Generic name: abatacept (a BAY ta sept)
Brand name: Orencia
Drug class: Antirheumatics, Selective immunosuppressants
Orencia (abatacept) 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 a prescription medicine used to treat symptoms of rheumatoid arthritis, and to prevent joint damage caused by these conditions. This medicine is for adults and children at least 2 years old.
Orencia is also used to treat active psoriatic arthritis in adults.
Orencia is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.
Warnings
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.
Before taking this medicine
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.
How should I use Orencia?
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.
Dosing information
Usual Adult Dose of Orencia for Rheumatoid Arthritis:
IV:
-Less than 60 kg, give 500 mg
-If 60 to 100 kg, give 750 mg
-If greater than 100 kg, give 1000 mg
Administer once as a 30-minute IV 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.
SUBCUTANEOUS:
-After a single IV infusion as a loading dose (as per body weight categories above), 125 mg administered by subcutaneous injection should be given within a day, followed by 125 mg subcutaneously once a week.
-Patients who are unable to receive an infusion may initiate weekly injections subcutaneously without an IV loading dose.
-Patients transitioning from IV therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled IV dose.
Comments:
-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
Use: For reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. This drug may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
Usual Pediatric Dose of Orencia for Juvenile Idiopathic Arthritis:
IV:
6 to 17 years:
If less than 75 kg, give 10 mg/kg IV
75 kg to 100 kg, give 750 mg IV
If greater than 100 kg, give 1000 mg IV
-The maximum dose per intravenous administration should not exceed 1000 mg.
-Administer once as a 30-minute IV 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.
SUBCUTANEOUS:
2 years and older:
The subcutaneous injection should be given without an IV loading dose:
10 kg to less than 25 kg: 50 mg subcutaneously once a week
25 kg to less than 50 kg: 87.5 mg subcutaneously once a week
50 kg or more: 125 mg subcutaneously once a week
Comments:
-This drug should not be administered concomitantly with TNF antagonists or used concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.
-The safety and efficacy of the auto-injector for subcutaneous injection has not been studied in patients under 18 years of age.
Use: For reducing signs and symptoms in pediatric patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. This drug may be used as monotherapy or concomitantly with methotrexate (MTX).
What happens if I miss a dose?
Call your doctor for instructions if you miss your Orencia dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Orencia?
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.
Orencia side effects
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.
What other drugs will affect Orencia?
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.