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Spevigo

Pronunciation: spea-VEE-go
Generic name: spesolimab-sbzo
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 Feb 12, 2025.

What is Spevigo?

Spevigo (spesolimab-sbzo) is used to treat generalized pustular psoriasis (GPP), including GPP flares, in adults and children aged 12 and older who weigh at least 88 pounds (40 kg).

Spevigo first gained FDA approval on September 1, 2022, and was the first treatment approved specifically for GPP. After favorable clinical trials, this approval was extended to include SC administration for GPP maintenance, and children aged 12 and older, weighing more than 40kg on March 18, 2024.

There are no Spevigo biosimilars or generics.

How does Spevigo work?

Spevigo's mechanism of action involves 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 and GPP flares is unknown.

Spevigo belongs to the drug class called interleukin inhibitors. Specifically, it is an interleukin-36 receptor antagonist. It may also be called a biologic.

Spevigo side effects

The most common side effects of Spevigo in patients experiencing a GPP flare are:

The most common side effects of Spevigo in patients not currently experiencing a GPP flare include:

Serious side effects and warnings

Spevigo may cause the following serious side effects.

Infections. Clinical trials have shown Spevigo 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:

Allergic reactions and infusion-related reactions. These 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, 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:

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.

Before receiving

You should not receive Spevigo 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 Spevigo, tell your healthcare provider about all of your medical conditions, including if you:

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

How is Spevigo administered?

The way Spevigo is administered depends on whether the patient is being treated for a GPP flare or GPP (no flare).

Dosing information

Spevigo infusion

When Spevigo is used to treat GPP flares, it 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.

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.

Subcutaneous injection

When Spevigo is used to treat GPP in those not experiencing a flare, it can be given by SC injection into the abdomen or upper thighs using the Spevigo prefilled syringe.

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

What other drugs will affect Spevigo?

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.

Does Spevigo interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Storage

Intravenous vials

Your healthcare provider will refrigerate these vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light. Do not freeze.

Before use, unopened Spevigo may be stored at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours in the original carton to protect from light.

Each carton contains two single-dose 450 mg/7.5 mL (60 mg/mL) glass vials.

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.

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 in direct sunlight.

Each carton contains two single-dose 150 mg/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 a 450mg/7.5mL (60mg/mL) solution in a single-dose vial and two single-dose 150 mg/mL prefilled syringes for SC use in a carton.

Who makes Spevigo?

Spevigo is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., headquartered in Ingelheim, Germany. Other notable drugs made by Boehringer Ingelheim Pharmaceuticals, Inc. include:

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.

Spevigo (spesolimab-sbzo) - Boehringer Ingelheim Pharmaceuticals, Inc.
Formulation type Strength
Pre-Filled Syringe 150 mg/mL
Single-Dose Vial 450 mg/7.5 mL (60 mg/mL)

Further information

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