Generic name: spesolimab-sbzo
Dosage form: injection, for intravenous use
Drug class: Interleukin inhibitors
What is Spevigo?
Spevigo is a prescription medicine used to treat generalized pustular psoriasis (GPP) flares in adults.
It works by blocking the activation of the interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.
It is not known if this medicine is safe and effective in children.
What is Spevigo used to treat?
Spevigo is used to treat generalized pustular psoriasis (GPP), a rare and extreme form of psoriasis.
GPP is characterized by repeated episodes in which large areas of skin become red and inflamed and develop small pus-filled blisters (pustules). It is caused by neutrophils (a type of white blood cell) accumulating in the skin.
The skin problems can be accompanied by fever, extreme tiredness, muscle weakness, an increased number of white blood cells, and other signs of inflammation throughout the body.
Episodes can be triggered by infection, exposure to or withdrawal from certain medications, menstruation, or pregnancy, although the trigger is often unknown. GPP can be life-threatening if not treated.
Spevigo is the first FDA-approved treatment option for generalized pustular psoriasis.
Important information
Spevigo may cause serious side effects, including:
Infections. Spevigo may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment, and may treat you for TB before you begin treatment if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB after treatment. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
- 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. Serious allergic reactions may happen during or after your infusion of 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 and treat your symptoms and may 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 than the rash from generalized pustular psoriasis (GPP)
- itching
- swollen lymph nodes
See Spevigo side effects for more information about side effects.
Who should not receive Spevigo?
You should not receive Spevigo if you have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the other ingredients. See the end of this page for a complete list of ingredients.
Before you receive Spevigo
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.
- have recently received or are scheduled to receive an immunization (vaccine). You should not receive live vaccines after treatment with Spevigo.
- are pregnant or plan to become pregnant. It is not known if Spevigo can harm your 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.
What other drugs will affect Spevigo?
There were no formal drug interactions studies conducted with Spevigo.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive Spevigo?
Your healthcare provider will give you Spevigo through a needle placed in your vein (intravenous infusion) over 90 minutes.
Spevigo is usually given one time. If GPP flare symptoms continue, your healthcare provider will decide if you should receive an additional treatment after 1 week.
Dosing information
Usual Adult Dose for Generalized Pustular Psoriasis
-Administer as a single 900 mg dose by intravenous infusion over 90 minutes.
Comment:
If flare symptoms persist, may administer an additional intravenous 900 mg dose one week after the initial dose.
Use: treatment of generalized pustular psoriasis flares in adults.
Spevigo side effects
Spevigo may cause serious side effects. See Important information.
The most common side effects include:
- 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
- urinary tract infection
These are not all of the possible side effects.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Spevigo.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients in Spevigo?
Active ingredient: spesolimab-sbzo
Inactive ingredients: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, and Water for Injection, USP
References
More about Spevigo (spesolimab)
- Check interactions
- Pricing & coupons
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: interleukin inhibitors
- En español
Patient resources
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.