Pronunciation: spea-VEE-go
Generic name: spesolimab-sbzo
Dosage form: single-dose vial for intravenous use (450 mg/7.5 mL), single-dose prefilled syringe for subcutaneous use (300 mg/2 mL, 150 mg/mL)
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 29, 2025.

What is Spevigo? GPP Treatment Overview

Spevigo (spesolimab) is used to treat generalized pustular psoriasis (GPP) in adults and children 12 years and older who weigh at least 88 pounds (40 kg). This monoclonal antibody therapy is given by intravenous infusion when used to treat a GPP flare, and by subcutaneous injection (under the skin) every 4 weeks when used for maintenance GPP treatment.

Key Facts About Spevigo

• Generic name: Spesolimab-sbzo
• Drug class: Interleukin (IL) inhibitors, monoclonal antibodies
• Target: IL-36 receptor antagonist
• Administration: IV infusion for flares, subcutaneous injection for maintenance
• FDA approval date: September 1, 2022
• Manufacturer: Boehringer Ingelheim
• Generic availability: No generic or biosimilar versions available.

How Does Spevigo Work for GPP?

Spevigo works by blocking the IL-36 receptor, which forms part of a key inflammatory pathway involved in GPP development and progression.  

Mechanism of Action

• Target pathway: Interleukin-36 receptor (IL-36R) inhibition
• Inflammatory cascade: Prevents overactivation of immune responses
• Keratinocyte regulation: Reduces excessive skin cell production
• Pustule formation: Blocks the inflammatory signals, causing pustular lesions
• Rapid action: Provides quick symptom relief during acute flares

Why IL-36R Targeting Matters

• GPP-specific pathway: IL-36R dysregulation is central to GPP pathogenesis
• Precision medicine: Targets the root cause rather than general inflammation
• Sustained benefit: Provides both acute treatment and long-term prevention.

Spevigo FDA Approval and Clinical Evidence

FDA Approval Details

• Approval date: September 1, 2022
• Indication: Generalized pustular psoriasis in adults and pediatric patients ≥12 years, ≥40 kg
• Breakthrough therapy designation: Granted due to significant clinical benefit
• Orphan drug status: For rare disease treatment

Clinical Trial Results

Effisayil 1 Trial, NCT03782792 (GPP Flare Treatment):

• Phase 3 trial for acute GPP flares.
• Primary endpoint: Pustular clearance within 1 week.
• Key results: 54% achieved rapid pustular clearance within 1 week with IV Spevigo.
• Onset: 11.4% saw pustular clearance by Day 2.
• Duration: 60% maintained clearance throughout the 12-week trial period.

Effisayil 2 Trial, NCT06013969 (GPP Maintenance Treatment)

• Phase 3 maintenance therapy trial
• Duration: 48-week study period
• Key results: 87% flare-free with Spevigo, 48% flare-free with placebo
• Significant reduction in overall flare occurrence
• Well-tolerated long-term safety profile.

Spevigo Side Effects and Safety Profile

Common side effects during GPP flares (IV treatment)

• Systemic effects: Fatigue, weakness, headache
• Gastrointestinal: Nausea, vomiting
• Skin reactions: Itching, hives, injection site reactions
• Infections: Urinary tract infections
• Hematologic: Bruising, blood collection at the infusion site.

Common Side Effects During Maintenance (SC Treatment)

• Injection site reactions: Redness, pain, swelling, hardening, warmth
• Infections: Urinary tract infections, upper respiratory infections
• Musculoskeletal: Joint pain, muscle aches
• Dermatologic: Itchy skin, skin irritation.

Serious side effects and warnings

Spevigo may cause the following serious side effects:

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, and may treat you or your child for TB before you begin treatment 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 has an infection or has 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 has a serious allergic reaction, your healthcare provider will stop treatment with Spevigo. If you or your child is given Spevigo in a vein (intravenously) and has 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 injection:

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

You 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 treatment

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

These are not all the side effects of Spevigo. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before receiving

You should not receive Spevigo if you have had a severe or life-threatening allergic reaction to spesolimab, Spevigo, or any of the inactive ingredients in the injection.

