This medication is used alone or with other medications (e.g., methotrexate) to treat rheumatoid arthritis, a condition in which the body's own defense system (immune system) attacks the healthy tissues around the joints. It is usually used when other medications for rheumatoid arthritis are not successful in controlling the disease. Abatacept helps slow joint damage and reduce the joint pain/swelling so you can move better. It works by weakening your immune system and decreasing swelling (inflammation).

Read the Patient Information Leaflet provided by your pharmacist before you start receiving abatacept and each time you get a treatment. If you have any questions, consult your doctor or pharmacist.

This medication is given into a vein by a health care professional. Follow all instructions for proper mixing and dilution with the correct IV fluid. Use only the silicone-free disposable syringe provided with the medication to prepare the liquid. While preparing the liquid, gently swirl the vial to dissolve the powder. Do not shake the vial. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Use the correct filter (low-protein-binding) when giving this medication. If you have questions about the use of this medication, consult the pharmacist.

After the first dose, this medication is usually given again 2 weeks and 4 weeks later, then every 4 weeks or as directed by your doctor.

The dosage is based on your weight.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.

Tell your doctor if your symptoms do not improve or if they worsen.

Headache, nausea, dizziness, flushing, stuffy head/nose, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this unlikely but serious side effect occurs: shortness of breath.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, pain when urinating, severe abdominal pain.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

The immune system is also important in preventing and controlling cancer. Very rarely, patients using abatacept have developed cancer (e.g., lymphoma, lung cancer). Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, night sweats, unexplained weight loss, shortness of breath, wheezing, persistent cough.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving abatacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: chronic obstructive pulmonary disease-COPD, current/recent/returning infection (e.g., tuberculosis, hepatitis virus), cut or open sore, cancer, immune system disorder (e.g., HIV infection, bone marrow disorder), diabetes (especially if you are checking your blood sugar level at home).

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations while using this medication or up to 3 months after stopping this medication without the consent of your doctor. Also avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

It is recommended that children be up to date on all their childhood vaccinations before starting abatacept.

Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially increased risk of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: TNF blocking agents (e.g., adalimumab, etanercept, infliximab).

The manufacturer recommends that this medication not be used with anakinra, another drug for rheumatoid arthritis.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting abatacept.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other drugs that weaken the immune system (e.g., tacrolimus, cyclosporine).

This medication may interfere with certain tests (including certain blood sugar tests), possibly causing false test results. This can lead to serious (possibly fatal) consequences. Tell all laboratory personnel and all your doctors and pharmacists that you use this medication, and which type of blood sugar testing strips you use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

Store the vials of powder in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. The mixed vials must be further diluted and given within 24 hours. Store the diluted solution at room temperature between 59-86 degrees F (15-30 degrees C) or in the refrigerator between 36-46 degrees F (2-8 degrees C). Check the expiration date before using. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised August 2009 Copyright(c) 2009 First DataBank, Inc.