Atacicept-vymj Injection

Atacicept-vymj injection is used to reduce proteinuria (protein in the urine) in patients with primary immunglobulin A nephropathy (IgAN; a kidney disease where IgA deposits build up in the kidneys causing inflammation). Atacicept-vymj injection is in a class of medications called recombinant fusion glycoproteins. It works by reducing the production of IgA.

Atacicept-vymj injection comes as a solution (liquid) in a pre-filled autoinjector to be injected subcutaneously (under the skin). It is given once a week by a patient or a caregiver. Inject atacicept-vymj on the same day each week.

Use atacicpet-vymj 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 atacicept-vymj injection:

• Remove the autoinjector from the refrigerator and allow to warm to room temperature for 15 to 30 minutes. Do not use heat from a microwave, warmer, stove or other source to warm the syringe.
• 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.

You can inject atacicept-vymj into the front of the thighs or abdomen. 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.

Atacicept-vymj injection controls proteinuria from IgAN but does not cure it. Do not stop using atacicept-vymj injection without talking to your doctor.

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

Before using atacicept-vymj 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 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 atacicept-vymj injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving atacicept-vymj injection.
• do not have any vaccinations without talking to your doctor. You should not receive any live vaccines 30 days prior to or during treatment with atacicept-vymj injection.

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

Inject the missed dose as soon as you remember it and then resume a weekly dosing schedule after that, 7 days after injecting the missed dose. Do not inject a double dose to make up for a missed one.

Atacicept-vymj 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

Atacicept-vymj 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 it in the refrigerator and away from light. You can store autoinjectors at room temperature for up to 3 days. Once stored at room temperature, do not place back in the refrigerator. If it hasn't been used after 72 hours at room temperature, it must be thrown away.

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 and the laboratory. Your doctor may order certain lab tests to check your body's response to atacicept-vmyj injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking atacicept-vmyj injection.

Do not let anyone else use 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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