.

ONE THERAPY, TWO WAYS TO TREAT GPP

There are two ways SPEVIGO is administered, depending on your situation—as subcutaneous (SC) injection or an intravenous (IV) infusion. Take a closer look at the two ways SPEVIGO treats GPP. 

IV INFUSION 

To treat a GPP flare, SPEVIGO is prescribed as an IV infusion that is given by a healthcare professional when a GPP flare occurs.

SC INJECTION

To help treat GPP when not experiencing a flare, SPEVIGO is prescribed as subcutaneous injections every 4 weeks. The medicine is injected under your skin.

HOW SPEVIGO WORKS

SPEVIGO is a targeted treatment that works to help deter activity of the interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system that is believed to be involved in triggering GPP flares. Take a closer look at how SPEVIGO works.

RESULTS WITH SPEVIGO

INTRAVENOUS (IV) INFUSION

In a clinical trial of 53 patients (Effisayil® 1), adult patients receiving SPEVIGO IV reported:

RAPID RELIEF

With SPEVIGO, 54% (19 out of 35) of patients achieved rapid and complete pustular clearance within 1 week. 11.4% (4 out of 35) of patients started seeing pustular clearance by Day 2.

CLEAR RESULTS 

In 60% of patients, pustular clearance was sustained during the 12-week study period.

OTHER PATIENT-REPORTED OUTCOMES

While the clinical trial was not designed to measure these endpoints, patient-reported outcomes included assessment of pain, redness, itching, burning sensations, and fatigue.

Individual results may vary.

SAFETY & SIDE EFFECTS

SUBCUTANEOUS (SC) INJECTION

 

In a clinical trial (Effisayil® 2), SPEVIGO SC demonstrated:

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REDUCED RISK

SPEVIGO significantly reduced the risk of flare occurrence over 48 weeks versus placebo.

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RESULTS YOU CAN SEE

No flares were observed in patients taking SPEVIGO SC after Week 4.

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OTHER PATIENT-REPORTED OUTCOMES

While the clinical trial was not designed to measure these endpoints, patient-reported outcomes included assessment of pain, severity of symptoms, physical and social functioning, work productivity, and health-related quality of life.

Individual results may vary.

A dermatologist talks to a patient about GPP options.

TALK TO YOUR DERMATOLOGIST

Finding the right treatment plan starts with an informed conversation with your dermatologist. Use the doctor discussion guide to help you organize your thoughts, capture your questions, and prepare to make the most of your next appointment. Together, you can create a plan that complements your life and treatment needs.

Download the Guide 

READY TO GET STARTED WITH SPEVIGO?

Learn more about what to expect when treating your GPP with SPEVIGO.
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STAY INFORMED WITH SPEVIGO

Sign up to receive updates and information about SPEVIGO. Get GPP resources designed to help you move forward and take control of your care.

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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). 

Important Safety Information

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.  

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
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.
  • 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. 

What are the possible side effects of SPEVIGO?

The most common side effects of SPEVIGO given in a vein (intravenously) for GPP flare treatment include: 

  • feeling tired or weak
  • nausea and vomiting
  • headache
  • 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 when given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare include:  

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

These are not all of the possible side effects of SPEVIGO. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-SPG-100004 03.18.2024

SPEVIGO is a registered trademark of and BI SOLUTIONS PLUS is a service mark of Boehringer Ingelheim International GmbH, used under license.