Spevigo is a brand-name prescription medication. It’s used to treat generalized pustular psoriasis (GPP) flares in adults.
GPP is a rare, severe form of psoriasis. With a GPP flare, large areas of your skin suddenly become inflamed (hot, swollen, and painful) and develop pus-filled blisters called pustules. You may also develop symptoms of inflammation throughout your body, such as fever.
Spevigo contains the active drug spesolimab-sbzo. It’s a biologic medication called an interleukin-36 receptor antagonist. Biologic medications are drugs made using living cells.
You’ll receive Spevigo as an IV infusion in your doctor’s office, a hospital, or an infusion center. An IV infusion is an injection into a vein that’s given over a period of time.
The Food and Drug Administration (FDA) approved Spevigo to treat GPP flares in 2022. At this time, it’s the only medication approved for this use.
For information about the effectiveness of Spevigo, see the “Spevigo uses” section below.
Spevigo is a biologic drug that’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.
Biologic drugs are made using living cells, whereas traditional drugs are made using chemicals. It’s possible to make exact copies of drugs made from chemicals. These are called generics. A generic drug is an exact copy of the active drug in a brand-name medication. A generic is just as safe and effective as the brand-name drug. Generics usually cost less than brand-name drugs.
It’s not possible to make exact copies of biologic drugs. However, drugs similar to the brand-name biologic drug (the parent drug) can be made. These are called biosimilars. Like generics, biosimilars are just as safe and effective as the parent drug they’re based on. And they usually cost less than the parent drug.
As with all medications, the cost of Spevigo can vary. The actual price you’ll pay depends on factors such as your insurance plan.
Before approving coverage for Spevigo, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.
If you’re not sure if you’ll need to get prior authorization for Spevigo, contact your insurance company.
Financial and insurance assistance
If you need financial support to pay for Spevigo, or if you need help understanding your insurance coverage, help is available.
A program called BI Solutions Plus is available for Spevigo. For more information and to find out if you’re eligible for support, call 833-773-8446 or visit the program website.
To learn more about saving money on prescriptions, check out this article.
Spevigo is not available in a generic or biosimilar form.
Regular drugs, including generics, are typically made using chemicals. Generic drugs are made by producing exact copies of the active ingredient in a brand name drug.
Biologic drugs, including Spevigo, are made using living cells. Biologics cannot be copied exactly. So instead of having generic versions, biologic drugs have biosimilars. A biosimilar is similar to the brand-name drug it’s based on. Biosimilars are considered to be as effective and safe as brand-name medications. And like generics, biosimilars tend to cost less than brand-name drugs.
The following information describes dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.
Drug forms and strengths
Spevigo comes as a liquid solution in a single-dose vial. Each vial contains 450 milligrams (mg) of the drug in 7.5 milliliters (mL) of solution.
A healthcare professional will give your dose of Spevigo as an IV infusion. An IV infusion is an injection into a vein that’s given over a period of time. You’ll receive your Spevigo infusion in your doctor’s office, a hospital, or an infusion center.
Dosage for generalized pustular psoriasis
The recommended dose for generalized pustular psoriasis (GPP) flares is 900 mg, given by IV infusion over 90 minutes.
You’ll typically receive one dose of Spevigo to treat a GPP flare. However, if your symptoms haven’t got better after 1 week, your doctor may recommend a second dose of 900 mg. You’ll receive this dose 1 week after your first dose.
Will I need to use this drug long term?
No, Spevigo is meant as a short-term treatment for a GPP flare. However, if you and your doctor determine that Spevigo is safe and effective for you, you may also receive it for future GPP flares.
Spevigo is used to treat generalized pustular psoriasis (GPP) flares.
What happens with GPP
GPP is a severe form of psoriasis that causes repeated episodes of symptoms affecting your whole body. These episodes are called flares.
With a flare, large areas of your skin suddenly become inflamed (hot, swollen, and painful) and develop pus-filled blisters called pustules. You may also develop symptoms of inflammation throughout your body, such as fever.
GPP flares are caused by abnormal, uncontrolled inflammatory responses. An immune system protein called interleukin-36 (IL-36) is involved in producing these abnormal inflammatory responses. IL-36 produces its inflammatory effects by attaching to IL-36 receptors (docking stations).
What Spevigo does
Spevigo is a type of drug called an IL-36 receptor antagonist. It works by attaching to IL-36 receptors and blocking them. This stops IL-36 from producing its inflammatory effects.
Spevigo’s mechanism of action (the way it works) stops the specific inflammatory responses that cause a GPP flare. This helps manage the symptoms of the flare.
How long does it take to work?
Spevigo typically works within a week of receiving the treatment. If you still have symptoms after 1 week, your doctor may recommend a second dose.
Spevigo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Spevigo. These lists do not include all possible side effects.
For more information about the possible side effects of Spevigo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it’s approved. If you would like to notify the FDA about a side effect you’ve had with Spevigo, you can do so through MedWatch.
