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Overview: Spevigo is used to treat generalized pustular psoriasis. It works by blocking substances in your body that cause inflammation and skin problems, which may help reduce flare-ups of generalized pustular psoriasis. Common side effects include pain or itching near the injection site, kidney or bladder infection, and joint pain.

Uses

What is Spevigo used for?

Spevigo (spesolimub-sbz) is commonly used to treat generalized pustular psoriasis, which is a type of skin condition that causes skin bumps with pus (pustules).

Spevigo may also be used for other conditions as determined by your healthcare provider.

How does Spevigo work (mechanism of action)?

Spevigo works by blocking substances in your body that cause inflammation and skin problems. This may help reduce flare-ups of generalized pustular psoriasis.

How is Spevigo supplied (dosage forms)?

Brands and other names

  • Spevigo

Dosage forms and strengths

  • 150 mg/mL single-dose prefilled syringe

Spevigo is available in an injectable form that is given by a healthcare provider.

How should I store Spevigo?

If you store Spevigo at home, it should be stored in a refrigerator between 36 F to 46 F (2 C to 8 C). Keep it in its original container to protect it from light. Do not freeze Spevigo. Do not use Spevigo if it has been frozen, even if it is thawed.

Some forms of Spevigo are usually given by a healthcare provider in a hospital or clinic. If your healthcare provider gives you Spevigo, you will not store it at home.

Side Effects

What are the most common side effects of Spevigo?

The most common side effects of Spevigo are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, redness, or bruising near the injection site
  • Kidney or bladder infection
  • Joint pain
  • Itching or itchy skin bumps
  • Feeling unusually weak or tired
  • Nausea and vomiting
  • Headache

There may be other side effects of Spevigo that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Spevigo?

While less common, the most serious side effects of Spevigo are described below, along with what to do if they happen.

Severe Allergic Reactions. Spevigo may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Stop using the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Infections. Spevigo can increase your risk of infections, including serious infections. Call your healthcare provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Reactivated Infections. Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after you recover from that infection. When a microbe stays in the body but does not cause an infection, it is called a “latent” microbe. Spevigo may increase your risk of a latent microbe becoming active again, causing an infection. Before you start treatment with Spevigo, tell your healthcare provider if you have ever had tuberculosis (TB) or any other serious infections.

Infusion Reactions. Certain forms of Spevigo are given by a healthcare provider as an infusion into your vein, and it can cause reactions that can be serious. Your infusion may need to be slowed or stopped if you have these reactions. Tell your healthcare provider right away if you have any of the following symptoms when you get your infusion or afterwards.

  • Fever or chills
  • Dizziness or feeling faint
  • Joint or muscle pain
  • Redness of your face and neck
  • Trouble breathing
  • Chest pain
  • Hives
  • Nausea or vomiting

Warnings & Precautions

Who should not use Spevigo?

Allergies to Ingredients. People who are allergic to any of the following should not use Spevigo.

  • Spevigo
  • Spesolimab-sbzo
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Spevigo.

What should I know about Spevigo before using it?

Do not use Spevigo unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Spevigo with other people, even if they have the same condition as you. It may harm them.

Keep Spevigo out of the reach of children. Since this medicine should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

There are multiple forms of Spevigo available. Certain types of Spevigo are usually given by a healthcare provider in a hospital or clinic, and others are given at home.

If you are using Spevigo at home, read and follow the instructions for the product you have. Make sure that you or a caregiver understands how to properly prepare and use Spevigo. If you have any questions, talk to your healthcare provider.

What should I tell my healthcare provider before using Spevigo?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Spevigo is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines right before using Spevigo, while using it, and for at least 16 weeks after your last dose. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • An infection that keeps coming back or will not go away
  • Tuberculosis (TB) or you have been near someone who has tuberculosis

Pregnancy. It is not known if or how Spevigo could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.

Breastfeeding. It is not known if Spevigo passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Spevigo while breastfeeding.

How can I get more information about Spevigo?

For more information about Spevigo, you can visit the manufacturer’s website at www.spevigo.com or call them at 800-542-6257.

Interactions

Does Spevigo interact with foods or drinks?

There are no known interactions between Spevigo and foods or drinks.

It is unknown if drinking alcohol will affect Spevigo.

Does Spevigo interact with other medicines (drug interactions)?

There are no known interactions between Spevigo and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Spevigo?

If you or someone else has used too much Spevigo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Spevigo?

If you use Spevigo at home and you miss a dose, use it as soon as you remember. Use your next dose at your regularly scheduled time. Do not use double or extra doses. Call your healthcare provider if you are not sure when to use Spevigo.

Some forms of Spevigo are usually given by a healthcare provider in a hospital or clinic. Your healthcare provider will make sure you are receiving Spevigo as scheduled. If you miss your appointment to get your Spevigo dose, call to make another appointment as soon as possible.

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