Abatacept Injection

WHY is this medicine prescribed?

Abatacept is used:

• alone or in combination with other medications to reduce the pain, swelling, difficulty with daily activities, and joint damage caused by rheumatoid arthritis (a condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who have not been helped by other medications.
• alone or in combination with methotrexate (Otrexup, Rasuvo, Reditrex, Trexall, Xatmep) to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years of age or older.
• alone or in combination with other medications to treat psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults and children 2 years of age or older.
• in combination with a calcineurin inhibitor (e.g., cyclosporine [Gengraf, Neoral, Sandimmune], tacrolimus [Astagraf, Prograf]) and methotrexate to prevent graft-versus-host disease (GVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow]) in adults and children 2 years of age and older.

Abatacept is in a class of medications called selective costimulation modulators (immunomodulators). It works by blocking the activity of T-cells, a type of immune cell in the body that causes swelling and joint damage in people who have arthritis.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Abatacept comes as a powder to be mixed with sterile water to be given intravenously (into a vein) and as a solution (liquid) in a prefilled syringe or an autoinjector to be given subcutaneously (under the skin). It is usually given by a doctor or nurse in a doctor's office or healthcare facility when given intravenously. It also my be given subcutaneously by a doctor or nurse or you or a caregiver may be told to inject the medication subcutaneously at home.

When abatacept is given intravenously to treat rheumatoid arthritis or psoriatic arthritis, it is usually given every 2 weeks for the first 3 doses and then every 4 weeks for as long as treatment continues.

When abatacept is given intravenously to treat polyarticular juvenile idiopathic arthritis in children 6 years and older, it is usually given every two weeks for the first two doses and then every four weeks for as long as treatment continues.

If you are receiving abatacept intravenously to treat rheumatoid arthritis, psoriatic arthritis, or polyarticular juvenile idiopathic arthritis in children 6 years of age and older, it will take about 30 minutes for you to receive your entire dose.

When abatacept is given subcutaneously to treat rheumatoid arthritis or psoriatic arthritis in adults and children 2 years of age and older and polyarticular juvenile idiopathic arthritis in children 2 years and older, it is usually given once weekly.

When abatacept is given intravenously to prevent graft versus host disease, it is usually injected slowly over 60 minutes on the day before hematopoietic stem-cell transplant and then on days 5, 14, and 28 after the transplant.

If you will be injecting abatacept injection by yourself at home or having a friend or relative inject the medication for you, ask your doctor to show you or the person who will be injecting the medication how to inject it. You and the person who will be injecting the medication should also read the manufacturer's written instructions for use that come with the medication.

Before you open the package containing your medication, check to be sure that the expiration date printed on the package has not passed. After you open the package, look closely at the liquid in the syringe. The liquid should be clear or pale yellow and should not contain large, colored particles. Call your pharmacist, if there are any problems with the package or the syringe. Do not inject the medication.

You may inject abatacept injection anywhere on your stomach or thighs except your navel (belly button) and the area 2 inches around it. If someone else will be injecting the medication for you, that person can also inject it into the outer area of your upper arm. Use a different spot for each injection. Do not inject abatacept injection into a spot that is tender, bruised, red, or hard. Also, do not inject into areas with scars or stretch marks.

Remove the prefilled syringe or prefilled autoinjector from the refrigerator and allow it to warm to room temperature for 30 minutes before using it. Do not warm abatacept injection in hot water, microwave, or place it in sunlight. Do not remove the needle cover while allowing the prefilled syringe to reach room temperature.

Your doctor will give you the manufacturer's patient information sheet to read before you receive each dose of abatacept. Read the information carefully and ask your doctor any questions you have.

What SPECIAL PRECAUTIONS should I follow?

Before using abatacept,

• tell your doctor and pharmacist if you are allergic to abatacept, any other medications, or any of the ingredients in abatacept injection. Ask your pharmacist 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 while taking abatacept. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have an infection anywhere in the body, including infections that come and go, such as cold sores, and chronic infections that do not go away, or if you often get any type of infection such as bladder infections. Also tell your doctor if you have or have ever had chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); any disease that affects your nervous system, such as multiple sclerosis; hepatitis B (a virus that affects the liver); diabetes; high blood pressure; or any disease that affects your immune system, such as cancer, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or severe combined immunodeficiency syndrome (SCID). Also tell your doctor if you have or have ever had tuberculosis (TB; a lung infection that may not cause symptoms for many years and that may spread to other parts of the body) or if you have been around someone who has or has had tuberculosis. Your doctor may give you a skin test to see whether you are infected with tuberculosis. Tell your doctor if you have ever had a positive skin test for tuberculosis in the past.

• If you are receiving abatacept to prevent graft versus host disease, tell your doctor if you have ever had Epstein-Barr virus (EBV; a herpes virus that causes infectious mononucleosis and is associated with certain cancers) or cytomegalovirus (CMV). Your doctor may monitor you for 6 months after your transplant and may tell you to take antiviral medicines before, during, and for 6 months after your transplant to prevent EBV and CMV infections.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using abatacept, call your doctor.

• tell your doctor if you have recently received or are scheduled to receive any vaccines. You should not have any vaccinations while you are using abatacept or for 3 months after your final dose of abatacept without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you are receiving abatacept intravenously and miss an appointment to receive an abatacept infusion, call your doctor as soon as possible.

If you are receiving abatacept subcutaneously and miss a dose, ask your doctor for a new dosing schedule.

What SIDE EFFECTS can this medicine cause?

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

• headache
• runny nose
• nausea
• diarrhea
• stomach pain
• dizziness
• heartburn
• back pain
• arm or leg pain
• injection site bruising, redness, and itching
• nosebleed

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

• hives; rash; itching; swelling of the eyes, face, lips, tongue, or throat; difficulty breathing or swallowing
• shortness of breath
• fatigue, pale skin, fast or irregular heartbeat
• flu-like symptoms, fever, chills, cough, sore throat, and other signs of infection
• dry cough that doesn't go away
• weight loss
• night sweats
• frequent urination or sudden need to urinate right away
• burning during urination
• red, hot, swollen area on the skin

Abatacept may increase the risk of developing certain types of cancer including lymphoma (cancer that begins in the cells that fight infection) and skin cancer. People who have had severe rheumatoid arthritis for a long time may have a greater than normal risk of developing these cancers even if they do not use abatacept. Your doctor will also check your skin for any changes during your treatment. Talk to your doctor about the risks of using this medication.

Abatacept may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep the prefilled syringes and autoinjectors in the original carton it came in to protect them from light and out of reach of children. Store abatacept prefilled syringes or autoinjectors in the refrigerator and do not freeze.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to abatacept injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using abatacept injection.

If you are diabetic and receiving abatacept intravenously, abatacept injection may give falsely high blood glucose readings on the day of your infusion. Talk to your doctor or pharmacist about blood glucose monitoring tests to use during your treatment.

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.