Spevigo (spesolimab-sbzo) is an infusion that may be used to treat generalized pustular psoriasis (GPP) flares in adults. Most people only require a single 900mg dose, although a second dose of 900mg may be given one week after the initial dose if flare symptoms persist.

GPP flares are unpredictable and characterized by red, painful, itchy, pus-filled bumps (called pustules) that often cover large areas of the body. They can appear suddenly or slowly. The condition is rare and life-long and is very different from plaque psoriasis. Skin problems can be accompanied by fever, extreme tiredness, muscle weakness, an increased number of white blood cells, and other signs of inflammation throughout the body.

Spevigo works by blocking the activation of the interleukin-36 receptor (IL-36R), an inflammatory cytokine that is a key part of a signaling pathway within the immune system. Overstimulation or dysregulation of IL-36R is associated with the overproduction of keratinocytes and immune cells and psoriatic-like skin disorders. The exact way Spevigo works to reduce GPP flares is unknown.

Spevigo was FDA approved on September 1, 2022. It was the first treatment specifically for pustular psoriasis to be approved.

Spevigo may increase your risk of infections. Your healthcare provider should determine that you are free from infections, including tuberculosis (TB) before beginning Spevigo 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.

Hypersensitivity and infusion-related reactions have been reported during and after treatment with  Spevigo.

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 and treat your symptoms, and may 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 than the rash from generalized pustular psoriasis (GPP)
• itching
• swollen lymph nodes.

Spevigo is administered as an intravenous infusion over 90 minutes by a healthcare provider. Only one dose is usually needed, although a second dose may be given a week later if flares persist.

• Your healthcare provider will use an aseptic technique to draw up two vials of Spevigo (each vial contains 450mg/7.5 ml) and dilute it in 85 ml of sodium chloride to make a total volume of 100 ml.
• The solution should be administered immediately but can be kept for up to 4 hours if refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light.
• Spevigo should not be mixed with other medicinal products.
• The total infusion time, including any stop time, should not exceed 180 minutes.

You should not receive Spevigo if you have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the components of the infusion.

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. See Important information
• have TB or have been in close contact with someone with TB
• and have recently received or are scheduled to receive an immunization (vaccine). You should not receive live vaccines 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. Talk to your healthcare provider about the best way to feed your baby during treatment

It is not known if this medicine is safe and effective in children. Spevigo is not approved for young adults or children under the age of 18.

Hypersensitivity and infusion-related reactions have been reported during and after treatment with Spevigo. It may cause serious side effects such as an increased risk of infection. Tell your doctor if you have any signs of an infection such as fever, shortness of breath, pain when urinating, fatigue, or nausea and vomiting.

The most common side effects 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
• a urinary tract infection.

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

No formal drug interaction studies have been conducted with Spevigo, but because it has effects on 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.