• Orencia is a brand (trade) name for abatacept which may be used to treat inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and acute graft versus host disease.
• Orencia (abatacept) works by binding to two proteins, called CD80 and CD86 that are found on the surface of certain immune cells. These proteins activate T cells (also called T lymphocytes) which are a specific type of immune cell that help the immune system to fight infection. In conditions such as arthritis, T cells mistakenly attack normal cells and tissues, causing inflammation, swelling, and joint damage. By blocking these proteins, Orencia (abatacept) decreases T cell proliferation and inhibits the production of other immune system components, including cytokines, TNF alpha (TNFα), interferon-γ, and interleukin-2. This decreases inflammation and other symptoms.
• Orencia belongs to the class of medicines known as selective T-cell costimulation modulators. It may also be called an immunomodulator, a selective immunosuppressant, or an antirheumatic.

• May be used to treat moderately to severely active rheumatoid arthritis in adults and moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in children aged 2 years and older.
• May also be used to treat active psoriatic arthritis in adults.
• Also approved for the prevention of acute graft versus host disease, in combination with a calcineurin inhibitor and methotrexate, in adults and children 2 years of age and older undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor.
• Off-label uses include lupus and ankylosing spondylitis.
• May be used as monotherapy or together with other disease-modifying antirheumatic drugs (DMARDs) (does not include bDMARDs or Janus Kinase inhibitors (JKIs) when used for rheumatoid arthritis or psoriatic arthritis.
• May be administered as an intravenous infusion at 0, 2, and 4 weeks, then every 4 weeks, or via subcutaneous (under the skin) injection once weekly for adults with RA. For children with pJIA, use the IV infusion (aged 6 years and older) or the SC injection (aged 2 years and older) either as monotherapy or together with methotrexate.
• Available as prefilled syringes or as an autoinjector for self-administration.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Headaches, nasopharyngitis, dizziness, cough, back pain, high blood pressure, dyspepsia, urinary tract infections, rash, and extremity pain are the most common side effects reported.
• Infections, such as upper respiratory infections (eg, nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, and pharyngitis), and urinary tract infections have been reported in 54% of IV Orencia-treated patients and 48% of placebo-treated patients in trials of patients with RA. Serious infections including sepsis and pneumonia were reported in 3% and 1.9% of people treated with Orencia and placebo respectively. Exercise caution when giving the first dose of Orencia to patients prone to infection.
• Hypersensitivity reactions have also been reported, but are uncommon. Fatal anaphylaxis has occurred as well as life-threatening cases of angioedema.
• Should not be used with other potent immunosuppressants, such as biologic disease-modifying antirheumatic drugs (bDMARDs) or Janus Kinase inhibitors (JKIs).
• The dosage of Orencia is based on weight.
• Before starting treatment with Orencia, ensure all patients have received all their appropriate immunizations for their age as recommended by National guidelines. It is important people administered Orencia DO NOT receive live vaccines during treatment or for three months after the last dose.
• Be cautious when using Orencia for people with COPD as this population has experienced a greater rate of adverse effects, including COPD exacerbations, cough, or dyspnea.
• There have been reports of malignancies, including skin cancer in patients receiving Orencia. Advise regular skin checks, especially for those with risk factors for skin cancer.
• There is also the potential for immunogenicity and antibody formation. 2% of patients were reported to have developed antibodies to the entire abatacept molecule or to the CTLA-4 portion of abatacept. However, there has been no correlation between antibody development to clinical response or adverse effects.
• Orencia, like other biologics, should be monitored for effectiveness and side effects. A lack of response, loss of response, or severe side effects may warrant switching to a different biologic or the addition of other treatments. There have been reports of new or worsening psoriasis occurring.
• Vasculitis (inflammation of the blood vessels) has been reported in postmarketing studies.
• Intravenous infusions of Orencia contain maltose which may interfere with some blood glucose tests.
• There is not enough data to know the effect Orencia has during pregnancy on the unborn child, but in animal studies, Orencia altered immune function in female rats at 11 times the maximum recommended human dose. Advise women to use adequate contraception while taking Orencia; however, if they inadvertently become pregnant they should enroll themselves on the pregnancy register by calling 1-877-311-8972. There are no data on the effect of Orencia during lactation.
• No generic form of Orencia is available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• If you have been shown how to self-inject Orencia for PA or PA by your health professional, administer a dose once every week, preferably on the same day (such as every Monday), otherwise see your healthcare provider for an infusion once every four weeks. If you forget a dose, schedule it as soon as you can, then continue with your regular dosing schedule.
• Immediately before administration, remove one Orencia injection out of the refrigerator and leave it on a flat surface, away from children and pets, to warm up to room temperature for at least 30 minutes for the prefilled syringe or autoinjector. Do not warm it in any other way (such as by putting it in hot water). Orencia administered at room temperature reduces the risk of stinging. Inspect the injection for any discoloration or particulate matter and do not use it if the liquid is cloudy, contains particles, or is discolored. The liquid in Orencia should be clear, colorless, or have a slightly yellow tinge. Check the expiry date on the side of the injection and do not use Orencia if it has expired. Do not remove the needle cover until you are ready to inject and do not use the injection if it is cracked or broken or if the level of liquid is below the fill line. It is normal to see an air bubble in the syringe, do not attempt to remove it.
• Orencia is best administered into the front of your thighs or the lower part of your abdomen, avoiding the area around your belly button (stay an inch away from your belly button). If somebody else is giving you your injection they can also administer it into the outer area of your upper arm. Change your injection site each month so that you are not injecting into the same spot each time.
• Only inject into clear, healthy skin. Do not inject into any areas that are bruised, tender, red, scaly, or hard. You should also not inject into any scars, stretch marks, or areas of psoriasis.
• If you feel pain when you inject Orencia, placing an ice pack on the area of the skin where you inject Orencia for a few minutes before and after the injection can help reduce this pain.
• Wash your hands then clean the injection site with an alcohol wipe and let the area dry. Take the needle cover off the syringe and hold the syringe between your thumb and first finger. Pinch up a fold of skin at the cleaned injection site and insert the needle into the fold of skin at a 45-degree angle. Slowly push the plunger down as far as it will go until the syringe is empty. Pull the needle out and the needle guard should cover the needle automatically. Throw the syringe away in an approved sharps container.
• For the autoinjector, when you are ready to inject, twist off the orange needle cover, pinch up the skin, and hold the autoinjector at a 90-degree angle to the cleaned injection site (straight up and down). Make sure you can see the window. Press down and hold the pen firmly against your skin, you should hear a click when the injection starts. The window should turn solid blue and will take up to 15 seconds to complete. Lift the autoinjector from your skin and dispose of it in an approved sharps container. Do not rub the injection site.
• Store Orencia in the refrigerator at 36°F to 46°F (2°C to 8°C). Orencia is considered stable for up to six hours if left out of the refrigerator provided that it has been protected from light and at a temperature not exceeding 25°C. Do not put Orencia back in the refrigerator if it has been out of the refrigerator for more than a few minutes. Do not freeze Orencia. Protect Orencia from light.
• Seek urgent medical attention if you experience shortness of breath, or facial or throat tightness after administering Orencia. If you feel unwell, or experience other signs of infection, tell your doctor immediately. Also remember to tell your doctor about any other side effects that you may be experiencing, such as headaches, dizziness, or infections.
• Orencia can increase your risk of developing an infection, or worsening the infections you currently have. Tell your doctor about any infection you currently have if you are starting Orencia. See your doctor immediately if you develop any signs of an infection, such as fever, shortness of breath, fatigue, burning when urinating, red or discharging sores on your body, cough, diarrhea, or stomach pain.
• Tell other health professionals that you are being administered Orencia. Before you start Orencia, all your vaccinations should be up to date. While you are receiving Orencia, you should not receive any live vaccines (such as the MMR vaccine or the chickenpox vaccine).
• Orencia is not recommended during pregnancy unless the benefits outweigh the risks but tell your doctor immediately if you become pregnant while being administered Orencia.
• Talk to your doctor or pharmacist before taking any other medicines with Orencia.

