Spevigo
Spevigo (spesolimab or spesolimab-sbzo) treats generalized pustular psoriasis (GPP) in people ages 12 years and older. This medication is a biologic that's called an interleukin antagonist. For GPP flares, Spevigo (spesolimab) is given as an infusion through the vein (IV) by a healthcare professional. Side effects include fatigue and nausea for the IV infusion. For continued treatment of GPP, you inject the medication under the skin every month using a prefilled syringe. Pain and swelling is possible where the medication is injected under the skin.
What is Spevigo (spesolimab)?
What is Spevigo (spesolimab) used for?
- Generalized pustular psoriasis (GPP) in people ages 12 years and older who weigh at least 88 lbs
How Spevigo (spesolimab) works
Spevigo (spesolimab) is a monoclonal antibody that works as an interleukin antagonist. It blocks a protein in your immune system that plays a role in inflammation called interleukin-36 from attaching to its receptor. This helps lower inflammation.
Drug facts
Side effects of Spevigo (spesolimab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
IV infusion (for a GPP flare):
- Feeling weak and tired (9%)
- Nausea and vomiting (9%)
- Headache (9%)
- Itchy skin (6%)
- Bruising around the infusion site (6%)
- Urinary tract infection (6%)
Under-the-skin injection (when you're not having a GPP flare):
- Injection site reaction (e.g., redness, pain, swelling; 32%)
- Urinary tract infection (18%)
- Joint pain (13%)
- Itching (9%)
Less Common Side Effects
- Other types of infections
- Shortness of breath
- Eye swelling
- Hives
Spevigo (spesolimab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe infection: confusion, fever, weakness, sweating, chills, difficulty breathing, cough, stomach pain, diarrhea, burning sensation when you urinate
- Serious allergic reaction or skin reaction: sore throat, fever, fatigue, rash, hives, painful blisters, skin reddening, skin peeling, swollen lymph nodes
The following Spevigo (spesolimab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Rash, fever, and swollen lymph nodes
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Spevigo (spesolimab)
Pros
- Can clear up pustules as early as a week after an IV dose for a GPP flare
- Available as an under-the-skin injection to help prevent GPP flares
- Can give under-the-skin injections for maintenance treatment at home
- No known interactions with other medications
Cons
- Must be given as an injection into the vein or under the skin
- Must store in the refrigerator
- Hasn't been studied in children younger than 12 years old
- No lower-cost generic available; brand-name medication only
Pharmacist tips for Spevigo (spesolimab)
- Mark your calendar with your appointments to see your prescriber. This is important especially if you're getting Spevigo (spesolimab) as an IV infusion so that you avoid missing your doses. Regular check-ins with your prescriber also gives you time to discuss with them about how well Spevigo (spesolimab) is working and any bothersome side effects you might have.
- Spevigo (spesolimab) can raise your risk of getting a serious infection. Get medical help right away if you develop symptoms of an infection, such as fever, weakness, sweating, chills, cough, difficulty breathing, or diarrhea, while you're taking Spevigo (spesolimab). You might have to stop taking Spevigo (spesolimab) so your body can fight and fully recover from the infection.
- Before you get any vaccines, tell your prescriber or pharmacist that you're taking Spevigo (spesolimab). They can make sure it's safe to get the vaccine you're interested in. You shouldn't get any live vaccines during and for at least 4 months after treatment, because it's not known if Spevigo (spesolimab) affects your immune system and raises your risk of infection from the vaccine.
Tips for IV infusions of Spevigo (spesolimab):
- The IV infusion typically takes about 1.5 hours. But your care team might slow the infusion down and the infusion might take up to 3 hours if you have infusion-related reactions, such as weakness, nausea, vomiting, headache, or itchiness.
- If you'd like, bring a book or other activity to the medical office to help pass the time.
Tips for under-the-skin injections of Spevigo (spesolimab):
- After your first dose, your care team might let you inject Spevigo (spesolimab) at home. Carefully follow the instructions on how to inject Spevigo (spesolimab). You'll first get trained by a healthcare professional, but be sure to ask your care team if you have any questions about how to take the medication.
- For each monthly dose of Spevigo (spesolimab), you'll need to use two prefilled syringes to inject the full dose of medication. Each prefilled syringe for the under-the-skin injections contains 150 mg of medication.
- Keep Spevigo (spesolimab) prefilled syringes in the refrigerator and in the original carton to protect them from light. Before it's time for your dose, take the medication out of the refrigerator. Lay it on a flat surface for 15 to 30 minutes so it can reach room temperature. Don't try to warm up the medication any other way.
- Inject Spevigo (spesolimab) under the skin into the fat tissue of your upper thighs or stomach area (at least 2 inches away from your belly button). Avoid injecting near your waistline or into skin that's tender, bruised, red, hard, or scarred. Don't inject into your muscle or vein; it's not meant to be injected this way.
- To inject Spevigo (spesolimab), gently pinch the area of skin you're going to inject into with one hand. Then, use a dart-like motion to insert the needle of the prefilled syringe into the skin at a 45-degree angle with your other hand.
- Choose a different area of skin to inject into each time; it should be at least an inch away from the previous area you injected into. You can alternate between the stomach area and thigh. This helps lower your risk for bruising and skin irritation.
- After you inject the medication, throw away the used prefilled syringe in a sharps container or some heavy-duty plastic container, such as an empty milk carton or laundry detergent bottle. This helps lower the risk for needle-stick injuries. Don't throw away syringes in your trash can. Visit the FDA's website for guidance on how to safely throw away a full sharps container in your specific state.
