Orencia

The recommended dose of Orencia (Abatacept) varies according to body weight.

Orencia (Abatacept) can be given as an intravenous (into a vein) injection or a subcutaneous (under the skin) injection in adults and as an intravenous injection in children.

When Orencia (Abatacept) is given as an intravenous injection, most adults will receive between 2 and 4 vials per infusion. Children may receive fewer vials of Orencia (Abatacept) per infusion, depending on their weight. The appropriate dose is usually given once every 2 weeks for the first 3 doses, and once every 4 weeks after that. Intravenous injections take approximately 30 minutes and are given by a health care professional, usually in a clinical setting such as a hospital clinic.

If you are using subcutaneous Orencia (Abatacept), the first dose is given as an intravenous infusion by a health care professional, usually in a health care setting. Within 24 hours of the intravenous dose, you should receive the first subcutaneous dose of 125 mg Orencia (Abatacept). After this first subcutaneous dose, the usual dose is 125 mg injected once a week.

Subcutaneous Orencia (Abatacept) is available as single-use prefilled syringes. It is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject Orencia (Abatacept) on your own until you completely understand how to inject a dose.

There are special directions enclosed in the package with the injection. Read these directions carefully before using the medication. Follow the instructions closely to avoid accidentally contaminating the medication or needle and giving yourself an infection, or from damaging the equipment or losing the medication.

Rotate the injection sites (arms, thighs, upper buttocks, or stomach) to minimize injection site skin irritation.

Many things can affect the dose and schedule of medication that a person needs, such as body weight, other medical conditions, and other medications. Your doctor may choose a schedule different from the one above.

It is important to receive Orencia (Abatacept) exactly as recommended by your doctor. If you miss an appointment to receive Orencia (Abatacept), contact your doctor as soon as possible to reschedule your appointment.

Orencia (Abatacept) is stored in the refrigerator at 2°C to 8°C, protected from light, and kept from freezing.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause spots or redness of the skin; it could make you more prone to respiratory infections; it may increase your blood pressure; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

125 mg/mL prefilled syringes
Each 1 mL of sterile, clear, colourless-to-pale-yellow, preservative-free, ready-to-use solution for subcutaneous injection in a single-use prefilled syringe contains 125 mg of Orencia (Abatacept). Nonmedicinal ingredients: sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

250 mg/vial
Each vial of sterile powder contains 250 mg of Orencia (Abatacept). Nonmedicinal ingredients: maltose, sodium chloride, and sodium phosphate monobasic.

Do not use Orencia (Abatacept) if you:

• are allergic to Orencia (Abatacept) or any ingredients of the medication
• have or are at risk of sepsis syndrome (an infection that spreads through your body), such as people with weakened immune systems and people with HIV

There may be an interaction between Orencia (Abatacept) and any of the following:

• adalimumab
• anakinra
• BCG
• Belimumab
• certolizumab
• Denosumab
• echinacea
• etanercept
• Fingolimod
• Golimumab
• infliximab
• Leflunomide
• Lenalidomide
• Natalizumab
• Nivolumab
• Pimecrolimus
• rituximab
• Roflumilast
• Tocilizumab
• Tofacitinib
• Trastuzumab l
• vaccines (e.g., Measles, Mumps, and rubella [MMR], tuberculosis [BCG], yellow fever)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Orencia (Abatacept). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Orencia (Abatacept).

Allergic reactions: In rare cases, some people may develop an allergic reaction to Orencia (Abatacept). Signs of an allergic reaction include a severe rash, swollen face, chest pain, or difficulty breathing. If these occur, contact your doctor immediately.

Blood glucose: The intravenous form of Orencia (Abatacept) may affect blood glucose testing by giving falsely high blood glucose readings with certain types of blood glucose monitors. If you require blood glucose monitoring, talk to your doctor or pharmacist about using a blood glucose monitor that will not be affected by Orencia (Abatacept). The subcutaneous form of Orencia (Abatacept) does not have the same effect.

Cancer: In clinical trials, people using Orencia (Abatacept) reported developing Lung Cancer or a cancer of the immune system (known as lymphoma) more often than people who were given an inert treatment. Other types of cancer have also been reported. The number of reported cancer cases in people taking Orencia (Abatacept) appears to be consistent with the expected number of cancer cases reported in people with rheumatoid arthritis. In general, people with severe rheumatoid arthritis who have had the condition for a long time may also have a higher risk of developing lymphoma. If you take Orencia (Abatacept) or another rheumatoid arthritis biologic medication, your risk may increase. The role of Orencia (Abatacept) in the development of cancer is not known.

COPD (Chronic Obstructive Pulmonary Disease) (COPD): People with COPD have a higher risk of experiencing side effects when they are using Orencia (Abatacept). If you have COPD, your doctor will monitor you for signs of worsening disease.

Infections: Orencia (Abatacept) can increase the risk of developing an infection. If you notice signs of an infection, such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible. Also, Orencia (Abatacept) should not be started while you have an active or chronic infection. Orencia (Abatacept) is not recommended for use by people who have active Tuberculosis or if you come in contact with someone who has tuberculosis. Your doctor may examine you for tuberculosis and give you a skin test before you start Orencia (Abatacept).

People infected with hepatitis B virus (an infection that can damage the liver) have had a relapse of their condition while taking medications for rheumatoid arthritis. To determine if you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with Orencia (Abatacept) and will follow your condition closely while you are taking the medication. If you notice symptoms of liver problems, such as abdominal pain, yellow eyes or skin, loss of appetite, fatigue, or dark urine, contact your doctor immediately.

Use with other biologics: Orencia (Abatacept) should not be used at the same time with a class of medications called biologic response modifiers ("biologics") and other such medications (e.g., Anakinra, Etanercept, Infliximab, Adalimumab, Rituximab). Doing so could increase the risk of infections.

Vaccines: Live vaccines should not be given during treatment with Orencia (Abatacept) or within 3 months of stopping Orencia (Abatacept). Children who have JIA or JRA should complete the recommended vaccination schedule before starting treatment with Orencia (Abatacept).

Pregnancy: There have been no studies on the use of Orencia (Abatacept) by pregnant women. Orencia (Abatacept) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Orencia (Abatacept), contact your doctor immediately.

Breast-feeding: It is not known if Orencia (Abatacept) passes into breast milk. If you are a breast-feeding mother and are taking Orencia (Abatacept), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of the intravenous form of Orencia (Abatacept) have not been established for children less than 6 years of age. The subcutaneous form of Orencia (Abatacept) has not been studied for use by children and adolescents. It is not recommended for this age group.

Seniors: Seniors may be more likely to experience serious infections and cancer with Orencia (Abatacept). Talk to your doctor about the risks and benefits of using Orencia (Abatacept).

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this.