Spesolimab

Pronunciation: spes-oh-li-mab
Generic name: spesolimab-sbzo
Brand name: Spevigo
Dosage form: injection for intravenous use (450 mg/7.5 mL), prefilled syringe for subcutaneous use (150 mg/mL)
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2025.

What is spesolimab?

Spesolimab is 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 an injection that is either given intravenously (IV) by a healthcare provider for GPP flares or self-administered subcutaneously (SC) as GPP maintenance.

Sepesolimab-sbzo gained FDA approval on September 1, 2022, under the brand Spevigo. There is no generic or biosimilar.

Mechanism

Spesolimab works by specifically targeting and blocking the interleukin-36 receptor (IL-36R), a key inflammatory protein associated with psoriatic skin disorders. This interrupts cytokine signaling, reduces keratinocyte overproduction, and modulates the immune system response, relieving inflammation and other symptoms.

Spesolimab belongs to the drug class called interleukin inhibitors.

Side effects

The most common side effects of spesolimab when used for GPP flares (IV administration) are:

• fatigue or weakness
• nausea or vomiting
• headaches
• skin itching 
• infusion site redness or bruising
• urinary tract infections.

The most common side effects of spesolimab when used for GPP maintenance (SC administration) are:

• injection site reactions (redness, pain, swelling)
• urinary tract infections
• joint pain
• generalized skin itching.

Serious side effects and warnings

Spesolimab may cause the following serious side effects:

• Infections. Clinical trials have shown spesolimab may increase your risk of infections. Your healthcare provider should determine that you are free from infections, including tuberculosis (TB) before beginning treatment and monitor you for any infections that may develop. Tell your healthcare provider immediately if you have an infection or signs of an infection, such as:
  • 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. These have been reported during and after treatment with spesolimab. If you have a serious allergic reaction, your healthcare provider will stop treatment. If you have an infusion-related reaction, your healthcare provider will stop your infusion, treat your symptoms, and restart the infusion at a slower rate. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms during or after your infusion:
  • 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 from the rash from generalized pustular psoriasis (GPP)
  • itching
  • swollen lymph nodes.

These are not all the side effects of spesolimab. 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 spesolimab if you have had a severe or life-threatening allergic reaction to spesolimab-sbzo, Spevigo, or any of the components of the injection.

Before you receive spesolimab, 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
• have recently received or are scheduled to receive an immunization (vaccine). You should not receive live vaccines during and for at least 16 weeks after treatment with spesolimab. You or your child should be brought up to date with all vaccines before starting treatment
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed. 

It is not known if this medicine is safe and effective in children. spesolimab is not approved for children under the age of 12 or who weigh less than 88 pounds (40 kg).

Pregnancy

It is not known if spesolimab can harm you or your child's unborn baby. Talk to your doctor about using the medicine before you become pregnant.

Breastfeeding

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

How is spesolimab administered?

Spesolimab is administered by IV infusion (into a vein) to treat GPP flares and SC (under the skin) for GPP maintenance.

• IV infusion administration (one-off dose): Given by a healthcare provider intravenously (into a vein) over 90 minutes.
• SC administration: Self-administered or administered by a caregiver or healthcare provider every 4 weeks. Inject into the abdomen or upper thighs using the prefilled syringe.

Dosing information

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

Spesolimab IV infusion for the treatment of GPP flares

• 900 mg by IV infusion over 90 minutes.
• If flare symptoms persist, an additional 900 mg IV can be administered one week after the initial dose.

Spesolimab SC injection for the treatment of GPP when not experiencing a flare

• Loading dose: 600 mg SC (4 x 150 mg injections). A healthcare provider can give you this.
• Maintenance:  300 mg SC (2 x 150 mg injections) 4 weeks later and every 4 weeks thereafter. 

SC injection after IV spesolimab for the treatment of GPP flare

• Loading dose: No loading dose is needed.
• 4 weeks after IV spesolimab: 300 mg SC (2 x 150 mg injections) then every 4 weeks thereafter. 

What other drugs will affect this medicine?

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

No formal drug interaction studies have been conducted with spesolimab, but because it has effects on the immune system, there may be interactions with other immune-suppressing agents. Some herbal medicines and probiotics may also interact.

Do not receive live vaccines while you are being administered spesolimab. Make sure all your vaccinations are up to date before starting treatment.

Storage

Store your spesolimab prefilled syringes for SC use in the refrigerator 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 frozen, even if they are now thawed.
• 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 them in direct sunlight.

Keep out of the reach of children.

Ingredients (pre-filled syringe)

Active ingredient: spesolimab-sbzo

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

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

Manufacturer

Spesolimab is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., under the brand Spevigo. Boehringer's headquarters are in Ingelheim, Germany.

Spesolimab 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 spesolimab.

Further information

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

Medical Disclaimer