Sibeprenlimab-szsi Injection

Sibeprenlimab-szsi injection is used to reduce proteinuria (protein in the urine) in patients with primary immunoglobulin A nephropathy (IgAN; a kidney disease where IgA deposits build up in the kidneys causing inflammation). Sibeprenlimab-szsi is in a class of medications called monoclonal antibodies. It works by reducing levels of IgA in the body.

Sibeprenlimab-szsi injection comes as a solution (liquid) in a prefilled syringe to be given subcutaneously (under the skin). Inject once every 4 weeks.

Use sibeprenlimab-szsi injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You or a caregiver will be shown how to inject the medicine before your first dose. You will also be given the instructions for use. Read these carefully. Talk to your doctor or pharmacist if you have any questions on how to use the medicine.

Before injecting sibeprenlimab-szsi:

• Inspect the prefilled syringe carefully. The solution should be free of particulates and clear to colorless yellow. Do not use if it is cloudy, discolored, or has particulates.
• Allow the prefilled syringe to warm to room temperature for 15 to 30 minutes.

You can inject sibeprenlimab-szsi into the front of the thighs or abdomen. If being given by a caregiver, it can also be injected in the back of the upper arm. Rotate injection sites. Do not use the same site twice in a row. Do not inject in skin that is scarred or bruised or in moles or in areas where skin is damaged, scaly, red, hard, or tender.

Do not shake sibeprenlimab-szsi prefilled syringes.

Sibeprenlimab-szsi injection controls proteinuria from IgAN but does not cure it. Do not stop taking using sibeprenlimab-szsi injection without talking to your doctor.

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

Before using sibeprenlimab-szsi injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• 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 an active infection or have or have ever had a chronic or recurring infection such as infections with hepatitis B virus, human immunodeficiency virus (HIV), tuberculosis, herpes simplex virus or varicella zoster virus (also known as shingles).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving sibeprenlimab-szsi injection, call your doctor immediately.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using sibeprenlimab-szsi injection.
• do not have any vaccinations without talking to your doctor.

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

Inject the missed dose as soon as you remember it and give the next dose 4 weeks after that.

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

• redness, pain, and swelling at the site of injection
• sneezing, runny nose, congestion

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever; chills; extreme tiredness; cough, shortness or breath or difficulty breathing; warm, red or painful skin; painful urination or increased frequency

Sibeprenlimab-szsi injection 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 in the refrigerator and away from light. Once removed from refrigerator, sibeprenlimab-szsi prefilled syringes must be used within 7 days. Do not heat or expose sibeprenlimab-szsi prefilled syringes to sunlight.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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