• Most people will start to feel relief from their symptoms within 2 to 24 weeks.
• Response rates vary depending on the condition being treated, but for Rheumatoid Arthritis, response rates reported after 3 months include: a 20% improvement from the baseline scores reported by 46% to 68% of people; a 50% improvement from the baseline score was reported by 16% to 40% of people; a 70% improvement from their baseline scores was reported by 6% to 19% of people. Health-related quality of life studies showed significantly greater improvement in the Orencia group compared with the placebo group in categories such as dressing and grooming, eating, and walking.
• For PJIA, ACR 30/50/70 responses were 65%, 50%, and 28% respectively in the open-label lead-in part of the study (period not defined) and during the double-blind randomized part of the study, Orencia-treated patients experienced significantly fewer disease flares compared to placebo-treated patients. Patients who continued on Orencia were 33% less likely to experience disease flares than those withdrawn from the medication. ACR responses remained consistent for at least one year.
• For psoriatic arthritis, after 24 weeks a 20% improvement from the baseline scores was reported by 39.4% to 47.5% of people; a 50% improvement from the baseline score was reported by 19.2% to 25% of people; a 70% improvement from their baseline scores was reported by 10.3% to 12.5% of people.

Medicines that interact with Orencia may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Orencia. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Orencia include:

• etanercept
• herbals, such as brewer's yeast
• immunosuppressants (such as azathioprine, cyclosporine, or tacrolimus)
• live vaccines and some other vaccines, such as BCG, cholera, measles, or hepatitis b vaccines
• medications used to treat multiple sclerosis, such as fingolimod
• other biologics, such as adalimumab, golimumab, or infliximab
• other vaccines, such as influenza inactivated or hepatitis A (may suppress the immune response)
• probiotics, such as bifidobacterium or lactobacillus
• zinc.

Note that this list is not all-inclusive and includes only common medications that may interact with Orencia. You should refer to the prescribing information for Orencia for a complete list of interactions.