Spevigo

Pronunciation: spea-VEE-go
Generic name: spesolimab-sbzo
Dosage form: injection, for subcutaneous or intravenous use
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 26, 2024.

What is Spevigo?

Spevigo (spesolimab-sbzo) is an injectable interleukin-36 blocker that may be used to treat generalized pustular psoriasis (GPP), including GPP flares, in adults and children aged 12 and older who weigh at least 40kg. When used to treat a GPP flare, it is given by a healthcare provider intravenously (into a vein) over 90 minutes. When used to treat GPP in those not experiencing a flare, it is given as a subcutaneous (SC) (under the skin) injection using a prefilled pen, which a patient can be taught to self-administer.

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 and GPP flares is unknown.

Spevigo was FDA-approved on September 1, 2022, making it the first treatment specifically for GPP to be approved. On 18 March 2024, its approval was expanded to include SC administration for GPP maintenance and children aged 12 and older, weighing more than 40kg.

Warnings

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, 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.

Before taking this medicine

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 children under the age of 12.

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).

When used to treat a GPP flare, it is given by a healthcare provider intravenously (into a vein) over 90 minutes.
When used to treat GPP in those not experiencing a flare, it is given as a subcutaneous (SC) (under the skin) injection using a prefilled pen every 4 weeks, which a patient can be taught to self-administer.

Intravenous 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.

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.

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.

If you have not recently been treated for a GPP flare, you will initially require a loading dose of 600mg Spevigo SC (four 150 mg injections). A healthcare provider can give you this.
This will be followed by 300 mg (two 150 mg injections) SC 4 weeks later and every 4 weeks thereafter. Your healthcare provider will tell you how much to inject.
If you have just been treated with intravenous 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 are the side effects of Spevigo?

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 reported by 5% or more people treated with Spevigo while experiencing a GPP flare 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.

The most common side effects reported by 9% or more people treated with Spevigo when not experiencing a GPP flare include:

injection site reactions
urinary treat infections
joint pain
and itchy skin.

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

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.

Storage

Intravenous vials

Refrigerate 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 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.

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, USP.

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.

No incompatibilities have been observed between Spevigo and infusion sets composed of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene, and polyurethane (PUR), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).