abatacept

Generic Name: abatacept (a BAY ta sept)Brand Names: Orencia

What is abatacept?

Abatacept is a man-made protein that prevents your body's immune system from attacking healthy tissues such as joints. The immune system helps your body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.

Abatacept is used to treat the symptoms of rheumatoid arthritis, and to prevent joint damage caused by these conditions. It is also used to treat arthritis in children who are at least 6 years old.

Abatacept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Abatacept may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about abatacept?

You should not use this medication if you are allergic to abatacept, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), or infliximab (Remicade).

Before using abatacept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Also tell your doctor if you have a weak immune system, any type of infection (including skin infection or open sores), COPD, diabetes, a history of hepatitis, or if you have scheduled to receive any vaccinations.

Children using this medication should be current on all childhood immunizations before starting treatment with abatacept. Serious infections may occur during treatment with abatacept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Using abatacept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk.

What should I discuss with my healthcare provider before using abatacept?

You should not use this medication if you are allergic to abatacept, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), or infliximab (Remicade).

Before using abatacept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• a weak immune system;

• any type of infection including a skin infection or open sores;

• COPD (chronic obstructive pulmonary disease);

• diabetes;

• if you have ever had hepatitis; or

• if you are scheduled to receive any vaccines.

FDA pregnancy category B. Abatacept is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on a pregnancy registry if you become pregnant while using this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether abatacept had any effect on the baby.

Abatacept can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Children using this medication should be current on all childhood immunizations before starting treatment with abatacept.

Using abatacept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk.

How should I use abatacept?

Before you start treatment with abatacept, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Abatacept is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Abatacept must be given slowly through an IV infusion, and can take at least 30 minutes to complete. This medication is usually given every 2 to 4 weeks. Follow your doctor's instructions.

You will need to mix abatacept with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using abatacept.

If you have chronic hepatitis B you may develop liver symptoms while using abatacept and even months after you stop using it. Your doctor may want to check your liver function at regular visits for up to several months after you stop using abatacept. Do not miss any scheduled appointments.

This medication can cause you to have false results with certain blood glucose tests, showing high blood sugar readings. If you have diabetes, talk to your doctor about the best way to check your blood sugar while you are using abatacept.

Autoimmune disorders are often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

Store this medication in the refrigerator. Do not freeze. Keep the medicine in original carton to protect it from light. Do not use abatacept if the expiration date on the medicine label has passed. Abatacept that has been mixed with a diluent may be stored in a refrigerator or at room temperature and used within 24 hours. Do not shake the mixed medicine. Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors or appears cloudy. Call your doctor for a new prescription.

What happens if I miss a dose?

Call your doctor for instructions if you miss your abatacept dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of abatacept is not expected to produce life-threatening symptoms.

What should I avoid while using abatacept?

Do not receive a "live" vaccine while you are being treated with abatacept, and for at least 3 months after your treatment ends. The live vaccine may not work as well during this time, and may not fully protect you from disease. Also avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Abatacept side effects

Some people receiving an abatacept injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Serious infections may occur during treatment with abatacept. Stop using abatacept and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;

• feeling short of breath;

• dry cough, sore throat; or

• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• trouble breathing;

• easy bruising or bleeding, pale skin, unusual weakness;

• pain or burning when you urinate; or

• signs of skin infection such as itching, swelling, warmth, redness, or oozing.

Less serious side effects may include:

• headache, dizziness;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• nausea, diarrhea, stomach pain, indigestion; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Abatacept Dosing Information

Usual Adult Dose for Rheumatoid Arthritis:

If less than 60 kg, give 500 mgIf 60 to 100 kg, give 750 mgIf greater than 100 kg, give 1000 mgAdminister once as a 30-minute intravenous infusion. The dose is repeated 2 and 4 weeks after the initial dose, then every 4 weeks thereafter. It may be administered alone or with disease-modifying antirheumatic drugs other than TNF antagonists.

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

Reduction of signs and symptoms in patients with moderately to severely active polyarticular juvenile idiopathic arthritis: 6 to 17 years: If less than 75 kg, give 10 mg/kg 75 kg to 100 kg, give 750 mg If greater than 100 kg, give 1000 mgThe maximum dose per intravenous administration should not exceed 1000 mg.Administer once as a 30-minute intravenous infusion. The dose is repeated 2 and 4 weeks after the initial dose, then every 4 weeks thereafter. It may be administered alone or concomitantly with methotrexate.

What other drugs will affect abatacept?

There may be other drugs that can interact with abatacept. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about abatacept.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 12/08/2009 6:59:29 PM.