orencia

Orencia (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.

Orencia 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.

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

Important information

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.

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

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.

You should not use Orencia if you are allergic to abatacept, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), natalizumab (Tysabri), rituximab (Rituxan), or tocilizumab (Actemra).

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:

• 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;

• if you have ever had 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.

It is not known whether Orencia will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Orencia on the baby.

It is not known whether abatacept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.

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

How should I use Orencia?

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, or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

Orencia must be given slowly when infected 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.

You may need to mix Orencia 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.

Do not shake the Orencia bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

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

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container 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 have ever had hepatitis B, Orencia can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

This medicine 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 check your blood sugar while you are using Orencia.

Autoimmune disorders are often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor"s advice.

Store Orencia in the refrigerator. Do not freeze. Keep the medicine in original carton to protect it from light. Do not use Orencia if the expiration date on the medicine label has passed.

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

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

Orencia dosing information

Usual Adult Dose of Orencia for Rheumatoid Arthritis:

IV administration:
If 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 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.

Subcutaneous administration:
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 intravenous loading dose.
Patients transitioning from IV therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Usual Pediatric Dose of Orencia 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 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 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 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), polio, 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

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.

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.

Serious and sometimes fatal infections may occur during treatment with Orencia. Stop using this medicine and 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.

See also: Side effects (in more detail)

What other drugs will affect Orencia?

Other drugs may interact with abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.