Spesolimab-sbzo injection

Spesolimab-sbzo is used for the treatment of generalized pustular psoriasis (GPP; a skin disease in which pus-filled bumps form on some areas of the body) in adults and children 12 years of age and older weighing at least 40 kg (88 lbs). Spesolimab-sbzo is in a class of medications called monoclonal immunoglobulin G1 antibodies. It works by blocking a certain substance in the immune system that may cause GPP.

Spesolimab-sbzo comes as a solution to inject intravenously (into a vein) over about 90 minutes by a doctor or nurse in a medical office or hospital outpatient clinic to treat a GPP flare. If symptoms of the flare continue, your may receive another dose one week later. Spesolimab-sbzo also comes as a solution (liquid) in a prefilled syringe to inject subcutaneously (just under the skin) by a doctor or nurse or by yourself or a caregiver at home every four weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use spesolimab-sbzo exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

You will receive your first subcutaneous dose of spesolimab-sbzo in your doctor's office. If you will be injecting spesolimab-sbzo subcutaneously to yourself or your child at home or having a caregiver inject the medication for you, your doctor will show you or the person who will be injecting the medication how to inject it. The person who will be injecting the medication should also read the written instructions for use that come with the medication. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Spesolimab-sbzo injection may cause a severe reaction during or shortly after the infusion of the medication. A doctor or nurse will monitor you carefully while you are receiving the medication. If you experience any of the following symptoms, tell your doctor immediately: skin redness, itching, hives or rash; swelling of your face, eyelids, lips, mouth, tongue, or throat; mouth sores; lightheadedness, faintness, or dizziness; chest tightness; or shortness of breath.

To give spesolimab-sbzo subcutaneously, follow these steps:

1. Review the manufacturer's instructions for use.
2. Remove spesolimab-sbzo prefilled syringes from the refrigerator and allow to reach room temperature (15 to 30 minutes) without removing the needle cap.
3. Give your dose subcutaneously (just under the skin) into your upper thigh or abdomen (stomach area). Do not inject into areas where the skin is tender, bruised, red, hardened, or scarred.
4. For a complete dose, usually two prefilled syringes are required to be injected, one right after the other.
5. Choose a different injection site for each injection, at least 1 inch away from the other injection sites. Rotate between the upper thigh and abdomen injection sites for each complete dose.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving spesolimab-sbzo,

• tell your doctor and pharmacist if you are allergic to spesolimab-sbzo, any other medications, or any of the ingredients in spesolimab-sbzo injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had tuberculosis (TB) or currently have an infection.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking spesolimab-sbzo, call your doctor.
• you should know that spesolimab-sbzo injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with spesolimab-sbzo injection, call your doctor immediately: fever, sweats, or chills; muscle aches; cough; bloody mucus; shortness of breath; sore throat or difficulty swallowing; warm, red, or painful skin or sores on your body; diarrhea; stomach pain; frequent, urgent, or painful urination; or other signs of infection.
• you should know that receiving spesolimab-sbzo injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with TB but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB. Your doctor will check you for TB before starting treatment with spesolimab-sbzo injection and may treat you for TB if you have a history of TB or have active TB. If you have any of the following symptoms of TB or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.
• ask your doctor whether you should receive any vaccinations before you begin your treatment with a spesolimab-sbzo. If possible, all vaccinations should be brought up to date before beginning treatment. Do not have any vaccinations without talking to your doctor during your treatment and for 16 weeks after the final dose.

Unless your doctor tells you otherwise, continue your normal diet.

Use the missed dose as soon as you remember it. Then resume your regular schedule. Do not take a double dose to make up for a missed one.

Spesolimab-sbzo may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, pain, bruising, or swelling in the place where spesolimab-sbzo was injected
• tiredness or weakness
• nausea or vomiting
• headache
• itching or itchy bumps on the skin
• joint pain

Some side effects can be serious. If you experience any of these symptoms, or those listed in the HOW section and SPECIAL PRECAUTIONS section, stop using spesolimab-sbzo and call your doctor immediately or get emergency medical treatment:

• rash or hives (different than GPP rash); fever; itching; mouth sores; swelling of the eyes, face, lips, tongue, or throat; difficulty breathing or swallowing; dizziness or fainting; or tightness in your chest
• signs of infection
• frequent, painful, or urgent urination

Spesolimab-sbzo may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in a refrigerator and protect from light. Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before receiving this medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Spevigo^®