ORENCIA is prescribed for moderate to severe rheumatoid arthritis (RA). RA is a disease that causes pain and joint inflammation (tenderness and swelling). RA can also cause joint damage. Your physician has decided to treat you with ORENCIA because your disease is still active even though you have tried other treatments.

ORENCIA is a medicine used to treat rheumatoid arthritis; it is administered either intravenously (IV) through a needle placed in your arm or subcutaneously (SC) under the skin of your abdomen, arms or legs. ORENCIA keeps the immune system from attacking healthy tissues in the body. The immune system is the body’s defence against attack by, for example, bacteria and viruses. A normal immune system leaves healthy body tissues alone. In people with RA, the immune system attacks normal body tissues. This can cause damage and inflammation, especially in the tissues of your joints. ORENCIA modifies an important step in this attack.

By decreasing the immune system’s attack on normal tissues, ORENCIA can reduce pain, joint inflammation, and damage to your bones and cartilage. ORENCIA may also help you with your daily activities (such as getting dressed, walking and climbing stairs). However, ORENCIA also can lower your body’s ability to fight infection. ORENCIA treatment can make you more prone to getting infections or make any infection you have worse. It is important to tell your doctor if you think you have any infections, like a cold, flu, infected cuts, etc.

• ORENCIA is used to treat adults with moderate to severe rheumatoid arthritis. RA is a disease that causes pain and joint inflammation (tenderness and swelling). RA can also cause joint damage. Your doctor has decided to treat you with ORENCIA because your disease is still active even though you have tried other treatments.
• ORENCIA IV is used to treat children and adolescents with moderately to severely active juvenile idiopathic arthritis (JIA) /juvenile rheumatoid arthritis (JRA) with polyarticular course after one or more JIA/JRA medicines have been used and have not worked.
• ORENCIA has not been studied in children under 6 years of age.

You should not take ORENCIA if you have:

• Ever had an allergic reaction to ORENCIA
• An infection that has spread through your body (sepsis)

ORENCIA is available in two dosage forms: vials for IV use and prefilled syringes for SC injection.

The IV formulation is supplied in 15 mL vials containing 250 mg of the active ingredient called “abatacept.” Each pack contains 1 vial.

The subcutaneous injection is supplied in single-dose disposable prefilled glass syringes that contain 125 mg of abatacept per 1.0 mL of solution. It is available in cartons of 1 and 4.

Abatacept. Each vial for IV infusion contains 250 mg abatacept and each prefilled syringe for SC injection contains 125 mg of abatacept per 1.0 mL of solution.

ORENCIA IV: maltose, sodium chloride and sodium phosphate. Please refer to question number 14 regarding the maltose warning for patients with diabetes.

ORENCIA SC: sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, water for injection.

ORENCIA is administered two different ways:

• IV infusion: ORENCIA will be given to you by a health care professional using an IV, which means that the medicine will be given to you through a needle placed in a vein in your arm. It will take about 30 minutes to give you the full dose of medicine.
• SC injection: ORENCIA is injected subcutaneously (under the skin).

IV infusion: You will receive your first dose of ORENCIA IV followed by additional doses at 2 and 4 weeks after the first dose. You will then receive a dose every 4 weeks

SC injection: ORENCIA SC is injected once a week. Treatment with ORENCIA may start with one IV dose given the same day as your first ORENCIA SC injection, and then continue with once-weekly SC injections.

Your first ORENCIA SC dose should be administered by your health care provider. If your health care provider decides that you or a caregiver may be able to give your injections of ORENCIA at home, you should receive training on the right way to prepare and inject ORENCIA. Do not try to inject ORENCIA yourself until you have been shown the right way to give the injections by your health care provider or a nurse.

For a step-by-step guide on how to administer ORENICA SC, click here.

If you miss your regularly scheduled dose of ORENCIA, call your rheumatologist to discuss when your next dose should be administered.

ORENCIA IV: Your ORENCIA IV vials should be stored under refrigeration (2°C-8°C) and protected from light. Your health care professional will prepare the solution for your IV administration.

ORENCIA SC: Your ORENCIA SC prefilled syringes should be stored under refrigeration (2°C-8°C) and protected from light. Do not allow the prefilled syringe to freeze and do not use beyond the expiration date on the syringe. If frozen, do not use.

No special studies were done to look at whether ORENCIA interferes with blood levels of common RA medications; nor were they done to look at whether common RA medications interfere with blood levels of ORENCIA. Information from clinical studies so far have not suggested a problem like this.

