Abatacept, Injection

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KEY POINTS

• This medicine is given by IV to treat certain kinds of arthritis.
• Keep all appointments for tests to see how this medicine affects you.
• You may get serious or life-threatening infections when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: T-cell inhibitor

Generic and brand names: abatacept, injection; Orencia

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) or by subcutaneous injection (just under the skin) to treat:

• Rheumatoid arthritis (RA)
• Juvenile idiopathic arthritis (JIA) in children over the age of 6 years.

This medicine may be used alone or along with another medicine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blood disorder
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diabetes
• High blood pressure
• Lung disease such as COPD
• Hepatitis B or other liver problems
• Tuberculosis (TB), a positive skin test for TB, or close contact with someone who has TB (your healthcare provider may give you a skin test to check for this).

You should NOT receive shots of this medicine if you have any kind of infection. Tell your healthcare provider if you:

• Currently have an infection
• Have any open cuts or sores
• Often have infections or infections come back
• Are scheduled to receive any vaccines
• Are scheduled to have major surgery

Some infections are more likely in certain parts of the country. Tell your provider where you have lived or recently traveled or where you plan to travel to during treatment.

Tell your provider if you take any other medicines for RA or JIA, especially anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), adalimumab (Humira), rituximab (Rituxan), infliximab (Remicade), or tocilizumab (Actemra).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

The IV infusions (slow drip through a needle into a large vein) are given by your healthcare provider. Keep all appointments for infusions.

Check with your healthcare provider before using this medicine in children under age 18.

You may also receive this medicine as shot under your skin. It comes in a single-use disposable prefilled syringe and is usually given weekly. If your healthcare provider is giving you the shots, keep all your appointments.

Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have shots and how much medicine to use. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

Carefully read and follow the directions that come in the package of medicine for preparing and giving the shots. Wash your hands before using this medicine.

Do NOT remove the needle cap until you are ready to inject the medicine.

Let the medicine warm to room temperature outside the carton for 30 to 60 minutes before you inject it. The shots should not be given into areas where the skin is tender, bruised, or red, or where you have scars or stretch marks.

Use each prefilled syringe or pen only once and dispose of it safely, following your healthcare provider's instructions. Do not use the medicine if it looks cloudy or contains particles.

Do not stop using this medicine without your healthcare provider's approval.

What if I miss a dose?

If you miss a dose, contact your healthcare provider for instructions.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You should not have live vaccines while you are receiving this medicine and for 3 months after you stop treatment with this medicine.

This medicine increases your risk for serious or life-threatening infections. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may increase your risk for lymphoma, leukemia, melanoma, and other cancers. Talk to your healthcare provider about this.

Your healthcare provider will check you regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: The infusion form of this medicine may affect blood sugar test results with certain blood glucose monitors on the day you receive the infusion. Talk to your healthcare provider before you change your diet or dosage of diabetes medicine. Your healthcare provider may recommend a different blood sugar monitor.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Cough, fever, unexplained sore throat, trouble breathing, pain while urinating or urinating more often than usual, mouth sores, painful rash, severe headache, stiff neck, unexplained tiredness or weight loss, night sweats, skin changes, severe dizziness or fainting, severe nausea or vomiting.

Other: Redness, swelling, or bruising around the injection site; headache; mild nausea; mild dizziness; runny nose; heartburn; back pain; diarrhea; mild stomach pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking any other medicines.

• Echinacea
• Fingolimod (Gilenya)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), belimumab (Benlysta), canakinumab (Ilaris), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), rituximab (Rituxan), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Natalizumab (Tysabri)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in its original container in the refrigerator. Do not let it freeze. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.