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

• 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
• and have recently received or are scheduled to receive an immunization (vaccine)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Spevigo can harm an unborn baby

Breastfeeding

It is not known if Spevigo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment

How is Spevigo administered?

The way Spevigo is administered depends on whether the patient is being treated for a GPP flare or using it for the maintenance treatment of GPP.

• When used to treat a GPP flare, it is given as an intravenous infusion by a healthcare provider over 90 minutes.
• When used for maintenance treatment of GPP (no flare), it is given as a subcutaneous (SC) injection every 4 weeks, after an initial loading dose. Patients can be taught how to self-administer the prefilled syringe.

Dosing information

Dose of Spevigo for IV treatment of a GPP flare (adults and children 12 and older)

• GPP flare: 900 mg as a single dose (dilute before use)
• Administered as an intravenous infusion over 90 minutes (maximum time 180 minutes) 
• 1 week later, if symptoms persist: 900 mg as a single dose.

Subcutaneous dose of Spevigo for the treatment of GPP when not experiencing a flare (adults and children 12 and older)

• Loading dose: 600 mg SC. A healthcare provider can give you this.
• 4 weeks later: 300 mg SC.
• Every 4 weeks thereafter: 300 mg SC.

Administer subcutaneously into the abdomen or upper thighs using the Spevigo prefilled syringe.

If you have just been treated with IV Spevigo for a GPP flare, then a loading dose is not required.

Do not self-administer Spevigo until you have been taught how to do so by a healthcare provider.

• Children aged 12 to 17 years should administer Spevigo under the supervision of an adult.
• If you experience a GPP flare while receiving subcutaneous Spevigo, your healthcare provider may treat the GPP flare with intravenous Spevigo. 

What is Generalized Pustular Psoriasis?

Generalized pustular psoriasis is a rare, severe form of psoriasis characterized by widespread pustules (pus-filled bumps) across the body. Unlike common plaque psoriasis, GPP can be life-threatening and requires immediate medical attention.

GPP Key Characteristics

• Prevalence: Affects approximately 1-2 people per million
• Symptoms: Widespread sterile pustules, fever, fatigue, joint pain
• Triggers: Infections, medications, pregnancy, stress
• Complications: Secondary infections, organ dysfunction, sepsis
• Flare patterns: Unpredictable episodes requiring emergency treatment.

What other drugs will affect Spevigo?

No formal drug interaction studies have been conducted with Spevigo, but because it affects the immune system, there are likely to be interactions with other immune-suppressing agents, such as infliximab, and most vaccines, because they require a response from the immune system to vaccination. Some herbal medicines and probiotics may also interact.

Do not administer live vaccines concurrently with Spevigo.

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

Storage

Prefilled syringes (for subcutaneous use)

Store your Spevigo prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in the original carton to
protect them from light.

• Do not freeze.
• Do not use them if they have been frozen, even if they are now thawed.

Keep out of the reach of children.

Take the box of prefilled syringes out of the refrigerator and leave for 15 to 30 minutes to warm up to room temperature before injecting. Do not speed up the warming process in any way, and do not leave it in direct sunlight.

Each carton contains two single-dose 150 mg/mL or 300 mg/2 mL prefilled syringes.

Ingredients

Active ingredient: spesolimab-sbzo

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

Available as:

• 450 mg/7.5 mL (60 mg/mL) solution in a single-dose vial
• 2 single-dose 150 mg/mL prefilled syringes for SC use in a carton
• 2 single-dose 300 mg/2 mL prefilled syringes for SC use in a carton.

Manufacturer

Spevigo (spesolimab-sbzo) is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., headquartered in Ingelheim, Germany.

Spevigo Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Spevigo.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer