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
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).
- 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 syringe, which a patient can be taught to self-administer.
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:
- 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 of Spevigo in patients not currently experiencing a GPP flare include:
- redness, pain, swelling, hardening, hives, or warmth at the injection site
- urinary tract infections
- joint pain
- itchy skin.
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:
- 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 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:
- 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 Spevigo. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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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:
- 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 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
- are pregnant or plan to become pregnant. It is not known if Spevigo can harm you or your child's 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 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).
- 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 (no flare), it is given as a subcutaneous (SC) (under the skin) injection using a prefilled syringe every 4 weeks, which a patient can be taught to self-administer.
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.
- Your healthcare provider will use an aseptic technique to draw up and reconstitute two vials of Spevigo (each vial contains 450 mg/7.5 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 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
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.
- 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 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:
- Spiriva (tiotropium inhalation) for asthma and COPD
- Pradaxa (dabigatran) to treat blood clots
- Synjardy and Jentadueto for diabetes.
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) |
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.