Common questions about Spevigo
In a clinical study, it took about a week for pustules to completely go away in a little over 50% of people who got an IV infusion of Spevigo to treat a GPP flare. Tell your prescriber if you're still having flare symptoms after your infusion. Your prescriber might recommend a second IV infusion of Spevigo.
For treating generalized pustular psoriasis (GPP) flares, Spevigo is administered as an infusion through the vein (IV). The infusion is administered by a healthcare professional (HCP) at a medical office or clinic. The IV infusion typically takes about 1.5 hours. But your HCP might slow down the infusion and it can take up to 3 hours if you're having infusion-related reactions like fatigue, nausea, and chills. For maintenance treatment of GPP to help prevent flares, Spevigo can be given as an injection under the skin using prefilled syringes. Under-the-skin injections of Spevigo can't be used to treat a flare that's already started.
IV infusions of Spevigo aren't given at certain intervals of time. Instead, an IV infusion of medication is given when you have a GPP flare so that it can treat the flare symptoms. But for the under-the-skin injections of Spevigo, it's typically given once per month to keep your GPP at bay.
The Spevigo IV infusion for treating GPP flares can only be given by a healthcare professional (HCP). To manage your GPP when you're not having a flare, you can use the Spevigo prefilled syringes to give yourself the medication as an injection under the skin. But you'll need to be properly trained by your care team first. Sometimes, an HCP might need to give you your first under-the-skin injection. Ask your prescriber about whether you can inject the medication to yourself.
There isn't enough information to know whether Spevigo is safe to take during pregnancy because it hasn't been studied in humans. But in animal studies, babies born to mothers exposed to a similar medication weren't harmed. Discuss the risks and benefits of Spevigo with your care team if you're pregnant or thinking of becoming pregnant.
Yes, Spevigo is a type of biologic medication. Biologics are medications that are made from living sources, like cells, in the lab. Spevigo is a monoclonal antibody, which is a lab-made protein that's made from cells. The medication helps lower inflammation in your body to relieve symptoms of an inflammatory skin condition called generalized pustular psoriasis (GPP).
Spevigo first received its FDA approval for treating GPP in adults in September 2022. Then, the medication received FDA approval for use in children ages 12 years and older who weigh at least 88 lbs in March 2024.
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Risks and warnings for Spevigo (spesolimab)
Spevigo (spesolimab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk for serious infections
- Risk factors: Severe infection | Long-term or recurrent infection | Other conditions that raise your risk of infection | Taking medications that weaken your immune system
Spevigo (spesolimab) can affect your body's ability to fight off infections. This can raise your risk of getting serious and sometimes life-threatening infections. For example, Spevigo (spesolimab) can raise your risk for a new tuberculosis (TB) infection or for a previous TB infection to come back.
Before you start Spevigo (spesolimab), tell your care team about the medical conditions you have. You'll need to get tested for TB before you start this medication and get treated if it's confirmed that you have TB. Also let your care team know about the medications you take because some medications can weaken your immune system further and put your at even higher risk for infection.
Get immediate medical care right away if you develop symptoms of an infection like fever, cough, difficulty breathing, weakness, sweating, chills, and confusion. You might have to stop taking Spevigo (spesolimab) so your body can fight the infection.
Serious allergic reactions and infusion-related reactions
- Risk factors: Getting Spevigo (spesolimab) as an IV infusion
Severe allergic reactions to Spevigo (spesolimab) are possible, including life-threatening reactions like facial swelling and anaphylaxis (e.g., closing of the throat). Some people have also reported developing an allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), which has symptoms like fever, rash, and swollen lymph nodes. Get medical help right away if you think you're experiencing an allergic reaction.
For allergic reactions during an IV infusion of Spevigo (spesolimab), your care team will pause the infusion and consider giving you medications to relieve your symptoms. Once your symptoms get better, your care team might restart the infusion at a slower speed. For more severe allergic reactions, your care team might stop treatment altogether.
Avoid live vaccines
Avoid getting live vaccines during your treatment with Spevigo (spesolimab) and for at least 4 months after your last dose. It's not known whether live vaccines are safe to get while you're taking Spevigo (spesolimab). Examples of live vaccines include the nasal spray version of the flu vaccine (FluMist), Varivax (chickenpox vaccine), and MMR (measles, mumps, and rubella vaccine). It's best to be up to date on all your vaccines before you start Spevigo (spesolimab). Let your prescriber or pharmacist know that you're taking Spevigo (spesolimab) before you get any vaccines.
Spevigo (spesolimab) dosage
Typical dosage for Spevigo (spesolimab)
Injection into the vein (IV)
- Treatment of a GPP flare: The typical dose is 900 mg IV once for a GPP flare. The infusion is given over at least 1.5 hours. If your flare symptoms don't go away, your prescriber might give you an additional 900 mg dose of medication as an IV infusion one week after the first dose.
Injection under the skin
- Maintenance treatment of GPP when you haven't had any flares: The typical dose is 600 mg injected under the skin once. Then 4 weeks later, the typical dose is 300 mg injected under the skin every 4 weeks.
- Maintenance treatment after an IV infusion of Spevigo (spesolimab) for a GPP flare: Starting 4 weeks after you complete IV treatment with Spevigo (spesolimab), you can continue taking the medication as an injection under the skin using the prefilled syringes. The typical dose is 300 mg injected under the skin every 4 weeks.
Spevigo (spesolimab) images
