Orencia is a 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.

Orencia is used to treat adults with moderate to severe rheumatoid arthritis (RA), including those who have not been helped enough by other medicines for RA. It is thought to work by prevent further damage to your bones and joints and may help your ability to perform daily activities. It be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

Orencia is used to treat people 2 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (pJIA). It may be used alone or with methotrexate.

Orencia is used to treat adults with active psoriatic arthritis (PsA). It can be used alone or with other PsA treatments.

Orencia is also used for the preventative treatment of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate. It is used in people 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

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

It is not known if Orencia is safe and effective in children less than two years of age for the treatment of pJIA and the preventative treatment of aGVHD.

Before using Orencia, tell your doctor if you have ever had tuberculosis (TB), 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 Orencia. Serious infections may occur during treatment with Orencia. Contact your doctor right away if you have signs of infection such as: fever, chills, dry cough, sore throat, night sweats, tired feeling, weight loss, or painful warmth or redness of your skin.

Orencia is injected under the skin, or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

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

Orencia is injected under the skin when given to a child between 2 and 6 years old.

Orencia must be given slowly when injected into a vein, and the IV infusion can take at least 30 minutes to complete.

This medicine is usually given every 1 to 4 weeks. Follow your doctor's instructions.

Orencia must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Gently swirl but do not shake the medication bottle. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Each vial (bottle) or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

If you need surgery, tell the surgeon ahead of time that you are using Orencia.

If you've ever had hepatitis B, using Orencia can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

Orencia can cause 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 test your blood sugar.

Autoimmune disorders are often treated with a combination of different drugs. Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

Store Orencia in original carton in a refrigerator. Protect from light and do not freeze. Do not use after the expiration date on the medicine label has passed.

If you need to travel with your medicine, place the syringes in a cooler with ice packs.

Orencia mixed with a diluent may be stored in a refrigerator or at room temperature and must be used within 24 hours.

Usual Adult Dose for Rheumatoid Arthritis:

IV Dosing Regimen:
-Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
-Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
-Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter

Subcutaneous Dosing Regimen:
-Optional IV loading dose:
---Weight less than 60 kg: 500 mg IV once
---Weight 60 to 100 kg: 750 mg IV once
---Weight more than 100 kg: 1000 mg IV once
-Subcutaneous injection: 125 mg subcutaneously once a week

Comments:
-This drug may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDS), such as tumor necrosis factor (TNF) antagonists.
-The IV infusion should be administered over 30 minutes.
-Before the first subcutaneous dose, an optional loading dose may be administered as a single IV infusion; if an IV loading dose is used, the first subcutaneous injection should be administered within 1 day of the infusion.
-For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose.

Use: For the treatment of patients with moderately to severely active rheumatoid arthritis

Usual Adult Dose for Psoriatic Arthritis:

IV Dosing Regimen:
-Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
-Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
-Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter

Subcutaneous Dosing Regimen: 125 mg subcutaneously once a week

Comments:
-This drug may be used with or without nonbiologic DMARDs.
-The IV infusion should be administered over 30 minutes.
-For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose.

Use: For the treatment of patients with active psoriatic arthritis

Usual Adult Dose for Graft Versus Host Disease -- Prophylaxis:

10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation
Maximum dose: 1000 mg/dose

Comments:
-Before administering this drug, recommended antiviral prophylaxis for Epstein-Barr virus (EBV) reactivation should be administered and continued for 6 months after hematopoietic stem cell transplantation (HSCT); additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT.
-The IV infusion should be administered over 60 minutes.

Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of acute graft versus host disease (aGVHD) in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

IV Dosing Regimen:
6 years or older:
-Weight less than 75 kg: 10 mg/kg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
-Weight 75 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
-Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Maximum dose: 1000 mg/dose

Subcutaneous Dosing Regimen:
2 years or older:
-Weight 10 to less than 25 kg: 50 mg subcutaneously once a week
-Weight 25 to less than 50 kg: 87.5 mg subcutaneously once a week
-Weight at least 50 kg: 125 mg subcutaneously once a week

Comments:
-This drug may be used as monotherapy or concomitantly with methotrexate.
-The IV infusion should be administered over 30 minutes.
-Subcutaneous administration: Patients may self-inject or the patient's caregiver may administer this drug if both the health care provider and parent/legal guardian decides it is appropriate; the ability of pediatric patients to self-inject with the autoinjector has not been tested.

Use: For the treatment of patients with moderately to severely active polyarticular juvenile idiopathic arthritis

Usual Pediatric Dose for Graft Versus Host Disease -- Prophylaxis:

2 to less than 6 years: 15 mg/kg IV on the day before transplantation (Day -1), then 12 mg/kg IV on Days 5, 14, and 28 after transplantation
6 years or older: 10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation
Maximum dose: 1000 mg/dose

Comments:
-Before administering this drug, recommended antiviral prophylaxis for EBV reactivation should be administered and continued for 6 months after HSCT; additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT.
-The IV infusion should be administered over 60 minutes.

Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of aGVHD in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor

You should not use Orencia if you are allergic to abatacept.

Before using Orencia, 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.

To make sure Orencia is safe for you, tell your doctor if you have ever had:

• a weak immune system;

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

• infections that go away and come back;

• COPD (chronic obstructive pulmonary disease);

• diabetes;

• hepatitis; or

• if you are scheduled to receive any vaccines.

Using Orencia 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.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of abatacept on the baby.

Children using Orencia should be current on all childhood immunizations before starting treatment.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Orencia, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction to Orencia: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. 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.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, night sweats, flu symptoms, weight loss;

• feeling very tired;

• dry cough, sore throat; or

• warmth, pain, or redness of your skin.

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

• trouble breathing;

• stabbing chest pain, wheezing, cough with yellow or green mucus;

• pain or burning when you urinate; or

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

Common Orencia side effects may include:

• fever;

• nausea, diarrhea, stomach pain;

• headache; or

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

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.

Tell your doctor about all your other medicines, especially:

• adalimumab;

• anakinra;

• certolizumab;

• etanercept;

• golimumab;

• infliximab;

• rituximab; or

• tocilizumab.

This list is not complete. Other drugs may interact with abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.