Mild side effects
Below is a partial list of mild side effects of Spevigo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Spevigo’s prescribing information.
Mild side effects of Spevigo can include:
- asthenia (weakness)
- nausea and vomiting
- itching or itchy bumps
- bruising or hematoma (collection of blood under the skin) at the infusion site)
- mild allergic reaction*
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
* For more information about allergic reaction and Spevigo, see “Allergic reaction” below.
Serious side effects
Serious side effects from Spevigo aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- Infections, such as cold sores, respiratory infections, skin infections, and urinary tract infections (UTIs). Symptoms can include:
- swollen lymph glands
- cough or coughing up blood
- burning sensation or pain when urinating
- hot, swollen, painful skin
- Infusion reactions. Symptoms can include:
- feeling faint, lightheaded, or dizzy
- chest tightness
- mouth sores
- Severe allergic reactions, including drug rash with eosinophilia and systemic symptoms (DRESS).*
* For details about allergic reaction and Spevigo, see “Allergic reaction” below.
As with most drugs, some people can have an allergic reaction during or after receiving Spevigo. It’s not clear how often this side effect occurred in clinical trials of this drug.
Symptoms of a mild allergic reaction can include:
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your tongue, mouth, or throat
- trouble breathing
A delayed allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) may rarely occur weeks after receiving Spevigo. Symptoms can include:
- skin rash that’s different from generalized pustular psoriasis
- swollen lymph nodes
Call your doctor right away if you have symptoms of an allergic reaction to Spevigo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
A healthcare professional will give your dose of Spevigo as an IV infusion. An IV infusion is an injection into a vein (usually in your arm) that’s given over a period of time. You’ll receive Spevigo infusion in your doctor’s office, a hospital, or an infusion center.
An infusion of Spevigo typically takes about 90 minutes. A healthcare professional will monitor you for side effects during the infusion. If you have a reaction to the infusion, your healthcare professional may slow down or stop your infusion.
Your healthcare professional will continue to monitor you for a period of time after the infusion has finished. Be sure to tell your healthcare professional if you have any symptoms such as shortness of breath or chest tightness during or after your infusion.
When to receive
Spevigo is only used to treat generalized pustular psoriasis (GPP) flares. So, you’ll only receive it when needed to treat a flare. You’ll typically receive one infusion of Spevigo to treat the flare. However, if your symptoms don’t get better within 1 week, your doctor may recommend a second infusion.
The Food and Drug Administration (FDA) approves prescription drugs such as Spevigo to treat certain conditions. Spevigo may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.
Spevigo is FDA-approved to treat generalized pustular psoriasis (GPP) flares in adults.
Generalized pustular psoriasis explained
GPP is a rare, severe form of psoriasis. It’s a lifelong condition that causes repeated episodes of symptoms that can affect your whole body. These episodes are called flares. They’re caused by an abnormal inflammatory response in your body.
With a flare, large areas of your skin suddenly become inflamed (hot, swollen, and painful) and develop pus-filled blisters called pustules. You may also develop symptoms of inflammation throughout your body, such as fever. If not treated, GPP flares can cause life-threatening complications such as low blood pressure, breathing problems, or heart failure.
GPP flares can occur unexpectedly, or they may be triggered by certain factors. Triggers can include stress, infections, pregnancy, and stopping corticosteroid medications.
Symptoms of a GPP flare can include:
- burning sensation in the skin
- dry, hot, and tender skin
- red, purple, dark, or discolored patches of skin
- painful pustules that appear within hours, join together, and burst
- red, shiny, fragile, sore skin after the pustules burst
- intense itching
- fever or chills
- increased heart rate
- muscle weakness
- joint pain
Spevigo treats GPP flares by stopping the abnormal inflammatory response that’s causing the symptoms.
To learn more about different types of psoriasis and their management, refer to our psoriasis hub.
Effectiveness for generalized pustular psoriasis
Spevigo is an effective treatment for GPP flares. It can help manage flares in as little as 1 week. To find out how the drug performed in clinical trials, see Spevigo’s prescribing information.
Spevigo and children
Spevigo is only FDA-approved to treat GPP flares in adults. It hasn’t been studied in children under age 18 years. It’s not known if the medication is safe or effective in children.
Alcohol isn’t known to interact with Spevigo. However, alcohol and Spevigo can cause some similar side effects, such as headache and nausea. So, you may have a raised risk for these side effects if you drink alcohol with Spevigo.
Generalized pustular psoriasis (GPP) flares can also cause headache and nausea, as well as making you feel very unwell. It’s usually best to avoid drinking alcohol if you’re having a GPP flare.
If you want to drink alcohol after receiving Spevigo, talk with your doctor. They can recommend how much, if any, alcohol is safe to consume.
Spevigo is not expected to interact with other medications, herbs, supplements, or foods. The manufacturer of Spevigo didn’t look at interactions in clinical trials of the drug.
