Spesolimab-sbzo (spe-SOE-li-mab - sbzo)

Treats generalized pustular psoriasis (GPP) flares.

Brand Name(s):

Spevigo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV catheter placed into a vein or as a shot under your skin (usually in the stomach or thigh).
• If spesolimab-sbzo is injected into a vein, it must be given slowly, so the IV will have to stay in place for at least 90 minutes.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Allow the prefilled syringe to warm to room temperature for 15 to 30 minutes before using it. Do not warm it in any other way (eg, microwave, hot water, or direct sunlight).
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, damaged, hard, or areas with scars. Do not inject an area near your waistline or belly button.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Do not remove the needle cap.
  • Check the liquid in the syringe. It should be clear and colorless to slightly brownish-yellow. Do not use it if it is cloudy, discolored, or has flakes or large or colored particles in it. Do not use the syringe if it is damaged, dropped, broken, leaking, or has cracks.
  • Hold the syringe by the finger grip with one hand. Using your other hand, pull the cap straight off. Do not pull on or hold the plunger rod. Do not twist the cap. Do not put the cap back on.
  • Gently pinch the skin. Hold the syringe by the blue finger grip. Using a quick, "dart-like" motion, insert the needle into the pinched skin at a 45 degree angle. Do not move the needle.
  • Use your thumb to slowly press down on the blue thumb pad to push the plunger rod inside the syringe body. Continue pressing the blue thumb pad until the plunger rod has moved all the way down.
  • Make sure the blue thumb pad cannot be pressed any further so that the built-in safety cover can be activated. Check that the thumb pad springs back and that the needle is inside the safety cover to make sure you have received the full dose.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep it in its original package until you are ready to use it. Do not use the prefilled syringe if frozen, even if it has been thawed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live virus vaccines during and for at least 16 weeks after treatment with this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have any type of infection (including tuberculosis).
• This medicine may cause the following problems:
  • Increased risk for infections
  • Serious skin reaction, including drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Infusion reactions
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, lower back or side pain, difficult or painful urination
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Pain, bruising, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice these less serious side effects, talk with your doctor:

• Headache, nausea, vomiting
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088