Spesolimab is used in adults to treat a certain type of psoriasis called generalized pustular psoriasis (GPP).

Spesolimab may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have fever, chills, sweats, cough, shortness of breath, blood in your mucus, any burning when you urinate, or if you urinate more than usual.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Spesolimab is injected into a vein by a healthcare provider over 90 minutes.

Spesolimab is given usually once. If your symptoms continue, your healthcare provider may give you an additional treatment with spesolimab after 1 week.

Before you use spesolimab, your doctor will test you for tuberculosis or other infections.

Usual Adult Dose for Pustular Psoriasis:

900 mg by intravenous infusion over 90 minutes once

Comment:
-One week after the initial dose, consider administering an additional 900 mg IV dose (over 90 minutes) if generalized pustular psoriasis (GPP) symptoms persist.

Use: Treatment of generalized pustular psoriasis flares in adults

You should not use spesolimab if you are allergic to it.

Tell your doctor if you have:

• tuberculosis or have been exposed to tuberculosis;

• an infection that keeps returning or does not go away; or

• recently received or are scheduled to receive a vaccine.

Tell your doctor if you are pregnant or breastfeeding.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid receiving a "live" vaccine while you are being treated with spesolimab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Spesolimab may cause serious side effects. Call your doctor at once if you have:

• signs of an infection--fever, chills, sweats, cough, shortness of breath, blood in your mucus, any burning when you urinate, or if you urinate more than usual.

Common side effects of spesolimab may include:

• tiredness or weakness;

• nausea, vomiting;

• headache;

• itching or itchy bumps;

• bruising or blood under the skin where the injection was given; or

• pain or burning when you urinate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect spesolimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.