However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that may interact with Spevigo.
Before starting Spevigo treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.
Spevigo and vaccines
You should not get live vaccines if you’ve recently received treatment with Spevigo.
Live vaccines contain live but weakened forms of viruses or bacteria that cause infections. If your immune system is working as usual, live vaccines don’t cause infections. However, if you have a weakened immune system, getting a live vaccine could cause the infection it’s meant to protect you from.
Spevigo reduces certain responses in your immune system and can raise your risk for infections. So, treatment with Spevigo may raise your risk for getting infections with live vaccines.
Examples of live vaccines that interact with Spevigo include:
- the nasal spray flu vaccine (FluMist)
- chickenpox vaccine
- measles, mumps, and rubella vaccine
- rotavirus vaccine
- yellow fever vaccine
Before receiving Spevigo, tell your doctor if you’ve recently had any vaccines. Be sure to check with your doctor before getting any vaccines after receiving Spevigo.
It’s not known if Spevigo is safe to receive during pregnancy. The drug hasn’t been studied in people who are pregnant.
In animal studies, Spevigo didn’t have harmful effects when given to pregnant animals. However, animal studies don’t always predict what will happen in people.
If you’re pregnant or plan to become pregnant, talk with your doctor about the possible risks and benefits of receiving Spevigo.
It’s not known if Spevigo is safe to receive during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Spevigo.
For more information about taking Spevigo during pregnancy, see the “Spevigo and pregnancy” section above.
It’s not known if it’s safe to breastfeed after receiving Spevigo. The drug hasn’t been studied in people who are breastfeeding. However, Spevigo can pass into breastmilk. It’s unknown what affect the drug may have on a child who’s breastfed.
If you’re breastfeeding or plan to breastfeed, talk with your doctor. They can recommend ways to feed your child after receiving Spevigo.
Here are answers to some frequently asked questions about Spevigo.
Does Spevigo cause long-term side effects?
It’s possible. Spevigo may raise your risk of infections for several weeks after receiving a dose.
In clinical trials, some people had mild or moderate infections up to 17 weeks after receiving one or two doses of Spevigo. Examples of these infections include respiratory infections such as flu, ear infections, vaginal yeast infections, and skin infections such as boils.
If you have symptoms of an infection after receiving Spevigo, talk with your doctor. They’ll likely prescribe medication to treat the infection.
Will Spevigo cure my generalized pustular psoriasis?
No, Spevigo doesn’t cure generalized pustular psoriasis (GPP). GPP is a genetic disease that’s caused by one or more of your genes not working correctly. Spevigo doesn’t alter your genes, so it can’t cure the disease. However, it can quickly manage a GPP flare.
It’s not currently known how long the effects of Spevigo last. However, it’s being investigated as a maintenance (long-term) treatment to help prevent GPP flares.
If you have questions about GPP flares and Spevigo, talk with your doctor.
Can I receive my Spevigo dose at home?
No, that’s not likely. You’ll typically need to receive your Spevigo infusion in your doctor’s office, a hospital, or an infusion center. These places have the facilities needed to administer the infusion safely, monitor you for side effects, and treat any side effects you may have.
GPP flares, which Spevigo is prescribed to treat, can be life threatening. You’ll usually need to go to a hospital so you can be monitored and receive treatment for any complications.
Talk with your doctor if you have questions about your Spevigo dose.
This drug comes with several precautions. These are considered drug-condition interactions.
Before taking Spevigo, talk with your doctor about your health history. Spevigo may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
- Infections. Spevigo can raise your risk of infection. It can also make it harder for your body to fight infections you already have. Before receiving Spevigo, tell your doctor if you have any infections that won’t go away or keep coming back. If you have a serious infection, this may need to be treated before you can receive Spevigo.
- Tuberculosis. Before receiving Spevigo, tell your doctor if you’ve recently had tuberculosis (TB) or have been in close contact with someone who has TB. Your doctor may test you for TB. If you have active TB, your doctor will likely not prescribe Spevigo because it could make the infection worse. If you’ve had TB in the past, your doctor may start you on anti-TB medication before you receive Spevigo.
- Immunizations. Before receiving Spevigo, tell your doctor if you’ve recently received or are scheduled to receive any vaccines. You shouldn’t get live vaccines after receiving Spevigo. To learn more about this, see “Spevigo interactions” above.
- Allergic reaction. If you’ve had an allergic reaction to Spevigo or any of its ingredients, your doctor will likely not prescribe Spevigo. Ask your doctor what other medications may be better options for you.
- Pregnancy. It’s not known if Spevigo is safe to receive during pregnancy. For more information, see the “Spevigo and pregnancy” section above.
- Breastfeeding. It’s not known if it’s safe to breastfeed after receiving Spevigo. For more information, see the “Spevigo and breastfeeding” section above.
Note: For more information about the potential negative effects of Spevigo, see the “Spevigo side effects” section above.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.