Key takeaways

  • Spevigo is a brand-name prescription medication used to treat generalized pustular psoriasis (GPP) in adults and certain children. It works by targeting and blocking an immune system protein that causes inflammation.
  • For GPP flares, Spevigo is administered via intravenous (IV) infusion by a healthcare professional. For ongoing management of GPP, subcutaneous injections of Spevigo may be self-administered or given by a healthcare professional.
  • While Spevigo can cause side effects like infections and allergic reactions, it’s currently the only FDA-approved medication for GPP flares.

Spevigo is a brand-name prescription medication. It’s used to treat generalized pustular psoriasis (GPP) in adults and children ages 12 years and older who weigh at least 40 kilograms (about 88 pounds).

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.

Drug details

Spevigo is a biologic medication. It belongs to a group of drugs called interleukin-36 receptor antagonists.

For GPP flares, you will receive Spevigo via an intravenous (IV) infusion given by a healthcare professional. An IV infusion is a method of administering medication where the drug is given as a liquid solution through an injection into a vein (usually in your arm) over a period of time. This process typically occurs in a clinical setting, such as a doctor’s office or a clinic, where healthcare professionals manage the dosage and administration.

For long-term management of GPP, doses of Spevigo are given by subcutaneous (under the skin) injections. These can be self-administered after an initial loading dose provided by a healthcare professional. (A loading dose is typically larger than the subsequent maintenance doses of a drug.)

Spevigo is available only as a brand-name medication. It’s not currently available in generic or biosimilar form. A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the reference drug). Spevigo is a biologic medication, which is also called a biologic.

Biologic drugs are made from living cells. It’s not possible to make an exact copy of biologic drugs. A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active ingredient in a brand-name medication.

The active ingredient in Spevigo is spesolimab-sbzo. An active ingredient is what makes a medication work.

Biosimilars are considered to be as safe and effective as their reference biologic drug. Like generics, biosimilars tend to cost less than brand-name medications.

The Spevigo dosage your doctor prescribes will depend on several factors. These include:

  • the severity of your GPP
  • your age
  • the form of Spevigo prescribed (intravenous [IV] infusion versus subcutaneous injection)
  • other medical conditions you may have

The following information describes the dosages of Spevigo that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

For IV infusion

Spevigo for IV infusion comes as a liquid solution in a single-dose vial for dilution prior to infusion. Each vial contains 450 milligrams (mg) of the drug per 7.5 milliliters (mL) of solution (60 mg/mL).

The recommended dose for GPP flares is 900 mg, given by an IV infusion lasting about 90 minutes.

A healthcare professional will give you the infusion in your doctor’s office or clinic, a hospital, or an infusion center.

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.

You’ll typically receive one dose of Spevigo to treat a GPP flare. However, if your symptoms haven’t improved after 1 week, your doctor may recommend a second dose of 900 mg. You’ll receive this dose 1 week after your first dose.

For subcutaneous injection

Spevigo for subcutaneous injection comes in single-dose prefilled syringes in two doses:

  • 300 mg in 2 mL of solution
  • 150 mg in 1 mL of solution

Spevigo injections should be given in the upper thigh or abdomen. Do not inject into areas where the skin is tender, irritated, bruised, or scarred.

If more than one injection is needed to achieve the recommended Spevigo dose, administer each injection one right after the other. Choose a different injection site for each injection, at least 1 inch away from the other injection site.

Dosage for children

The dosage of Spevigo for children ages 12 years and older who weigh at least 40 kilograms (about 88 pounds) is the same as the dosage for adults.

Will I need to use this drug long term?

IV infusions of Spevigo are administered only short term for GPP flares. Infusions are given only by a trained healthcare professional.

But if you and your doctor determine that Spevigo is safe and effective for you to manage your GPP, you may self-administer subcutaneous injections of Spevigo on a long-term basis (after an initial loading dose injection provided by a healthcare professional).

Spevigo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur from Spevigo treatment. These lists do not include all possible side effects.

For more information about the possible side effects of Spevigo, talk with your doctor. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect from Spevigo treatment and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Mild side effects

Here is a partial list of mild side effects of Spevigo. To learn about other mild side effects, talk with your doctor or view Spevigo’s prescribing information.

Mild side effects of Spevigo can include:

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.

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 can include:

Allergic reaction

For some people, Spevigo can cause an allergic reaction. In general, symptoms of an allergic reaction can be mild or serious.

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

In rare cases, a delayed allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) may occur weeks after receiving Spevigo. Symptoms can include:

  • fever
  • skin rash that’s different from generalized pustular psoriasis
  • swollen lymph nodes

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Spevigo, your doctor may recommend a different medication instead.

Spevigo is approved by the Food and Drug Administration (FDA) to treat generalized pustular psoriasis (GPP) flares in adults.

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 may be triggered by certain factors. Triggers can include stress, infections, pregnancy, and stopping corticosteroid medications.

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

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 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.

As with all medications, the cost of Spevigo can vary. The actual price you’ll pay depends on factors such as your insurance plan, your location, and the pharmacy you use.

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 whether 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.

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 make you feel very unwell. If you drink alcohol, it’s usually best to avoid it 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:

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 whether 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 whether 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 options while you’re using Spevigo.

For more information about taking Spevigo during pregnancy, see the “Spevigo and pregnancy” section.

It’s not known whether it’s safe to breastfeed after receiving Spevigo. The drug hasn’t been studied in people who are breastfeeding. However, Spevigo can pass into breast milk. It’s unknown what effect the drug may have on a child who is 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.

In a clinical trial, Spevigo helped clear up pustules associated with GPP flares in 1 week. It also helped reduce other symptoms of GPP flares, such as pain, redness and other color changes, itching, and fatigue in 1 week. In this trial, people whose GPP flare symptoms improved with Spevigo didn’t have any worsening of their symptoms for the next 12 weeks.

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.

Before starting Spevigo treatment, 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.

Be sure to talk with your doctor if any of the following apply to you:

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.