You can take other medicines with ORENCIA if your doctor has prescribed them or has told you it is okay to take them while you are receiving ORENCIA. It is important to tell your doctor if you are taking any other medicines including hormones, over the counter medicines, vitamins, supplements, or herbal products before you are treated with ORENCIA. If you start taking or plan to start taking any new medicine while you are receiving ORENCIA, tell your doctor.

ORENCIA should not be taken with other biologic medications for RA such as Enbrel®, Humira®, Remicade®, Kineret®, Cimzia®, Simponi®, Rituxan® or Actemra®.

Before you receive treatment with ORENCIA, you should tell your doctor or nurse if you:

• Have any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from ORENCIA. If you are not sure, please ask your physician or nurse.
• Have an infection that won’t go away or a history of infections that keep coming back.
• Have had tuberculosis (TB), or if you recently have been in close contact with someone who has had TB. If you develop any of the symptoms of TB (a dry cough that doesn’t go away, weight loss, fever, night sweats) call your doctor right away. Before you start ORENCIA, your physician may examine you for TB or perform a skin test.
• Have or have had viral hepatitis. Before you use ORENCIA your doctor may examine you for hepatitis.
• Have diabetes and are using a blood glucose monitor to check your blood glucose levels. ORENCIA for intravenous infusion (given through a needle placed in a vein) contains maltose, which is a type of sugar that can give falsely high blood glucose readings with certain types of blood glucose monitors on the day of ORENCIA infusion. Your physician may recommend a different method for monitoring your blood glucose levels. ORENCIA for subcutaneous administration (injected under the skin) does not contain maltose; therefore, you do not need to change your glucose monitoring.
• Are scheduled to have surgery.
• Recently received a vaccination or are scheduled for any vaccination. Some vaccines should not be given while you are receiving ORENCIA. If your child is to receive ORENCIA, discuss your child’s vaccination history and plans with your physician. All vaccines should be brought up-to-date before starting ORENCIA and patients taking ORENCIA should not receive live vaccines.
• Have a history of chronic obstructive pulmonary (lung) disease (COPD).
• Are pregnant or are planning to become pregnant. If you took ORENCIA during pregnancy, talk to your doctor before your baby receives any vaccines.
• Are breastfeeding.

Like all medicines that affect your immune system, ORENCIA can cause side effects, some of which may be serious.

The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat and nausea. Infusion related reactions were infrequent during the clinical studies with ORENCIA.

Uncommon serious infections (occurred in 1 in every 100 to 1000 patients (less than 1% of patients):

• Pneumonia (lung infection)
• Cellulitis (skin infection)
• Urinary tract infection
• Bronchitis (lung infection)
• Diverticulitis (infection of large intestine)
• Pyelonephritis (kidney infection)

This is not a complete list of side effects. If you have any unexpected effects while taking ORENCIA, contact your doctor or pharmacist.

Information to know about serious side effects with ORENCIA

Serious infections: There have been some cases where patients receiving ORENCIA, or other RA biologic treatment, have developed serious infections, including tuberculosis (TB) and infections caused by viruses, bacteria, or fungi.

Malignancies: During the clinical trials, certain kinds of cancer have been reported in patients treated with ORENCIA, these case reports are regarded as uncommon. Lung cancer and cancer of the lymph glands were reported more often in patients treated with ORENCIA than in patients treated with placebo. The current number of reported cancer cases in the ORENCIA studies appears to be consistent with the expected number of cancer cases reported in the RA population. People with more serious RA that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma. If you take ORENCIA or other RA biologic treatment, your risk may increase. The role of ORENCIA in the development of cancer is not known.

Allergic reactions: If you develop a severe rash, chest pain, swollen face or difficulty breathing during or after receiving ORENCIA, call your doctor immediately. The prefilled syringe components do not contain any latex or dry natural rubber.

ORENCIA has not been studied in pregnant women or nursing mothers, so we don’t know what the effects are on pregnant women or nursing babies. You should tell your doctor if you are pregnant, or are planning to become pregnant. If you took ORENCIA during pregnancy, talk to your doctor before your baby receives any vaccines.

Open communication with your rheumatologist and rheumatology nurse is a very important part of your treatment. The more they know about how you feel, the more they can help. Always ask questions!

Ask your specialist, nurse and family physician if you have any other questions about rheumatoid arthritis and your medication.